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Sample records for prospective randomized single-blind

  1. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

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    Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

    2015-01-01

    To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (Pcryotherapy group than the control group for pain relief (P.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  2. What Is the Outcome of an Incision and Drainage Procedure in Endodontic Patients? A Prospective, Randomized, Single-blind Study.

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    Beus, Hannah; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike; Jatana, Courtney

    2018-02-01

    There are no prospective endodontic studies to determine the outcome of an incision and drainage (I&D) procedure for swelling in healthy, endodontic patients. The purpose of this prospective, randomized, single-blind study was to compare the postoperative course of I&D with drain placement versus a mock I&D procedure with mock drain placement after endodontic debridement in swollen emergency patients with symptomatic teeth and a pulpal diagnosis of necrosis. Eighty-one adult emergency patients presenting with clinical swelling received either penicillin or, if allergic, clindamycin and complete endodontic debridement, and then were randomly divided into 2 treatment groups: I&D with drain placement or a mock I&D procedure with mock drain placement. At the end of the appointment, all patients received a combination of ibuprofen/acetaminophen and, if needed, an opioid-containing escape medication. Patients recorded their pain and medication use for 4 days postoperatively. Success was defined as no or mild postoperative pain and no use of an opioid-containing escape medication. Success was evaluated using repeated measure mixed model logistic regression. Both groups had a decrease in postoperative pain and medication use over the 4 days. The mock I&D group had significantly higher success than the I&D group (odds ratio = 2.00; 95% confidence interval, 1.16-3.41). The success rate was 45% with the mock I&D and 33% with the I&D. After endodontic debridement, patients who received a mock I&D procedure with mock drain placement had more success than patients who received I&D with drain placement. Both groups clinically improved over 4 days. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  3. A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

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    I. L. Toscano Jr.

    Full Text Available ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week. Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5 score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019 and 50.4° and 42.08° before and after verapamil, respectively (p=0.012. The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23 in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58. In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine.

  4. Air charged and microtip catheters cannot be used interchangeably for urethral pressure measurement: a prospective, single-blind, randomized trial.

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    Zehnder, Pascal; Roth, Beat; Burkhard, Fiona C; Kessler, Thomas M

    2008-09-01

    We determined and compared urethral pressure measurements using air charged and microtip catheters in a prospective, single-blind, randomized trial. A consecutive series of 64 women referred for urodynamic investigation underwent sequential urethral pressure measurements using an air charged and a microtip catheter in randomized order. Patients were blinded to the type and sequence of catheter used. Agreement between the 2 catheter systems was assessed using the Bland and Altman 95% limits of agreement method. Intraclass correlation coefficients of air charged and microtip catheters for maximum urethral closure pressure at rest were 0.97 and 0.93, and for functional profile length they were 0.9 and 0.78, respectively. Pearson's correlation coefficients and Lin's concordance coefficients of air charged and microtip catheters were r = 0.82 and rho = 0.79 for maximum urethral closure pressure at rest, and r = 0.73 and rho = 0.7 for functional profile length, respectively. When applying the Bland and Altman method, air charged catheters gave higher readings than microtip catheters for maximum urethral closure pressure at rest (mean difference 7.5 cm H(2)O) and functional profile length (mean difference 1.8 mm). There were wide 95% limits of agreement for differences in maximum urethral closure pressure at rest (-24.1 to 39 cm H(2)O) and functional profile length (-7.7 to 11.3 mm). For urethral pressure measurement the air charged catheter is at least as reliable as the microtip catheter and it generally gives higher readings. However, air charged and microtip catheters cannot be used interchangeably for clinical purposes because of insufficient agreement. Hence, clinicians should be aware that air charged and microtip catheters may yield completely different results, and these differences should be acknowledged during clinical decision making.

  5. Gait analysis following treadmill training with body weight support versus conventional physical therapy: a prospective randomized controlled single blind study.

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    Lucareli, P R; Lima, M O; Lima, F P S; de Almeida, J G; Brech, G C; D'Andréa Greve, J M

    2011-09-01

    Single-blind randomized, controlled clinical study. To evaluate, using kinematic gait analysis, the results obtained from gait training on a treadmill with body weight support versus those obtained with conventional gait training and physiotherapy. Thirty patients with sequelae from traumatic incomplete spinal cord injuries at least 12 months earlier; patients were able to walk and were classified according to motor function as ASIA (American Spinal Injury Association) impairment scale C or D. Patients were divided randomly into two groups of 15 patients by the drawing of opaque envelopes: group A (weight support) and group B (conventional). After an initial assessment, both groups underwent 30 sessions of gait training. Sessions occurred twice a week, lasted for 30 min each and continued for four months. All of the patients were evaluated by a single blinded examiner using movement analysis to measure angular and linear kinematic gait parameters. Six patients (three from group A and three from group B) were excluded because they attended fewer than 85% of the training sessions. There were no statistically significant differences in intra-group comparisons among the spatial-temporal variables in group B. In group A, the following significant differences in the studied spatial-temporal variables were observed: increases in velocity, distance, cadence, step length, swing phase and gait cycle duration, in addition to a reduction in stance phase. There were also no significant differences in intra-group comparisons among the angular variables in group B. However, group A achieved significant improvements in maximum hip extension and plantar flexion during stance. Gait training with body weight support was more effective than conventional physiotherapy for improving the spatial-temporal and kinematic gait parameters among patients with incomplete spinal cord injuries.

  6. A prospective randomized single blind trial of Fleet phosphate enema versus glycerin suppositories as preparation for flexible sigmoidoscopy.

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    Underwood, D; Makar, R R; Gidwani, A L; Najfi, S M; Neilly, P; Gilliland, R

    2010-03-01

    This study compared the efficacy and patient acceptability of two methods of bowel preparation for flexible sigmoidoscopy. Patients attending for outpatient flexible sigmoidoscopy were prospectively randomized to receive one Fleet ready-to-use enema or 2 x 4 g glycerin suppositories, 2 h preprocedure. Patient and endoscopist questionnaires were used to compare the outcomes. From November 2000 to August 2001, 203 (male = 95; female = 108) patients were randomized. Patient data available for 163 patients (enema = 93; suppository = 70) revealed: ease of use (enema = 52; suppository = 25; P suppositories.

  7. Impact of selected magnetic fields on the therapeutic effect in patients with lumbar discopathy: A prospective, randomized, single-blinded, and placebo-controlled clinical trial.

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    Taradaj, Jakub; Ozon, Marcin; Dymarek, Robert; Bolach, Bartosz; Walewicz, Karolina; Rosińczuk, Joanna

    2018-03-23

    Interdisciplinary physical therapy together with pharmacological treatment constitute conservative treatment strategies related to low back pain (LBP). There is still a lack of high quality studies aimed at an objective evaluation of physiotherapeutic procedures according to their effectiveness in LBP. The aim of this study is to carry out a prospective, randomized, single-blinded, and placebocontrolled clinical trial to evaluate the effectiveness of magnetic fields in discopathy-related LBP. A group of 177 patients was assessed for eligibility based on inclusion and exclusion criteria. In the end, 106 patients were randomly assigned into 5 comparative groups: A (n = 23; magnetic therapy: 10 mT, 50 Hz); B (n = 23; magnetic therapy: 5 mT, 50 Hz); C (n = 20; placebo magnetic therapy); D (n = 20; magnetic stimulation: 49.2 μT, 195 Hz); and E (n = 20; placebo magnetic stimulation). All patients were assessed using tests for pain intensity, degree of disability and range of motion. Also, postural stability was assessed using a stabilographic platform. In this study, positive changes in all clinical outcomes were demonstrated in group A (p 0.05). It was determined that the application of magnetic therapy (10 mT, 50 Hz, 20 min) significantly reduces pain symptoms and leads to an improvement of functional ability in patients with LBP.

  8. Effects of fixed orthodontic treatment and two new mouth rinses on gingival health: A prospective cohort followed by a single-blind placebo-controlled randomized clinical trial.

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    Sobouti, Farhad; Rakhshan, Vahid; Heydari, Mohaddeseh; Keikavusi, Shohreh; Dadgar, Sepideh; Shariati, Mahsa

    2018-03-01

    Routine brushing protocols might not suffice to reduce the increased plaque accumulation in orthodontic patients. Antimicrobial mouth rinses are favorable in this regard. This two-phase study evaluated the effects of orthodontic treatment and the application of two mouthwashes not studied before on oral health indices. In this two-phase study (a prospective cohort followed by a parallel randomized controlled trial), plaque index (PI), gingival index (GI), gingival bleeding index (GBI), and pocket probing depth (PPD) were measured in 54 orthodontic patients before orthodontic treatment and 4 months later. Then patients were randomized into three groups of mouthrinses: Persica (herbal), Ortho-Kin (containing diluted chlorhexidine), and Placebo (n=18×3). The effects of orthodontic treatment and mouthrinses were analyzed statistically (α=0.05). All the 4 indices increased between the baseline and 4th month of treatment (P values<0.01, paired t-test). They decreased back to baseline levels or below them, after one month of mouthwash application (P values<0.002). Both mouthwashes showed therapeutic effects compared to placebo in terms of PI and GBI. In the case of GI, only Persica showed significantly better results compared to placebo. Regarding PPD, only Ortho-Kin acted better than placebo (P values≤0.05, Tukey). Lack of positive control (regular chlorhexidine mouth rinse) and negative control (a group with no mouthwashes, even without the placebo). Lack of sample size predetermination based on a priori power calculations. The difference between the regime of Persica with that of Ortho-Kin and placebo (which had similar application protocols) disallowed perfectly effective blinding of the patients (hence, single-blind). Fixed orthodontic treatment might disrupt gingival health. Antimicrobial mouthwashes might reverse this. Both evaluated mouthwashes might have therapeutic effects. Copyright © 2018 CEO. Published by Elsevier Masson SAS. All rights reserved.

  9. A single dose of erythropoietin reduces perioperative transfusions in cardiac surgery: results of a prospective single-blind randomized controlled trial.

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    Weltert, Luca; Rondinelli, Beatrice; Bello, Ricardo; Falco, Mauro; Bellisario, Alessandro; Maselli, Daniele; Turani, Franco; De Paulis, Ruggero; Pierelli, Luca

    2015-07-01

    We conducted a prospective single-blind randomized study to assess whether a single 80,000 IU dose of human recombinant erythropoietin (HRE), given just 2 days before cardiac surgery, could be effective in reducing perioperative allogeneic red blood cell transfusion (aRBCt). Six-hundred patients presenting with preoperative hemoglobin (Hb) level of not more than 14.5 g/dL were randomly assigned to either HRE or control. The primary endpoint was the incidence of perioperative aRBCt. The secondary endpoints were mortality and the incidence of adverse events in the first 45 days after surgery, Hb level on Postoperative Day 4, and number of units of RBC transfusions in the first 4 days after surgery. A total of 17% (HRE) versus 39% (control) required transfusion (relative risk, 0.436; pHRE (0%) and control (3.5%) among the patients with baseline Hb of 13.0 g/dL or more, which included the nonanemic fraction of the study population. The mean (range) Hb level on Postoperative Day 4 was 10.2 (9.9-10.6) g/dL (HRE) versus 8.7 (8.5-9.2) g/dL (control; pHRE (pHRE) versus 3.33% (control). The 45-day adverse event rate was 4.33% (HRE) versus 5.67% (control; both p=NS). In anemic patients (HbHRE administered 2 days before cardiac surgery is effective in reducing the incidence of aRBCt without increasing adverse events. © 2015 AABB.

  10. Efficacy, Safety, and Preparation of Standardized Parenteral Nutrition Regimens: Three-Chamber Bags vs Compounded Monobags-A Prospective, Multicenter, Randomized, Single-Blind Clinical Trial.

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    Yu, Jianchun; Wu, Guohao; Tang, Yun; Ye, Yingjiang; Zhang, Zhongtao

    2017-08-01

    Parenteral nutrition (PN) covering the need for carbohydrates, amino acids, and lipids can either be compounded from single nutrients or purchased as an industrially manufactured ready-to-use regimen. This study compares a commercially available 3-chamber bag (study group) with a conventionally compounded monobag regarding nutrition efficacy, safety, and regimen preparation time. This prospective, randomized, single-blind study was conducted at 5 Chinese hospitals from October 2010-October 2011. Postsurgical patients requiring PN for at least 6 days were randomly assigned to receive the study or control regimen. Plasma concentrations of prealbumin and C-reactive protein (CRP), regimen preparation time, length of hospital stay (LOS), 30-day mortality, safety laboratory parameters, and adverse events (AEs) were recorded. In total, 240 patients (121 vs 119 in study and control groups) participated in this study. Changes in prealbumin concentrations during nutrition support (Δ Prealb(StudyGroup) = 2.65 mg/dL, P < .001 vs Δ Prealb(ControlGroup) = 0.27 mg/dL, P = .606) and CRP values were comparable. Regimen preparation time was significantly reduced in the study group by the use of 3-chamber bags (t (StudyGroup) = 4.90 ± 4.41 minutes vs t (ControlGroup) = 12.13 ± 5.62 minutes, P < .001). No differences were detected for LOS, 30-day mortality, safety laboratory parameters, and postoperative AEs (37 vs 38 in study and control groups). The PN regimen provided by the 3-chamber bag was comparable to the compounded regimen and safe in use. Time savings during regimen preparation indicates that use of 3-chamber bags simplifies the process of regimen preparation.

  11. Effectiveness of the custom-mold room temperature vulcanizing silicone toe separator on hallux valgus: A prospective, randomized single-blinded controlled trial.

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    Chadchavalpanichaya, Navaporn; Prakotmongkol, Voraluck; Polhan, Nattapong; Rayothee, Pitchaya; Seng-Iad, Sirirat

    2018-04-01

    Silicone toe separator is considered as a conservative treatment for hallux valgus. The prefabricated toe separator does not fit all. However, effectiveness in prescription of the custom-mold toe separator is still unknown. To investigate the effect of using a custom-mold room temperature vulcanizing silicone toe separator to decrease hallux valgus angle and hallux pain. The compliances, complications, and satisfactions of toe separator were also explored. A prospective, randomized single-blinded controlled trial. A total of 90 patients with a moderate degree of hallux valgus were enrolled in a study at the Foot Clinic, Siriraj Hospital, Thailand. Patients were randomized into two groups; the study group was prescribed a custom-mold room temperature vulcanizing silicone toe separator for 6 h per night for 12 months. Patients in both groups received proper foot care and shoes and were permitted to continue drug treatment. In total, 40 patients in the study group and 39 patients in the control group completed the study. The hallux valgus angle was obtained through radiographic measurement. At month 12, both groups had significant differences in mean hallux valgus angle with a decrease of 3.3° ± 2.4° for the study group and increase of 1.9° ± 1.9° for the control group. There were statistically significant differences of hallux valgus angle between the two groups ( p Hallux pain was decreased in the study group. A custom-mold room temperature vulcanizing silicone toe separator can decrease hallux valgus angle and pain with no serious complications. Clinical relevance The custom-mold room temperature vulcanizing silicone toe separator for treatment of hallux valgus reduces deformity and hallux pain.

  12. Tourniquet application after local forearm warming to improve venodilation for peripheral intravenous cannulation in young and middle-aged adults: A single-blind prospective randomized controlled trial.

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    Yamagami, Yuki; Tomita, Kohei; Tsujimoto, Tomomi; Inoue, Tomoko

    2017-07-01

    Local forearm warming before tourniquet application is often used to promote venodilation for peripheral intravenous cannulation; however, few studies have compared the effect of tourniquet application with and without local warming on vein size. To evaluate the effectiveness of tourniquet application after local forearm warming with that of tourniquet application alone in young and middle-aged adults. A single-blind, prospective, parallel group, randomized controlled trial. A national university in Japan. Seventy-two volunteers aged 20-64 years. Participants were randomly allocated to one of two groups: tourniquet application for 30s after forearm application of a heat pack warmed to 40°C±2°C for 15min (active warming group; n=36) or tourniquet application for 30s after applying a non-warmed heat pack for 15min (passive warming group; n=36). The primary outcomes were vein cross-sectional area on the forearm, measured after the intervention by blinded research assistants using ultrasound. Secondary outcomes were shortest diameter, and longest diameter of vein on the forearm, forearm skin temperature, body temperature, pulse, systolic blood pressure, and diastolic blood pressure. All outcomes were assessed at the same site before and immediately after the intervention, once per participant. Vein cross-sectional area, shortest vein diameter, and longest vein diameter were significantly increased in the active warming group compared with the passive warming group (p application after local warming was superior to tourniquet application alone in increasing vein cross-sectional, shortest diameter, and longest diameter (between-group differences of 2.2mm 2 , 0.5mm, and 0.5mm, respectively), and in raising skin temperature (between-group difference: 5.2°C). However, there were no significant differences in body temperature, pulse, or systolic or diastolic blood pressure between the groups. There were no adverse events associated with either intervention. Tourniquet

  13. [Simulation-based training and OR apprenticeship for medical students : A prospective, randomized, single-blind study of clinical skills].

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    Ott, T; Schmidtmann, I; Limbach, T; Gottschling, P F; Buggenhagen, H; Kurz, S; Pestel, G

    2016-11-01

    Simulation-based training (SBT) has developed into an established method of medical training. Studies focusing on the education of medical students have used simulation as an evaluation tool for defined skills. A small number of studies provide evidence that SBT improves medical students' skills in the clinical setting. Moreover, they were strictly limited to a few areas, such as the diagnosis of heart murmurs or the correct application of cricoid pressure. Other studies could not prove adequate transferability from the skills gained in SBT to the patient site. Whether SBT has an effect on medical students' skills in anesthesiology in the clinical setting is controversial. To explore this issue, we designed a prospective, randomized, single-blind trial that was integrated into the undergraduate anesthesiology curriculum of our department during the second year of the clinical phase of medical school. This study intended to explore the effect of SBT on medical students within the mandatory undergraduate anesthesiology curriculum of our department in the operating room with respect to basic skills in anesthesiology. After obtaining ethical approval, the participating students of the third clinical semester were randomized into two groups: the SIM-OR group was trained by a 225 min long SBT in basic skills in anesthesiology before attending the operating room (OR) apprenticeship. The OR-SIM group was trained after the operating room apprenticeship by SBT. During SBT the students were trained in five clinical skills detailed below. Further, two clinical scenarios were simulated using a full-scale simulator. The students had to prepare the patient and perform induction of anesthesia, including bag-mask ventilation after induction in scenario 1 and rapid sequence induction in scenario 2. Using the five-point Likert scale, five defined skills were evaluated at defined time points during the study period. 1) application of the safety checklist, 2) application of

  14. Ultrasound-guided versus fluoroscopy-guided sacroiliac joint intra-articular injections in the noninflammatory sacroiliac joint dysfunction: a prospective, randomized, single-blinded study.

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    Jee, Haemi; Lee, Ji-Hae; Park, Ki Deok; Ahn, Jaeki; Park, Yongbum

    2014-02-01

    To compare the short-term effects and safety of ultrasound (US)-guided sacroiliac joint (SIJ) injections with fluoroscopy (FL)-guided SIJ injections in patients with noninflammatory SIJ dysfunction. Prospective, randomized controlled trial. University hospital. Patients (N=120) with noninflammatory sacroiliac arthritis were enrolled. All procedures were performed using an FL or US apparatus. Subjects were randomly assigned to either the FL or US group. Immediately after the SIJ injections, fluoroscopy was applied to verify the correct placement of the injected medication and intravascular injections. Treatment effects and functional improvement were compared at 2 and 12 weeks after the procedures. The verbal numeric pain scale and Oswestry Disability Index improved at 2 and 12 weeks after the injections without statistical significances between groups. Of 55 US-guided injections, 48 (87.3%) were successful and 7 (12.7%) were missed. The FL-guided SIJ approach exhibited a greater accuracy (98.2%) than the US-guided approach. Vascularization around the SIJ was seen in 34 of 55 patients. Among the 34 patients, 7 had vascularization inside the joint, 23 had vascularization around the joint, and 4 had vascularization both inside and around the joint. Three cases of intravascular injections occurred in the FL group. The US-guided approach may facilitate the identification and avoidance of the critical vessels around or within the SIJ. Function and pain relief significantly improved in both groups without significant differences between groups. The US-guided approach was shown to be as effective as the FL-guided approach in treatment effects. However, diagnostic application in the SIJ may be limited because of the significantly lower accuracy rate (87.3%). Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  15. Improvement of nutritional support strategies after surgery for benign liver tumor through nutritional risk screening: a prospective, randomized, controlled, single-blind clinical study.

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    Lu, Xin; Li, Ying; Yang, Huayu; Sang, Xinting; Zhao, Haitao; Xu, Haifeng; Du, Shunda; Xu, Yiyao; Chi, Tianyi; Zhong, Shouxian; Yu, Kang; Mao, Yilei

    2013-02-01

    The rising of individualized therapy requires nutritional risk screening has become a major topic for each particular disease, yet most of the screenings were for malignancies, less for benign diseases. There is no report on the screening of patients with benign liver tumors postoperatively. We aim to evaluate the nutritional support strategies post operation for benign liver tumors through nutritional risk screening. In this prospective, randomized, controlled study, 95 patients who underwent hepatectomy for benign tumors were divided into two groups. Fifty patients in the control group were given routine permissive underfeeding nutritional supply (75 kJ/kg/d), and 45 patients in the experimental group were given lower energy (42 kJ/kg/d) in accordance of their surgical trauma. Routine blood tests, liver/kidney function were monitored before surgery and at the day 1, 3, 5, 9 after surgery, patients were observed for the time of flatus, complications, length of hospitalization (LOH), nutrition-related costs, and other clinical parameters. This completed study is registered with Clinicaltrials.gov, number NCT01292330. The nutrition-related expenses (494.0±181.0 vs. 1,514.4±348.4 RMB, Pgroup were significantly lower than those in the control group. Meanwhile, the lowered energy supply after the surgeries did not have adverse effects on clinical parameters, complications, and LOH. Patient with benign liver tumors can adopt an even lower postoperative nutritional supply that close to that for mild non-surgical conditions, and lower than the postoperative permissive underfeeding standard.

  16. Comparison of multi-modal early oral nutrition for the tolerance of oral nutrition with conventional care after major abdominal surgery: a prospective, randomized, single-blind trial.

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    Sun, Da-Li; Li, Wei-Ming; Li, Shu-Min; Cen, Yun-Yun; Xu, Qing-Wen; Li, Yi-Jun; Sun, Yan-Bo; Qi, Yu-Xing; Lin, Yue-Ying; Yang, Ting; Lu, Qi-Ping; Xu, Peng-Yuan

    2017-02-10

    Early oral nutrition (EON) has been shown to improve recovery of gastrointestinal function, length of stay and mortality after abdominal surgery; however, early oral nutrition often fails during the first week after surgery. Here, a multi-modal early oral nutrition program is introduced to promote recovery of gastrointestinal function and tolerance of oral nutrition. Consecutive patients scheduled for abdominal surgery were randomized to the multimodal EON group or a group receiving conventional care. The primary endpoint was the time of first defecation. The secondary endpoints were outcomes and the cost-effectiveness ratio in treating infectious complications. The rate of infectious-free patients was regarded as the index of effectiveness. One hundred seven patients were randomly assigned to groups. Baseline characteristics were similar for both groups. In intention-to-treat analysis, the success rate of oral nutrition during the first week after surgery in the multimodal EON group was 44 (83.0%) versus 31 (57.4%) in the conventional care group (P = 0.004). Time to first defecation, time to flatus, recovery time of bowel sounds, and prolonged postoperative ileus were all less in the multimodal EON group (P oral nutrition group (P oral nutrition program was an effective way to improve tolerance of oral nutrition during the first week after surgery, decrease the length of stay and improve cost-effectiveness after abdominal surgery. Registration number: ChiCTR-TRC-14004395 . Registered 15 March 2014.

  17. Comparison of New Technology Integrated and Nonintegrated Arterial Filters Used in Cardiopulmonary Bypass Surgery: A Randomized, Prospective, and Single Blind Study

    Directory of Open Access Journals (Sweden)

    Özgür Gürsu

    2013-01-01

    Full Text Available Background. Innovative cardiopulmonary bypass (CPB settings have been developed in order to integrate the concepts of “surface-coating,” “blood-filtration,” and “miniaturization.” Objectives. To compare integrated and nonintegrated arterial line filters in terms of peri- and postoperative clinical variables, inflammatory response, and transfusion needs. Material and Methods. Thirty-six patients who underwent coronary bypass surgery were randomized into integrated (Group In and nonintegrated arterial line filter (Group NIn groups. Arterial blood samples for the assessments of complete hemogram, biochemical screening, interleukin-6, interleukin-2R, and C-reactive protein were analyzed before and after surgery. Need for postoperative dialysis, inotropic therapy and transfusion, in addition to extubation time, total amount of drainage (mL, length of intensive care unit, and hospital stay, and mortality rates was also recorded for each patient. Results. Prime volume was significantly higher and mean intraoperative hematocrit value was lower in Group NIn, but need for erythrocyte transfusion was significantly higher in Group NIn. C-reactive protein values did not differ significantly except for postoperative second day's results, which were found significantly lower in Group In than in Group NIn. Conclusion. Intraoperative hematocrit levels were higher and need for postoperative erythrocyte transfusion was decreased in Group In.

  18. Effect of three different doses of arginine enhanced enteral nutrition on nutritional status and outcomes in well nourished postsurgical cancer patients: a randomized single blinded prospective trial.

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    De Luis, D A; Izaola, O; Terroba, M C; Cuellar, L; Ventosa, M; Martin, T

    2015-01-01

    Patients with head and neck cancer undergoing surgery have a high occurrence of postoperative complications. The aim of our study was to investigate whether postoperative nutrition of head and neck cancer patients, using an enhanced enteral formula with three different doses of arginine could improve nutritional variables as well as clinical outcome, depending of arginine dose. A population of 84 patients with oral and laryngeal cancer was enrolled. At surgery patients were randomly assigned to three different treatment groups, each one containing at less 28 patients. Group I (28 patients) received an enteral diet supplements with a low physiological dose of arginine (5.7 g per day), group II (28 patients) received an isocaloric, isonitrogenous enteral formula with a medium dose of arginine (12.3 g per day) and group III (28 patients) received an isocaloric, isonitrogenous enteral formula with a high dose of arginine (18.9 g per day). The length of postoperative stay had a trend to be better with high dose of arginine received (31.9 ± 17.2 days in group I vs 27.8 ± 15.2 days in group II vs 24.8 ± 18.3 days in group III: p = 0.034). No differences were detected in postoperative infections complications and diarrhea. Fistula was less frequent in groups II and III than I (10.7% group I vs 3.6% group II vs 3.6% group III: p = 0.033), The length of postoperative stay had a trend to be better with high dose of arginine received (31.9 ± 17.2 days in group I vs 27.8 ± 15.2 days in group II vs 24.8 ± 18.3 days in group III: p = 0.034). Our results suggest that these patients could benefit from a high dose of arginine enhanced enteral formula to decrease length of hospital stay and fistula wound complications.

  19. Effect of dual-chamber minimal ventricular pacing on paroxysmal atrial fibrillation incidence in myotonic dystrophy type 1 patients: A prospective, randomized, single-blind, crossover study.

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    Russo, Vincenzo; Papa, Andrea Antonio; Rago, Anna; Ciardiello, Carmine; Nigro, Gerardo

    2018-03-08

    Atrial fibrillation (AF) is a common finding in the myotonic dystrophy type 1 (DM1) population. Pacemakers (PMs) may facilitate the diagnosis and management of frequent subclinical asymptomatic AF episodes. The purpose of this study was to evaluate the effect of minimal ventricular pacing on paroxysmal AF incidence in DM1 patients during a 24-month follow-up period. We enrolled 70 DM1 patients (age 43.4 ± 13.8 years; 39 women) who underwent dual-chamber PM implantation. Patients were randomized to minimizing ventricular pacing features (ON) or not (OFF). Patients crossed over to the opposite pacing programming 12 months later. We counted the number of DM1 patients with at least 1 episode of AF, the AF total duration, and the burden recorded by PM diagnostics during the MVP ON and OFF phases. Twenty-five DM1 patients (41.7%) showed at least 1 AF episode. Seven patients (11.7%) demonstrated AF episodes during MVP ON phase and 25 patients (41.7%) during MVP OFF phase (P MVP ON or OFF phase, 3 patients had AF episodes only during MVP ON phase, 21 patients had AF episodes only during MVP OFF phase, and 4 patients had AF episodes during MVP ON and OFF phases. Activation of the MVP algorithm was associated with a 44% reduction in relative risk of developing AF. Furthermore, during the MVP ON phases, the study population showed a shorter total AF duration and a lower AF burden. MVP is an efficacy strategy for reducing the risk of AF in DM1 patients who have undergone PM implantation. Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  20. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

    Science.gov (United States)

    Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

    2012-07-01

    We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia.

  1. The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

    Science.gov (United States)

    Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

    2013-11-01

    In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

  2. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

    Directory of Open Access Journals (Sweden)

    Vasanop Vachiramon

    2016-01-01

    Full Text Available Objective. Keratosis pilaris (KP is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2 laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians’ global assessment (p=0.02. Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution.

  3. The safety and immunogenicity of two hepatitis B vaccine formulations (thiomersal-free and thiomersal-containing) in healthy vietnamese infants: a phase III, prospective, single-blinded, randomized, controlled trial.

    Science.gov (United States)

    Hieu, Nguyen Trong; Sarnecki, Michal; Tolboom, Jeroen

    2015-01-01

    To evaluate the safety and immunogenicity of the thiomersal-free (TF) and thiomersal-containing (TC) formulations of Hepavax-Gene in healthy Vietnamese neonates. A single-blind, randomized, controlled study in Ho Chi Minh City, Vietnam. Healthy infants, born after a normal gestational period (37-42 weeks) to hepatitis B surface antigen-negative mothers, participated in the study. Subjects were randomly allocated in a 1:1 ratio to receive either Hepavax-Gene TC or Hepavax-Gene TF using a standard 0-1-6-month administration schedule. Postvaccination blood samples were taken at months 1, 6 and 7. Parents/legal guardians recorded solicited local and systemic adverse events up to 4 weeks after each vaccination. Very high proportions of subjects were seroprotected. Seroprotection rates at 1, 6 and 7 months were all above 95% using a 10 IU/L cutoff, and were mostly above 90% using a 100 IU/L cutoff. Seroprotection rates between the 2 formulations were equivalent within a 5% margin for either cutoff titer both after 6 and 7 months. There were no significant differences in the number of adverse events reported between the 2 formulations. Safety results were in line with previous reports for Hepavax-Gene. Both formulations of Hepavax-Gene were well tolerated. There were no local adverse events reported in the TF group. No serious adverse events were reported during the study. The thiomersal-free formulation of Hepavax-Gene was noninferior to the thiomersal-containing formulation of Hepavax-Gene in terms of immunogenicity. There was evidence that the thiomersal-free vaccine was associated with fewer local adverse events.

  4. Alga Ecklonia bicyclis, Tribulus terrestris, and Glucosamine Oligosaccharide Improve Erectile Function, Sexual Quality of Life, and Ejaculation Function in Patients with Moderate Mild-Moderate Erectile Dysfunction: A Prospective, Randomized, Placebo-Controlled, Single-Blinded Study

    Science.gov (United States)

    Sansalone, Salvatore; Leonardi, Rosario; Antonini, Gabriele; Vitarelli, Antonio; Vespasiani, Giuseppe

    2014-01-01

    We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000) in patients with erectile dysfunction (ED) at 3 months of follow-up. From January 2013 to September 2013, 177 patients diagnosed with mild-moderate ED (IIEF-EF < 26) were enrolled in this multicenter, single-blinded, placebo-controlled study and randomized in Group A (Tradamix, n = 87) and Group B (placebo, n = 90). Penile color Doppler ultrasound measures, IIEF-15 questionnaire, male sexual health questionnaire-ejaculation disorder (MSHQ-EjD), and sexual quality of life (SQoL-M) were collected. We observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P < 0.05) at 3 months versus Group B (P < 0.05). PSV (P < 0.05), IIEF-intercourse satisfaction (P < 0.05), IIEF-orgasmic function (mean P < 0.05), IIEF-sexual desire (P < 0.05), IIEF-overall satisfaction (P < 0.05), MSHQ-EjD (mean difference: 1.21; P < 0.05), and SQoL-M (mean difference: 10.2; P < 0.05) were significantly changed in Group A versus baseline and Group B. Patients with moderate arterial dysfunction showed significant increase of PSV (P < 0.05), IIEF-EF (P < 0.05), MSHQ-EjD (P < 0.05), and SQoL-M (P < 0.05) in Group A. Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction. PMID:25136552

  5. Alga Ecklonia bicyclis, Tribulus terrestris, and Glucosamine Oligosaccharide Improve Erectile Function, Sexual Quality of Life, and Ejaculation Function in Patients with Moderate Mild-Moderate Erectile Dysfunction: A Prospective, Randomized, Placebo-Controlled, Single-Blinded Study

    Directory of Open Access Journals (Sweden)

    Salvatore Sansalone

    2014-01-01

    Full Text Available We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000 in patients with erectile dysfunction (ED at 3 months of follow-up. From January 2013 to September 2013, 177 patients diagnosed with mild-moderate ED (IIEF-EF < 26 were enrolled in this multicenter, single-blinded, placebo-controlled study and randomized in Group A (Tradamix, n=87 and Group B (placebo, n=90. Penile color Doppler ultrasound measures, IIEF-15 questionnaire, male sexual health questionnaire-ejaculation disorder (MSHQ-EjD, and sexual quality of life (SQoL-M were collected. We observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P<0.05 at 3 months versus Group B (P<0.05. PSV (P<0.05, IIEF-intercourse satisfaction (P<0.05, IIEF-orgasmic function (mean P<0.05, IIEF-sexual desire (P<0.05, IIEF-overall satisfaction (P<0.05, MSHQ-EjD (mean difference: 1.21; P<0.05, and SQoL-M (mean difference: 10.2; P<0.05 were significantly changed in Group A versus baseline and Group B. Patients with moderate arterial dysfunction showed significant increase of PSV (P<0.05, IIEF-EF (P<0.05, MSHQ-EjD (P<0.05, and SQoL-M (P<0.05 in Group A. Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction.

  6. Alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide improve erectile function, sexual quality of life, and ejaculation function in patients with moderate mild-moderate erectile dysfunction: a prospective, randomized, placebo-controlled, single-blinded study.

    Science.gov (United States)

    Sansalone, Salvatore; Leonardi, Rosario; Antonini, Gabriele; Vitarelli, Antonio; Vespasiani, Giuseppe; Basic, Dragoslav; Morgia, Giuseppe; Cimino, Sebastiano; Russo, Giorgio Ivan

    2014-01-01

    We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000) in patients with erectile dysfunction (ED) at 3 months of follow-up. From January 2013 to September 2013, 177 patients diagnosed with mild-moderate ED (IIEF-EF < 26) were enrolled in this multicenter, single-blinded, placebo-controlled study and randomized in Group A (Tradamix, n = 87) and Group B (placebo, n = 90). Penile color Doppler ultrasound measures, IIEF-15 questionnaire, male sexual health questionnaire-ejaculation disorder (MSHQ-EjD), and sexual quality of life (SQoL-M) were collected. We observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P < 0.05) at 3 months versus Group B (P < 0.05). PSV (P < 0.05), IIEF-intercourse satisfaction (P < 0.05), IIEF-orgasmic function (mean P < 0.05), IIEF-sexual desire (P < 0.05), IIEF-overall satisfaction (P < 0.05), MSHQ-EjD (mean difference: 1.21; P < 0.05), and SQoL-M (mean difference: 10.2; P < 0.05) were significantly changed in Group A versus baseline and Group B. Patients with moderate arterial dysfunction showed significant increase of PSV (P < 0.05), IIEF-EF (P < 0.05), MSHQ-EjD (P < 0.05), and SQoL-M (P < 0.05) in Group A. Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction.

  7. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Dilek, Banu; Gözüm, Mehtap; Şahin, Ebru; Baydar, Meltem; Ergör, Gül; El, Ozlem; Bircan, Çigdem; Gülbahar, Selmin

    2013-04-01

    To evaluate the efficacy of paraffin bath therapy on pain, function, and muscle strength in patients with hand osteoarthritis. Prospective single-blinded randomized controlled trial. Department of physical medicine and rehabilitation in a university hospital. Patients with bilateral hand osteoarthritis (N=56). Patients were randomized into 2 groups with a random number table by using block randomization with 4 patients in a block. Group 1 (n=29) had paraffin bath therapy (5 times per week, for 3-week duration) for both hands. Group 2 (n=27) was the control group. All patients were informed about joint-protection techniques, and paracetamol intake was recorded. The primary outcome measures were pain (at last 48h) at rest and during activities of daily living (ADL), assessed with a visual analog scale (0-10cm) at 12 weeks. The secondary outcome measures were the Australian Canadian Osteoarthritis Hand Index (AUSCAN) and the Dreiser Functional Index (DFI), used for subjective functional evaluation, loss of range of motion (ROM), grip and pinch strength, painful and tender joint counts, and paracetamol intake. A researcher blind to group allocation recorded the measures for both hands at baseline, 3 weeks, and 12 weeks at the hospital setting. At baseline, there were no significant differences between groups in any of the parameters (P>.05). After treatment, the paraffin group exhibited significant improvement in pain at rest and during ADL, ROM of the right hand, and pain and stiffness dimensions of the AUSCAN (P.05). The control group showed a significant deterioration in right hand grip and bilateral lateral pinch and right chuck pinch strength (Pparaffin group (Pparaffin group were significantly higher than the control group at 12 weeks (PParaffin bath therapy seemed to be effective both in reducing pain and tenderness and maintaining muscle strength in hand osteoarthritis. It may be regarded as a beneficial short-term therapy option, which is effective for a 12

  8. Single-Blinded Prospective Implementation of a Preoperative Imaging Checklist for Endoscopic Sinus Surgery.

    Science.gov (United States)

    Error, Marc; Ashby, Shaelene; Orlandi, Richard R; Alt, Jeremiah A

    2018-01-01

    Objective To determine if the introduction of a systematic preoperative sinus computed tomography (CT) checklist improves identification of critical anatomic variations in sinus anatomy among patients undergoing endoscopic sinus surgery. Study Design Single-blinded prospective cohort study. Setting Tertiary care hospital. Subjects and Methods Otolaryngology residents were asked to identify critical surgical sinus anatomy on preoperative CT scans before and after introduction of a systematic approach to reviewing sinus CT scans. The percentage of correctly identified structures was documented and compared with a 2-sample t test. Results A total of 57 scans were reviewed: 28 preimplementation and 29 postimplementation. Implementation of the sinus CT checklist improved identification of critical sinus anatomy from 24% to 84% correct ( P identification of sinus anatomic variants, including those not directly included in the systematic review implemented. Conclusion The implementation of a preoperative endoscopic sinus surgery radiographic checklist improves identification of critical anatomic sinus variations in a training population.

  9. Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial.

    Science.gov (United States)

    Gilliaux, Maxime; Renders, Anne; Dispa, Delphine; Holvoet, Dominique; Sapin, Julien; Dehez, Bruno; Detrembleur, Christine; Lejeune, Thierry M; Stoquart, Gaëtan

    2015-02-01

    Several pilot studies have evoked interest in robot-assisted therapy (RAT) in children with cerebral palsy (CP). To assess the effectiveness of RAT in children with CP through a single-blind randomized controlled trial. Sixteen children with CP were randomized into 2 groups. Eight children performed 5 conventional therapy sessions per week over 8 weeks (control group). Eight children completed 3 conventional therapy sessions and 2 robot-assisted sessions per week over 8 weeks (robotic group). For both groups, each therapy session lasted 45 minutes. Throughout each RAT session, the patient attempted to reach several targets consecutively with the REAPlan. The REAPlan is a distal effector robot that allows for displacements of the upper limb in the horizontal plane. A blinded assessment was performed before and after the intervention with respect to the International Classification of Functioning framework: body structure and function (upper limb kinematics, Box and Block test, Quality of Upper Extremity Skills Test, strength, and spasticity), activities (Abilhand-Kids, Pediatric Evaluation of Disability Inventory), and participation (Life Habits). During each RAT session, patients performed 744 movements on average with the REAPlan. Among the variables assessed, the smoothness of movement (P robotic group than in the control group. This single-blind randomized controlled trial provides the first evidence that RAT is effective in children with CP. Future studies should investigate the long-term effects of this therapy. © The Author(s) 2014.

  10. Efficacy of peloid therapy in patients with chronic lateral epicondylitis: a randomized, controlled, single blind study

    Science.gov (United States)

    Ökmen, Burcu Metin; Eröksüz, Rıza; Altan, Lale; Aksoy, Meliha Kasapoğlu

    2017-11-01

    The aim of this study was to assess the effect of peloid on pain, functionality, daily life activities, and quality of life of lateral epicondylitis (LE) patients. In this randomized, controlled, single-blind study, 75 patients who were diagnosed with chronic LE were enrolled to the study. Patients were randomized into two groups using the random number table. The patients in the first group (group 1) ( n = 33), were given lateral epicondylitis band (LEB) (during the day for 6 weeks) + peloid therapy (five consecutive days a week for 2 weeks), and the second group (group 2) ( n = 32), received LEB treatment alone. The patients were assessed by using Patient Rated Tennis Elbow Evaluation (PRTEE) and Nottingham Health Profile (NHP). The data were obtained before treatment (W0), immediately after treatment (W2), and 1 month after treatment (W6). In analysis of the collected data, the Wilcoxon signed rank test for intra-group comparisons and Mann-Whitney U test for comparisons between groups were used. Both in groups 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0 ( p 0.05), a statistically significant difference was found in favor of group 1 for all the evaluation parameters at W6 ( p < 0.05). Our results have shown that peloid treatment could be effective in providing improvement in pain relief, function, daily life activities, and quality of life in LE patients.

  11. Randomized, single blind, controlled trial of inhaled glutathione vs placebo in patients with cystic fibrosis.

    Science.gov (United States)

    Calabrese, C; Tosco, A; Abete, P; Carnovale, V; Basile, C; Magliocca, A; Quattrucci, S; De Sanctis, S; Alatri, F; Mazzarella, G; De Pietro, L; Turino, C; Melillo, E; Buonpensiero, P; Di Pasqua, A; Raia, V

    2015-03-01

    In cystic fibrosis (CF) the defective CF transmembrane conductance regulator protein may be responsible for the impaired transport of glutathione (GSH), the first line defense of the lung against oxidative stress. The aim of this single-blind, randomized, placebo-controlled trial was to evaluate the effect of inhaled GSH in patients with CF. 54 adult and 51 pediatric patients were randomized to receive inhaled GSH or placebo twice daily for 12 months. Twelve month treatment with inhaled GSH did not achieve our predetermined primary outcome measure of 15% improvement in FEV1%. Only in patients with moderate lung disease, 3, 6 and 9 months therapy with GSH resulted in a statistically significant increase of FEV1 values from the baseline. Moreover GSH therapy improved 6-minute walking test in pediatric population. GSH was well tolerated by all patients. Inhaled GSH has slight positive effects in CF patients with moderate lung disease warranting further study. ClinicalTrials.gov; No.: NCT01450267; URL: www.clinicaltrialsgov. Copyright © 2014 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

  12. Complex antioxidants in a randomized single-blinded study of memory in seniors.

    Science.gov (United States)

    Summers, William K; Martin, Roy L; Liu, Yimeng; Peña, Bernice; Marsh, Gary M

    2018-04-01

    Oxidative injury to the brain and aging are theoretical co-causes of Alzheimer's Disease (AD). Amyloid plaques and tangles are then secondary phenomenon. The preclinical state would then be 'normal' elderly. A potent complex antioxidant (antiOx) was tested against a popular one-a-day multivitamin (mV) in a randomized single blind design in 'normal' senior subjects over 6 months. Memory testing was done at baseline, 1, 3, and 6 months. The generalized estimating equation (GEE) approach was used to compare the change score of NLT 100 and 20 WR between two groups over time. Analysis of the antiOx group (30 subjects) demonstrated significant improvement in declarative memory (change score for NLT 100 at month 6 = 6.36 p working memory (change score for 20 WR at month 6 = 3.23, p < 0.0001). A change-score analysis over 6 months suggests possible neurogenesis in the antiOx group. The mV group (33 subjects) had a change score of the NLT 100 and 20WR on the sixth month of 2.20 and 0.32 (p = 0.07, 0.35). A complex antioxidant blend, sold as an over-the-counter (OTC) supplement, can improve memory in elder subjects. Antioxidants may be beneficial in AD and other neurodegerative diseases.

  13. Dense cranial electroacupuncture stimulation for major depressive disorder--a single-blind, randomized, controlled study.

    Directory of Open Access Journals (Sweden)

    Zhang-Jin Zhang

    Full Text Available BACKGROUND: Previous studies suggest that electroacupuncture possesses therapeutic benefits for depressive disorders. The purpose of this study was to determine whether dense cranial electroacupuncture stimulation (DCEAS could enhance the antidepressant efficacy in the early phase of selective serotonin reuptake inhibitor (SSRI treatment of major depressive disorder (MDD. METHODS: In this single-blind, randomized, controlled study, patients with MDD were randomly assigned to 9-session DCEAS or noninvasive electroacupuncture (n-EA control procedure in combination with fluoxetine (FLX for 3 weeks. Clinical outcomes were measured using the 17-item Hamilton Depression Rating Scale (HAMD-17, Clinical Global Impression-severity (CGI-S, and Self-rating Depression Scale (SDS as well as the response and remission rates. RESULTS: Seventy-three patients were randomly assigned to n-EA (n = 35 and DCEAS (n = 38, of whom 34 in n-EA and 36 in DCEAS group were analyzed. DCEAS-treated patients displayed a significantly greater reduction from baseline in HAMD-17 scores at Day 3 through Day 21 and in SDS scores at Day 3 and Day 21 compared to patients receiving n-EA. DCEAS intervention also produced a higher rate of clinically significant response compared to n-EA procedure (19.4% (7/36 vs. 8.8% (3/34. The incidence of adverse events was similar in the two groups. CONCLUSIONS: DCEAS is a safe and effective intervention that augments the antidepressant efficacy. It can be considered as an additional therapy in the early phase of SSRI treatment of depressed patients. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN88008690.

  14. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study

    Science.gov (United States)

    Metin Ökmen, Burcu; Kasapoğlu Aksoy, Meliha; Güneş, Aygül; Eröksüz, Riza; Altan, Lale

    2017-08-01

    Carpal tunnel syndrome(CTS) is the most common neuromuscular cause of upper extremity disability. We aimed to investigate the effectiveness of peloid therapy in patients with CTS. This randomized, controlled, single-blind study enrolled 70 patients between the ages of 30 to 65 who had a diagnosis of either mild, mild-to-moderate, or moderate CTS. The patients were randomized into two groups using random number table. In the first group, (Group 1)( n = 35), patients were given splint (every night for 6 weeks) + peloid treatment(five consecutive days a week for 2 weeks) and in the second group, (Group 2)( n = 28), patients received splint treatment(every night for 6 weeks) alone. The patients were assessed by using visual analog scale(VAS) for pain, electroneuromyography(ENMG), the Boston Carpal Tunnel Syndrome Questionnaire(BCTSQ), hand grip strength(HGS), finger grip strength(FGS), and Short Form-12(SF-12). The data were obtained before treatment(W0), immediately after treatment(W2), and one month after treatment(W6). Both in Group 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0( p < 0.05). Comparison of the groups with each other revealed significantly better results for VAS, BCTSQ, mSNCV, SF-12 in Group 1 than in Group 2 at W2( p < 0.05). There was also a statistically significant difference in favor of Group 1 for VAS, BCTSQ, FGS and MCS at W6 when compared to W0 ( p < 0.05). The results of our study demonstrated that in patients with CTS; peloid + splint treatment was more effective than splint treatment alone in pain, functionality and life quality both at after treatment(W2) and one month after treatment (W6). We may suggest peloid as a supplementary therapeutic agent in CTS.

  15. Distance education and diabetes empowerment: A single-blind randomized control trial.

    Science.gov (United States)

    Zamanzadeh, Vahid; Zirak, Mohammad; Hemmati Maslakpak, Masomeh; Parizad, Naser

    2017-11-01

    Diabetes is one of the biggest problems in healthcare systems and kills many people every year. Diabetes management is impossible when only utilizing medication. So, patients must be educated to manage their diabetes. This study aims to assess the effect of education by telephone and short message service on empowering patients with type 2 diabetes (primary outcome). A single-blind randomized controlled trial was conducted in the Urmia diabetes association in Iran. Sixty six participants with definitive diagnosis of type 2 diabetes entered into the study. Patients with secondary health problems were excluded. Patients were selected by simple random sampling then allocated into intervention (n=33) and control (n=33) groups. The intervention group received an educational text message daily and instructive phone calls three days a week for three months along with usual care. The Diabetes Empowerment Scale (DES) with confirmed validity and reliability was used for collecting data. Data was analyzed using SPSS V6.1. Independent t-test, paired t-test and chi-square were used to analyze the data. The empowerment of the intervention group compared with the control group significantly improved after three months of distance education (p<0.00, EF=1. 16). The study findings show that the distance education has a significant effect on empowering patients with type 2 diabetes. Therefore, using distance education along with other diabetes management intervention is highly effective and should be part of the care in diabetes treatment. Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  16. Relay model for recruiting alcohol dependent patients in general hospitals--a single-blind pragmatic randomized trial

    DEFF Research Database (Denmark)

    Schwarz, Anne-Sophie; Bilberg, Randi; Bjerregaard, Lene Berit Skov

    2016-01-01

    - The Relay Model. METHOD/DESIGN: The study is a single-blind pragmatic randomized controlled trial including patients admitted to the hospital. The study group (n = 500) will receive an intervention, and the control group (n = 500) will be referred to treatment by usual procedures. All patients complete......://register.clinicaltrials.gov/by identifier: RESCueH_Relay NCT02188043 Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals (TRN Registration: 07/09/2014)....

  17. Effect of Auricular Acupress Therapy on Insomnia of Cancer Patients : Randomized, Single Blinded, Placebo Controlled Trial

    Directory of Open Access Journals (Sweden)

    In-Sook Jung

    2010-06-01

    Full Text Available Background: Auricular acupressure is one of the traditional health care treatments in oriental medicine. Approximately, 30~40% of the cancer patients have said to be suffering from insomnia and half of them having chronic and severe insomnia at the same time. Insomnia caused cancer patients feel more pain, fatigue, depression and anxiety and it sometimes let the power to have the best of cancer pull down. Objective: To investigate how effective the auricular acupressure treatment to cancer patients suffering from insomnia. Methods: We recruited participants from East-West Cancer Center of Daejeon University. Finally, of the people whose age range from 20 to 75, 12 patients who got less than 40 points from the score of Oh's sleeping score (OSS were recruited. Single-blind, randomized pilot study was performed. The treatment group received auricular acupressure treatment (AAT on active points and the control group had received sham acupressure treatment (SAT for five times. Sleep parameters were checked by using OSS and numeric rating scale (NRS. We checked the scale everytime, both before and after treatment. We analyzed the data statistically by using independent T-test, paired T-test and analysis of variance (ANOVA test. (p<0.05 Results: Twelve cancer patients participated in this pilot study and there was no significant difference between control and treatment group. Only 7 of them had completed the whole treatment process, 4 patients of AAT group and 3 participants of SAT. The OSS of AAT group had increased from 34.0± 4.3 to 39.5±3.1 and that of SAT group had increased from 38.3±3.5 to 40.0±0.0. There was no significant difference between them. The NRS of AAT group had increased from 6.3±2.9 to 4.8±2.1 and that of SAT group had increased from 7.0±1.0 to 5.0±2.6. No significant difference was observed between them. Conclusion: Although both groups did not show significant differences, most of the experimental participants showed

  18. Effect of tomato consumption on high-density lipoprotein cholesterol level: a randomized, single-blinded, controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Cuevas-Ramos D

    2013-07-01

    Full Text Available Daniel Cuevas-Ramos,1 Paloma Almeda-Valdés,1 Emma Chávez-Manzanera,1 Clara Elena Meza-Arana,2 Griselda Brito-Córdova,1 Roopa Mehta,1 Oscar Pérez-Méndez,3 Francisco J Gómez-Pérez1 1Department of Endocrinology and Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; 2Department of Internal Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; 3Department of Molecular Biology, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico Introduction: Epidemiologic evidence suggests that tomato-based products could reduce the risk of cardiovascular diseases. One of the main cardiovascular risk factors is low levels of high-density lipoprotein cholesterol (HDL-C. This study aimed to prospectively evaluate the effect of tomato consumption on HDL-C levels. Subject and methods: We conducted a randomized, single-blinded, controlled clinical trial. We screened 432 subjects with a complete lipid profile. Those individuals with low HDL-C (men 40 mg/dL. A linear regression model that adjusted for those parameters that impact HDL-C levels (age, gender, waist-to-hip ratio, body mass index, fasting triglyceride concentration, simple sugars, alcohol, physical activity, and omega-3 consumption showed an independent association between tomato consumption and the increase in HDL-C (r2 = 0.69; P > 0.0001. Conclusion: Raw tomato consumption produced a favorable effect on HDL-C levels in overweight women. Keywords: lycopene, hypoalphalipoproteinemia, dyslipidemia, overweight, cardiovascular diseases

  19. Efficacy of the Power Balance Silicone Wristband: a single-blind, randomized, triple placebo-controlled study.

    Science.gov (United States)

    Pothier, David D; Thiel, Gundula; Khoo, S G; Dillon, Wanda A; Sulway, Shaleen; Rutka, John A

    2012-06-01

    The Power Balance Silicone Wristband (Power Balance LLC, Laguna Niguel, CA) (power balance band; PBB) consists of a silicone wristband, incorporating two holograms, which is meant to confer improvements in balance on the wearer. Despite its popularity, the PBB has become somewhat controversial, with a number of articles being published in the news media regarding its efficacy. The PBB has not been formally evaluated but remains popular, largely based on anecdotal evidence. This study subjectively and objectively measured the effects of the PBB on balance in normal participants. A prospective, single-blind, randomized, triple placebo-controlled crossover study was undertaken. Twenty participants underwent measurement using the modified Test of Sensory Interaction on Balance (mCTSIB) and gave subjective feedback (visual analogue scale [VAS]) for each of four band conditions: no band, a silicone band, a deactivated PBB, and the PBB. Participants acted as their own controls. The mean of the four mCTSIB conditions (eyes open and closed on both firm and compliant surfaces) was calculated. This mean value and condition 4 of the mCTSIB were compared between band conditions using path length (PL) and root mean square (RMS) as outcome measures. No significant differences were found between band conditions for PL (p  =  .91 and p  =  .94, respectively) and RMS (p  =  .85 and p  =  .96, respectively). VASs also showed no difference between bands (p  =  .25). The PBB appears to have no effect on mCTSIB or VAS measurements of balance.

  20. Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers

    DEFF Research Database (Denmark)

    Bagi, Per; Hannibalsen, Jane; Permild, Rikke

    2011-01-01

    in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p catheter; it was preferred by nurses for 20 of 23......Introduction: A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. Methods: In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice...... with a regular catheter. Results: 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95% confidence interval -0.73 to 0.19); there was no significant difference...

  1. Post-operative pain following coblation or monopolar electrocautery tonsillectomy in children: a prospective, single-blinded, randomised comparison.

    Science.gov (United States)

    Parker, N P; Walner, D L

    2011-10-01

    To compare post-operative pain following tonsillectomy by either coblation or monopolar electrocautery in children. A parallel-designed, prospective, single-blinded, randomised trial. Ambulatory surgical facility. Eighty otherwise healthy paediatric patients undergoing coblation or electrocautery tonsillectomy by a fellowship-trained paediatric otolaryngologist. (i) The number of post-operative days with severe pain based on subjective qualification by the caretaker, (ii) post-operative days with pain rated ≥ 5 on a scale of 1-10, (iii) post-operative days requiring oral paracetamol/acetaminophen with codeine solution and (iv) post-operative days until resumption of a regular diet were assessed and recorded daily using a post-operative pain survey as a form of daily diary that was returned at the 2-week follow-up visit. Patients were consecutively enrolled into two groups of 40 patients. Average ages were 5.2 years for coblation tonsillectomy and 6.0 years for electrocautery tonsillectomy. The average number of post-operative days with severe pain was 4.2 for coblation and 5.9 for electrocautery (P = 0.006), days rating pain ≥ 5 were 3.6 for coblation and 4.8 for electrocautery (P = 0.037), days of codeine use were 2.5 for coblation and 2.9 for electrocautery (P = 0.324), and days until resumption of a regular diet were 5.2 for coblation and 6.2 for electrocautery (0.329). Coblation tonsillectomy may reduce post-operative pain and the time until resumption of a regular diet compared to electrocautery tonsillectomy. © 2011 Blackwell Publishing Ltd.

  2. Varenicline for opioid withdrawal in patients with chronic pain: a randomized, single-blinded, placebo controlled pilot trial.

    Science.gov (United States)

    Hooten, W Michael; Warner, David O

    2015-03-01

    The objectives of this randomized, single-blinded, placebo-controlled pilot trial were to investigate the effects of varenicline on opioid withdrawal among chronic pain patients undergoing opioid detoxification in an interdisciplinary pain program and the feasibility of varenicline use in this population. Twenty-one patients were recruited (varenicline=10, placebo=11), and 7 patients in the varenicline and 11 in the placebo group completed the study. Opioid withdrawal was quantified using the Clinical Opiate Withdrawal Scale, and varenicline-related adverse effects were assessed. Opioid withdrawal scores tended to decrease over the course of opioid tapering in those receiving varenicline and increase in those receiving placebo. Varenicline was well-tolerated in this population, with no adverse drug effects (including nausea) observed and no effect on improvements in pain severity and depression. This randomized pilot study provides preliminary data for future trials of varenicline in opioid-dependent adults with chronic pain undergoing medically directed opioid detoxification. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. The FINISH-3 Trial : A Phase 3, International, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis

    NARCIS (Netherlands)

    Bochicchio, Grant V.; Gupta, Navyash; Porte, Robert J.; Renkens, Kenneth L.; Pattyn, Piet; Topal, Baki; Troisi, Roberto Ivan; Muir, William; Chetter, Ian; Gillen, Daniel L.; Zuckerman, Linda A.; Frohna, Paul A.

    BACKGROUND: This Phase 3, international, randomized, single-blind, controlled trial (FINISH-3) compared the efficacy and safety of Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, vs gelatin sponge alone for use as a hemostat for surgical

  4. Anesthesia machine checkout and room setup: a randomized, single-blind, comparison of two teaching modalities.

    Science.gov (United States)

    Spofford, Christina M; Bayman, Emine O; Szeluga, Debra J; From, Robert P

    2012-01-01

    Novel methods for teaching are needed to enhance the efficiency of academic anesthesia departments as well as provide approaches to learning that are aligned with current trends and advances in technology. A video was produced that taught the key elements of anesthesia machine checkout and room set up. Novice learners were randomly assigned to receive either the new video format or traditional lecture-based format for this topic during their regularly scheduled lecture series. Primary outcome was the difference in written examination score before and after teaching between the two groups. Secondary outcome was the satisfaction score of the trainees in the two groups. Forty-two students assigned to the video group and 36 students assigned to the lecture group completed the study. Students in each group similar interest in anesthesia, pre-test scores, post-test scores, and final exam scores. The median posttest to pretest difference was greater in the video groups (3.5 (3.0-5.0) vs 2.5 (2.0-3.0), for video and lecture groups respectively, p 0.002). Despite improved test scores, students reported higher satisfaction the traditional, lecture-based format (22.0 (18.0-24.0) vs 24.0 (20.0-28.0), for video and lecture groups respectively, p students in the video-based teaching group, however students rated traditional, live lectures higher than newer video-based teaching.

  5. A single blind randomized control trial on support groups for Chinese persons with mild dementia

    Directory of Open Access Journals (Sweden)

    Young DKW

    2014-12-01

    Full Text Available Daniel KW Young,1 Timothy CY Kwok,2 Petrus YN Ng1 1Department of Social Work, Hong Kong Baptist University, Kowloon Tong, Hong Kong; 2Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong Purpose: Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Research methods: Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. Results: At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59% of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48 to 7.35 (standard deviation =2.18, which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05, while the control group’s participants did not show any significant change. Conclusion: This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants. Keywords: support group, mild dementia, Chinese, depression

  6. Upper limb training using Wii Sports Resort for children with hemiplegic cerebral palsy: a randomized, single-blind trial.

    Science.gov (United States)

    Chiu, Hsiu-Ching; Ada, Louise; Lee, Hsin-Min

    2014-10-01

    To investigate whether Wii Sports Resort training is effective and if any benefits are maintained. Randomized, single-blind trial. Sixty-two hemiplegic children with cerebral palsy (6-13 years). Experimental group undertook six weeks of home-based Wii Sports Resort training plus usual therapy, while the control group received usual therapy. Outcomes were coordination, strength, hand function, and carers' perception of hand function, measured at baseline, six, and 12 weeks by a blinded assessor. There was a trend of mean difference (MD) for the experimental group to have more grip strength by six (MD 4.0 N, 95% confidence interval (CI) -0.8 to 8.8, p = 0.10) and 12 (MD 4.1 N, 95% CI -2.1 to 10.3, p = 0.19) weeks, and to have a higher quantity of hand function according to carers' perception by six (MD 4.5 N, 95% CI -0.7 to 9.7, p = 0.09) and strengthened by 12 (MD 6.4, 95% CI 0.6 to 12.3, p = 0.03) weeks than the control group. There was no difference between groups in coordination and hand function by six or 12 weeks. Wii training did not improve coordination, strength, or hand function. Beyond the intervention, carers perceived that the children used their hands more. © The Author(s) 2014.

  7. One-year follow-up of mud-bath therapy in patients with bilateral knee osteoarthritis: a randomized, single-blind controlled trial

    Science.gov (United States)

    Fioravanti, A.; Bacaro, G.; Giannitti, C.; Tenti, S.; Cheleschi, S.; Guidelli, G. M.; Pascarelli, N. A.; Galeazzi, M.

    2015-09-01

    The objective of this prospective parallel randomized single-blind study was to assess that a cycle of mud-bath therapy (MBT) provides any benefits over usual treatment in patients with bilateral knee osteoarthritis (OA). Patients with symptomatic primary bilateral knee OA, according to ACR criteria, were included in the study and randomized to one of two groups: one group received a cycle of MBT at spa center of Chianciano Terme (Italy) in addition to the usual treatment, and one group continued their regular care routine alone. Clinical assessments were performed 7 days before enrollment (screening visit), at the time of enrollment (basal time), after 2 weeks, and after 3, 6, 9, and 12 months after the beginning of the study. All assessments were conducted by two researchers blinded to treatment allocation. The primary efficacy outcomes were the global pain score evaluated by Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore for physical function (W-TPFS). Of the 235 patients screened, 103 met the inclusion criteria: 53 patients were included in the MBT group and 50 in the control group. In the group of patients treated with MBT, we observed a statistically significant ( p knee OA that lasts over time. Mud-bath therapy can represent a useful backup to pharmacologic treatment of knee OA or a valid alternative for patients who do not tolerate pharmacological treatments.

  8. Perceptive rehabilitation and trunk posture alignment in patients with Parkinson disease: a single blind randomized controlled trial.

    Science.gov (United States)

    Morrone, Michelangelo; Miccinilli, Sandra; Bravi, Marco; Paolucci, Teresa; Melgari, Jean M; Salomone, Gaetano; Picelli, Alessandro; Spadini, Ennio; Ranavolo, Alberto; Saraceni, Vincenzo M; DI Lazzaro, Vincenzo; Sterzi, Silvia

    2016-12-01

    Recent studies aimed to evaluate the potential effects of perceptive rehabilitation in Parkinson Disease reporting promising preliminary results for postural balance and pain symptoms. To date, no randomized controlled trial was carried out to compare the effects of perceptive rehabilitation and conventional treatment in patients with Parkinson Disease. To evaluate whether a perceptive rehabilitation treatment could be more effective than a conventional physical therapy program in improving postural control and gait pattern in patients with Parkinson Disease. Single blind, randomized controlled trial. Department of Physical and Rehabilitation Medicine of a University Hospital. Twenty outpatients affected by idiopathic Parkinson Disease at Hoehn and Yahr stage ≤3. Recruited patients were divided into two groups: the first one underwent individual treatment with Surfaces for Perceptive Rehabilitation (Su-Per), consisting of rigid wood surfaces supporting deformable latex cones of various dimensions, and the second one received conventional group physical therapy treatment. Each patient underwent a training program consisting of ten, 45-minute sessions, three days a week for 4 consecutive weeks. Each subject was evaluated before treatment, immediately after treatment and at one month of follow-up, by an optoelectronic stereophotogrammetric system for gait and posture analysis, and by a computerized platform for stabilometric assessment. Kyphosis angle decreased after ten sessions of perceptive rehabilitation, thus showing a substantial difference with respect to the control group. No significant differences were found as for gait parameters (cadence, gait speed and stride length) within Su-Per group and between groups. Parameters of static and dynamic evaluation on stabilometric platform failed to demonstrate any statistically relevant difference both within-groups and between-groups. Perceptive training may help patients affected by Parkinson Disease into restoring

  9. Comparison between group and personal rehabilitation for dementia in a geriatric health service facility: single-blinded randomized controlled study.

    Science.gov (United States)

    Tanaka, Shigeya; Honda, Shin; Nakano, Hajime; Sato, Yuko; Araya, Kazufumi; Yamaguchi, Haruyasu

    2017-05-01

    The aim of this study was to compare the effects of rehabilitation involving group and personal sessions on demented participants. This single-blinded randomized controlled trial included 60 elderly participants with dementia in a geriatric health service facility, or R oken. Staff members, who did not participate in the intervention, examined cognitive function, mood, communication ability, severity of dementia, objective quality of life, vitality, and daily behaviour. After a baseline assessment, participants were randomly divided into three groups: (i) group intervention; (ii) personal intervention; and (iii) control. The 1-h group intervention (3-5 subjects) and 20-min personal intervention (one staff member per participant) were performed twice a week for 12 weeks (24 total sessions). The cognitive rehabilitation programme consisted of reminiscence, reality orientation, and physical exercise, and it was based on five principles of brain-activating rehabilitation; (i) pleasant atmosphere; (ii) communication; (iii) social roles; (iv) praising; and (v) errorless support. Data were analyzed after the second assessment. Outcome measures were analyzed in 43 participants-14 in the control group, 13 in group intervention, and 16 in personal intervention. Repeated measure ancova showed a significant interaction for cognitive function score (Mini-Mental State Examination) between group intervention and controls ( F  = 5.535, P = 0.029). In the post-hoc analysis, group intervention showed significant improvement (P = 0.016). Global severity of dementia tended to improve (P = 0.094) in group intervention compared to control (Mann-Whitney U -test). There were no significant interactions or improvements for other measurements. Group rehabilitation for dementia is more effective for improving cognitive function and global severity of dementia than personal rehabilitation in Roken. © 2016 Japanese Psychogeriatric Society.

  10. Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kwok T

    2013-09-01

    Full Text Available Timothy Kwok,1,2 Bel Wong,2 Isaac Ip,2 Kenny Chui,2 Daniel Young,2 Florence Ho2 1Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region; 2Jockey Club Centre for Positive Ageing, Hong Kong, Special Administrative Region Purpose: Many family caregivers of persons with dementia (PWD are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. Subjects and methods: In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann–Whitney U tests were used to compare the differences between the intervention and control groups. Results: The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. Conclusion: A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed. Keywords: telephone intervention, psychoeducation, dementia caregivers

  11. Impact of complete bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy: a randomized, controlled, single blind trial.

    Science.gov (United States)

    Nyarangi-Dix, Joanne N; Radtke, Jan Philipp; Hadaschik, Boris; Pahernik, Sascha; Hohenfellner, Markus

    2013-03-01

    We investigated the influence of bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy. A total of 208 men who presented for radical prostatectomy were randomized to complete bladder neck preservation with subsequent urethro-urethral anastomosis or to no preservation as controls. Patients with failed bladder neck preservation were not included in study. We documented objective continence by the 24-hour pad test, social continence by the number of pads per day and quality of life outcomes by the validated Incontinence Quality of Life questionnaire in a single blind setting. Cancer resection was assessed by surgical margin status. At 0, 3, 6 and 12 months mean urine loss in the control vs the bladder neck preservation group was 713.3 vs 237.0, 49.6 vs 15.6, 44.4 vs 5.5 and 25.4 vs 3.1 gm, respectively (each p <0.001). At 3, 6 and 12 months in the control vs the preservation group the social continence rate was 55.3% vs 84.2% (p <0.001), 74.8% vs 89.5% (p = 0.05) and 81.4% vs 94.7% (p = 0.027), and the quality of life score was 80.4 vs 90.3 (p <0.001), 85.4 vs 91.7 (p = 0.016) and 86.0 vs 93.8 (p = 0.001), respectively. We noted significantly less urine loss, higher objective and social continence rates, and higher quality of life scores after complete bladder neck preservation at all followup points. On multiple logistic regression analysis complete bladder neck preservation was an independent positive predictor of continence. No significant difference was found in surgical margin status between the control and bladder neck preservation groups (12.5% vs 14.7%, p = 0.65). In what is to our knowledge the first prospective, randomized, controlled, single blind trial complete bladder neck preservation during radical prostatectomy was associated with a significantly higher urinary continence rate and increased patient satisfaction without compromising resection margins. Copyright © 2013 American Urological

  12. Comparison of photobiomodulation therapy and suprascapular nerve-pulsed radiofrequency in chronic shoulder pain: a randomized controlled, single-blind, clinical trial.

    Science.gov (United States)

    Ökmen, Burcu Metin; Ökmen, Korgün

    2017-11-01

    Shoulder pain can be difficult to treat due to its complex anatomic structure, and different treatment methods can be used. We aimed to examine the efficacy of photobiomodulation therapy (PBMT) and suprascapular nerve (SSN)-pulsed radiofrequency (RF) therapy. In this prospective, randomized, controlled, single-blind study, 59 patients with chronic shoulder pain due to impingement syndrome received PBMT (group H) or SSN-pulsed RF therapy (group P) in addition to exercise therapy for 14 sessions over 2 weeks. Records were taken using visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), and Nottingham Health Profile (NHP) scoring systems for pretreatment (PRT), posttreatment (PST), and PST follow-up at months 1, 3, and 6. There was no statistically significant difference in initial VAS score, SPADI, and NHP values between group H and group P (p > 0.05). Compared to the values of PRT, PST, and PST at months 1, 3, and 6, VAS, SPADI, and NHP values were statistically significantly lower in both groups (p measurement times in VAS, SPADI, and NHP between the two groups. We established that PBMT and SSN-pulsed RF therapy are effective methods, in addition to exercise therapy, in patients with chronic shoulder pain. PBMT seems to be advantageous compared to SSN-pulsed RF therapy, as it is a noninvasive method.

  13. No difference in terms of radiostereometric analysis between fixed- and mobile-bearing total knee arthroplasty: a randomized, single-blind, controlled trial.

    Science.gov (United States)

    Schotanus, M G M; Pilot, P; Kaptein, B L; Draijer, W F; Tilman, P B J; Vos, R; Kort, N P

    2017-09-01

    A concern that arises with any new prosthesis is whether it will achieve satisfactory long-term implant stability. The gold standard of assessing the quality of fixation in a new or relatively new implant is to undertake a randomized controlled trial using radiostereometric analysis. It was hypothesized that both mobile-bearing total knee arthroplasty and fixed-bearing total knee arthroplasty have comparable migration patterns at 2-year follow-up. This study investigated two types of cemented total knee arthroplasty, the mobile- or fixed-bearing variant from the same family with use of radiostereometric analysis. This prospective, patient-blinded, randomized, controlled trial was designed to investigate early migration of the tibia component after two years of follow-up with use of radiostereometric analysis. A total of 50 patients were randomized to receive a mobile- or fixed-bearing TKA from the same family. Patients were evaluated during 2-year follow-up, including radiostereometric analysis, physical and clinical examination and patient reported outcome measures (PROMs). At two-year follow-up, the mean (±SD) maximum total point motion (MTPM) in the fixed-bearing group was 0.82 (±1.16) versus 0.92 mm (±0.64) in the mobile-bearing group (p = n.s) with the largest migration seen during the first 6 weeks (0.45 ± 0.32 vs. 0.54 ± 0.30). The clinical outcome and PROMs significantly improved within each group, not between both groups. Measuring early micromotion is useful for predicting clinical loosening that can lead to revision. The results of this study demonstrate that early migration of the mobile-bearing is similar to that of the fixed-bearing component at two years and was mainly seen in the first weeks after implantation. Randomized, single-blind, controlled trial, Level I.

  14. Lysine clonixinate versus dipyrone (metamizole) for the acute treatment of severe migraine attacks: a single-blind, randomized study.

    Science.gov (United States)

    Krymchantowski, Abouch Valenty; Carneiro, Henrique; Barbosa, Jackeline; Jevoux, Carla

    2008-06-01

    Nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Lysine clonixinate (LC) and dipyrone (metamizol) have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. Thirty patients (28 women, 2 men), aged 18 to 48 years with migraine according the International Headache Society (IHS) (2004) were studied. The patients were randomized into 2 groups when presenting to an emergency department with a severe migraine attack. The study was single-blind. Headache intensity, nausea, photophobia and side effects were evaluated at 0, 30, 60 and 90 minutes after the drug administration. Rectal indomethacin as rescue medication (RM) was available after 2 hours and its use compared between groups. All patients completed the study. At 30 minutes, 0% of the dipyrone group 13% of the LC group were pain free (p=0.46). At 60 and 90 minutes, 2 (13%) and 5 (33%) patients from the dipyrone group and 11 (73%) and 13 (86.7%) patients from the LC group were pain free (p<0.001). At 60 minutes, significantly more patients from the LC group were nausea-free (p<0.001). Regarding photophobia, there were no differences between groups at 60 minutes (p=0.11). The use of RM at 2 hours did not differ among groups (p=0.50). Pain in the site of the injection was reported by more patients of the LC group compared to the dipyrone group (p<0.0001). LC is significantly superior to dipyrone in treating severe migraine attacks. LC promotes significantly more burning at the site of the injection.

  15. Comparison of Effectiveness of Reflexology and Abdominal Massage on Constipation among Orthopedic Patients: A single-blind Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Alehe Seyyedrassoli

    2016-10-01

    Full Text Available Constipation is one of the most common health problems presenting in patients hospitalized within orthopedic settings. This present study was done with the aim of determining the effect of foot reflexology and abdominal massage on constipation severity. This study is a single -blind randomized controlled trial completed using 3 groups comprising a total of 60 patients hospitalized in the orthopedic wards of shohada hospital in the Northwest Azerbaijan- Iran. One of the intervention groups involved the use of foot reflexology and in the other abdominal massage was carried out once daily for 6 days. An assessor blinded to the group allocation measured and recorded constipation severity before the intervention, then daily from day 1 until day 6 post intervention by constipation evaluation scale. For data analysis, ANOVA, ANCOVA and repeated measurement ANOVA tests was used in SPSS version 16. There was no significant difference between the intervention and control groups in constipation severity over the first two days (p>0. 05 built from the 3rd until the 6th days after the intervention, the difference was significant (p0.05. After modification and deleting covariate variables, again, there was a significant difference between intervention groups with a control group from day 3 until day 6 of the intervention(p<0. 05, (effect size from 34% to 50%. Time had a significant effect on constipation severity reduction during the study, meaning that constipation, severe in the intervention groups decreased significantly as the study progressed (p<0. 05. The positive effects of foot reflexology and abdominal massage on the severity of constipation in hospitalized patients means that both can be used as economical and noninvasive nursing interventions for the relief of constipation.

  16. Effects of Guided Imagery on Postoperative Outcomes in Patients Undergoing Same-Day Surgical Procedures: A Randomized, Single-Blind Study

    Science.gov (United States)

    2010-06-01

    2O0O;9Ot3):706-712. 20. Bertrand P, Maye J. A description of the indices of heart rate variabil- ity in orofacial pain paticnis. Bcihcsda, MD: National...neck proce- dures were randomly assigned into 2 groups for this single-blind investigation. Anxiety and baseline pain levels were documented...control group patients received no intervention. Data were collected on pain and nar- cotic consumption at 7- and 2-hour postoperative inter- vals. In

  17. Comparative electrocardiographic effects of intravenous ondansetron and granisetron in patients undergoing surgery for carcinoma breast: A prospective single-blind randomised trial

    Directory of Open Access Journals (Sweden)

    Ashish Ganjare

    2013-01-01

    Full Text Available Background: Postoperative nausea and vomiting (PONV are common and distressing symptoms after surgery performed under general anaesthesia. 5-hydroxytryptamine 3 antagonists are routinely used for prevention and treatment of PONV. The aim of our study was to compare the incidence of QTc prolongation and quantify the amount of QTc prolongation with ondansetron and granisetron. Methods: This prospective, randomised, single-blind study was carried out in the OT and Recovery Room (RR of a tertiary referral cancer centre. After obtaining Institutional Review Board approval and written informed consent from the patients, 70 patients undergoing elective surgery for carcinoma breast were included. In the RR, patients randomly received 8 mg of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at various intervals, Non-invasive blood pressure and SpO 2 were also recorded. Chi-square test and Mann-Whiteny test were used for statistical analysis. Results: The demographics were similar in both groups. The incidence of significant QTc prolongation was significantly higher in the ondansetron group (22 of 37 (59.4% vs. 11 of 33 patients (33.33% ( P<0.05. There was an increase in the QTc interval in both the groups as compared to the baseline. The median prolongation in QTc interval from baseline was much more in the ondansetron group; this was statistically significant only at 5 and 15 min. Conclusion: Granisetron may be a safer option than ondanasetron for prevention and treatment of PONV due to lesser prolongation QTc interval. (ClinicalTrials.gov ID: NCT01352130

  18. The effect of laughter therapy on radiation dermatitis in patients with breast cancer: a single-blind prospective pilot study

    Science.gov (United States)

    Kong, Moonkyoo; Shin, Sung Hee; Lee, Eunmi; Yun, Eun Kyoung

    2014-01-01

    Background There have not yet been any published studies on the effects of laughter therapy on radiation-induced dermatitis in breast cancer patients treated with radiotherapy (RT). We assessed the effectiveness of laughter therapy in preventing radiation dermatitis in patients with breast cancer. Methods Thirty-seven patients were prospectively enrolled in this study. Eighteen patients were assigned to the experimental group and the other 19 patients were assigned to the control group. The patients who were assigned to the experimental group received laughter therapy during RT. Laughter therapy was started at the onset of RT and was provided twice a week until completion of RT. The patients who were assigned to the control group only received RT without laughter therapy. The grade of radiation dermatitis was scored by a radiation oncologist who was blinded to subject assignment. The patients’ evaluation of pain within the RT field was also assessed. Results In the experimental group, radiation dermatitis of grade 3, 2, and 1 developed in five (33.3%), five (33.3%), and five patients (33.3%), respectively. In comparison, in the control group, radiation dermatitis of grade 3, 2, 1, and 0 developed in seven (36.8%), nine (47.4%), two (10.5%), and one patient (5.3%), respectively. The experimental group exhibited a lower incidence of grade 2 or worse radiation dermatitis than the control group (33.3% versus 47.4%). The mean maximal pain scores in the experimental and control group were 2.53 and 3.95, respectively. The experimental group complained of less severe pain than the control group during RT. However, these differences were not statistically significant. Conclusion The results of this study show that laughter therapy can have a beneficial role in preventing radiation dermatitis in patients with breast cancer. To confirm the results of our study, well-designed randomized studies with large sample sizes are required. PMID:25395864

  19. The effect of laughter therapy on radiation dermatitis in patients with breast cancer: a single-blind prospective pilot study

    Directory of Open Access Journals (Sweden)

    Kong M

    2014-11-01

    Full Text Available Moonkyoo Kong,1 Sung Hee Shin,2 Eunmi Lee,3 Eun Kyoung Yun2 1Department of Radiation Oncology, Kyung Hee University Medical Center, Kyung Hee University School of Medicine, 2College of Nursing Science, Kyung Hee University, 3Department of Quality Improvement, Kyung Hee University Medical Center, Seoul, Republic of Korea Background: There have not yet been any published studies on the effects of laughter therapy on radiation-induced dermatitis in breast cancer patients treated with radiotherapy (RT. We assessed the effectiveness of laughter therapy in preventing radiation dermatitis in patients with breast cancer. Methods: Thirty-seven patients were prospectively enrolled in this study. Eighteen patients were assigned to the experimental group and the other 19 patients were assigned to the control group. The patients who were assigned to the experimental group received laughter therapy during RT. Laughter therapy was started at the onset of RT and was provided twice a week until completion of RT. The patients who were assigned to the control group only received RT without laughter therapy. The grade of radiation dermatitis was scored by a radiation oncologist who was blinded to subject assignment. The patients' evaluation of pain within the RT field was also assessed. Results: In the experimental group, radiation dermatitis of grade 3, 2, and 1 developed in five (33.3%, five (33.3%, and five patients (33.3%, respectively. In comparison, in the control group, radiation dermatitis of grade 3, 2, 1, and 0 developed in seven (36.8%, nine (47.4%, two (10.5%, and one patient (5.3%, respectively. The experimental group exhibited a lower incidence of grade 2 or worse radiation dermatitis than the control group (33.3% versus 47.4%. The mean maximal pain scores in the experimental and control group were 2.53 and 3.95, respectively. The experimental group complained of less severe pain than the control group during RT. However, these differences were not

  20. Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease

    NARCIS (Netherlands)

    Fockens, P.; Cohen, L.; Edmundowicz, S.A.; Binmoeller, K.; Rothstein, R.I.; Smith, D.; Lin, E.; Nickl, N.; Overholt, B.; Kahrilas, P.J.; Vakil, N.; Abdel Aziz Hassan, A.M.; Lehman, G.A.

    2010-01-01

    This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD). A prospective, randomized, sham-controlled, single-blinded,

  1. Effectiveness of balneotherapy in chronic low back pain -- a randomized single-blind controlled follow-up study.

    Science.gov (United States)

    Balogh, Zoltán; Ordögh, József; Gász, Attila; Német, László; Bender, Tamás

    2005-08-01

    Balneotherapy, a domain of medical science, focuses on utilizing the beneficial effects of medicinal waters. Low back pain is among the most prevalent musculoskeletal disorders affecting a large proportion of the population during their lifetime. Although small in number, all controlled studies published on this subject have demonstrated the benefits of balneotherapy. This present study was undertaken to compare the effects of hydrotherapy with mineral water vs. tap water on low back pain. A single-blind clinical study was carried out to appraise the therapeutic efficacy of reduced sulphurous water on 60 patients with low back pain. 30 subjects took baths in reduced sulphurous mineral water, whereas the other 30 patients used modified tap water of matching odor. Parameters determined at baseline, after balneo-/hydrotherapy, and at the end of the 3-month follow-up period included the results of the Visual Analogue Scale (VAS) score, the modified Oswestry index, mobility of the spine, antalgic posture, tenderness of the paravertebral muscles on palpation, the dose requirements for analgesics, and the efficacy assessed by the investigators and by the patients. Bathing in mineral water resulted in a statistically significant improvement. This was reflected by the VAS (p balneotherapy. By contrast, hydrotherapy with tap water resulted only in the temporary improvement of just a single parameter: the VAS score improved significantly (p Balneotherapy in itself can alleviate low back pain. As demonstrated by this study, the analgesic efficacy and improvement of mobility accomplished by the use of mineral water is significantly superior to that afforded by hydrotherapy with tap water. Our results clearly establish the beneficial effects of mineral water. Moreover, it is a valuable adjunct to other forms of physical treatment as well as to pharmacotherapy.

  2. Functional weight-bearing mobilization after Achilles tendon rupture enhances early healing response: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Valkering, Kars P; Aufwerber, Susanna; Ranuccio, Francesco; Lunini, Enricomaria; Edman, Gunnar; Ackermann, Paul W

    2017-06-01

    Functional weight-bearing mobilization may improve repair of Achilles tendon rupture (ATR), but the underlying mechanisms and outcome were unknown. We hypothesized that functional weight-bearing mobilization by means of increased metabolism could improve both early and long-term healing. In this prospective randomized controlled trial, patients with acute ATR were randomized to either direct post-operative functional weight-bearing mobilization (n = 27) in an orthosis or to non-weight-bearing (n = 29) plaster cast immobilization. During the first two post-operative weeks, 15°-30° of plantar flexion was allowed and encouraged in the functional weight-bearing mobilization group. At 2 weeks, patients in the non-weight-bearing cast immobilization group received a stiff orthosis, while the functional weight-bearing mobilization group continued with increased range of motion. At 6 weeks, all patients discontinued immobilization. At 2 weeks, healing metabolites and markers of procollagen type I (PINP) and III (PIIINP) were examined using microdialysis. At 6 and 12 months, functional outcome using heel-rise test was assessed. Healing tendons of both groups exhibited increased levels of metabolites glutamate, lactate, pyruvate, and of PIIINP (all p bearing mobilization group demonstrated significantly higher concentrations of glutamate compared to the non-weight-bearing cast immobilization group (p = 0.045).The upregulated glutamate levels were significantly correlated with the concentrations of PINP (r = 0.5, p = 0.002) as well as with improved functional outcome at 6 months (r = 0.4; p = 0.014). Heel-rise tests at 6 and 12 months did not display any differences between the two groups. Functional weight-bearing mobilization enhanced the early healing response of ATR. In addition, early ankle range of motion was improved without the risk of Achilles tendon elongation and without altering long-term functional outcome. The relationship between

  3. The effect of non-weight bearing group-exercising on females with non-specific chronic low back pain: a randomized single blind controlled pilot study.

    Science.gov (United States)

    Masharawi, Youssef; Nadaf, Nedal

    2013-01-01

    The aim of this study was to investigate the effect of active non-weight-bearing (NWB) group exercising on women with non specific chronic low back pain (NSCLBP). Forty females with NSCLBP were assigned in a randomized control longitudinal single blinded pilot study. 20 of them were assigned to a NWB bi-weekly group exercise class and 20 females were included in the control group. The exercises involved the entire lumbo-pelvic spine aimed at improving lumbar mobility/flexibility and stability. Pain intensity (VAS), back specific disability (Rolland Morris questionnaire-RMQ), and lumbar flexion and extension ranges of motion measurements were taken prior to intervention (t(0)), immediately following 4 weeks of intervention (t(1)) and 8 weeks later (t(fu)). Reliability trials were conducted on 10 females. Non-parametric tests were used for statistical significance (p exercising improves functional, painful status, lumbar flexion and extension ranges of motion in women suffering from NSCLBP.

  4. Study of the therapeutic effects of a hippotherapy simulator in children with cerebral palsy: a stratified single-blind randomized controlled trial.

    Science.gov (United States)

    Herrero, Pablo; Gómez-Trullén, Eva M; Asensio, Angel; García, Elena; Casas, Roberto; Monserrat, Esther; Pandyan, Anand

    2012-12-01

    To investigate whether hippotherapy (when applied by a simulator) improves postural control and balance in children with cerebral palsy. Stratified single-blind randomized controlled trial with an independent assessor. Stratification was made by gross motor function classification system levels, and allocation was concealed. Children between 4 and 18 years old with cerebral palsy. Participants were randomized to an intervention (simulator ON) or control (simulator OFF) group after getting informed consent. Treatment was provided once a week (15 minutes) for 10 weeks. Gross Motor Function Measure (dimension B for balance and the Total Score) and Sitting Assessment Scale were carried out at baseline (prior to randomization), end of intervention and 12 weeks after completing the intervention. Thirty-eight children participated. The groups were balanced at baseline. Sitting balance (measured by dimension B of the Gross Motor Function Measure) improved significantly in the treatment group (effect size = 0.36; 95% CI 0.01-0.71) and the effect size was greater in the severely disabled group (effect size = 0.80; 95% CI 0.13-1.47). The improvements in sitting balance were not maintained over the follow-up period. Changes in the total score of the Gross Motor Function Measure and the Sitting Assessment Scale were not significant. Hippotherapy with a simulator can improve sitting balance in cerebral palsy children who have higher levels of disability. However, this did not lead to a change in the overall function of these children (Gross Motor Function Classification System level V).

  5. Short-term and practice effects of metronome pacing in Parkinson's disease patients with gait freezing while in the 'on' state: randomized single blind evaluation.

    Science.gov (United States)

    Cubo, Esther; Leurgans, Sue; Goetz, Christopher G

    2004-12-01

    In a randomized single blind parallel study, we tested the efficacy of an auditory metronome on walking speed and freezing in Parkinson's disease (PD) patients with freezing gait impairment during their 'on' function. No pharmacological treatment is effective in managing 'on' freezing in PD. Like visual cues that can help overcome freezing, rhythmic auditory pacing may provide cues that help normalize walking pace and overcome freezing. Non-demented PD patients with freezing during their 'on' state walked under two conditions, in randomized order: unassisted walking and walking with the use of an audiocassette with a metronome recording. The walking trials were randomized and gait variables were rated from videotapes by a blinded evaluator. Outcome measures were total walking time (total trial time-total freezing time), which was considered the time over a course of specified length, freezing time, average freeze duration and number of freezes. All outcomes were averaged across trials for each person and then compared across conditions using Signed Rank tests. Twelve non-demented PD patients with a mean age of 65.8 +/- 11.2 years, and mean PD duration of 12.4 +/- 7.3 years were included. The use of the metronome slowed ambulation and increased the total walking time (P metronome recording home and used it daily for 1 week while walking, freezing remained unimproved. Though advocated in prior publications as a walking aid for PD patients, auditory metronome pacing slows walking and is not a beneficial intervention for freezing during their 'on' periods.

  6. A randomized, controlled, single-blind, 6-month pilot study to evaluate the efficacy of MS-Line!: a cognitive rehabilitation programme for patients with multiple sclerosis.

    Science.gov (United States)

    Gich, Jordi; Freixanet, Jordi; García, Rafael; Vilanova, Joan Carles; Genís, David; Silva, Yolanda; Montalban, Xavier; Ramió-Torrentà, Lluís

    2015-09-01

    MS-Line! was created to provide an effective treatment for cognitive impairment in multiple sclerosis (MS) patients. To assess the efficacy of MS-Line!. A randomized, controlled, single-blind, 6-month pilot study. Patients were randomly assigned to an experimental group (cognitive rehabilitation with the programme) or to a control group (no cognitive rehabilitation). Randomization was stratified by cognitive impairment level. Cognitive assessment included: selective reminding test, 10/36 spatial recall test (10/36 SPART), symbol digit modalities test, paced auditory serial addition test, word list generation (WLG), FAS test, subtests of WAIS-III, Boston naming test (BNT), and trail making test (TMT). Forty-three patients (22 in the experimental group, 21 in the control group) were analyzed. Covariance analysis showed significant differences in 10/36 SPART (P=0.0002), 10/36 SPART delayed recall (P=0.0021), WLG (P=0.0123), LNS (P=0.0413), BNT (P=0.0007) and TMT-A (P=0.010) scores between groups. The study showed a significant improvement related to learning and visual memory, executive functions, attention and information processing speed, and naming ability in those patients who received cognitive rehabilitation. The results suggest that MS-Line! is effective in improving cognitive impairment in MS patients. © The Author(s), 2015.

  7. The Efficacy of Daily Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) for Burning Mouth Syndrome (BMS): A Randomized Controlled Single-blind Study.

    Science.gov (United States)

    Umezaki, Yojiro; Badran, Bashar W; DeVries, William H; Moss, Jkeonye; Gonzales, Theresa; George, Mark S

    2016-01-01

    Burning mouth syndrome (BMS) is a burning oral sensation without any corresponding abnormal findings. In some cases, BMS is refractory to pharmacologic treatments. Repetitive transcranial magnetic stimulation (rTMS) over left prefrontal cortex induces analgesic effect in both acute and chronic pain. However, its effect for BMS has not been evaluated. The aim of this randomized, controlled, single-blind study was to assess the efficacy of prefrontal rTMS for BMS. Twenty patients with BMS were recruited and randomized to receive 30,000 pulses in total at 10 Hz TMS (n = 12) or sham TMS (n = 8). We assessed the change of BMS pain condition, functional status and mood until 2 months after the beginning of treatment. In the real group, the BMS pain intensity decreased 67%, and 75% of the patients reported >50% pain decrease on final assessment compared to baseline, without heavy side effects. There was significant pain reduction in subjects in the real group immediately after 1 week of treatment, whereas there was none in those in the sham group. Similar tendency was confirmed in change of functional status. Mood and the affective aspect of pain were not changed in this study. BMS pain was significantly improved with 2 weeks of treatment of high frequency rTMS over left DLPFC compared to sham stimulation. Further study is needed to refine and improve TMS as a potential treatment of BMS. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial.

    Science.gov (United States)

    Ferraz, Daniel Dominguez; Trippo, Karen Valadares; Duarte, Gabriel Pereira; Neto, Mansueto Gomes; Bernardes Santos, Kionna Oliveira; Filho, Jamary Oliveira

    2018-05-01

    To compare the effects of functional training, bicycle exercise, and exergaming on walking capacity of elderly with Parkinson disease (PD). A pilot randomized, controlled, single-blinded trial. A state reference health care center for elderly, a public reference outpatient clinic for the elderly. Elderly individuals (≥60 years of age; N=62) with idiopathic PD (stage 2 to 3 of modified Hoehn and Yahr staging scale) according to the London Brain Bank. The participants were randomly assigned to three groups. Group 1 (G1) participated in functional training (n=22); group 2 (G2) performed bicycle exercise (n=20), and group 3 (G3) trained with Kinect Adventures (Microsoft, Redmond, WA) exergames (n=20). The primary outcome measure was the 6-minute walk test (6MWT); secondary outcome measures were the 10-m walk test (10MWT), sitting-rising test (SRT), body mass index, Parkinson Disease Questionnaire-39, World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), and 15-item Geriatric Depression Scale. All groups showed significant improvements in 6MWT (G1 P=.008; G2 P=.001; G3 P=.005), SRT (G1 Ptraining had similar outcomes compared with functional training and bicycle exercise. The three physical exercise modalities presented significant improvements on walking capacity, ability to stand up and sit, and functionality of the participants. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  9. Evaluation of the effect of balneotherapy in patients with osteoarthritis of the hands: a randomized controlled single-blind follow-up study.

    Science.gov (United States)

    Horváth, Katalin; Kulisch, Ágota; Németh, András; Bender, Tamás

    2012-05-01

    To evaluate the effectiveness of thermal mineral water compared with magnetotherapy without balneotherapy as control, in the treatment of hand osteoarthritis. Randomized controlled single-blind follow-up study. Rheumatology specialist clinic of Gunaras Health Spa. Patients between 50 and 70 years of age with hand osteoarthritis, randomly assigned into three groups. The subjects in the first two groups bathed in thermal mineral water of two different temperatures (36°C and 38°C) for three weeks five times a week for 20 minutes a day and received magnetotherapy to their hands three times weekly. The third group received only magnetotherapy. Visual analogue scale scores, handgrip strength, pinchgrip strength, the number of swollen and tender joints of the hand, the duration of morning joint stiffness, Health Assessment Questionnaire, and Short Form-36 questionnaire. The study parameters were administered at baseline, immediately after treatment and after 13 weeks. The study included 63 patients. Statistically significant improvement was observed in several studied parameters after the treatment and during the follow-up study in the thermal water groups versus the control group. The 38°C thermal water treatment significantly improved the pinch strength of the right hand (0.6 (95% confidence interval (CI) 0.2 to 1.1) vs. 0.03 (95% CI -0.3 to 0.4), P magnetotherapy improved the pain and function as well as the quality of life in patients with hand osteoarthritis.

  10. The effect of counseling on anxiety after traumatic childbirth in nulliparous women; a single blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mahnaz Azizi

    2010-09-01

    Full Text Available Background: Traumatic birthing mothers may expose more susceptible to experiences posttraumatic mental disorder such as anxiety. This study aimed to determine the effect of midwifery counseling intervention on the anxiety level after traumatic childbirth of primiparous women.Methods: In a randomized control trial 180 woman who had experienced traumatic childbirth based on DSM-IV criteria have been selected. The subjects were randomly divided into an intervention (n=90 and control (n=90 groups. The intervention group received midwifery counseling during two sessions and control group just received routin health care after childbirth. Both groups were followed up with partial – blind technique and compared 4-6 weeks and 3 months post partum. The data were analyzed using descriptive statistics by SPSS software. Results: Demographic characteristics, pregnancy complications and social support level were the same in both groups. In addition, there was no significant difference between two groups according to stress, depression and anxiety level before intervention (P>0.05. There was significant difference between two groups in anxiety level after 4-6 weeks and 3 months followup (P<0.001.Conclusion: Findings of this research shows that performing midwifery-counseling program may have significant effect on decreasing of anxiety level after traumatic childbirth.

  11. Effect of Aerobic Exercise on Improving Symptoms of Individuals With Schizophrenia: A Single Blinded Randomized Control Study

    Directory of Open Access Journals (Sweden)

    Peng-Wei Wang

    2018-05-01

    Full Text Available Introduction: Antipsychotic treatment can improve the symptoms of schizophrenia; however, residual symptoms after antipsychotic treatment are frequent. The effects of exercise on the symptoms of schizophrenic patients under antipsychotic treatment are inconclusive. The aim of this randomized case-control study was to examine the effects of aerobic exercise (AE on the symptoms of schizophrenic patients receiving antipsychotic treatment.Methods: In total, 33 and 29 participants being treated with antipsychotics for schizophrenia were randomly assigned into the aerobic exercise (AE group and the control group, respectively. The severities of schizophrenic symptoms were measured using the Chinese version of the Positive and Negative Syndrome Scale (PANSS before, immediately after, and 3 months after the intervention in both groups.Results: In total, 24 participants (72.7% in the AE group and 22 (75.9% in the control group completed the study. The results indicated that the severities of positive symptoms and general psychopathology in the AE group significantly decreased during the 12 weeks of intervention but did not further significantly change during the 3-month follow-up period. The severities of negative symptoms in the AE group decreased significantly after 12 weeks of intervention and continued decreasing during the 3-month follow-up period. Interaction effects between time and group on the severities of symptoms on the negative and general psychopathology scales were observed.Conclusion: AE can improve the severities of symptoms on the negative and general psychopathology scales in individuals with schizophrenia being treated with antipsychotics.

  12. Bilateral and unilateral arm training improve motor function through differing neuroplastic mechanisms: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Whitall, Jill; Waller, Sandy McCombe; Sorkin, John D; Forrester, Larry W; Macko, Richard F; Hanley, Daniel F; Goldberg, Andrew P; Luft, Andreas

    2011-02-01

    This randomized controlled trial tests the efficacy of bilateral arm training with rhythmic auditory cueing (BATRAC) versus dose-matched therapeutic exercises (DMTEs) on upper-extremity (UE) function in stroke survivors and uses functional magnetic resonance imaging (fMRI) to examine effects on cortical reorganization. A total of 111 adults with chronic UE paresis were randomized to 6 weeks (3×/week) of BATRAC or DMTE. Primary end points of UE assessments of Fugl-Meyer UE Test (FM) and modified Wolf Motor Function Test Time (WT) were performed 6 weeks prior to and at baseline, after training, and 4 months later. Pretraining and posttraining, fMRI for UE movement was evaluated in 17 BATRAC and 21 DMTE participants. The improvements in UE function (BATRAC: FM Δ = 1.1 + 0.5, P = .03; WT Δ = -2.6 + 0.8, P frontal gyrus (P < .05). Activation change in the latter was correlated with improvement in the WMFT (P = .01). BATRAC is not superior to DMTE, but both rehabilitation programs durably improve motor function for individuals with chronic UE hemiparesis and with varied deficit severity. Adaptations in brain activation are greater after BATRAC than DMTE, suggesting that given similar benefits to motor function, these therapies operate through different mechanisms.

  13. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

    Science.gov (United States)

    Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

    2009-01-01

    Background To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Canadian Occupational Performance Measure (COPM) and Jamar dynamometer by an observer blinded to treatment allocation. Results Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43), improved hand function and increased grip strength compared to baseline (all p leather splint compared to the commercially available splint. Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction. PMID:19843345

  14. Association Between In-Office And At-Home Tooth Bleaching: A Single Blind Randomized Clinical Trial.

    Science.gov (United States)

    Rodrigues, João Lima; Rocha, Patrícia Souza; Pardim, Silvia Letícia de Souza; Machado, Ana Cláudia Vieira; Faria-E-Silva, André Luis; Seraidarian, Paulo Isaías

    2018-01-01

    This controlled randomized clinical trial evaluated the effect of associating at-home and in-office bleaching procedures on tooth sensitivity (TS) and bleaching effectiveness. Forty patients subjected to on session of in-office bleaching with 38% peroxide hydrogen. Subsequently, the patients were randomly allocated to receive a second session of in-office bleaching or to use a tray containing 10% carbamide peroxide delivered during 7 consecutive days. The worst TS score reported during or after each bleaching procedure was recorded using a verbal rating scale and TS risk (score different from 0) was calculated. Color changes were measured 7 days after each in-office session (for patients receiving in-office procedures only) or after the end of at-home bleaching (for the combined protocol), and 6 months after the last procedure for both bleaching protocols. Color was assessed by a spectrophotometer and by color match with the Vita Classical and Bleach guide scales. Statistical analyses were carried out to assess possible differences between the protocols regarding the outcomes and to analyze the effect of time of assessment on color changes. The bleaching protocol did not affect the risk for and the maximum level of TS reported, irrespective of the time of assessment. In the color evaluation, the bleaching protocol also did not affect the ultimate tooth color. In conclusion, after one in-office bleaching session, there was no difference in bleaching effectiveness and TS between performing a second in-office session and associating it with 1-week at-home bleaching.

  15. Single-Blind Randomized Controlled Trial of Poly-Herbal Formula Sahatsatara for Acute Low Back Pain: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Thiyapha Verayachankul

    2016-01-01

    Full Text Available Objective: To evaluate the efficacy and safety of poly-herbal formula Sahatsatara (SHT in pain reduction in acute low back pain (LBP patients. Methods: Twenty-nine patients aged 18-65 years with a history of moderate to severe acute LBP ≤3-day (score ≥4 on a 0-10 numeric rating scale [NRS] were enrolled and randomized to receive an ibuprofen (400 mg after meals three times daily or SHT (1,350 mg before meals three times daily for 7 days. The non-inferiority trial margin was set at ±10 percentage points. The outcomes were measured on pain intensity on the 0-10 NRS, disability on the Thai version of the Oswestry disability index [ODI], total analgesic consumption, patient satisfaction, and safety. Results: Fourteen patients and 15 patients were randomly allocated to ibuprofen and SHT groups, respectively. The mean difference in pain intensity and disability between the two groups at day 7 adjusted according to baseline was within ±1 for pain (-0.3; 95% CI, -1.48 to 0.96 and ±10% (-4.9%; 95% CI, -14.86% to 5.02% for the NRS and ODI scores, respectively. One patient in the SHT group and 5 in the ibuprofen group had gastrointestinal irritation, but the difference was not statistically significant. Conclusion: SHT was not inferior to ibuprofen in pain relieving and disability in patients with acute LBP. The result suggests a role for SHT as an alternative analgesic in acute LBP. (Thai Clinical Trials Registry number 20141027001

  16. Effect of treatment of temporomandibular disorders (TMD) in patients with cervicogenic headache: a single-blind, randomized controlled study.

    Science.gov (United States)

    von Piekartz, Harry; Lüdtke, Kerstin

    2011-01-01

    The present study was comprised of 43 patients (16 men) with cervicogenic headaches for over three months, diagnosed according to the International Classification of Diagnostic Criteria of Headaches (ICDH-II). The patients were randomly assigned to receive either manual therapy for the cervical region (usual care group) or additional manual therapy techniques to the temporomandibular region to additionally influence temporomandibular disorders (TMD). All patients were assessed prior to treatment, after six sessions of treatment, and at a six-month follow-up. The outcome criteria were: intensity of headaches measured on a colored analog scale, the Neck Disability Index (Dutch version), the Conti Anamnestic Questionnaire, noise registration at the mandibular joint using a stethoscope, the Graded Chronic Pain Status (Dutch version), mandibular deviation, range of mouth opening, and pressure/pain threshold of the masticatory muscles. The results indicate in the studied sample of cervicogenic headache patients, 44.1% had TMD. The group that received additional temporomandibular manual therapy techniques showed significantly decreased headache intensities and increased neck function after the treatment period. These improvements persisted during the treatment-free period (follow-up) and were not observed in the usual care group. This trend was also reflected on the questionnaires and the clinical temporomandibular signs. Based on these observations, we strongly believe that treatment of the temporomandibular region has beneficial effects for patients with cervicogenic headaches, even in the long-term.

  17. Virtual Reality Telerehabilitation for Postural Instability in Parkinson’s Disease: A Multicenter, Single-Blind, Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Marialuisa Gandolfi

    2017-01-01

    Full Text Available Introduction. Telerehabilitation enables patients to access remote rehabilitation services for patient-physiotherapist videoconferencing in their own homes. Home-based virtual reality (VR balance training has been shown to reduce postural instability in patients with Parkinson’s disease (PD. The primary aim was to compare improvements in postural stability after remotely supervised in-home VR balance training and in-clinic sensory integration balance training (SIBT. Methods. In this multicenter study, 76 PD patients (modified Hoehn and Yahr stages 2.5–3 were randomly assigned to receive either in-home VR telerehabilitation (n=38 or in-clinic SIBT (n=38 in 21 sessions of 50 minutes each, 3 days/week for 7 consecutive weeks. VR telerehabilitation consisted of graded exergames using the Nintendo Wii Fit system; SIBT included exercises to improve postural stability. Patients were evaluated before treatment, after treatment, and at 1-month follow-up. Results. Analysis revealed significant between-group differences in improvement on the Berg Balance Scale for the VR telerehabilitation group (p=0.04 and significant Time × Group interactions in the Dynamic Gait Index (p=0.04 for the in-clinic group. Both groups showed differences in all outcome measures over time, except for fall frequency. Cost comparison yielded between-group differences in treatment and equipment costs. Conclusions. VR is a feasible alternative to in-clinic SIBT for reducing postural instability in PD patients having a caregiver.

  18. Combination of intracostal sutures with muscle flap to decrease post thoracotomy pain: A single blinded randomized clinical trial.

    Science.gov (United States)

    Montazer, Majid; Hashemzade, Shahryar; Gargari, Reza Movassaghi; Ramouz, Ali; Sanaie, Sarvin; Rasihashemi, Seyed Ziaeddin

    2017-01-01

    To assess the efficacy of intercostal nerve protection by intercostal muscle (ICM) flap in post-thoracotomy pain improvement compared to intracostal suturing. In a randomized controlled trial, ninety-four patients undergoing posterolateral thoracotomy surgery were divided into two subgroups. Intracostal sutures in isolation and in combination with ICM flap techniques were used for thoracotomy closure in both groups. Numeric Pain Scale and Visual Pain Scale as pain scores were assessed on the first, second, third, fourth, fifth, sixth and seventh postoperative days and follow-up visits during the 2 nd week, 1 st , 2 nd , 4 th and 6 th months after thoracotomy. Out of 94 patients, 58 were male and 36 were females. While the mean age of patients in intracostal group was 45.3 ± 17.6 years, it was 47.4 ± 16.1 years in intracostal plus ICM flap group. The mean operation time for the first group was 191.0 ± 74.7 minutes, while it was 219.3 ± 68.8 minutes in the second (p>0.05). Numeric rating score and visual pain scale did not demonstrate any significant difference in pain severity on postoperative days and follow-up visits between both groups (p>0.05). Although the trend of pain reduction was significant in each group (p0.001). Intracostal sutures in combination with muscle flap did not reduce postoperative pain in thoracotomy compared with intracostal sutures alone in thoracotomy closure.

  19. Effects of a modified technique for TVT-O positioning on postoperative pain: single-blind randomized study.

    Science.gov (United States)

    Tommaselli, Giovanni A; Formisano, Carmen; Di Carlo, Costantino; Fabozzi, Annamaria; Nappi, Carmine

    2012-09-01

    One of the most frequent and distressing complications of the tension-free vaginal tape obturator (TVT-O) procedure for stress urinary incontinence (SUI) is groin pain, which may be related to the surgical technique or to the tape. The aim of this study was to evaluate the impact of a more limited dissection and a more medial trocar trajectory in TVT-O positioning on postoperative pain. Seventy-two SUI patients were randomized to undergo TVT-O either with the traditional technique (group A) or a modified procedure (reduced paraurethral dissection and a more medial trocar trajectory) (group B). Visual analog scale pain scores 12 h, 24 h, and 1 month after the procedure, number of analgesic vials, objective cure rate, and patient functional and quality of life scores 6 months after the procedure were evaluated. Data were analyzed by the Student's t test for parametric variables, the Mann-Whitney U and Wilcoxon tests for nonparametric variables, and Fisher's exact test for categorical variables. Pain scores were significantly lower in group B compared with group A 24 h after surgery (P = 0.01). Pain scores significantly decreased from 12-24 h postoperatively to 1 month follow-up in both groups (P TVT-O seem to reduce postoperative groin pain at 24 h after the procedure, but not the analgesic requirement.

  20. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    Science.gov (United States)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-11-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls ( p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  1. Eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy: a randomized, single blinded, clinical trial.

    Science.gov (United States)

    Dejaco, Beate; Habets, Bas; van Loon, Corné; van Grinsven, Susan; van Cingel, Robert

    2017-07-01

    To investigate the effectiveness of isolated eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy. Thirty-six patients with rotator cuff tendinopathy, diagnosed by an orthopaedic surgeon, were included and randomly allocated to an isolated eccentric exercise (EE) group (n = 20, mean age = 50.2 ± 10.8 years) or a conventional exercise (CG) group (n = 16, mean age = 48.6 ± 12.3 years). Both groups fulfilled a 12-week daily home-based exercise programme and received a total amount of nine treatment sessions. The Constant Murley score was used to evaluate both objective (e.g. range of motion and strength) and subjective measures (e.g. pain and activities of daily living). A visual analogue scale (VAS) was used to evaluate pain during daily activities. As secondary outcomes, shoulder range of motion and isometric abduction strength in 45° in the scapular plane were evaluated. All measurements were taken at baseline, at 6, 12 and 26 weeks. After 26 weeks, both groups showed a significant increase in the Constant Murley score and a significant decrease in VAS scores. No difference was found between the groups, for any of the evaluated outcome measures. A 12-week-isolated eccentric training programme of the rotator cuff is beneficial for shoulder function and pain after 26 weeks in patients with rotator cuff tendinopathy. However, it is no more beneficial than a conventional exercise programme for the rotator cuff and scapular muscles. Based on the results, clinicians should take into account that performing two eccentric exercises twice a day is as effective as performing six concentric/eccentric exercises once a day in patients with rotator cuff tendinopathy.

  2. Lithium trial in Alzheimer's disease: a randomized, single-blind, placebo-controlled, multicenter 10-week study.

    LENUS (Irish Health Repository)

    Hampel, Harald

    2012-02-01

    OBJECTIVE: Lithium, a first-line drug for the treatment of bipolar depression, has recently been shown to regulate glycogen synthase kinase-3 (GSK-3), a kinase that is involved in the phosphorylation of the tau protein. Since hyperphosphorylation of tau is a core pathological feature in Alzheimer\\'s disease, lithium-induced inhibition of GSK-3 activity may have therapeutic effects in Alzheimer\\'s disease. In the current study, we tested the effect of short-term lithium treatment in patients with Alzheimer\\'s disease. METHOD: A total of 71 patients with mild Alzheimer\\'s disease (Mini-Mental State Examination score > or = 21 and < or = 26) were successfully randomly assigned to placebo (N = 38) or lithium treatment (N = 33) at 6 academic expert memory clinics. The 10-week treatment included a 6-week titration phase to reach the target serum level of lithium (0.5-0.8 mmol\\/L). The primary outcome measures were cerebrospinal fluid (CSF) levels of phosphorylated tau (p-tau) and GSK-3 activity in lymphocytes. Secondary outcome measures were CSF concentration of total tau and beta-amyloid(1-42) (Abeta(1-42)), plasma levels of Abeta(1-42), Alzheimer\\'s Disease Assessment Scale (ADAS)-Cognitive summary scores, MMSE, and Neuropsychiatric Inventory (NPI). Patients were enrolled in the study from November 2004 to July 2005. RESULTS: No treatment effect on GSK-3 activity or CSF-based biomarker concentrations (P > .05) was observed. Lithium treatment did not lead to change in global cognitive performance as measured by the ADAS-Cog subscale (P = .11) or in depressive symptoms. CONCLUSIONS: The current results do not support the notion that lithium treatment may lead to reduced hyperphosphorylation of tau protein after a short 10-week treatment in the Alzheimer\\'s disease target population. TRIAL REGISTRATION: (Controlled-Trials.com) Identifier: ISRCTN72046462.

  3. Acute effects of exergames on cognitive function of institutionalized older persons: a single-blinded, randomized and controlled pilot study.

    Science.gov (United States)

    Monteiro-Junior, Renato Sobral; da Silva Figueiredo, Luiz Felipe; Maciel-Pinheiro, Paulo de Tarso; Abud, Erick Lohan Rodrigues; Braga, Ana Elisa Mendes Montalvão; Barca, Maria Lage; Engedal, Knut; Nascimento, Osvaldo José M; Deslandes, Andrea Camaz; Laks, Jerson

    2017-06-01

    Improvements on balance, gait and cognition are some of the benefits of exergames. Few studies have investigated the cognitive effects of exergames in institutionalized older persons. To assess the acute effect of a single session of exergames on cognition of institutionalized older persons. Nineteen institutionalized older persons were randomly allocated to Wii (WG, n = 10, 86 ± 7 year, two males) or control groups (CG, n = 9, 86 ± 5 year, one male). The WG performed six exercises with virtual reality, whereas CG performed six exercises without virtual reality. Verbal fluency test (VFT), digit span forward and digit span backward were used to evaluate semantic memory/executive function, short-term memory and work memory, respectively, before and after exergames and Δ post- to pre-session (absolute) and Δ % (relative) were calculated. Parametric (t independent test) and nonparametric (Mann-Whitney test) statistics and effect size were applied to tests for efficacy. VFT was statistically significant within WG (-3.07, df = 9, p = 0.013). We found no statistically significant differences between the two groups (p > 0.05). Effect size between groups of Δ % (median = 21 %) showed moderate effect for WG (0.63). Our data show moderate improvement of semantic memory/executive function due to exergames session. It is possible that cognitive brain areas are activated during exergames, increasing clinical response. A single session of exergames showed no significant improvement in short-term memory, working memory and semantic memory/executive function. The effect size for verbal fluency was promising, and future studies on this issue should be developed. RBR-6rytw2.

  4. Efficacy of Anticholinergics for Chronic Prostatitis/Chronic Pelvic Pain Syndrome in Young and Middle-Aged Patients: A Single-Blinded, Prospective, Multi-Center Study

    Directory of Open Access Journals (Sweden)

    Doo Sang Kim

    2011-09-01

    Full Text Available Purpose Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS exhibits variable lower urinary tract symptoms (LUTS. The aim of this study was to evaluate the incidence of LUTS and the efficacy of an anticholinergic agent in young and middle-aged CP/CPPS patients. Methods Ninety-six men with CP/CPPS were randomly assigned in a single-blind fashion and received either ciprofloxacin (group 1, 49 patients or ciprofloxacin and solifenacin (5 mg/day; group 2, 47 patients for 8 weeks. The National Institutes of Health chronic prostatitis symptom index (NIH-CPSI, the International Prostate Symptom Score (IPSS, and the International Index of Erectile Function-5 (IIEF-5 were used to grade the patients' symptoms and the quality of life impact at the start of the study, and at 4 and 8 weeks from the initiation of the study. Results There was no significant difference between groups 1 and 2 with respect to age, duration of disease, or sub-domains of the IPSS, NIH-CPSI, or IIEF-5 at baseline. Of these patients, 67.4% had LUTS. Statistically significant differences were determined via the NIH-CPSI for total score and the pain and urinary domain scores. Statistically significant differences were determined via the IPSS for total score and the storage domain score. The total score of the IIEF-5 increased, but the change was not significant. There was no statistically significant difference in residual urine. Conclusions Many CP/CPPS patients had LUTS. Solifenacin in CP/CPPS demonstrated improvements in the NIH-CPSI and the IPSS total score and storage score. Storage factors significantly improved via the NIH-CPSI and IPSS assessments in the solifenacin treatment group.

  5. Effect of Aromatherapy with Peppermint Oil on the Severity of Nausea and Vomiting in Pregnancy: A Single-blind, Randomized, Placebo-controlled trial.

    Science.gov (United States)

    Joulaeerad, Narges; Ozgoli, Giti; Hajimehdipoor, Homa; Ghasemi, Erfan; Salehimoghaddam, Fatemeh

    2018-01-01

    Nausea and vomiting are common complaints in the first half of pregnancy. These symptoms can significantly affect a person's personal and professional life. Aromatherapy is one of the types of complementary medicine that is used in the treatment of nausea and vomiting. The objective of this study was to determine the effect of aromatherapy with peppermint oil on the severity of nausea and vomiting of pregnancy (NVP). This was a single-blind clinical trial that was conducted on 56 pregnant women with mild to moderate severity of NVP and 6 to 20 weeks of gestational age. After the determination of gestational age and base severity of NVP in each woman, they were randomly assigned to one of the two groups: peppermint oil (n=28) or placebo (n=28). Inhalation aromatherapy was done for four days and at the end of each day, they responded to the Pregnancy Unique Quantification of Emesis/Nausea questionnaire (PUQE). The data obtained were analyzed with Mann-Whitney test and ANOVA with repeated measures using SPSS software version 22. Also, the level of significance was paromatherapy with peppermint oil and placebo were the same in this study. This similarity can be due to psychological impacts of intervention on pregnant women.

  6. Effect of inhalation aromatherapy with lavender essential oil on stress and vital signs in patients undergoing coronary artery bypass surgery: A single-blinded randomized clinical trial.

    Science.gov (United States)

    Bikmoradi, Ali; Seifi, Zahra; Poorolajal, Jalal; Araghchian, Malihe; Safiaryan, Reza; Oshvandi, Khodayar

    2015-06-01

    At present, aromatherapy is used widely in medical research. This study aimed to investigate the effects of inhalation aromatherapy using lavender essential oil to reduce mental stress and improve the vital signs of patients after coronary artery bypass surgery (CABG). A single-blinded randomized controlled trial was conducted with 60 patients who had undergone CABG in a 2-day intervention that targeted stress reduction. Sixty subjects following coronary artery bypass surgery in two aromatherapy and control groups. The study was conducted in Ekbatan Therapeutic and Educational Center, Hamadan, Iran, in 2013. On the second and third days after surgery, the aromatherapy group patients received two drops of 2% lavender essential oil for 20min and the control group received two drops of distilled water as a placebo. The primary outcome was mental stress, which was measured before and after the intervention using the DASS-21 questionnaire. The secondary outcomes were vital signs, including the heart rate, respiratory rate, and systolic and diastolic blood pressure, which were measured before and after the intervention. The individual characteristics of the aromatherapy and control groups were the same. There were no significant difference in the mean mental stress scores and vital signs of the aromatherapy and control groups on the second or third days after surgery. Inhalation aromatherapy with lavender essential oil had no significant effects on mental stress and vital signs in patients following CABG, except the systolic blood pressure. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose-comparison trial.

    Directory of Open Access Journals (Sweden)

    Leonore Lovis

    Full Text Available BACKGROUND: Schistosomiasis and opisthorchiasis are of public health importance in Southeast Asia. Praziquantel (PZQ is the drug of choice for morbidity control but few dose comparisons have been made. METHODOLOGY: Ninety-three schoolchildren were enrolled in an area of Lao PDR where Schistosoma mekongi and Opisthorchis viverrini coexist for a PZQ dose-comparison trial. Prevalence and intensity of infections were determined by a rigorous diagnostic effort (3 stool specimens, each examined with triplicate Kato-Katz before and 28-30 days after treatment. Ninety children with full baseline data were randomized to receive PZQ: the 40 mg/kg standard single dose (n = 45 or a 75 mg/kg total dose (50 mg/kg+25 mg/kg, 4 hours apart; n = 45. Adverse events were assessed at 3 and 24 hours posttreatment. PRINCIPAL FINDINGS: Baseline infection prevalence of S. mekongi and O. viverrini were 87.8% and 98.9%, respectively. S. mekongi cure rates were 75.0% (95% confidence interval (CI: 56.6-88.5% and 80.8% (95% CI: 60.6-93.4% for 40 mg/kg and 75 mg/kg PZQ, respectively (P = 0.60. O. viverrini cure rates were significantly different at 71.4% (95% CI: 53.4-84.4% and 96.6% (95% CI: not defined, respectively (P = 0.009. Egg reduction rates (ERRs against O. viverrini were very high for both doses (>99%, but slightly lower for S. mekongi at 40 mg/kg (96.4% vs. 98.1% and not influenced by increasing diagnostic effort. O. viverrini cure rates would have been overestimated and no statistical difference between doses found if efficacy was based on a minimum sampling effort (single Kato-Katz before and after treatment. Adverse events were common (96%, mainly mild with no significant differences between the two treatment groups. CONCLUSIONS/SIGNIFICANCE: Cure rate from the 75 mg/kg PZQ dose was more efficacious than 40 mg/kg against O. viverrini but not against S. mekongi infections, while ERRs were similar for both doses. TRIAL REGISTRATION: Controlled

  8. Can Dual Task Walking Improve in Parkinson's Disease After External Focus of Attention Exercise? A Single Blind Randomized Controlled Trial.

    Science.gov (United States)

    Beck, Eric N; Intzandt, Brittany N; Almeida, Quincy J

    2018-01-01

    It may be possible to use attention-based exercise to decrease demands associated with walking in Parkinson's disease (PD), and thus improve dual task walking ability. For example, an external focus of attention (focusing on the effect of an action on the environment) may recruit automatic control processes degenerated in PD, whereas an internal focus (limb movement) may recruit conscious (nonautomatic) control processes. Thus, we aimed to investigate how externally and internally focused exercise influences dual task walking and symptom severity in PD. Forty-seven participants with PD were randomized to either an Externally (n = 24) or Internally (n = 23) focused group and completed 33 one-hour attention-based exercise sessions over 11 weeks. In addition, 16 participants were part of a control group. Before, after, and 8 weeks following the program (pre/post/washout), gait patterns were measured during single and dual task walking (digit-monitoring task, ie, walking while counting numbers announced by an audio-track), and symptom severity (UPDRS-III) was assessed ON and OFF dopamine replacement. Pairwise comparisons (95% confidence intervals [CIs]) and repeated-measures analyses of variance were conducted. Pre to post: Dual task step time decreased in the external group (Δ = 0.02 seconds, CI 0.01-0.04). Dual task step length (Δ = 2.3 cm, CI 0.86-3.75) and velocity (Δ = 4.5 cm/s, CI 0.59-8.48) decreased (became worse) in the internal group. UPDRS-III scores (ON and OFF) decreased (improved) in only the External group. Pre to washout: Dual task step time ( P = .005) and percentage in double support ( P = .014) significantly decreased (improved) in both exercise groups, although only the internal group increased error on the secondary counting task (ie, more errors monitoring numbers). UPDRS-III scores in both exercise groups significantly decreased ( P = .001). Since dual task walking improvements were found immediately, and 8 weeks after the cessation of an

  9. A Pilot Randomized, Single Blind, Placebo-Controlled Trial of Traditional Acupuncture for Vasomotor Symptoms and Mechanistic Pathways of Menopause

    Science.gov (United States)

    Painovich, Jeannette M.; Shufelt, Chrisandra L.; Azziz, Ricardo; Yang, Yuching; Goodarzi, Mark O.; Braunstein, Glenn D.; Karlan, Beth Y.; Stewart, Paul M.; Merz, C. Noel Bairey

    2011-01-01

    Objective To conduct a pilot study for feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) to sham acupuncture (SA) and waiting control (WC) on menopause related vasomotor symptoms (VMS), quality of life (QOL), and the hypothalamic-pituitary-adrenal (HPA) axis in peri and post-menopausal women. Methods Thirty-three peri and post-menopausal women with at least 7 VMS daily were randomized to TA, SA or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, MENQOL questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24 hour urine cortisol and metabolites, and ACTH stimulation testing. Results Both TA and SA groups demonstrated improved VMS trends compared to WC (Δ −3.5±3.00 vs. −4.1±3.79 vs. −1.2±2.4, respectively, p=.20), and significantly improved MENQOL vasomotor scores (Δ − 1.5±2.02 vs. −1.8±1.52 vs. 0.3±0.64, respectively, p=.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA vs the SA or WC in total cortisol metabolites (4,658.9±1,670.9 vs 7,735.8±3,747.9 vs 5,166.0±2,234.5, p=0.03, respectively) and DHEA (41.4±27.46, 161.2±222.77, 252.4±385.40, respectively, p=0.05). The ACTH stimulation cortisol response data also trended in the hypothesized direction (p=0.17). Conclusion Both TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared to WC; however, TA alone may impact the HPA axis. This association is viewed as preliminary and hypothesis-generating and should be explored in a large clinical trial. PMID:21968279

  10. Whole body and local cryotherapy in restless legs syndrome: A randomized, single-blind, controlled parallel group pilot study.

    Science.gov (United States)

    Happe, Svenja; Evers, Stefan; Thiedemann, Christian; Bunten, Sabine; Siegert, Rudolf

    2016-11-15

    Treatment of restless legs syndrome (RLS) is primarily based on drugs. Since many patients report improvement of symptoms due to cooling their legs, we examined the efficacy of cryotherapy in RLS. 35 patients (28 women, 60.9±12.5years) with idiopathic RLS and symptoms starting not later than 6pm were randomized into three groups: cold air chamber at -60°C (n=12); cold air chamber at -10°C (n=12); local cryotherapy at -17°C (n=11). After a two week baseline, the different therapies were applied three minutes daily at 6pm over two weeks, followed by a four week observation period. The patients completed several questionnaires regarding RLS symptoms, sleep, and quality of life on a weekly basis (IRLS, ESS), VAS and sleep/morning protocol were completed daily, MOSS/RLS-QLI were completed once in each period. Additionally, the PLM index was measured by a mobile device at the end of baseline, intervention, and follow-up. The IRLS score was chosen as primary efficacy parameter. At the end of follow-up, significant improvement of RLS symptoms and quality of life could be observed only in the -60°C group as compared to baseline (IRLS: p=0.009; RLS-QLI: p=0.006; ESS: p=0.020). Local cryotherapy led to improvement in quality of life (VAS4: p=0.028; RLS-QLI: p=0.014) and sleep quality (MOSS: p=0.020; MOSS2: p=0.022) but not in IRLS and ESS. In the -10°C group, the only significant effect was shortening of number of wake phases per night. Serious side-effects were not reported. Whole body cryotherapy at -60°C and, to a less extent, local cryotherapy seem to be a treatment option for RLS in addition to conventional pharmacological treatment. However, the exact mode of cryotherapy needs to be established. Copyright © 2016. Published by Elsevier B.V.

  11. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial.

    Science.gov (United States)

    Bobrow, Kirsten; Farmer, Andrew J; Springer, David; Shanyinde, Milensu; Yu, Ly-Mee; Brennan, Thomas; Rayner, Brian; Namane, Mosedi; Steyn, Krisela; Tarassenko, Lionel; Levitt, Naomi

    2016-02-09

    We assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure. In this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141. © 2016 American Heart Association, Inc.

  12. Does addition of `mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study

    Science.gov (United States)

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

  13. The effect of instruction in analgesic use compared with neuromuscular exercise on knee-joint load in patients with knee osteoarthritis: a randomized, single-blind, controlled trial.

    Science.gov (United States)

    Holsgaard-Larsen, A; Clausen, B; Søndergaard, J; Christensen, R; Andriacchi, T P; Roos, E M

    2017-04-01

    To investigate the effect of a neuro-muscular exercise (NEMEX) therapy program compared with instructions in optimized analgesics and anti-inflammatory drug use (PHARMA), on measures of knee-joint load in people with mild to moderate knee osteoarthritis (OA). We hypothesized that knee joint loading during walking would be reduced by NEMEX and potentially increased by PHARMA. Single-blind, randomized controlled trial (RCT) comparing NEMEX therapy twice a week with PHARMA. Participants with mild-to-moderate medial tibiofemoral knee OA were randomly allocated (1:1) to one of two 8-week treatments. Primary outcome was change in knee load during walking (Knee Index, a composite score from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes were frontal plane peak knee adduction moment (KAM), Knee Injury and Osteoarthritis Outcome Scores (KOOS) and functional performance tests. Ninety three participants (57% women, 58 ± 8 years with a body mass index [BMI] of 27 ± 4 kg/m 2 (mean ± standard deviation [SD])) were randomized to NEMEX group (n = 47) or PHARMA (n = 46); data from 44 (94%) and 41 (89%) participants respectively, were available at follow-up. 49% of the participants in NEMEX and only 7% in PHARMA demonstrated good compliance. We found no difference in the primary outcome as evaluated by the Knee Index -0.07 [-0.17; 0.04] Nm/%BW HT. Secondary outcomes largely supported this finding. We found no difference in the primary outcome; knee joint load change during walking from a NEMEX program vs information on the recommended use of analgesics and anti-inflammatory drugs. ClinicalTrials.gov Identifier: NCT01638962 (July 3, 2012). Ethical Committee: S-20110153. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  14. Does addition of 'mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study.

    Science.gov (United States)

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

  15. The efficacy of early initiated, supervised, progressive resistance training compared to unsupervised, home-based exercise after unicompartmental knee arthroplasty: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Jørgensen, Peter B; Bogh, Søren B; Kierkegaard, Signe; Sørensen, Henrik; Odgaard, Anders; Søballe, Kjeld; Mechlenburg, Inger

    2017-01-01

    To examine if supervised progressive resistance training was superior to home-based exercise in rehabilitation after unicompartmental knee arthroplasty. Single blinded, randomized clinical trial. Surgery, progressive resistance training and testing was carried out at Aarhus University Hospital and home-based exercise was carried out in the home of the patient. Fifty five patients were randomized to either progressive resistance training or home-based exercise. Patients were randomized to either progressive resistance training (home based exercise five days/week and progressive resistance training two days/week) or control group (home based exercise seven days/week). Preoperative assessment, 10-week (primary endpoint) and one-year follow-up were performed for leg extension power, spatiotemporal gait parameters and knee injury and osteoarthritis outcome score (KOOS). Forty patients (73%) completed 1-year follow-up. Patients in the progressive resistance training group participated in average 11 of 16 training sessions. Leg extension power increased from baseline to 10-week follow-up in progressive resistance training group (progressive resistance training: 0.28 W/kg, P= 0.01, control group: 0.01 W/kg, P=0.93) with no between-group difference. Walking speed and KOOS scores increased from baseline to 10-week follow-up in both groups with no between-group difference (six minutes walk test P=0.63, KOOS P>0.29). Progressive resistance training two days/week combined with home based exercise five days/week was not superior to home based exercise seven days/week in improving leg extension power of the operated leg.

  16. The effect of vitamin C and/or E supplementations on type 2 diabetic adult males under metformin treatment: A single-blinded randomized controlled clinical trial.

    Science.gov (United States)

    El-Aal, Ali Abd; El-Ghffar, Eman A Abd; Ghali, Asmaa Abu; Zughbur, Mohammed R; Sirdah, Mahmoud M

    2018-03-16

    Recently, there has been an increasing interest in the influence of antioxidant vitamins on the efficacy of oral hypoglycemic therapy in type 2 diabetic patients (T2DM). This single-blinded randomized controlled clinical trial aimed to investigate the effect of vitamin C and/or E supplementation on the efficacy of oral hypoglycemic therapy in T2DM Palestinian male patients from the Gaza Strip. Forty T2DM male patients aged 40-60 years on metformin treatment were randomly divided into four groups, each group received an additional one of the following daily oral supplements for 90 days: placebo; vitamin C; vitamin E and vitamin C plus vitamin E. After overnight fasting, venous blood specimens were collected from all individuals into K3-EDTA tubes and serum tubes for measuring the biochemical and hematological parameters of the study at baseline and after 90 days of vitamins supplementation. The results revealed that vitamin C and/or E improve fasting blood sugar (FBS), HbA1c, lipid profile, insulin, homeostasis model assessment of insulin resistance (HOMA-IR), reduced glutathione (GSH); and Quantitative Insulin Sensitivity Check Index (QISCI) compared with diabetic patients group that received placebo. This study provided additional evidence on the beneficial effects of supplementing antioxidant vitamins in T2DM which could improve the clinical condition and attenuate or prevent diabetic pathogenesis and complications that, secondly to poor glycemic control, could attribute to the imbalance between the decline in the endogenous antioxidants and increasing production of the reactive oxygen species leading to the oxidant-mediated damage present in the diabetic context. Copyright © 2018 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  17. Effects of Taping on Pain and Functional Outcome of Patients with Knee Osteoarthritis: A Pilot Randomized Single-blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Parisa Taheri

    2017-01-01

    Full Text Available Background: To determine the effects of knee taping in combination with exercise and medical treatment on functional outcome and pain of patients with knee osteoarthritis (OA. Materials and Methods: In a randomized single-blinded clinical trial, 36 patients with knee OA were randomly assigned to two study groups. Both groups received exercise and medical therapy for 6 weeks. In addition, the first group (20 patients received taping in the first 3 weeks. Pain severity (assessed by visual analog scaling, weekly amount of analgesics consumption, timed get up and go test (TUG, and step tests were recorded at baseline, 3 and 6 weeks after the treatment and were further compared between two study groups. Results: There was no significant difference between two groups in pain severity score (P = 0.228, step test score (P = 0.771, TUG test score (P = 0.821 and weekly amount of analgesics consumption (P = 0.873 at baseline. After 3 weeks, weekly amount of analgesics consumption (P = 0.006, pain severity (P < 0.001 was significantly lower in taping group whereas step test score (P = 0.006 was significantly higher in the taping group. After 6 weeks, patients in taping group had significantly lower pain severity (P = 0.011 and higher step test score (P = 0.042. However, there was no significant difference in TUG test score (P = 0.443 and weekly amount of analgesics consumption (P = 0.270 between two groups. Conclusion: Therapeutic knee taping may be an effective method for short-term management of pain and disability in patients with knee OA.

  18. Impairment-oriented training or Bobath therapy for severe arm paresis after stroke: a single-blind, multicentre randomized controlled trial.

    Science.gov (United States)

    Platz, T; Eickhof, C; van Kaick, S; Engel, U; Pinkowski, C; Kalok, S; Pause, M

    2005-10-01

    To study the effects of augmented exercise therapy time for arm rehabilitation as either Bobath therapy or the impairment-oriented training (Arm BASIS training) in stroke patients with arm severe paresis. Single blind, multicentre randomized control trial. Three inpatient neurorehabilitation centres. Sixty-two anterior circulation ischaemic stroke patients. Random assignment to three group: (A) no augmented exercise therapy time, (B) augmented exercise therapy time as Bobath therapy and (C) augmented exercise therapy time as Arm BASIS training. Fugl-Meyer arm motor score. Secondary measure: Action Research Arm Test (ARA). Ancillary measures: Fugl-Meyer arm sensation and joint motion/pain scores and the Ashworth Scale (elbow flexors). An overall effect of augmented exercise therapy time on Fugl-Meyer scores after four weeks was not corroborated (mean and 95% confidence interval (CI) of change scores: no augmented exercise therapy time (n=20) 8.8, 5.2-12.3; augmented exercise therapy time (n=40) 9.9, 6.8-13.9; p = 0.2657). The group who received the augmented exercise therapy time as Arm BASIS training (n=20) had, however, higher gains than the group receiving the augmented exercise therapy time as Bobath therapy (n=20) (mean and 95% CI of change scores: Bobath 7.2, 2.6-11.8; BASIS 12.6, 8.4-16.8; p = 0.0432). Passive joint motion/pain deteriorated less in the group who received BASIS training (mean and 95% CI of change scores: Bobath -3.2, -5.2 to -1.1; BASIS 0.1, -1.8-2.0; p = 0.0090). ARA, Fugl-Meyer arm sensation, and Ashworth Scale scores were not differentially affected. The augmented exercise therapy time as Arm BASIS training enhanced selective motor control. Type of training was more relevant for recovery of motor control than therapeutic time spent.

  19. The Immediate Effects of Conventional Physical Therapy on the Knee Joint Load in Subjects with Moderate Knee Osteoarthritis; A Preliminary Single Blinded Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Leila Fattahi

    2015-12-01

    Full Text Available Background: Subjects with knee osteoarthritis typically have higher knee adduction moment. Current research efforts are mainly focused on therapeutic procedures that potentially may modify disease progression. This preliminary study was designed as a single blind (examiner randomized control trial to investigate the impact of conventional physical therapy on pain, and knee joint load in subjects with moderate knee osteoarthritis. Methods: Twelve participants diagnosed with moderate knee OA were randomly assigned into control and intervention groups. Three-dimensional knee kinematic and kinetic data were recorded during the gait before and after 10 sessions of conventional physical therapy. In addition, pain intensity was evaluated by visual analog scale and pain subscale of KOOS questionnaire. The control group did not receive any intervention during the same period. Gait parameters were analyzed within and between groups using nonparametric tests. Results: There was a significant difference between groups in baseline KOOS-pain Score and ML knee force (P=0.048 and P=0.01. Immediately after ten sessions of physical therapy the initial (first peak of knee adduction moment was significantly (P=0.03 lower than that of the control group while the first and second peak of knee AP velocity were significantly (P=0.02, P=0.01 respectively higher. In the intervention group, the second peaks of vertical and anteroposterior (AP knee forces were strongly correlated with the pretest KOOS-pain Score (r=0.99 and r=0.98, P<0.001. Therefore a multivariate general linear model was adopted with adjustment to baseline KOOS-pain. By this adjustment, 51% alleviation of VAS pain score and 81% decrement of first peak of knee adduction moment in comparison to control group was statistically significant (P=0.02, P=0.03 respectively. Conclusion: It seems that ten sessions of conventional physical therapy may modify knee joint load in subjects with moderate knee

  20. Effects of Nintendo Wii™ Training on Occupational Performance, Balance, and Daily Living Activities in Children with Spastic Hemiplegic Cerebral Palsy: A Single-Blind and Randomized Trial.

    Science.gov (United States)

    Atasavun Uysal, Songül; Baltaci, Gül

    2016-10-05

    This study aimed at assessing how the addition of Nintendo Wii ™ (NW) system to the traditional therapy influences occupational performance, balance, and daily living activities in children with spastic hemiplegic Cerebral Palsy (CP). The present study is a single-blind and randomized trial involving 24 children aged 6-14 years, classified as level I or II on the Gross Motor Function Classification System. The children were allocated into two groups: an intervention and a control group, and their families participated in the study. The activity performance analysis of the children was undertaken by using the Canadian Occupational Performance Measure (COPM), functional balance was measured with the Pediatric Balance Scale (PBS), and activities of daily living were assessed with Pediatric Evaluation of Disability Inventory (PEDI). Twenty-four children with CP were randomly divided into two groups: intervention (n = 12) and control group (n = 12). All children in both groups continued their traditional physiotherapy program twice a week, 45 minutes per session, whereas the participants in the intervention group, additionally, were trained with NW, two other days of the week for 12 weeks, with each session lasting for 30 minutes. Self-care, mobility, PEDI total, PBS, and performance of COPM scores increased in the NW group after intervention. Self-care, mobility, and total PEDI increased in the control group as well. However, there was no statistically significant difference found between the groups, except for PBS (P < 0.05). NW contributed to the implementation of occupational performance, daily living activities, and functional balance. We recommend that NW could be used in the rehabilitation program to engage play-based activities with fun.

  1. Consuming High-Carotenoid Fruit and Vegetables Influences Skin Yellowness and Plasma Carotenoids in Young Women: A Single-Blind Randomized Crossover Trial.

    Science.gov (United States)

    Pezdirc, Kristine; Hutchesson, Melinda J; Williams, Rebecca L; Rollo, Megan E; Burrows, Tracy L; Wood, Lisa G; Oldmeadow, Christopher; Collins, Clare E

    2016-08-01

    Consumption of dietary carotenoids from fruits and vegetables (F/V) leads to accumulations in human skin, altering skin yellowness. The influence of the quantity of F/V consumed on skin yellowness and plasma carotenoid concentrations has not been examined previously. To compare the influence of consuming high-carotenoid-containing F/V (HCFV) (176,425 μg beta carotene/wk) vs low-carotenoid F/V (LCFV) (2,073 μg beta carotene/wk) on skin yellowness and plasma carotenoid concentrations, over 4 weeks. A single-blind randomized controlled crossover trial from October 2013 to March 2014. Thirty women were randomized to receive 7 daily servings of HCFV or LCFV for 4 weeks. Following a 2-week washout period they followed the alternate intervention. Skin color (Commission Internationale de l'Eclairage L*a*b* color space, where L* represents skin lightness and positive values of a* and b* represent degrees of redness and yellowness, respectively) was assessed by reflectance spectroscopy in both sun-exposed and nonexposed skin areas. Fasting plasma carotenoids were determined by high-performance liquid chromatography, before and after each intervention period. Linear mixed models were used to determine the HCFV and LCFV response on skin color and plasma carotenoids, adjusting for intervention order, time, and interaction between baseline differences and time. There were no significant differences in mean daily fruit (P=0.42) and vegetable (P=0.17) intakes between HCFV and LCFV groups. Dietary alpha carotene, beta carotene, lutein, and beta cryptoxanthin intakes were significantly different between the two groups (Pcarotenoid concentrations were significantly higher following HCFV than LCFV over 4 weeks. Copyright © 2016 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  2. The effect of balneotherapy on chronic shoulder pain. A randomized, controlled, single-blind follow-up trial. A pilot study.

    Science.gov (United States)

    Tefner, Ildikó Katalin; Kovács, Csaba; Gaál, Ramóna; Koroknai, András; Horváth, Remény; Badruddin, Rakib Mohammed; Borbély, Ildikó; Nagy, Katalin; Bender, Tamás

    2015-06-01

    The effects of balneotherapy on chronic shoulder pain were studied. In this single-blind, randomized, follow-up study involving 46 patients with chronic shoulder pain, one group of patients received physiotherapy--exercise and transcutaneous electrical nerve stimulation--and the other group received balneotherapy in addition to physiotherapy for 4 weeks on 15 occasions. The following parameters were recorded before treatment (at week 0) and after treatment (at weeks 4, 7, and 13): Shoulder Pain and Disability Index (SPADI), the Short Form (36) Health Survey (SF-36) and EuroQuol-5D (EQ-5D) quality of life questionnaires, pain at rest and on movement on the visual analog scale (VAS), and active and passive range of motion. The SPADI pain, function, and total scores and the VAS scores at rest and on movement significantly improved in both groups after treatments. A greater improvement was observed in the balneotherapy group compared to the control group; regarding some parameters (VAS score on movement and SPADI function score at visit 2; VAS score at rest at visits 3 and 4), the difference between the groups was significant. The improvement of SF-36 and EQ-5D quality of life scores and the active range of motion was more pronounced in the balneotherapy group, the difference between the groups was not significant, except for EQ-5D at visit 2. Improvement of passive range of motion was not significant. Balneotherapy may have a beneficial effect on the clinical parameters and quality of life of patients with chronic shoulder pain. The number of patients should be increased.

  3. A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

    Science.gov (United States)

    Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

    2014-04-01

    To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

  4. A Randomized Single Blind Parallel Group Study Comparing Monoherbal Formulation Containing Holarrhena antidysenterica Extract with Mesalamine in Chronic Ulcerative Colitis Patients

    Directory of Open Access Journals (Sweden)

    Sarika Johari

    2016-01-01

    Full Text Available Background: Incidences of side effects and relapses are very common in chronic ulcerative colitis patients after termination of the treatment. Aims and Objectives: This study aims to compare the treatment with monoherbal formulation of Holarrhena antidysenterica with Mesalamine in chronic ulcerative colitis patients with special emphasis to side effects and relapse. Settings and Design: Patients were enrolled from an Ayurveda Hospital and a private Hospital, Gujarat. The study was randomized, parallel group and single blind design. Materials and Methods: The protocol was approved by Institutional Human Research Ethics Committee of Anand Pharmacy College on 23rd Jan 2013. Three groups (n = 10 were treated with drug Mesalamine (Group I, monoherbal tablet (Group II and combination of both (Group III respectively. Baseline characteristics, factors affecting quality of life, chronicity of disease, signs and symptoms, body weight and laboratory investigations were recorded. Side effects and complications developed, if any were recorded during and after the study. Statistical Analysis Used: Results were expressed as mean ± SEM. Data was statistically evaluated using t-test, Wilcoxon test, Mann Whitney U test, Kruskal Wallis test and ANOVA, wherever applicable, using GraphPad Prism 6. Results: All the groups responded positively to the treatments. All the patients were positive for occult blood in stool which reversed significantly after treatment along with rise in hemoglobin. Patients treated with herbal tablets alone showed maximal reduction in abdominal pain, diarrhea, and bowel frequency and stool consistency scores than Mesalamine treated patients. Treatment with herbal tablet alone and in combination with Mesalamine significantly reduced the stool infection. Patients treated with herbal drug alone and in combination did not report any side effects, relapse or complications while 50% patients treated with Mesalamine exhibited the relapse with

  5. The SyBil-AA real-time fMRI neurofeedback study: protocol of a single-blind randomized controlled trial in alcohol use disorder.

    Science.gov (United States)

    Gerchen, Martin Fungisai; Kirsch, Martina; Bahs, Nathalie; Halli, Patrick; Gerhardt, Sarah; Schäfer, Axel; Sommer, Wolfgang H; Kiefer, Falk; Kirsch, Peter

    2018-01-17

    Alcohol Use Disorder is a highly prevalent mental disorder which puts a severe burden on individuals, families, and society. The treatment of Alcohol Use Disorder is challenging and novel and innovative treatment approaches are needed to expand treatment options. A promising neuroscience-based intervention method that allows targeting cortical as well as subcortical brain processes is real-time functional magnetic resonance imaging neurofeedback. However, the efficacy of this technique as an add-on treatment of Alcohol Use Disorder in a clinical setting is hitherto unclear and will be assessed in the Systems Biology of Alcohol Addiction (SyBil-AA) neurofeedback study. N = 100 patients with Alcohol Use Disorder will be randomized to 5 parallel groups in a single-blind fashion and receive real-time functional magnetic resonance imaging neurofeedback while they are presented pictures of alcoholic beverages. The groups will either downregulate the ventral striatum, upregulate the right inferior frontal gyrus, negatively modulate the connectivity between these regions, upregulate, or downregulate the auditory cortex as a control region. After receiving 3 sessions of neurofeedback training within a maximum of 2 weeks, participants will be followed up monthly for a period of 3 months and relapse rates will be assessed as the primary outcome measure. The results of this study will provide insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback training in the treatment of Alcohol Use Disorder as well as in the involved brain systems. This might help to identify predictors of successful neurofeedback treatment which could potentially be useful in developing personalized treatment approaches. The study was retrospectively registered in the German Clinical Trials Register (trial identifier: DRKS00010253 ; WHO Universal Trial Number (UTN): U1111-1181-4218) on May 10th, 2016.

  6. A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects.

    Science.gov (United States)

    Hanes, Vladimir; Chow, Vincent; Zhang, Nan; Markus, Richard

    2017-05-01

    This study compared the pharmacokinetic (PK) profiles of the proposed biosimilar ABP 980 and trastuzumab in healthy males. In this single-blind study, 157 healthy males were randomized 1:1:1 to a single 6 mg/kg intravenous infusion of ABP 980, FDA-licensed trastuzumab [trastuzumab (US)], or EU-authorized trastuzumab [trastuzumab (EU)]. Primary endpoints were area under the serum concentration-time curve from time 0 to infinity (AUC inf ) and maximum observed serum concentration (C max ). To establish equivalence, the geometric mean ratio (GMR) and 90% confidence interval (CI) for C max and AUC inf had to be within the equivalence criteria of 0.80-1.25. The GMRs and 90% CIs for C max and AUC inf , respectively, were: 1.04 (0.99-1.08) and 1.06 (1.00-1.12) for ABP 980 versus trastuzumab (US); 0.99 (0.95-1.03) and 1.00 (0.95-1.06) for ABP 980 versus trastuzumab (EU); and 0.96 (0.92-1.00) and 0.95 (0.90-1.01) for trastuzumab (US) versus trastuzumab (EU). All comparisons were within the equivalence criteria of 0.80-1.25. Treatment-emergent adverse events (TEAEs) were reported in 84.0, 75.0, and 78.2 of subjects in the ABP 980, trastuzumab (US), and trastuzumab (EU) groups, respectively. There were no deaths or TEAEs leading to study discontinuation and no binding or neutralizing anti-drug anti-bodies were detected. This study demonstrated the PK similarity of ABP 980 to both trastuzumab (US) and trastuzumab (EU), and of trastuzumab (US) to trastuzumab (EU). No differences in safety and tolerability between treatments were noted; no subject tested positive for binding anti-bodies.

  7. The Effect of G-ORS Along With Rice Soup in the Treatment of Acute Diarrhea in Children: A Single-Blind Randomized Controlled Trial.

    Science.gov (United States)

    Kianmehr, Mojtaba; Saber, Ashraf; Moshari, Jalil; Ahmadi, Reza; Basiri-Moghadam, Mahdi

    2016-06-01

    The world health organization guidelines for treatment of diarrhea in children emphasize on continued feeding together with prescription of oral rehydration solution (ORS) and supplementary zinc therapy. However, conflicting viewpoints exist regarding the optimal diet and dietary ingredients for children with diarrhea. Moreover, few studies have investigated the effect of rice soup along with ORS in the treatment of this disease. This study aimed to explore effects of simultaneous taking of glucose oral rehydration solution (G-ORS) and rice soup in the treatment of acute diarrhea in 8 to 24-month-old children. This single-blind controlled clinical trial was conducted in the pediatric ward of 22nd of Bahman hospital, Gonabad, Iran between June 2013 and February 2014. Forty children aged 8-24 months with acute diarrhea were randomly assigned into an intervention group (G-ORS plus rice soup group) comprising 20 babies and a control group (G-ORS) of 20 children based on balanced blocking randomization. The variables under investigation were diarrhea duration, patient hospitalization, need for intravenous (IV) fluids and stool output frequency. Data was analyzed using independent samples t and chi-square test. At the end of study, the time for treating acute watery diarrhea in the intervention and control groups were 21.10 ± 8.81 and 34.55 ± 5.82 hours (P < 0.001) and hospital stay were 34.05 ± 6.62 and 40.20 ± 6.32 hours (P = 0.005). Moreover, stool output frequency were 4.20 ± 0.95 and 8.00 ± 1.37 (P < 0.001) in the first 24 hours, and 2.18 ± 0.60 and 2.80 ± 0.76 (P = 0.03) in the second 24 hours of treatment in intervention and control groups, respectively. Rice soup regimen was highly effective and inexpensive in the treatment of acute diarrhea in children. Thus, in addition to the common treatment by G-ORS, rice soup can be consumed simultaneously with G-ORS.

  8. Effect of Pet Insects on the Psychological Health of Community-Dwelling Elderly People: A Single-Blinded, Randomized, Controlled Trial.

    Science.gov (United States)

    Ko, Hae-Jin; Youn, Chang-Ho; Kim, Seong-Hyun; Kim, So-Yun

    2016-01-01

    There is evidence that animal-assisted therapy has positive effects on mental health, especially in elderly people. Caring for insects is easy, relatively inexpensive, and does not require much space. The aim of this 8-week randomized, controlled, single-blinded study was to investigate the effect of pet insects on the psychological health of community-dwelling elderly people. Elderly subjects (≥65 years old) attending a community center in Daegu, Korea, were enrolled in the study between April and May 2014 and randomized at a 1:1 ratio to receive insect therapy and health advice or only health advice. The insect group received 5 crickets in a cage with sufficient fodder and a detailed instruction manual. At baseline and at 8 weeks, all subjects underwent psychometric tests via a direct interview [Beck Anxiety Inventory, Geriatric Depression Scale (GDS-15), Mini-Mental State Examination (MMSE), 36-Item Short Form Health Survey, Insomnia Severity Index, Fatigue Severity Scale, and Brief Encounter Psychosocial Instrument] and laboratory analyses of inflammatory and oxidative stress markers (erythrocyte sedimentation rate, high-sensitivity C-reactive protein, biological antioxidant potential, and derivatives of reactive oxygen metabolites). The insect-caring (n = 46) and control (n = 48) groups did not differ in baseline characteristics. The insect-caring group had significantly lower GDS-15 scores at week 8 (3.20 vs. 4.90, p = 0.004) and, after adjustment for baseline values, a significantly greater change in GDS-15 scores relative to baseline (-1.12 vs. 0.20, p = 0.011). They also had a significantly greater change in MMSE scores relative to baseline (1.13 vs. 0.31, p = 0.045). The two groups did not differ in terms of other psychometric and laboratory tests. No serious risks or adverse events were reported. Caring for insects, which is cost-effective and safe, was associated with a small to medium positive effect on depression and cognitive function in community

  9. Effects of chair yoga therapy on physical fitness in patients with psychiatric disorders: A 12-week single-blind randomized controlled trial.

    Science.gov (United States)

    Ikai, Saeko; Uchida, Hiroyuki; Mizuno, Yuya; Tani, Hideaki; Nagaoka, Maki; Tsunoda, Kenichi; Mimura, Masaru; Suzuki, Takefumi

    2017-11-01

    Since falls may lead to fractures and have serious, potentially fatal outcomes, prevention of falls is an urgent public health issue. We examined the effects of chair yoga therapy on physical fitness among psychiatric patients in order to reduce the risk of falls, which has not been previously reported in the literature. In this 12-week single-blind randomized controlled trial with a 6-week follow-up, inpatients with mixed psychiatric diagnoses were randomly assigned to either chair yoga therapy in addition to ongoing treatment, or treatment-as-usual. Chair yoga therapy was conducted as twice-weekly 20-min sessions over 12 weeks. Assessments included anteflexion in sitting, degree of muscle strength, and Modified Falls Efficacy Scale (MFES) as well as QOL, psychopathology and functioning. Fifty-six inpatients participated in this study (36 men; mean ± SD age, 55.3 ± 13.7 years; schizophrenia 87.5%). In the chair yoga group, significant improvements were observed in flexibility, hand-grip, lower limb muscle endurance, and MFES at week 12 (mean ± SD: 55.1 ± 16.6 to 67.2 ± 14.0 cm, 23.6 ± 10.6 to 26.8 ± 9.7 kg, 4.9 ± 4.0 to 7.0 ± 3.9 kg, and 114.9 ± 29.2 to 134.1 ± 11.6, respectively). Additionally, these improvements were observable six weeks after the intervention was over. The QOL-VAS improved in the intervention group while no differences were noted in psychopathology and functioning between the groups. The intervention appeared to be highly tolerable without any notable adverse effects. The results indicated sustainable effects of 20-min, 12-week, 24-session chair yoga therapy on physical fitness. Chair yoga therapy may contribute to reduce the risk of falls and their unwanted consequences in psychiatric patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Comparison of the effectiveness of orthotic intervention, kinesiotaping, and paraffin treatments in patients with carpal tunnel syndrome: A single-blind and randomized controlled study.

    Science.gov (United States)

    Mansiz Kaplan, Basak; Akyuz, Gulseren; Kokar, Serdar; Yagci, Ilker

    2018-02-17

    The aim of the study was to compare different conservative treatments in patients with carpal tunnel syndrome (CTS). A single-blind randomized controlled study. Patients (n = 169) diagnosed with mild or moderate CTS were screened; 110 met study requirements. The patients were randomized into 3 groups. The control (CON) comparison provided to all patients was a fabricated night orthotic which held the wrist in a neutral position. The second group received adjunctive kinesiotaping (KIN) and the third group received paraffin (PARA). All patients were evaluated clinically, electrophysiologically, and ultrasonographically before treatment and at 3 weeks, 3 months, and 6 months. There were 36 patients in CON, 37 in KIN, and 37 in PARA. Pain reduction in KIN was better than the other groups at 3 weeks (mean difference [MD] in CON 2.4 ± 2.5, KIN 3.7 ± 2.0, PARA 2.7 ± 2.3; P < .01) and 6 months (MD in CON 3.4 ± 3.0, KIN 4.9 ± 3.1, PARA 3.7 ± 2.9; P < .05). KIN pain reduction was better than CON at 3 months (MD in CON 3.8 ± 2.8, KIN 5.0 ± 2.5; P < .05). Reduction of the cross-sectional area of median nerve at the level of radioulnar joint was greater for KIN than CON at 3 weeks (MD in CON 0.0 ± 0.5, KIN 0.3 ± 0.7; P < .01) than PARA at 3 months (MD in KIN 0.3 ± 0.8, PARA 0.0 ± 0.8; P < .05) and both groups at 6 months (MD in CON 0.1 ± 0.8, KIN 0.5 ± 0.9, PARA 0.0 ± 1.0 P < .05). Adding KIN to night use of an orthotic was more effective in achieving symptomatic and structural improvements than either the orthotic alone or adjunctive use of paraffin in patients with mild and moderate CTS. Copyright © 2018 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

  11. Short-term therapy with combination dipeptidyl peptidase-4 inhibitor saxagliptin/metformin extended release (XR) is superior to saxagliptin or metformin XR monotherapy in prediabetic women with polycystic ovary syndrome: a single-blind, randomized, pilot study.

    Science.gov (United States)

    Elkind-Hirsch, Karen E; Paterson, Martha S; Seidemann, Ericka L; Gutowski, Hanh C

    2017-01-01

    To evaluate efficacy with the dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA), metformin extended release (MET), and combination (SAXA-MET) in patients with polycystic ovary syndrome (PCOS) and impaired glucose regulation. Prospective, randomized, single-blind drug study. Outpatient clinic. Patients (n = 38) with PCOS (aged 18-42 years) and prediabetic hyperglycemia determined by a 75-gram oral glucose tolerance test. Patients were randomized to SAXA-MET (5 mg/2,000 mg), SAXA (5 mg), or MET (2,000 mg) for 16 weeks. Fasting and mean blood glucose, insulin sensitivity, insulin secretion, and insulin secretion-sensitivity index (IS-SI) by oral glucose tolerance tests. Free androgen index and lipid levels, average menstrual interval, and anthropometric measurements (body mass index, waist circumference, and waist/height ratio). The study was completed by 34 patients. Nineteen patients had normal glucose tolerance: 3 of 12 (25%) on MET; 6 of 11 (55%) on SAXA; and 10 of 11 (91%) on SAXA-MET (SAXA-MET statistically superior to MET) at study completion. Body mass index, waist circumference, waist/height ratio, free androgen index, insulin sensitivity, IS-SI, and menses improved in all groups; however, IS-SI and menstrual regularity were significantly better with SAXA-MET vs. MET treatment. Triglyceride, triglyceride/high-density lipoprotein cholesterol ratio and mean blood glucose significantly declined in the SAXA-MET and SAXA groups only. This pilot work provides the first evidence regarding the effects of a dipeptidyl peptidase-4 inhibitor alone and in combination with MET in this patient population. Treatment with SAXA-MET was superior to either drug alone in terms of clinical and metabolic benefits in prediabetic patients with PCOS. NCT02022007. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  12. Can shielded brackets reduce mucosa alteration and increase comfort perception in orthodontic patients in the first 3 days of treatment? A single-blind randomized controlled trial.

    Science.gov (United States)

    Pires, Lívia Pereira Brocos; de Oliveira, Augusto Henrique Alves; da Silva, Hillionne Ferreira; de Oliveira, Patrícia Teixeira; dos Santos, Patrícia Bittencourt Dutra; Pinheiro, Fabio Henrique de Sá Leitão

    2015-12-01

    Orthodontic patients can experience pain and discomfort on the oral mucosa from trauma caused by friction with the brackets and the wires. In this split-mouth design, single-blind randomized controlled trial, we aimed to investigate whether brackets with a self-snapping customized plastic shield would induce less mucosa alteration and discomfort than those without the shield. The overall sample comprised 42 patients (22 female, 20 male) from a government-funded orthodontic practice, with a mean age of 16.7 years. Eligibility criteria included, among others, no history of mouth ulcers or systemic diseases. Customized shields for the maxillary and mandibular brackets were fabricated and inserted on one side of the mouth. The null hypothesis was that bracket shielding would have no advantage. The primary outcomes were mucosal and discomfort assessments. As the secondary outcome, the numbers of spontaneous detachments of the shields were reported. Treatment allocation was mainly implemented using a random number table for selection of the intervention side. Only the raters in charge of assessing the oral mucosa were blinded to the side of the mouth where the shields had been placed. The mucosa was assessed by 3 calibrated raters at the following time points: immediately before bracket placement (baseline assessment, T0), 3 days after delivering the shields (direct assessment of intervention, T1), and 4 days after removal of the shields (indirect assessment of intervention, T2). The raters used a newly devised yardstick in which the higher the score, the more severe the alteration. Discomfort was assessed at T1 and T2 using a visual analog scale. The Mann-Whitney U test was performed at the 5% level of significance. Of 60 patients, 42 were eligible, and 35 were randomly selected to have one side of the mouth receive the intervention. Two patients discontinued the intervention at T1, and 5 stopped at T2. Seven additional patients were recruited and completed all time

  13. Effect of novel inhaler technique reminder labels on the retention of inhaler technique skills in asthma: a single-blind randomized controlled trial.

    Science.gov (United States)

    Basheti, Iman A; Obeidat, Nathir M; Reddel, Helen K

    2017-02-09

    Inhaler technique can be corrected with training, but skills drop off quickly without repeated training. The aim of our study was to explore the effect of novel inhaler technique labels on the retention of correct inhaler technique. In this single-blind randomized parallel-group active-controlled study, clinical pharmacists enrolled asthma patients using controller medication by Accuhaler [Diskus] or Turbuhaler. Inhaler technique was assessed using published checklists (score 0-9). Symptom control was assessed by asthma control test. Patients were randomized into active (ACCa; THa) and control (ACCc; THc) groups. All patients received a "Show-and-Tell" inhaler technique counseling service. Active patients also received inhaler labels highlighting their initial errors. Baseline data were available for 95 patients, 68% females, mean age 44.9 (SD 15.2) years. Mean inhaler scores were ACCa:5.3 ± 1.0; THa:4.7 ± 0.9, ACCc:5.5 ± 1.1; THc:4.2 ± 1.0. Asthma was poorly controlled (mean ACT scores ACCa:13.9 ± 4.3; THa:12.1 ± 3.9; ACCc:12.7 ± 3.3; THc:14.3 ± 3.7). After training, all patients had correct technique (score 9/9). After 3 months, there was significantly less decline in inhaler technique scores for active than control groups (mean difference: Accuhaler -1.04 (95% confidence interval -1.92, -0.16, P = 0.022); Turbuhaler -1.61 (-2.63, -0.59, P = 0.003). Symptom control improved significantly, with no significant difference between active and control patients, but active patients used less reliever medication (active 2.19 (SD 1.78) vs. control 3.42 (1.83) puffs/day, P = 0.002). After inhaler training, novel inhaler technique labels improve retention of correct inhaler technique skills with dry powder inhalers. Inhaler technique labels represent a simple, scalable intervention that has the potential to extend the benefit of inhaler training on asthma outcomes. REMINDER LABELS IMPROVE INHALER TECHNIQUE: Personalized

  14. Comparing the effects of aromatherapy massage and inhalation aromatherapy on anxiety and pain in burn patients: A single-blind randomized clinical trial.

    Science.gov (United States)

    Seyyed-Rasooli, Alehe; Salehi, Feridoon; Mohammadpoorasl, Asghar; Goljaryan, Sakineh; Seyyedi, Zahra; Thomson, Brian

    2016-12-01

    Anxiety and pain are recognized as major problems of burn patients; because pharmaceutical treatments for controlling anxiety and pain symptoms lead to complications and an increase in health costs, nonpharmacological nursing interventions were considered for this group of patients. This led to the present study aimed at comparing the effect of aromatherapy massage with inhalation aromatherapy for anxiety and pain in burn patients. This single-blind clinical trial was carried out on 90 patients with burns aromatherapy massage, inhalation aromatherapy, and control group. The patients assigned to the aromatherapy massage group received a massage for half an hour using a blend of lavender and almond oils, while a blend of rose and lavender aroma was used for the inhalation aromatherapy group. Spielberger State Anxiety Inventory was used for measuring anxiety and the visual analog scale (VAS) scale was used for measuring pain. The results showed that three groups were equal in terms of demographics, disease characteristics, and scores of anxiety and pain at the baseline. The mean decreases of anxiety scores were -0.04±5.08, 6.33±12.55, and 6.43±10.60 in the control group, aromatherapy massage group, and inhalation group, respectively (p=0.007). The mean decrease of pain scores were -0.10±0.96, 1.70±1.84, and 0.97±1.56 in the control group, aromatherapy massage group, and inhalation group, respectively (paromatherapy massage and inhalation aromatherapy compared with the control group in reducing both anxiety and pain of burn patients. Therefore, both interventions, which are inexpensive, and noninvasive nursing tasks can be proposed for alleviating anxiety and pain of burn patients. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  15. Topical Hyaluronic Acid vs. Standard of Care for the Prevention of Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer: Single-Blind Randomized Phase III Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Pinnix, Chelsea; Perkins, George H.; Strom, Eric A.; Tereffe, Welela; Woodward, Wendy; Oh, Julia L.; Arriaga, Lisa [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Munsell, Mark F. [Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Kelly, Patrick; Hoffman, Karen E.; Smith, Benjamin D.; Buchholz, Thomas A. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Yu, T. Kuan, E-mail: tkyu@houstonprecisioncc.com [Houston Precision Cancer Center, Houston, TX (United States)

    2012-07-15

    Purpose: To determine the efficacy of an emulsion containing hyaluronic acid to reduce the development of {>=}Grade 2 radiation dermatitis after adjuvant breast radiation compared with best supportive care. Methods and Materials: Women with breast cancer who had undergone lumpectomy and were to receive whole-breast radiotherapy to 50 Gy with a 10- to 16-Gy surgical bed boost were enrolled in a prospective randomized trial to compare the effectiveness of a hyaluronic acid-based gel (RadiaPlex) and a petrolatum-based gel (Aquaphor) for preventing the development of dermatitis. Each patient was randomly assigned to use hyaluronic acid gel on the medial half or the lateral half of the irradiated breast and to use the control gel on the other half. Dermatitis was graded weekly according to the Common Terminology Criteria v3.0 by the treating physician, who was blinded as to which gel was used on which area of the breast. The primary endpoint was development of {>=}Grade 2 dermatitis. Results: The study closed early on the basis of a recommendation from the Data and Safety Monitoring Board after 74 of the planned 92 patients were enrolled. Breast skin treated with the hyaluronic acid gel developed a significantly higher rate of {>=}Grade 2 dermatitis than did skin treated with petrolatum gel: 61.5% (40/65) vs. 47.7% (31/65) (p = 0.027). Only 1ne patient developed Grade 3 dermatitis using either gel. A higher proportion of patients had worse dermatitis in the breast segment treated with hyaluronic acid gel than in that treated with petrolatum gel at the end of radiotherapy (42% vs. 14%, p = 0.003). Conclusion: We found no benefit from the use of a topical hyaluronic acid-based gel for reducing the development of {>=}Grade 2 dermatitis after adjuvant radiotherapy for breast cancer. Additional studies are needed to determine the efficacy of hyaluronic acid-based gel in controlling radiation dermatitis symptoms after they develop.

  16. Topical Hyaluronic Acid vs. Standard of Care for the Prevention of Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer: Single-Blind Randomized Phase III Clinical Trial

    International Nuclear Information System (INIS)

    Pinnix, Chelsea; Perkins, George H.; Strom, Eric A.; Tereffe, Welela; Woodward, Wendy; Oh, Julia L.; Arriaga, Lisa; Munsell, Mark F.; Kelly, Patrick; Hoffman, Karen E.; Smith, Benjamin D.; Buchholz, Thomas A.; Yu, T. Kuan

    2012-01-01

    Purpose: To determine the efficacy of an emulsion containing hyaluronic acid to reduce the development of ≥Grade 2 radiation dermatitis after adjuvant breast radiation compared with best supportive care. Methods and Materials: Women with breast cancer who had undergone lumpectomy and were to receive whole-breast radiotherapy to 50 Gy with a 10- to 16-Gy surgical bed boost were enrolled in a prospective randomized trial to compare the effectiveness of a hyaluronic acid–based gel (RadiaPlex) and a petrolatum-based gel (Aquaphor) for preventing the development of dermatitis. Each patient was randomly assigned to use hyaluronic acid gel on the medial half or the lateral half of the irradiated breast and to use the control gel on the other half. Dermatitis was graded weekly according to the Common Terminology Criteria v3.0 by the treating physician, who was blinded as to which gel was used on which area of the breast. The primary endpoint was development of ≥Grade 2 dermatitis. Results: The study closed early on the basis of a recommendation from the Data and Safety Monitoring Board after 74 of the planned 92 patients were enrolled. Breast skin treated with the hyaluronic acid gel developed a significantly higher rate of ≥Grade 2 dermatitis than did skin treated with petrolatum gel: 61.5% (40/65) vs. 47.7% (31/65) (p = 0.027). Only 1ne patient developed Grade 3 dermatitis using either gel. A higher proportion of patients had worse dermatitis in the breast segment treated with hyaluronic acid gel than in that treated with petrolatum gel at the end of radiotherapy (42% vs. 14%, p = 0.003). Conclusion: We found no benefit from the use of a topical hyaluronic acid–based gel for reducing the development of ≥Grade 2 dermatitis after adjuvant radiotherapy for breast cancer. Additional studies are needed to determine the efficacy of hyaluronic acid–based gel in controlling radiation dermatitis symptoms after they develop

  17. A novel technique of harmonic tissue dissection reduces seroma formation after modified radical mastectomy compared to conventional electrocautery: a single-blind randomized controlled trial.

    Science.gov (United States)

    Faisal, Mohammed; Fathy, Hamada; Shaban, Hamdy; Abuelela, Sameh T; Marie, Ahmed; Khaled, Islam

    2018-01-01

    Seroma is the most frequent postoperative complication following breast cancer surgery. Our aim was to evaluate the effect of the harmonic focus scalpel versus electrocautery in reducing seroma formation post-mastectomy and axillary clearance. A prospective randomized controlled trial study was conducted at the Department of Surgery of Suez Canal University Hospital from April 26th 2014 to 30th June 2016. Seventy-two women, in whom a mastectomy and axillary clearance for breast cancer were performed, were randomly allocated to either harmonic dissection ( n  = 36) or electrocautery ( n  = 36). The mean operative time was significantly longer for harmonic dissection compared with electrocautery (2.63 ± 0.41 vs. 1.75 ± 0.26 h; p  < 0.0001). In addition, a significantly smaller amount of intraoperative blood loss (69.4 ± 25.1 vs. 255.5 ± 41.6 ml; p  = 0.002) and total drainage volume (1277.8 ± 172.5 ml vs. 3300 ± 167.5 ml; p  = 0.002) were found in the harmonic group. Moreover, there was a significant reduction in the time of drain removal (10.9 ± 1.12 vs. 15.9 ± 1.44; p  = 0.001) and the incidence of seroma formation after drain removal [8.3% vs 33.3%; p  = 0.003] in the harmonic group compared with those in the electrocautery group. Harmonic dissection technique leads to significant decreases in intraoperative blood loss, total drainage volume and postoperative seroma in terms of shorter drain duration with a minimal increase in the operative time and better quality of life. Here, we recommend the use of the harmonic dissection technique in mastectomy and axillary clearance.

  18. Two-year survival analysis of twisted wire fixed retainer versus spiral wire and fiber-reinforced composite retainers: a preliminary explorative single-blind randomized clinical trial.

    Science.gov (United States)

    Sobouti, Farhad; Rakhshan, Vahid; Saravi, Mahdi Gholamrezaei; Zamanian, Ali; Shariati, Mahsa

    2016-03-01

    Traditional retainers (both metal and fiber-reinforced composite [FRC]) have limitations, and a retainer made from more flexible ligature wires might be advantageous. We aimed to compare an experimental design with two traditional retainers. In this prospective preliminary clinical trial, 150 post-treatment patients were enrolled and randomly divided into three groups of 50 patients each to receive mandibular canine-to-canine retainers made of FRC, flexible spiral wire (FSW), and twisted wire (TW). The patients were monitored monthly. The time at which the first signs of breakage/debonding were detected was recorded. The success rates of the retainers were compared using chi-squared, Kaplan-Meier, and Cox proportional-hazard regression analyses (α = 0.05). In total, 42 patients in the FRC group, 41 in the FSW group, and 45 in the TW group completed the study. The 2-year failure rates were 35.7% in the FRC group, 26.8% in the FSW group, and 17.8% in the TW group. These rates differed insignificantly (chi-squared p = 0.167). According to the Kaplan-Meier analysis, failure occurred at 19.95 months in the FRC group, 21.37 months in the FSW group, and 22.36 months in the TW group. The differences between the survival rates in the three groups were not significant (Cox regression p = 0.146). Although the failure rate of the experimental retainer was two times lower than that of the FRC retainer, the difference was not statistically significant. The experimental TW retainer was successful, and larger studies are warranted to verify these results.

  19. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

    LENUS (Irish Health Repository)

    O'Leary, D Peter

    2013-03-01

    Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

  20. Lathosterol to cholesterol ratio in serum predicts cholesterol lowering response to plant sterol consumption in a dual center, randomized, single-blind placebo controlled trial

    Science.gov (United States)

    Benefits of plant sterols (PS) for cholesterol lowering are compromised by large variability in efficacy across individuals. High fractional cholesterol synthesis measured by deuterium incorporation has been associated with non-response to PS consumption; however, prospective studies showing this as...

  1. Efficacy of ankle control balance training on postural balance and gait ability in community-dwelling older adults: a single-blinded, randomized clinical trial

    OpenAIRE

    Lee, Kyeongjin; Lee, Yong Woo

    2017-01-01

    [Purpose] This study was conducted to investigate the effects of ankle control balance training (ACBT) on postural balance and gait ability in community-dwelling older adults. [Subjects and Methods] Fifty-four subjects were randomly divided into two groups, with 27 subjects in the ACBT group and 27 subjects in the control group. Subjects in the ACBT group received ACBT for 60 minutes, twice per week for 4 weeks, and all subjects had undergone fall prevention education for 60 minutes, once per...

  2. A randomized, single-blind trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in the treatment of androgenetic alopecia in women.

    Science.gov (United States)

    Blume-Peytavi, Ulrike; Hillmann, Kathrin; Dietz, Ekkehart; Canfield, Douglas; Garcia Bartels, Natalie

    2011-12-01

    Although twice-daily application of propylene glycol-containing 2% minoxidil topical solution (MTS) stimulates new hair growth, higher concentrations of minoxidil in a once-daily, propylene glycol-free formulation may improve efficacy and reduce unpleasant side effects. We sought to compare the efficacy, safety, and acceptability and to show noninferiority of once-daily 5% minoxidil topical foam (MTF) with twice-daily 2% MTS in women with androgenetic alopecia. A total of 113 women with androgenetic alopecia were randomized to 24 weeks of treatment with 5% MTF or 2% MTS. The primary efficacy parameter was change from baseline in nonvellus target area hair count at week 24. Secondary end points included change in nonvellus target area hair width, overall efficacy by global photographic review as assessed by treatment-blinded evaluators and the subject herself, adverse events, and participants' assessment of product aesthetics. After 24 weeks, women randomized to 5% MTF once daily showed noninferior target area hair count and target area hair width and experienced greater, but nonsignificant, improvements in target area hair count, target area hair width, and overall efficacy by global photographic review than those randomized to 2% MTS used twice daily. 5% MTF was significantly superior to 2% MTS in participants' agreement with "the treatment does not interfere with styling my hair" (P = .002). Women randomized to 5% MTF experienced significantly lower rates of local intolerance (P = .046) especially in pruritus and dandruff compared with 2% MTS. Because of differences in the formulations tested, study participants were not blinded to treatment. Once-daily 5% MTF is noninferior and as effective for stimulating hair growth as twice-daily 2% MTS in women with androgenetic alopecia and is associated with several aesthetic and practical advantages. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  3. Analysis of Postural Control During Quiet Standing in a Population with Diabetic Peripheral Neuropathy Undergoing Moderate Intensity Aerobic Exercise Training: A Single Blind, Randomized Controlled Trial.

    Science.gov (United States)

    Dixit, Snehil; Maiya, Arun; Shastry, Barkur A; Guddattu, Vasudev

    2016-07-01

    The aim of this study was to investigate the effect of 8 wks of moderate-intensity aerobic exercise on postural control during quiet standing in type 2 diabetic peripheral neuropathy. Individuals were included in the study if they had type 2 diabetes with clinical neuropathy, defined by a minimum score of 7 on the Michigan Diabetic Neuropathy Score, following which the patients were randomly assigned to an 8-wk program by computer-generated random number tables to study or control group. Repeated-measures analysis of variance was used for data analysis (P < 0.05 was considered significant). After final randomization, there were 36 patients in the study group and 45 in the control group. On comparison of results for control and study groups using repeated-measures analysis of variance only in the eyes closed on foam condition was there was a significant difference between the two groups for sway velocity along the x-axis (df1, df2 = 1, 18, F = 3.86, P = 0.04) and mediolateral displacement (df1, df2 = 1, 18, F = 4.04, P = 0.03). Aerobic exercise training could exert a therapeutic effect on center of pressure movement only along the x-axis in the eyes closed condition on foam surface during quiet standing.

  4. The Efficacy of Treatment of Different Intervention Programs for Patellofemoral Pain Syndrome–A Single Blinded Randomized Clinical Trial. Pilot Study

    Directory of Open Access Journals (Sweden)

    Feazadeh Avraham

    2007-01-01

    Full Text Available Patello-femoral pain syndrome (PFPS is a common knee joint disability. The integration of hip soft tissue regimens are not always emphasized, although current literature implies that there is a significant relationship between the two and there is a lack of randomized clinical trials to substantiate this relationship in clinical practice. A randomized controlled assessor blinded trial was designed to explore different rehabilitation programs related to PFPS. The study was conducted at RAZIEL institute of physical therapy, Netania, Israel with a total of 30 consecutive patients (mean age 35y, diagnosed with PFPS. All patients were randomly allocated into 3 groups. Group I conventional knee rehabilitation program. Included quadriceps strengthening and Trans Electric Neuromuscular Stimulation (TENS. Group II hip oriented rehabilitation program. included stretching, Hip external rotators strengthening and TENS. Group III a combination of the two above programs. Pain and function were documented on initial of the program and again 3 weeks later, on the completion. Pain was assessed by a numeric visual analogue scale (VAS; function was assessed by Patello-femoral joint evaluation scale (PFJES (0-100 points. At end of trial, all groups showed significant improvements in VAS and PFJES (p<0.0001; these improvements did not vary significantly between the 3 groups. The conclusions were that the explored different rehabilitation programs showed a similar beneficial effect.

  5. Effects of Reiki on Pain and Vital Signs When Applied to the Incision Area of the Body After Cesarean Section Surgery: A Single-Blinded, Randomized, Double-Controlled Study.

    Science.gov (United States)

    Sagkal Midilli, Tulay; Ciray Gunduzoglu, Nazmiye

    This study was conducted to determine the effects of Reiki on pain and vital signs when applied for 15 minutes to the incision area of the body after cesarean section surgery. The study was single-blinded, randomized, and double-controlled (Reiki, sham Reiki, and control groups). Forty-five patients, equalized by age and number of births, were randomly assigned to the Reiki, sham Reiki, and control groups. The treatment, which was applied to the patients in these 3 groups, was applied for 15 minutes to the incision area of body in the first 24 and 48 hours after the operation within 4 to 8 hours of the application of standard analgesics. The study data were collected using a patient follow-up form and a visual analog scale. Mean visual analog scale measurement values were significantly different from each other according to groups and times (P Reiki group patients between day 1 pre-tx and after application on the second day (day 2 post-tx) measurements. Mean breathing rate and systolic blood pressure measurement values were significantly different from each other according to groups (P Reiki group was observed to use fewer analgesics throughout the study and to need them after a longer time than the sham Reiki and control groups (P Reiki applied for 15 minutes to the incision area after a cesarean operation had the expected effects on pain and the need for the use of analgesics, but it had no effect on vital signs.

  6. Fixed, low radiant exposure vs. incremental radiant exposure approach for diode laser hair reduction: a randomized, split axilla, comparative single-blinded trial.

    Science.gov (United States)

    Pavlović, M D; Adamič, M; Nenadić, D

    2015-12-01

    Diode lasers are the most commonly used treatment modalities for unwanted hair reduction. Only a few controlled clinical trials but not a single randomized controlled trial (RCT) compared the impact of various laser parameters, especially radiant exposure, onto efficacy, tolerability and safety of laser hair reduction. To compare the safety, tolerability and mid-term efficacy of fixed, low and incremental radiant exposures of diode lasers (800 nm) for axillary hair removal, we conducted an intrapatient, left-to-right, patient- and assessor-blinded and controlled trial. Diode laser (800 nm) treatments were evaluated in 39 study participants (skin type II-III) with unwanted axillary hairs. Randomization and allocation to split axilla treatments were carried out by a web-based randomization tool. Six treatments were performed at 4- to 6-week intervals with study subjects blinded to the type of treatment. Final assessment of hair reduction was conducted 6 months after the last treatment by means of blinded 4-point clinical scale using photographs. The primary endpoint was reduction in hair growth, and secondary endpoints were patient-rated tolerability and satisfaction with the treatment, treatment-related pain and adverse effects. Excellent reduction in axillary hairs (≥ 76%) at 6-month follow-up visit after receiving fixed, low and incremental radiant exposure diode laser treatments was obtained in 59% and 67% of study participants respectively (Z value: 1.342, P = 0.180). Patients reported lower visual analogue scale (VAS) pain score on the fixed (4.26) than on the incremental radiant exposure side (5.64) (P diode laser treatments were less painful and better tolerated. © 2015 European Academy of Dermatology and Venereology.

  7. A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

    Directory of Open Access Journals (Sweden)

    Marrone Gaetano

    2011-07-01

    Full Text Available Abstract Background Many newly screened people living with HIV (PLHIV in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400 from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills, the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1. No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by

  8. Effects of a multimodal exercise program on balance, functional mobility and fall risk in older adults with cognitive impairment: a randomized controlled single-blind study.

    Science.gov (United States)

    Kovács, E; Sztruhár Jónásné, I; Karóczi, C K; Korpos, A; Gondos, T

    2013-10-01

    Exercise programs have important role in prevention of falls, but to date, there are conflicting findings about the effects of exercise programs on balance, functional performance and fall risk among cognitively impaired older adults. AIM. To investigate the effects of a multimodal exercise program on static and dynamic balance, and risk of falls in older adults with mild or moderate cognitive impairment. A randomized controlled study. A long-term care institute. Cognitively impaired individuals aged over 60 years. Eighty-six participants were randomized to an exercise group providing multimodal exercise program for 12 months or a control group which did not participate in any exercise program. The Performance Oriented Mobility Assessment scale, Timed Up and Go test, and incidence of falls were measured at baseline, at 6 months and at 12 months. There was a significant improvement in balance-related items of Performance Oriented Mobility Assessment scale in the exercise group both at 6 month and 12 month (Pfalls. Our results confirmed that a 12-month multimodal exercise program can improve the balance in cognitively impaired older adults. Based on our results, the multimodal exercise program may be a promising fall prevention exercise program for older adults with mild or moderate cognitive impairment improving static balance but it is supposed that more emphasis should be put on walking component of exercise program and environmental fall risk assessment.

  9. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Kristensen, Anne Zoëga; Jay, Kenneth; Stelter, Reinhard; Lavendt, Ebbe; Aagaard, Per; Andersen, Lars L

    2014-04-07

    The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder (primary outcome) and physical

  10. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. Methods/Design This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder

  11. Effect of Yoga in the Treatment of Eating Disorders: A Single-blinded Randomized Controlled Trial with 6-Months Follow-up.

    Science.gov (United States)

    Karlsen, Kari Ebbesen; Vrabel, Karianne; Bratland-Sanda, Solfrid; Ulleberg, Pål; Benum, Kirsten

    2018-01-01

    The aim of this study is to examine the effect of yoga treatment of eating disorders (EDs). Adult females meeting the Diagnostic and Statistical Manual-IV criteria for bulimia nervosa or ED not otherwise specified ( n = 30) were randomized to 11-week yoga intervention group (2 × 90 min/week) or a control group. Outcome measures, the Eating Disorder Examination (EDE)-Interview and Eating Disorders Inventory-2 (EDI-2) scores, were administered at baseline, posttest, and at 6-month follow-up. There was a dropout rate of 30% (posttest) and 37% (6-month follow-up). The intervention group showed reductions in EDE global score ( P control group. The differences between the groups increased at 6-month follow-up. There were no differences between the groups in the EDI-2 score. The results indicate that yoga could be effective in the treatment of ED.

  12. The effects of complex exercise on shoulder range of motion and pain for women with breast cancer-related lymphedema: a single-blind, randomized controlled trial.

    Science.gov (United States)

    Park, Jin-Hyuck

    2017-07-01

    This study was to investigate the effects of complex exercise on shoulder range of motion and pain for women with breast cancer-related lymphedema. 69 women participated in this study and then they were randomly allocated to complex exercise group (n = 35) or the conventional decongestive therapy group (n = 34). All subjects received 8 sessions for 4 weeks. To identify the effects on shoulder range of motion and pain, goniometer and visual analog scale were used, respectively. The outcome measurements were performed before and after the 4 week intervention. After 4 weeks, complex exercise group had greater improvements in shoulder range of motion and pain compared with the conventional decongestive therapy group (p women with breast cancer-related lymphedema. Complex exercise would be useful to improve shoulder range of motion and pain of the women with breast cancer-related lymphedema.

  13. Effectiveness of low-level laser therapy for patients with carpal tunnel syndrome: design of a randomized single-blinded controlled trial

    Directory of Open Access Journals (Sweden)

    Barbosa Rafael Inácio

    2012-12-01

    Full Text Available Abstract Background Carpal tunnel syndrome is the most common neuropathy in the upper extremity, resulting from the compression of the median nerve at wrist level. Clinical studies are essentials to present evidence on therapeutic resources use at early restoration on peripheral nerve functionality. Low-level laser therapy has been widely investigated in researches related to nerve regeneration. Therefore, it is suggested that the effect of low-level laser therapy associated with other conservative rehabilitation techniques may positively affect symptoms and overall hand function in compressive neuropathies such as carpal tunnel syndrome. The aim of this study is to evaluate the effectiveness of low-level laser therapy in addition to orthoses therapy and home orientations in patients with carpal tunnel syndrome. Methods/Design Patients older than 18 years old will be included, with clinical diagnosis of carpal tunnel syndrome, excluding comorbidies. A physiotherapist will conduct intervention, with a blinding evaluator. Randomization will be applied to allocate the patients in each group: with association or not to low-level laser therapy. All of them will be submitted to orthoses therapy and home orientations. Outcome will be assessed through: pain visual analogic scale, Semmes Weinstein monofilaments™ threshold sensibility test, Pinch Gauge™, Boston Carpal Tunnel Questionnaire and two point discrimination test. Discussion This paper describes the design of a randomized controlled trial, which aim to assess the effectiveness of conservative treatment added to low-level laser therapy for patients with carpal tunnel syndrome. Trial registration Brazilian Clinical Trials Registry (ReBec - 75ddtf / Universal Trial Number: U1111-1121-5184

  14. A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study

    Directory of Open Access Journals (Sweden)

    Galynker Igor I

    2009-05-01

    Full Text Available Abstract Background Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks. Methods Fifty six subjects with a history of panic attacks were randomized to receive either risperidone or paroxetine. The subjects were then followed for eight weeks. Outcome measures included the Panic Disorder Severity Scale (PDSS, the Hamilton Anxiety Scale (Ham-A, the Hamilton Depression Rating Scale (Ham-D, the Sheehan Panic Anxiety Scale-Patient (SPAS-P, and the Clinical Global Impression scale (CGI. Results All subjects demonstrated a reduction in both the frequency and severity of panic attacks regardless of treatment received. Statistically significant improvements in rating scale scores for both groups were identified for the PDSS, the Ham-A, the Ham-D, and the CGI. There was no difference between treatment groups in the improvement in scores on the measures PDSS, Ham-A, Ham-D, and CGI. Post hoc tests suggest that subjects receiving risperidone may have a quicker clinical response than subjects receiving paroxetine. Conclusion We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. Trial Registration ClinicalTrials.gov Identifier: NCT100457106

  15. Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial.

    Science.gov (United States)

    Faurholt-Jepsen, M; Frost, M; Ritz, C; Christensen, E M; Jacoby, A S; Mikkelsen, R L; Knorr, U; Bardram, J E; Vinberg, M; Kessing, L V

    2015-10-01

    The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group. These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

  16. Effect of spa therapy with saline balneotherapy on oxidant/antioxidant status in patients with rheumatoid arthritis: a single-blind randomized controlled trial

    Science.gov (United States)

    Karagülle, Mine; Kardeş, Sinan; Karagülle, Oğuz; Dişçi, Rian; Avcı, Aslıhan; Durak, İlker; Karagülle, Müfit Zeki

    2017-01-01

    Oxidative stress has been shown to play a contributory role in the pathogenesis of rheumatoid arthritis (RA). Recent studies have provided evidence for antioxidant properties of spa therapy. The purpose of this study is to investigate whether spa therapy with saline balneotherapy has any influence on the oxidant/antioxidant status in patients with RA and to assess clinical effects of spa therapy. In this investigator-blind randomized controlled trial, we randomly assigned 50 patients in a 1:1 ratio to spa therapy plus standard drug treatment (spa group) or standard drug treatment alone (control group). Spa group followed a 2-week course of spa therapy regimen consisting of a total of 12 balneotherapy sessions in a thermal mineral water pool at 36-37 °C for 20 min every day except Sunday. All clinical and biochemical parameters were assessed at baseline and after spa therapy (2 weeks). The clinical parameters were pain intensity, patient global assessment, physician global assessment, Health Assessment Questionnaire disability index (HAQ-DI), Disease Activity Score for 28-joints based on erythrocyte sedimentation rate (DAS28-4[ESR]). Oxidative status parameters were malondialdehyde (MDA), nonenzymatic superoxide radical scavenger activity (NSSA), antioxidant potential (AOP), and superoxide dismutase (SOD). The NSSA levels were increased significantly in the spa group ( p = 0.003) but not in the control group ( p = 0.509); and there was a trend in favor of spa therapy for improvements in NSSA levels compared to control ( p = 0.091). Significant clinical improvement was found in the spa group compared to the control in terms of patient global assessment ( p = 0.011), physician global assessment ( p = 0.043), function (HAQ-DI) ( p = 0.037), disease activity (DAS28-4[ESR]) (0.044) and swollen joint count (0.009), and a trend toward improvement in pain scores (0.057). Spa therapy with saline balneotherapy exerts antioxidant effect in patients with RA as reflected by the

  17. A Developmental and Sequenced One-to-One Educational Intervention for Autism Spectrum Disorder: A Randomized Single-Blind Controlled Trial.

    Science.gov (United States)

    Tanet, Antoine; Hubert-Barthelemy, Annik; Crespin, Graciela C; Bodeau, Nicolas; Cohen, David; Saint-Georges, Catherine

    2016-01-01

    Individuals with autism spectrum disorder (ASD) who also exhibit severe-to-moderate ranges of intellectual disability (ID) still face many challenges (i.e., less evidence-based trials, less inclusion in school with peers). We implemented a novel model called the "Developmental and Sequenced One-to-One Educational Intervention" (DS1-EI) in 5- to 9-year-old children with co-occurring ASD and ID. The treatment protocol was adapted for school implementation by designing it using an educational agenda. The intervention was based on intensity, regular assessments, updating objectives, encouraging spontaneous communication, promoting skills through play with peers, supporting positive behaviors, providing supervision, capitalizing on teachers' unique skills, and providing developmental and sequenced learning. Developmental learning implies that the focus of training is what is close to the developmental expectations given a child's development in a specific domain. Sequenced learning means that the teacher changes the learning activities every 10-15 min to maintain the child's attention in the context of an anticipated time agenda. We selected 11 French institutions in which we implemented the model in small classrooms. Each institution recruited participants per dyads matched by age, sex, and developmental quotient. Patients from each dyad were then randomized to a DS1-EI group or a Treatment as usual (TAU) group for 36 months. The primary variables - the Childhood Autism Rating scale (CARS) and the psychoeducational profile (PEP-3) - will be blindly assessed by independent raters at the 18-month and 36-month follow-up. We enrolled 75 participants: 38 were randomized to the DS1-EI and 37 to the TAU groups. At enrollment, we found no significant differences in participants' characteristics between groups. As expected, exposure to school was the only significant difference [9.4 (±4.1) h/week in the DS1-EI group vs. 3.4 (±4.5) h/week in the TAU group, Student's t

  18. Immediate effect of nonspecific mandibular mobilization on postural control in subjects with temporomandibular disorder: a single-blind, randomized, controlled clinical trial.

    Science.gov (United States)

    Amaral, Ana P; Politti, Fabiano; Hage, Yasmin E; Arruda, Eric E C; Amorin, Cesar F; Biasotto-Gonzalez, Daniela A

    2013-01-01

    Temporomandibular disorder (TMD) is considered multifactorial and is defined as a group of pain conditions characterized by functional stomatognathic system alterations, which may be affected by or related disrupted postural control. Assess the immediate effect of nonspecific mandibular mobilization (NMM) on the postural control of subjects diagnosed or not with TMD. A simple-blind, randomized, controlled clinical trial was performed involving 50 subjects of both genders assigned to two groups: the TMD group and the control group. TMD was diagnosed according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). A stabilometric assessment was performed by testing subjects in a quiet stance on a dual force platform under two visual conditions (eyes open and eyes closed). The Center of Pressure (CoP)-related variables analyzed were displacement, amplitude, speed of anterior-posterior (AP) and medial-lateral (ML) displacements and CoP sway area. The mean values of each variable were compared, considering the accepted significance value of ppostural control in patients with TMD.

  19. Efficacy of ankle control balance training on postural balance and gait ability in community-dwelling older adults: a single-blinded, randomized clinical trial.

    Science.gov (United States)

    Lee, Kyeongjin; Lee, Yong Woo

    2017-09-01

    [Purpose] This study was conducted to investigate the effects of ankle control balance training (ACBT) on postural balance and gait ability in community-dwelling older adults. [Subjects and Methods] Fifty-four subjects were randomly divided into two groups, with 27 subjects in the ACBT group and 27 subjects in the control group. Subjects in the ACBT group received ACBT for 60 minutes, twice per week for 4 weeks, and all subjects had undergone fall prevention education for 60 minutes, once per week for 4 weeks. The main outcome measures, including the Berg balance scale; the functional reach test and one leg stance test for postural balance; and the timed up-and-go test and 10-meter walking test for gait ability, were assessed at baseline and after 4 weeks of training. [Results] The postural balance and gait ability in the ACBT group improved significantly compared to those in the control group, except BBS. [Conclusion] The results of this study showed improved postural balance and gait abilities after ACBT and that ACBT is a feasible method for improving postural balance and gait ability in community-dwelling older adults.

  20. The effects of eyeball exercise on balance ability and falls efficacy of the elderly who have experienced a fall: A single-blind, randomized controlled trial.

    Science.gov (United States)

    Park, Jin-Hyuck

    The purpose of this study was to investigate the effects of eyeball exercise on balance and fall efficacy of the elderly who have experienced a fall. Subjects were randomly assigned to the eyeball exercise group (n=30) or functional exercise group (n=31). All subjects received 30 sessions for 10 weeks. To identify the effects on balance, static and dynamic balance were measured using the center of pressure (CoP) measurement equipment and Timed Up and Go Test (TUGT) respectively. Fall efficacy was evaluated using the modified efficacy scale (MFES). The outcome measurements were performed before and after the 10 weeks training period. After 10 weeks, static balance, dynamic balance, and fall efficacy were significantly improved in both groups. Also, there were significant differences in the outcome measures between both groups (peyeball exercise is beneficial to improve the fall efficacy as well as the balance of the elderly compared with functional exercise. Eyeball exercise would be useful to improve balance and fall efficacy of the elderly who have experienced a fall. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  1. The impact of expert- and peer feedback on communication skills of undergraduate dental students - a single-blinded, randomized, controlled clinical trial.

    Science.gov (United States)

    Krause, Felix; Schmalz, Gerhard; Haak, Rainer; Rockenbauch, Katrin

    2017-12-01

    To evaluate the effect of peer- and expert feedback on communication skills of undergraduate dental students. All students of the first clinical treatment course (n=46) were randomly assigned into two groups. For three times a medical-dental interview/consultation of each student with a real patient was videotaped. After every consultation the videos were assessed either by a person experienced in communication (expert group) or by a fellow student (peer group), giving the students feedback regarding their chairside performed communication skills. Before and after the feedback-interventions all students conducted an interview with simulated patients, which was rated using a validated global rating and analyzed statistically. Global ratings mean scores after feedback-intervention were significantly improved (p0.05). During this study students improved their communication skills in dentist-patient interactions. The communication experience of the feedback provider seems not to have any impact on the communication skills in undergraduate dental students. The clinical courses in dentistry offer the opportunity to implement peer-feedback interventions in real treatment situation as part of communication training to longitudinally improve communication skills. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Effect of yoga in the treatment of eating disorders: A single-blinded randomized controlled trial with 6-months follow-up

    Directory of Open Access Journals (Sweden)

    Kari Ebbesen Karlsen

    2018-01-01

    Full Text Available Aim of the Study: The aim of this study is to examine the effect of yoga treatment of eating disorders (EDs. Methods: Adult females meeting the Diagnostic and Statistical Manual-IV criteria for bulimia nervosa or ED not otherwise specified (n = 30 were randomized to 11-week yoga intervention group (2 × 90 min/week or a control group. Outcome measures, the Eating Disorder Examination (EDE-Interview and Eating Disorders Inventory-2 (EDI-2 scores, were administered at baseline, posttest, and at 6-month follow-up. There was a dropout rate of 30% (posttest and 37% (6-month follow-up. Results: The intervention group showed reductions in EDE global score (P < 0.01, the EDE subscale restraint (P < 0.05, and eating concern (P < 0.01 compared to the control group. The differences between the groups increased at 6-month follow-up. There were no differences between the groups in the EDI-2 score. Conclusion: The results indicate that yoga could be effective in the treatment of ED.

  3. Comparison of quality of obturation and instrumentation time using hand files and two rotary file systems in primary molars: A single-blinded randomized controlled trial.

    Science.gov (United States)

    Govindaraju, Lavanya; Jeevanandan, Ganesh; Subramanian, E M G

    2017-01-01

    In permanent dentition, different rotary systems are used for canal cleaning and shaping. Rotary instrumentation in pediatric dentistry is an emerging concept. A very few studies have compared the efficiency of rotary instrumentation for canal preparation in primary teeth. Hence, this study was performed to compare the obturation quality and instrumentation time of two rotary files systems - Protaper, Mtwo with hand files in primary molars. Forty-five primary mandibular molars were randomly allotted to one of the three groups. Instrumentation was done using K-files in Group 1; Protaper in Group 2; and Mtwo in Group 3. Instrumentation time was recorded. The canal filling quality was assessed as underfill, optimal fill, and overfill. Statistical analysis was done using Chi-square, ANOVA, and post hoc Tukey test. No significant difference was observed in the quality of obturation among three groups. Intergroup comparison of the instrumentation time showed a statistically significant difference between the three groups. The use of rotary instrumentation in primary teeth results in marked reduction in the instrumentation time and improves the quality of obturation.

  4. Cervical stability training with and without core stability training for patients with cervical disc herniation: A randomized, single-blind study.

    Science.gov (United States)

    Buyukturan, B; Guclu-Gunduz, A; Buyukturan, O; Dadali, Y; Bilgin, S; Kurt, E E

    2017-11-01

    This study aims at evaluating and comparing the effects of cervical stability training to combined cervical and core stability training in patients with neck pain and cervical disc herniation. Fifty patients with neck pain and cervical disc herniation were included in the study, randomly divided into two groups as cervical stability and cervical-core stability. Training was applied three times a week in three phases, and lasted for a total duration of 8 weeks. Pain, activation and static endurance of deep cervical flexor muscles, static endurance of neck muscles, cross-sectional diameter of M. Longus Colli, static endurance of trunk muscles, disability and kinesiophobia were assessed. Pain, activation and static endurance of deep cervical flexors, static endurance of neck muscles, cross-sectional diameter of M. Longus Colli, static endurance of trunk muscles, disability and kinesiophobia improved in both groups following the training sessions (p training methods revealed that the cervical stability group produced a greater increase in the right transverse diameter of M. Longus Colli (p training provided benefit to patients with cervical disc herniation. The addition of core stability training did not provide any additional significant benefit. Further research is required to investigate the efficacy of combining other techniques with cervical stability training in patients with cervical disc herniation. Both cervical stability training and its combination with core stability training were significantly and similarly effective on neck pain and neck muscle endurance in patients with cervical disc herniation. © 2017 European Pain Federation - EFIC®.

  5. The topical treatment of anthroponotic cutaneous leishmaniasis with the tincture of thioxolone plus benzoxonium chloride (Thio-Ben) along with cryotherapy: a single-blind randomized clinical trial.

    Science.gov (United States)

    Daie Parizi, Mohammad Hossein; Karvar, Mehran; Sharifi, Iraj; Bahrampour, Abbas; Heshmat Khah, Amireh; Rahnama, Zahra; Baziar, Zahra; Amiri, Rezvan

    2015-01-01

    A simple efficacious topical treatment for cutaneous leishmaniasis (CL) is still an unresolved challenge. This study aimed to evaluate the efficacy of the topical use of thioxolone plus benzoxonium chloride (Thio-Ben) tincture in combination with cryotherapy in comparison with intralesional meglumine antimoniate (Glucantime) along with cryotherapy in treating anthroponotic CL (ACL). The study was conducted in Leishmaniasis Center in Dadbin Health Care Clinic, Kerman, Iran. Sixty-four CL lesions were randomly assigned to receive Thio-Ben plus cryotherapy (TC) (n = 32) or Glucantime plus cryotherapy (GC) (n = 32). Thio-Ben was used topically every other day and Glucantime was used intralesionally once a week for a maximum of 3 months. In both study groups, cryotherapy was administered using liquid nitrogen once every 2 weeks. Of 64 recruited lesions, 47 lesions completed the study protocol. Twenty lesions (91%) in TC group and 23 lesions (92%) in GC group showed complete cure. TC group showed faster clinical response. Pain, hypersensitivity reaction, dizziness, and nausea were only seen in GC group. This study showed that the topical use of Thio-Ben combined with cryotherapy has a good efficacy in treating ACL with the benefit that Thio-Ben has more patient compliance and less side effects than intralesional Glucantime. © 2015 Wiley Periodicals, Inc.

  6. Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study

    Directory of Open Access Journals (Sweden)

    Irene Campa-Moran

    2015-01-01

    Full Text Available Objective. The aim of this study was to compare the efficacy of three interventions for the treatment of myofascial chronic neck pain. Methods. Thirty-six patients were randomly assigned to one of three intervention groups: orthopedic manual therapy (OMT, dry needling and stretching (DN-S, and soft tissue techniques (STT. All groups received two treatment sessions with a 48 h time interval. Outcome measures included neck pain intensity measured using a visual analogue scale, cervical range of motion (ROM, pressure pain threshold for measuring mechanical hyperalgesia, and two self-reported questionnaires (neck disability index and pain catastrophizing scale. Results. The ANOVA revealed significant differences for the group × time interaction for neck disability, neck pain intensity, and pain catastrophizing. The DN-S and OMT groups reduced neck disability. Only the OMT group showed decreases in mechanical hyperalgesia and pain catastrophizing. The cervical ROM increased in OMT (i.e., flexion, side-bending, and rotation and DN-S (i.e., side-bending and rotation groups. Conclusions. The three interventions are all effective in reducing pain intensity. Reduction in mechanical hyperalgesia and pain catastrophizing was only observed in the OMT group. Cervical ROM improved in the DN-S and OMT groups and also neck disability being only clinically relevant for OMT group.

  7. Single-blind, randomized, controlled trial of pelvic floor muscle training, electrical stimulation, vaginal cones, and no active treatment in the management of stress urinary incontinence

    Directory of Open Access Journals (Sweden)

    Rodrigo A. Castro

    2008-01-01

    Full Text Available PURPOSE: To compare the effectiveness of pelvic floor exercises, electrical stimulation, vaginal cones, and no active treatment in women with urodynamic stress urinary incontinence. PATIENTS AND METHODS: One hundred eighteen subjects were randomly selected to recieve pelvic floor exercises (n=31, ES (n=30, vaginal cones (n=27, or no treatment (untreated control (n=30. Women were evaluated before and after completion of six months of treatment by the pad test, quality of life questionnaire (I-QOL, urodynamic test, voiding diary, and subjective response. RESULTS: In the objective evaluation, we observed a statistically significant reduction in the pad test (p=0.003, in the number of stress urinary episodes (p<0.001, and a significant improvement in the quality of life (p<0.001 in subjects who used pelvic floor exercises, electrical stimulation, and vaginal cones compared to the control group. No significant difference was found between groups in the urodynamic parameters. In the subjective evaluation, 58%, 55%, and 54% of women who had used pelvic floor exercises, electrical stimulation, and vaginal cones, respectively, reported being satisfied after treatment. In the control group, only 21% patients were satisfied with the treatment. CONCLUSION: Based on this study, pelvic floor exercises, electrical stimulation, and vaginal cones are equally effective treatments and are far superior to no treatment in women with urodynamic stress urinary incontinence.

  8. Effectiveness of dry needling versus a classical physiotherapy program in patients with chronic low-back pain: a single-blind, randomized, controlled trial.

    Science.gov (United States)

    Tüzün, Emİne Handan; Gıldır, Sıla; Angın, Ender; Tecer, Büşra Hande; Dana, Kezban Öztürk; Malkoç, Mehtap

    2017-09-01

    [Purpose] We compared the effectiveness of dry needling with a classical physiotherapy program in patients with chronic low-back pain caused by lumbar disc hernia (LHNP). [Subjects and Methods] In total, 34 subjects were allocated randomly to the study (n=18) and control groups (n=16). In the study group, dry needling was applied using acupuncture needles. The control group performed a home exercise program in addition to hot pack, TENS, and ultrasound applications. Pain was assessed with the short form of the McGill Pain Questionnaire. The number of trigger points and their pressure sensitivity were evaluated with a physical examination (palpation). The Beck Depression Inventory was used to assess depression. The Tampa Kinesiophobia Scale was used to assess fear of movement. [Results] In the study group, the calculated Cohen's effect sizes were bigger than those in the control group in terms of pain, trigger point-related variables, and fear of movement. Effect sizes for reducing depressive symptoms were similar in both groups. [Conclusion] These results suggest that dry needling can be an effective treatment for reducing pain, number of trigger points, sensitivity, and kinesiophobia in patients with chronic low-back pain caused by lumbar disc hernia.

  9. Rehabilitation plus OnabotulinumtoxinA Improves Motor Function over OnabotulinumtoxinA Alone in Post-Stroke Upper Limb Spasticity: A Single-Blind, Randomized Trial

    Directory of Open Access Journals (Sweden)

    Deidre Devier

    2017-07-01

    Full Text Available Background: OnabotulinumtoxinA (BoNT-A can temporarily decrease spasticity following stroke, but whether there is an associated improvement in upper limb function is less clear. This study measured the benefit of adding weekly rehabilitation to a background of BoNT-A treatments for chronic upper limb spasticity following stroke. Methods: This was a multi-center clinical trial. Thirty-one patients with post-stroke upper limb spasticity were treated with BoNT-A. They were then randomly assigned to 24 weeks of weekly upper limb rehabilitation or no rehabilitation. They were injected up to two times, and followed for 24 weeks. The primary outcome was change in the Fugl–Meyer upper extremity score, which measures motor function, sensation, range of motion, coordination, and speed. Results: The ‘rehab’ group significantly improved on the Fugl–Meyer upper extremity score (Visit 1 = 60, Visit 5 = 67 while the ‘no rehab’ group did not improve (Visit 1 = 59, Visit 5 = 59; p = 0.006. This improvement was largely driven by the upper extremity “movement” subscale, which showed that the ‘rehab’ group was improving (Visit 1 = 33, Visit 5 = 37 while the ‘no rehab’ group remained virtually unchanged (Visit 1 = 34, Visit 5 = 33; p = 0.034. Conclusions: Following injection of BoNT-A, adding a program of rehabilitation improved motor recovery compared to an injected group with no rehabilitation.

  10. Rehabilitation plus OnabotulinumtoxinA Improves Motor Function over OnabotulinumtoxinA Alone in Post-Stroke Upper Limb Spasticity: A Single-Blind, Randomized Trial.

    Science.gov (United States)

    Devier, Deidre; Harnar, JoAnn; Lopez, Leandro; Brashear, Allison; Graham, Glenn

    2017-07-11

    OnabotulinumtoxinA (BoNT-A) can temporarily decrease spasticity following stroke, but whether there is an associated improvement in upper limb function is less clear. This study measured the benefit of adding weekly rehabilitation to a background of BoNT-A treatments for chronic upper limb spasticity following stroke. This was a multi-center clinical trial. Thirty-one patients with post-stroke upper limb spasticity were treated with BoNT-A. They were then randomly assigned to 24 weeks of weekly upper limb rehabilitation or no rehabilitation. They were injected up to two times, and followed for 24 weeks. The primary outcome was change in the Fugl-Meyer upper extremity score, which measures motor function, sensation, range of motion, coordination, and speed. The 'rehab' group significantly improved on the Fugl-Meyer upper extremity score (Visit 1 = 60, Visit 5 = 67) while the 'no rehab' group did not improve (Visit 1 = 59, Visit 5 = 59; p = 0.006). This improvement was largely driven by the upper extremity "movement" subscale, which showed that the 'rehab' group was improving (Visit 1 = 33, Visit 5 = 37) while the 'no rehab' group remained virtually unchanged (Visit 1 = 34, Visit 5 = 33; p = 0.034). Following injection of BoNT-A, adding a program of rehabilitation improved motor recovery compared to an injected group with no rehabilitation.

  11. The effects of plantar perception training on balance and falls efficacy of the elderly with a history of falls: A single-blind, randomized controlled trial.

    Science.gov (United States)

    Park, Jin-Hyuck

    2018-03-28

    The purpose of this study was to identify the effects of plantar perception training using a hardness discrimination task on balance and falls efficacy of the elderly who have experienced a fall. Sixty-two elderly persons 65 years of age or older were randomly allocated to the experimental group (n = 31) or the control group (n = 31). The experimental group performed a hardness discrimination task using five different levels of hardness of sponge mats, while the control group performed the same task except that they were not asked to discriminate hardness levels of sponge mats. All subjects performed 10 sessions for two weeks. Outcome measures were conducted using center of pressure (CoP) sway in the standing position, the Timed Up and Go (TUG) test, and falls efficacy scale (FES) to measure balance and falls efficacy. There were no significant differences in general characteristics between both groups (p > .05). After 10 sessions, plantar perception was significantly improved in the experimental group (F = 101.18, p falls efficacy as well as balance of the elderly. Copyright © 2018 Elsevier B.V. All rights reserved.

  12. fMRI Neurofeedback Training for Increasing Anterior Cingulate Cortex Activation in Adult Attention Deficit Hyperactivity Disorder. An Exploratory Randomized, Single-Blinded Study.

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    Zilverstand, Anna; Sorger, Bettina; Slaats-Willemse, Dorine; Kan, Cornelis C; Goebel, Rainer; Buitelaar, Jan K

    2017-01-01

    Attention Deficit Hyperactivity Disorder (ADHD) is characterized by poor cognitive control/attention and hypofunctioning of the dorsal anterior cingulate cortex (dACC). In the current study, we investigated for the first time whether real-time fMRI neurofeedback (rt-fMRI) training targeted at increasing activation levels within dACC in adults with ADHD leads to a reduction of clinical symptoms and improved cognitive functioning. An exploratory randomized controlled treatment study with blinding of the participants was conducted. Participants with ADHD (n = 7 in the neurofeedback group, and n = 6 in the control group) attended four weekly MRI training sessions (60-min training time/session), during which they performed a mental calculation task at varying levels of difficulty, in order to learn how to up-regulate dACC activation. Only neurofeedback participants received continuous feedback information on actual brain activation levels within dACC. Before and after the training, ADHD symptoms and relevant cognitive functioning was assessed. Results showed that both groups achieved a significant increase in dACC activation levels over sessions. While there was no significant difference between the neurofeedback and control group in clinical outcome, neurofeedback participants showed stronger improvement on cognitive functioning. The current study demonstrates the general feasibility of the suggested rt-fMRI neurofeedback training approach as a potential novel treatment option for ADHD patients. Due to the study's small sample size, potential clinical benefits need to be further investigated in future studies. ISRCTN12390961.

  13. The Effect of Home based Exercise on Treatment of Women with Poly Cystic Ovary Syndrome; a single-Blind Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Farzaneh Vasheghani-Farahani

    2017-01-01

    Full Text Available Background: The most common reproductive endocrine disorder of reproductive age women is a Poly cystic ovary syndrome (PCOS Metabolic syndrome has been more reported in patients with PCOS in comparison to general population. Few investigations have been performed to evaluate the independent effect of exercise on biochemical and clinical symptoms of patients with PCOS. The aim of the study was to find the effect of home base aerobic-strengthening exercises on anthropometric and hormonal variables of patients with PCOS.MaterialsandMethods:In this randomized controlled trial twenty women in the exercise group performed aerobic, strengthening exercises; the other 20 participants in the control group were advised to continue their previous physical activity pattern. Blood pressure, Waist to Hip ratio (WHR, BMI along with hormonal variables(including insulin related factors, sexual hormones and inflammatory factors were assessed at baselineand after the 12 week intervention.Results:16patients in the exercise group and 14 patients in control group finished the study. TheWHR (p<0.001 along with the blood level of insulin (p=0.016, FBS (p=0.044, Prolactine (p=0.022 and hsCRP (p=0.035 and HOMA index (p=0.009 were decreased significantly in the exercise group compared with the control group. No significant differences were found in lipid profile and sexual hormones between groups at the end of the study.Conclusion:We can conclude that 12 weeks combined aerobic-strengthening exercise program in women with poly cystic ovary syndrome can lead to a reduction of waist to hip ratio (WHR and some cardiovascular risk factors (including insulin, FBS, HOMA index and HsCRP along with an increase of prolactine level in these patients.

  14. The effect of staff training on agitation and use of restraint in nursing home residents with dementia: a single-blind, randomized controlled trial.

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    Testad, Ingelin; Ballard, Clive; Brønnick, Kolbjørn; Aarsland, Dag

    2010-01-01

    Agitation is common in dementia and is associated with use of restraints and use of psychotropic drugs. The aim of this study was to determine whether an education and supervision intervention could reduce agitation and the use of restraints and antipsychotic drugs in nursing homes. Four Norwegian nursing homes were randomly allocated to receive either treatment as usual or an intervention consisting of a 2-day educational seminar and monthly group guidance for 6 months. One hundred forty-five residents with dementia (based on medical records and corroborated with a Functional Assessment Staging score >or= 4) completed baseline and 6-month intervention assessments and were included in the analyses. The co-primary outcome measures were the proportion of residents subject to interactional restraint and the severity of agitation using the Cohen-Mansfield Agitation Inventory (CMAI). Patients were assessed at baseline, immediately after completion of the intervention at 6 months, and 12 months after baseline. Comparison of change in the 2 groups was made using repeated-measures analysis of variance (CMAI) and Mann-Whitney test (restraints). The study was conducted from 2003 to 2004. The proportion of residents starting new restraint was lower in the intervention than in the control group at 6-month evaluation (P = .02), but no statistically significant differences were found at 12-month assessment (P = .57). The total CMAI score declined from baseline to 6 and 12 months' follow-up in the intervention homes compared to a small increase in the control homes (F2,176 = 3.46, P = .034). There were no statistically significant differences in use of antipsychotic drugs. A brief 2-day staff education program followed by continued monthly guidance was able both to improve quality of care by reducing the frequency of interactional restraints and to reduce severity of agitation. ©Copyright 2010 Physicians Postgraduate Press, Inc.

  15. Effects of aripiprazole versus risperidone on brain activation during planning and social-emotional evaluation in schizophrenia: A single-blind randomized exploratory study.

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    Liemburg, Edith J; van Es, Frank; Knegtering, Henderikus; Aleman, André

    2017-10-03

    Impaired function of prefrontal brain networks may be the source of both negative symptoms and neurocognitive problems in psychotic disorders. Whereas most antipsychotics may decrease prefrontal activation, the partial dopamine D2-receptor agonist aripiprazole is hypothesized to improve prefrontal function. This study investigated whether patients with a psychotic disorder would show stronger activation of prefrontal areas and associated regions after treatment with aripiprazole compared to risperidone treatment. In this exploratory pharmacological neuroimaging study, 24 patients were randomly assigned to either aripiprazole or risperidone. At baseline and after nine weeks treatment they underwent an interview and MRI session. Here we report on brain activation (measured with arterial spin labeling) during performance of two tasks, the Tower of London and the Wall of Faces. Aripiprazole treatment decreased activation of the middle frontal, superior frontal and occipital gyrus (ToL) and medial temporal and inferior frontal gyrus, putamen and cuneus (WoF), while activation increased after risperidone. Activation increased in the ventral anterior cingulate and posterior insula (ToL), and superior frontal, superior temporal and precentral gyrus (WoF) after aripiprazole treatment and decreased after risperidone. Both treatment groups had increased ventral insula activation (ToL) and middle temporal gyrus (WoF), and decreased occipital cortex, precuneus and caudate head activation (ToL) activation. In conclusion, patients treated with aripiprazole may need less frontal resources for planning performance and may show increased frontotemporal and frontostriatal reactivity to emotional stimuli. More research is needed to corroborate and extend these preliminary findings. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Preventive Use of a Resin-based Desensitizer Containing Glutaraldehyde on Tooth Sensitivity Caused by In-office Bleaching: A Randomized, Single-blind Clinical Trial.

    Science.gov (United States)

    Diniz, Acs; Lima, Snl; Tavarez, RRdJ; Borges, A H; Pinto, Scs; Tonetto, M R; Loguercio, A D; Bandéca, M C

    2018-03-23

    To evaluate the risk and intensity of bleaching-induced tooth sensitivity (TS) after in-office bleaching following topical application of a resin-based glutaraldehyde desensitizer. Thirty-three patients were randomly assigned to the experimental (Gluma Desensitizer Liquid, Heraeus Kulzer, Hanau, Germany) and placebo groups. The placebo or Gluma Desensitizer Liquid was applied for one minute prior to application of an in-office bleaching gel. Bleaching was performed with 35% hydrogen peroxide gel (three applications × 15 minutes each) over two sessions, one week apart. The color of the anterior teeth was evaluated before and 21 days after treatment using the VITA Classical shade guide, Bleachedguide 3D, and Easyshade spectrophotometer. TS during and after the bleaching was recorded according to the visual analog (VAS) and numerical rating (NRS) scales. All data were submitted to statistical analysis (α=0.05). There was no significant difference in absolute risk or intensity of TS between the two groups (risk and VAS, p=0.93 and 0.31, respectively; NRS, p≥0.45). At the end of the bleaching protocol, tooth whitening was observed in both groups, as evident from color change in shade guide units (ΔSGU, 4.1-7.1; both guides) and overall color change (ΔE, 7.4-9.3 units); however, there were no significant differences in whitening between the two groups ( p>0.11). Gluma Desensitizer Liquid was not able to reduce the risk or intensity of TS. Bleaching efficacy was not affected by application of the desensitizer.

  17. Adapted physical activity is beneficial on balance, functional mobility, quality of life and fall risk in community-dwelling older women: a randomized single-blinded controlled trial.

    Science.gov (United States)

    Kovács, E; Prókai, L; Mészáros, L; Gondos, T

    2013-06-01

    Exercise programmes have important role in prevention of falls, but to date, we have little knowledge about the effects of Adapted Physical Activity programme on balance of older women. The aim of this study was to investigate the effects of an Adapted Physical Activity programme on balance, risk of falls and quality of life in community-dwelling older women. This was a randomized controlled study. Community, in a local sport centre. Older women aged over 60 years. Seventy-six women were randomised to an exercise group providing Adapted Physical Activity programme for 25 weeks or a control group (in which they did not participate in any exercise programme). The one-leg stance test, Timed Up and Go test, incidence of fall and the quality of life (SF-36V2) were measured at baseline and after 25 weeks. The one-leg stance test and the Timed Up and Go test in the exercise group was significantly better than in the control group after the intervention period (P=0.005; P=0.001, respectively). The Physical Functioning, Vitality and General Health subdomains of quality of life were also significantly better in the exercise group compared to the control group (P=0.004; P=0.005; P=0.038, respectively). Relative risk was 0.40 (90% CI 0.174 to 0.920) and the number needed to treat was 5 (95% CI 2.3 to 23.3). This 25-week Adapted Physical Activity programme improves static balance, functional mobility, as well as Physical Functioning, Vitality and General Health subdomains of quality of life. Based on our results, the Adapted Physical Activity programme may be a promising fall prevention exercise programme improving static balance and functional mobility for community-dwelling older women.

  18. Changes in implant stability using different site preparation techniques: twist drills versus piezosurgery. A single-blinded, randomized, controlled clinical trial.

    Science.gov (United States)

    Stacchi, Claudio; Vercellotti, Tomaso; Torelli, Lucio; Furlan, Fabio; Di Lenarda, Roberto

    2013-04-01

    The objective of the present investigation was to longitudinally monitor stability changes of implants inserted using traditional rotary instruments or piezoelectric inserts, and to follow their variations during the first 90 days of healing. A randomized, controlled trial was conducted on 20 patients. Each patient received two identical, adjacent implants in the upper premolar area: the test site was prepared with piezosurgery, and the control site was prepared using twist drills. Resonance frequency analysis measurements were taken by a blinded operator on the day of surgery and after 7, 14, 21, 28, 42, 56, and 90 days. At 90 days, 39 out of 40 implants were osseointegrated (one failure in the control group). Both groups showed an initial decrease in mean implant stability quotient (ISQ) values: a shift in implant stability to increasing ISQ values occurred after 14 days in the test group and after 21 days in the control group. The lowest mean ISQ value was recorded at 14 days for test implants (97.3% of the primary stability) and at 21 days for the control implants (90.8% of the primary stability). ISQ variations with respect to primary stability differed significantly between the two groups during the entire period of observation: from day 14 to day 42, in particular, the differences were extremely significant (p < .0001). All 39 implants were in function successfully at the visit scheduled 1 year after insertion. The findings from this study suggest that ultrasonic implant site preparation results in a limited decrease of ISQ values and in an earlier shifting from a decreasing to an increasing stability pattern, when compared with the traditional drilling technique. From a clinical point of view, implants inserted with the piezoelectric technique demonstrated a short-term clinical success similar to those inserted using twist drills. © 2011 Wiley Periodicals, Inc.

  19. Dose reduction of risperidone and olanzapine can improve cognitive function and negative symptoms in stable schizophrenic patients: A single-blinded, 52-week, randomized controlled study.

    Science.gov (United States)

    Zhou, Yanling; Li, Guannan; Li, Dan; Cui, Hongmei; Ning, Yuping

    2018-05-01

    The long-term effects of dose reduction of atypical antipsychotics on cognitive function and symptomatology in stable patients with schizophrenia remain unclear. We sought to determine the change in cognitive function and symptomatology after reducing risperidone or olanzapine dosage in stable schizophrenic patients. Seventy-five stabilized schizophrenic patients prescribed risperidone (≥4 mg/day) or olanzapine (≥10 mg/day) were randomly divided into a dose-reduction group ( n=37) and a maintenance group ( n=38). For the dose-reduction group, the dose of antipsychotics was reduced by 50%; for the maintenance group, the dose remained unchanged throughout the whole study. The Positive and Negative Syndrome Scale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, and Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery were measured at baseline, 12, 28, and 52 weeks. Linear mixed models were performed to compare the Positive and Negative Syndrome Scale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects and MATRICS Consensus Cognitive Battery scores between groups. The linear mixed model showed significant time by group interactions on the Positive and Negative Syndrome Scale negative symptoms, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, speed of processing, attention/vigilance, working memory and total score of MATRICS Consensus Cognitive Battery (all pNegative Syndrome Scale negative subscale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, speed of processing, working memory and total score of MATRICS Consensus Cognitive Battery for the dose reduction group compared with those for the maintenance group (all pnegative symptoms in patients with stabilized schizophrenia.

  20. Comparison of the urinary excretion of quercetin glycosides from red onion and aglycone from dietary supplements in healthy subjects: a randomized, single-blinded, cross-over study.

    Science.gov (United States)

    Shi, Yuanlu; Williamson, Gary

    2015-05-01

    Some intervention studies have shown that quercetin supplementation can regulate certain biomarkers, but it is not clear how the doses given relate to dietary quercetin (e.g. from onion). We conducted a two-period, two-sequence crossover study to compare the bioavailability of quercetin when administered in the form of a fresh red onion meal (naturally glycosylated quercetin) or dietary supplement (aglycone quercetin) under fasting conditions. Six healthy, non-smoking, adult males with BMI 22.7 ± 4.0 kg m(-2) and age 35.3 ± 12.3 y were grouped to take the two study meals in random order. In each of the 2 study periods, one serving of onion soup (made from 100 g fresh red onion, providing 156.3 ± 3.4 μmol (47 mg) quercetin) or a single dose of a quercetin dihydrate tablet (1800 ± 150 μmol (544 mg) of quercetin) were administered following 3 d washout. Urine samples were collected up to 24 h, and after enzyme deconjugation, quercetin was quantified by LC-MS. The 24 h urinary excretion of quercetin (1.69 ± 0.79 μmol) from red onion in soup was not significantly different to that (1.17 ± 0.44 μmol) for the quercetin supplement tablet (P = 0.065, paired t-test). This means that, in practice, 166 mg of quercetin supplement would be comparable to about 10 mg of quercetin aglycone equivalents from onion. These data allow intervention studies on quercetin giving either food or supplements to be more effectively compared.

  1. Effects of regularly consuming dietary fibre rich soluble cocoa products on bowel habits in healthy subjects: a free-living, two-stage, randomized, crossover, single-blind intervention

    Directory of Open Access Journals (Sweden)

    Sarriá Beatriz

    2012-04-01

    Full Text Available Abstract Background Dietary fibre is both preventive and therapeutic for bowel functional diseases. Soluble cocoa products are good sources of dietary fibre that may be supplemented with this dietary component. This study assessed the effects of regularly consuming two soluble cocoa products (A and B with different non-starch polysaccharides levels (NSP, 15.1 and 22.0% w/w, respectively on bowel habits using subjective intestinal function and symptom questionnaires, a daily diary and a faecal marker in healthy individuals. Methods A free-living, two-stage, randomized, crossover, single-blind intervention was carried out in 44 healthy men and women, between 18-55 y old, who had not taken dietary supplements, laxatives, or antibiotics six months before the start of the study. In the four-week-long intervention stages, separated by a three-week-wash-out stage, two servings of A and B, that provided 2.26 vs. 6.60 g/day of NSP respectively, were taken. In each stage, volunteers' diet was recorded using a 72-h food intake report. Results Regularly consuming cocoa A and B increased fibre intake, although only cocoa B significantly increased fibre intake (p Conclusions Regular consumption of the cocoa products increases dietary fibre intake to recommended levels and product B improves bowel habits. The use of both objective and subjective assessments to evaluate the effects of food on bowel habits is recommended.

  2. Supervised and non-supervised Nordic walking in the treatment of chronic low back pain: a single blind randomized clinical trial

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    Bendix Tom

    2010-02-01

    Full Text Available Abstract Background Active approaches including both specific and unspecific exercise are probably the most widely recommended treatment for patients with chronic low back pain but it is not known exactly which types of exercise provide the most benefit. Nordic Walking - power walking using ski poles - is a popular and fast growing type of exercise in Northern Europe that has been shown to improve cardiovascular metabolism. Until now, no studies have been performed to investigate whether Nordic Walking has beneficial effects in relation to back pain. Methods A total of 151 patients with low back and/or leg pain of greater than eight weeks duration were recruited from a hospital based outpatient back pain clinic. Patients continuing to have pain greater than three on the 11-point numeric rating scale after a multidisciplinary intervention were included. Fifteen patients were unable to complete the baseline evaluation and 136 patients were randomized to receive A Nordic walking supervised by a specially trained instructor twice a week for eight weeks B One-hour instruction in Nordic walking by a specially trained instructor followed by advice to perform Nordic walking at home as much as they liked for eight weeks or C Individual oral information consisting of advice to remain active and about maintaining the daily function level that they had achieved during their stay at the backcenter. Primary outcome measures were pain and disability using the Low Back Pain Rating Scale, and functional limitation further assessed using the Patient Specific Function Scale. Furthermore, information on time off work, use of medication, and concurrent treatment for their low back pain was collected. Objective measurements of physical activity levels for the supervised and unsupervised Nordic walking groups were performed using accelerometers. Data were analyzed on an intention-to-treat basis. Results No mean differences were found between the three groups in

  3. Supervised and non-supervised Nordic walking in the treatment of chronic low back pain: a single blind randomized clinical trial

    Science.gov (United States)

    2010-01-01

    Background Active approaches including both specific and unspecific exercise are probably the most widely recommended treatment for patients with chronic low back pain but it is not known exactly which types of exercise provide the most benefit. Nordic Walking - power walking using ski poles - is a popular and fast growing type of exercise in Northern Europe that has been shown to improve cardiovascular metabolism. Until now, no studies have been performed to investigate whether Nordic Walking has beneficial effects in relation to back pain. Methods A total of 151 patients with low back and/or leg pain of greater than eight weeks duration were recruited from a hospital based outpatient back pain clinic. Patients continuing to have pain greater than three on the 11-point numeric rating scale after a multidisciplinary intervention were included. Fifteen patients were unable to complete the baseline evaluation and 136 patients were randomized to receive A) Nordic walking supervised by a specially trained instructor twice a week for eight weeks B) One-hour instruction in Nordic walking by a specially trained instructor followed by advice to perform Nordic walking at home as much as they liked for eight weeks or C) Individual oral information consisting of advice to remain active and about maintaining the daily function level that they had achieved during their stay at the backcenter. Primary outcome measures were pain and disability using the Low Back Pain Rating Scale, and functional limitation further assessed using the Patient Specific Function Scale. Furthermore, information on time off work, use of medication, and concurrent treatment for their low back pain was collected. Objective measurements of physical activity levels for the supervised and unsupervised Nordic walking groups were performed using accelerometers. Data were analyzed on an intention-to-treat basis. Results No mean differences were found between the three groups in relation to any of the outcomes

  4. A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management.

    Science.gov (United States)

    Janice Jimenez-Torres, G; Weinstein, Benjamin L; Walker, Cory R; Christopher Fowler, J; Ashford, Philippa; Borckardt, Jeffrey J; Madan, Alok

    2017-03-01

    Available treatments for chronic pain (CP) are modestly effective or associated with iatrogenic harm. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may be an effective, adjunctive treatment to non-opioid therapies. In this randomized control trial (RCT), we compare adjunctive active versus sham tDCS among patients in a multimodal inpatient pain management program. The primary objectives of the RCT are to improve pain tolerance and subjective pain experience. Patients admitted to the Pain Management Program at The Menninger Clinic in Houston, Texas are eligible for this trial. Eighty-four participants will be randomized (1:1) into a single-blind, 2×12 (group×time) controlled trial. A battery-powered direct and constant current stimulator (Soterix Medical Inc. 2014) delivers anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the right DLPFC. Active tDCS is applied by supplying a 2mA current for 20min/session over 10 sessions. Participants complete self-report and performance-based assessments on a weekly basis just prior to brain stimulation. Self-report assessments are collected via Chronic Pain Tracker version 3.6, an iPad interfaced application. The performance-based pain tolerance task is completed through the cold presser task. Interventions with cross-symptomatic therapeutic potential are absolutely essential in the context of CP, in which psychiatric comorbidity is the norm. Modalities that can be used in tandem with evidence-based, non-opioid therapies have the potential to have a synergistic effect, resulting in increased effectiveness of what have been modestly effective treatments to date. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

    Science.gov (United States)

    Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

    2016-12-15

    The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

  6. Effects of exercise training on circulating levels of Dickkpof-1 and secreted frizzled-related protein-1 in breast cancer survivors: A pilot single-blind randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Tae Ho Kim

    Full Text Available Wingless and integration site growth factor (Wnt signaling is a tumorigenesis-related signaling pathway. Dickkpof-1 (DKK1 and secreted frizzled-related protein-1 (SFRP1 are endogenous negative regulators of Wnt/β-catenin signaling. Accumulating evidence indicates that higher serum levels of DKK1 are correlated with poor prognosis of various types of cancer. Here, we investigated whether exercise training causes changes in the serum levels of DKK1 and SFRP1 in patients with breast cancer.Twenty-four breast cancer survivors, after chemo- or radiotherapy, participated in this single-blind randomized, controlled pilot study. Subjects were randomized to either an exercise program or a control group for 12 weeks and completed pre- and post-training tests for health-related fitness and body composition as well as blood biomarkers. The serum levels of DKK1 and SFRP1 were measured using enzyme-linked immunosorbent assay as the primary outcome.Exercise training for 12 weeks remarkably increased muscle strength, endurance, and flexibility and decreased body fat percentage, waist circumference, and visceral fat area (all p < 0.05. Exercise training lowered serum insulin levels and leptin/adiponectin ratios (all p < 0.05. The levels of DKK1 and SFRP1 were also significantly decreased by exercise training in breast cancer survivors (all p < 0.01.Our results indicate that DKK1 and SFRP1 may be potentially useful biomarkers for evaluating the beneficial effects of long-term exercise on physical fitness and metabolism as well as the prognosis of patients with cancer.ClinicalTrials.gov NCT02895178.

  7. The effect of acupressure at spleen 6 acupuncture point on the anxiety level and sedative and analgesics consumption of women during labor: A randomized, single-blind clinical trial

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    Parisa Samadi

    2018-01-01

    Full Text Available Background: Labor pain is the most severe pain women would experience, which could lead to loss of emotional control that plays a key role in creating a traumatic delivery experience and psychological disorders. The goal of this study was to evaluate the effect of acupressure on anxiety level and sedative and analgesics consumption in women during labor. Materials and Methods: This study was a randomized, single-blind clinical trial performed at Maryam Hospital in Tehran, Iran. One hundred and thirty-one pregnant women in Labor Ward were selected by convenience sampling. Subjects were randomly allocated to three groups, namely experimental group (pressure group, control group 1(touh group and, control group 2 (routine care group. The study data were gathered using demographic information form, and assessed with Faces Anxiety Scale (FAS. For participants belonging to the experimental group, pressure was applied to the Spleen 6 acupoint for 30 min, and for those with only light touch was applied to the Spleen 6 acupoint for 30 min. The collected data were analyzed using Statistical Package for the Social Sciences 16 and descriptive statistics. Results: There was a significant difference between the three groups in terms of the mean of anxiety after 30 min of starting the intervention and 30 min after termination of the intervention; the anxiety of the experimental group was significantly decreased (p = 0.03. Sedative and analgesics consumption was significantly lower in the experimental group compared to the other groups (p = 0.006. Conclusions: This study showed that compression of the Spleen 6 acupoint was an effective complementary method to decrease maternal anxiety and analgesic consumption, especially pethidine.

  8. A Single-blind, Split-face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging

    Science.gov (United States)

    Sapra, Priya; Sapra, Sheetal; Khanna, Julie; Mraud, Kelli; Bonadonna, Jennifer

    2017-01-01

    Objective: To examine the effectiveness of intradermal botulinum toxin type A injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods. Design: A 16-week, single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal botulinum toxin type A injections at Week 0 and intramuscular botulinum toxin type A injections at Week 2. Participants: Ten women aged 35 to 65 years who exhibited static rhytids in the glabellar and periorbital area. Measurements: The primary endpoint was efficacy of split-face treatment of intradermal and intramuscular onabotulinumtoxinA and abobotulinumtoxinA as assessed by a blinded evaluator using baseline and post-treatment photographs. The secondary endpoints included safety as assessed by adverse events and patient satisfaction measured by questionnaires completed at baseline and post-treatment. Results: Intradermal injection of botulinum toxin type A led to a statistically significant improvement in skin texture (p=0.004) while also resulting in mild midface lift (p=0.024), but did not provide a significant reduction of pore size and sebum production. There was no statistically significant difference between onabotulinumtoxinA and abobotulinumtoxinA when injected intradermally or intramuscularly. Conclusion: Intradermal injection of botulinum toxin type A appears to be a safe and effective therapy that provides an improvement in facial skin texture and midface lift. Registry: clinicaltrials.gov (ID#: NCT02907268). PMID:28367260

  9. The effect of massage therapy by patients' companions on severity of pain in the patients undergoing post coronary artery bypass graft surgery: a single-blind randomized clinical trial.

    Science.gov (United States)

    Najafi, Sied Saeed; Rast, Fazlola; Momennasab, Marzieh; Ghazinoor, Mahmood; Dehghanrad, Fereshteh; Mousavizadeh, Sied Ali

    2014-07-01

    Pain on mid sternotomy incision site after Coronary Artery Bypass  Graft  Surgery (CABG) is a common problem that causes sleep disturbance, delayed wound healing, and increased use of analgesic drugs. Massage therapy which is mostly performed by healthcare providers is a non-pharmacological approach for managing this pain. The present study aimed to determine the effect of massage therapy by patient's companion on the severity of pain in post CABG patients. In this randomized single-blind clinical trial, 70 post CABG patients were randomly divided into an intervention and a control group. The intervention group received massage by one of their relatives who was trained by an expert nurse. The control group, on the other hand, received routine care. The pain intensity was assessed by Visual Analogue Scale (VAS) before and immediately, 30, 60, and 120 minutes after the intervention. Then, the data were entered into the SPSS statistical software (version 16) and analyzed using repeated measures ANOVA and post-hoc test (Scheffe). At the beginning of the study, no significant difference was found between the two groups regarding the pain severity. In the intervention group, the pain severity significantly decreased in all the four time points after the intervention (P=0.001). However, no significant difference was observed in this regard in the control group. Massage therapy by patient's companion trained by a nurse was an effective strategy for pain management in post CABG patients. This could also promote the patient's family participation in the process of care. IRCT201208218505N3.

  10. A pilot single-blind multicentre randomized controlled trial to evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on the arm function of children with spastic cerebral palsy.

    Science.gov (United States)

    Preston, Nick; Weightman, Andrew; Gallagher, Justin; Levesley, Martin; Mon-Williams, Mark; Clarke, Mike; O'Connor, Rory J

    2016-10-01

    To evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on arm function of children with spastic cerebral palsy. A single-blind randomized controlled trial design. Power calculations indicated that 58 children would be required to demonstrate a clinically important difference. Intervention was home-based; recruitment took place in regional spasticity clinics. A total of 15 children with cerebral palsy aged five to 12 years were recruited; eight to the device group. Both study groups received 'usual follow-up treatment' following spasticity treatment with botulinum toxin; the intervention group also received a rehabilitation gaming device. ABILHAND-kids and Canadian Occupational Performance Measure were performed by blinded assessors at baseline, six and 12 weeks. An analysis of covariance showed no group differences in mean ABILHAND-kids scores between time points. A non-parametric analysis of variance on Canadian Occupational Performance Measure scores showed a statistically significant improvement across time points (χ 2 (2,15) = 6.778, p = 0.031), but this improvement did not reach minimal clinically important difference. Mean daily device use was seven minutes. Recruitment did not reach target owing to unanticipated staff shortages in clinical services. Feedback from children and their families indicated that the games were not sufficiently engaging to promote sufficient use that was likely to result in functional benefits. This study suggests that computer-assisted arm rehabilitation gaming does not benefit arm function, but a Type II error cannot be ruled out. © The Author(s) 2015.

  11. [A follow-up study on a randomized, single-blind control of King's Brain pills in treatment of memory disorder in elderly people with MCI in a Beijing community].

    Science.gov (United States)

    Tian, Jin-zhou; Zhu, Ai-hua; Zhong, Jian

    2003-10-01

    To evaluate the effect of King's Brain pills (Compound Chinese ginseng extract from herbs) on the treatment and the delaying of memory decline in the elderly with mild cognitive impairment (MCI) in a community by a year follow-up of neuropsychology. 75 patients with MCI were selected from Beixinqiao community of Beijing by a cutoff score of 0.0/0.5 on CDR and were randomly assigned into a treatment group (n = 30 cases), given 4 pills of a compound Chinese ginseng extract (King's Brain) with 2 placebo tablets, and a positive control group (n = 30 cases), given 2 tablets of Piracetam with 4 placebo tablets, as well as a placebo group (n = 15 cases), given a placebo of 4 tablets and 2 pills. All subjects took this medication 3 times a day for 3 months. Single-blind and double-moulding control were used in this study. At a baseline and a middlepoint (after 3 months), and a follow-up end (one year later) following a three months of medication therapeutics, all subjects were assessed using a battery consisting of MMSE and 5 memory items on BNPT battery. In the treatment group, MMSE score 27.50 +/- 1.68 was increased to 28.27 +/- 1.70 after 3 months but decreased to 26.90 +/- 1.90 after one year of the treatment. However, the latter score was higher than that in a placebo group 26.33 +/- 1.03 (P Brain spills and piracetam tablets have protective effect on cognitive and memory decline in elderly with MCI.

  12. Effect of lyophilized lactobacilli and 0.03 mg estriol (Gynoflor®) on vaginitis and vaginosis with disrupted vaginal microflora: a multicenter, randomized, single-blind, active-controlled pilot study.

    Science.gov (United States)

    Donders, G G G; Van Bulck, B; Van de Walle, P; Kaiser, R R; Pohlig, G; Gonser, S; Graf, F

    2010-01-01

    To evaluate the efficacy of lyophilized lactobacilli in combination with 0.03 mg estriol when compared to metronidazole in the treatment of bacterial vaginal infections. Multicenter, randomized, single-blind, active-controlled pilot study in 3 independent gynecological practices in Belgium. Forty-six, 18- to 50-year-old premenopausal women with a disrupted vaginal flora due to a bacterial vaginal infection (bacterial vaginosis, aerobic vaginitis) were included, provided that fresh phase-contrast microscopy of the vaginal fluid showed lactobacillary flora grade 2B or 3. Patients were given a blinded box with either 12 vaginal tablets of Gynoflor® (study medication) or 6 vaginal suppositories containing 500 mg metronidazole (control medication). Eight efficacy variables were studied to assess the status of the vaginal flora at entry, 3-7 days (control 1), 4-6 (control 2) weeks and 4 months after the end of therapy. At control 1, the combined variables equally improved in the lactobacilli group as in the metronidazole group. At control 2, the lactobacillus preparation showed slightly inferior results when compared to metronidazole. At 4 months, this analysis could not be performed due to low numbers, but analysis of recurrence rate and extra medication needed was not different between both groups. Lyophilized lactobacilli in combination with low-dose estriol are equivalent to metronidazole in the short-term treatment of bacterial vaginal infections, but have less effect after 1 month. Further studies are required to evaluate the long-term efficacy of lactobacilli when applied repeatedly. Copyright © 2010 S. Karger AG, Basel.

  13. Effect of single-dose low-level helium-neon laser irradiation on orthodontic pain: a split-mouth single-blind placebo-controlled randomized clinical trial.

    Science.gov (United States)

    Sobouti, Farhad; Khatami, Maziar; Chiniforush, Nasim; Rakhshan, Vahid; Shariati, Mahsa

    2015-01-01

    Pain is the most common complication of orthodontic treatment. Low-level laser therapy (LLLT) has been suggested as a new analgesic treatment free of the adverse effects of analgesic medications. However, it is not studied thoroughly, and the available studies are quite controversial. Moreover, helium neon (He-Ne) laser has not been assessed before. This split-mouth placebo-controlled randomized clinical trial was performed on 16 male and 14 female orthodontic patients requiring bilateral upper canine retraction. The study was performed at a private clinic in Sari, Iran, in 2014. It was single blind: patients, orthodontist, and personnel were blinded of the allocations, but the laser operator (periodontist) was not blinded. Once canine retractor was activated, a randomly selected maxillary quarter received a single dose of He-Ne laser irradiation (632.8 nm, 10 mw, 6 j/cm(2) density). The other quarter served as the placebo side, treated by the same device but powered off. In the first, second, fourth, and seventh days, blinded patients rated their pain sensed on each side at home using visual analog scale (VAS) questionnaires. There was no harm identified during or after the study. Pain changes were analyzed using two- and one-way repeated-measures ANOVA, Bonferroni, and t-test (α = 0.01, β > 0.99). This trial was not registered. It was self-funded by the authors. Sixteen males and 11 females remained in the study (aged 12-21). Average pain scores sensed in all 4 intervals on control and laser sides were 4.06 ± 2.85 and 2.35 ± 1.77, respectively (t-test P < 0.0001). One-way ANOVA showed significant pain declines over time, in each group (P < 0.0001). Two-way ANOVA showed significant effects for LLLT (P < 0.0001) and time (P = <0.0001). Single-dose He-Ne laser therapy might reduce orthodontic pain caused by retracting maxillary canines.

  14. Does the addition of virtual reality training to a standard program of inpatient rehabilitation improve sitting balance ability and function after stroke? Protocol for a single-blind randomized controlled trial.

    Science.gov (United States)

    Sheehy, L; Taillon-Hobson, A; Sveistrup, H; Bilodeau, M; Fergusson, D; Levac, D; Finestone, H

    2016-03-31

    Sitting ability and function are commonly impaired after stroke. Balance training has been shown to be helpful, but abundant repetitions are required for optimal recovery and patients must be motivated to perform rehabilitation exercises repeatedly to maximize treatment intensity. Virtual reality training (VRT), which allows patients to interact with a virtual environment using computer software and hardware, is enjoyable and may encourage greater repetition of therapeutic exercises. However, the potential for VRT to promote sitting balance has not yet been explored. The objective of this study is to determine if supplemental VRT-based sitting balance exercises improve sitting balance ability and function in stroke rehabilitation inpatients. This is a single-site, single-blind, parallel-group randomized control trial. Seventy six stroke rehabilitation inpatients who cannot stand independently for greater than one minute but can sit for at least 20 minutes (including at least one minute without support) are being recruited from a tertiary-care dedicated stroke rehabilitation unit. Participants are randomly allocated to experimental or control groups. Both participate in 10-12 sessions of 30-45 minutes of VRT performed in sitting administered by a single physiotherapist, in addition to their traditional therapy. The experimental group plays five games which challenge sitting balance while the control group plays five games which minimize trunk lean. Outcome measures of sitting balance ability (Function in Sitting Test, Ottawa Sitting Scale, quantitative measures of postural sway) and function (Reaching Performance Scale, Wolf Motor Function Test, quantitative measures of the limits of stability) are administered prior to, immediately following, and one month following the intervention by a second physiotherapist blind to the participant's group allocation. The treatment of sitting balance post-stroke with VRT has not yet been explored. Results from the current study

  15. Feasibility of a randomized single-blind crossover trial to assess the effects of the second-generation slow-release dopamine agonists pramipexole and ropinirole on cued recall memory in idiopathic mild or moderate Parkinson's disease without cognitive impairment.

    Science.gov (United States)

    Shepherd, Thomas A; Edelstyn, Nicola M J; Longshaw, Laura; Sim, Julius; Watts, Keira; Mayes, Andrew R; Murray, Michael; Ellis, Simon J

    2018-01-01

    The aim was to assess the feasibility of a single-centre, single-blind, randomized, crossover design to explore the effects of two slow-release dopamine agonists, ropinirole and pramipexole, on cued recall in Parkinson's disease. As the design required a switch from the prescribed agonist (pramipexole-to-ropinirole, or ropinirole-to-pramipexole), the primary objectives were to (a) examine the efficacy of processes and procedures used to manage symptoms during the washout period and (b) to use cued recall estimates to inform a power calculation for a definitive trial. Secondary objectives were to assess consent and missing data rates, acceptability of clinical support for the OFF sessions, experience of the OFF sessions and of agonist switching, barriers-to-participation for patients and informal caregivers. Patients were randomized in a 1:1 ratio to two treatment arms and stabilized on each agonist for 6 weeks. The arms differed only in the sequence in which the agonists were administered. Cued recall was assessed ON medication and, following a washout period resulting in 93.75% agonist elimination, OFF medication. A total of 220 patients were screened: 145 were excluded and 75 invitations to participate were sent to eligible patients. Fifty-three patients declined, 22 consented and 16 completed the study. There were no serious adverse events, and rates of non-serious adverse events were equivalent between the agonists. Using the largest standard deviation (SD) of the ON-OFF difference cued recall score (inflated by ~25% to give a conservative estimate of the SD in a definitive trial) and assuming an effect of at least 10% of the observed range of OFF medication cued recall scores for either agonist to be clinically important, a main trial requires a sample size of just under 150 patients. The consent and missing data rates were 29 and 27% respectively. The washout period and the preparation for the OFF sessions were acceptable, and the sessions were manageable

  16. The effect of short-term low-energy ultraviolet B irradiation on bone mineral density and bone turnover markers in postmenopausal women with osteoporosis: A randomized single-blinded controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Micić Ivan

    2013-01-01

    Full Text Available Introduction. The importance of vitamin D on bone health and osteoporosis was studied by many researchers. The main role of the Vitamin D is to absorb calcium and phosphate and increase bone mineralization. Older people are at an increased risk of the inadequate vitamin D production in the skin because of lower sun exposure and reduced ability of the skin to synthesize vitamin D. Objective. The aim of this clinical trial was to evaluate the efficacy and tolerability of short-term (2 weeks low energy UVB irradiation in postmenopausal women with osteoporosis using bone mineral density and bone turnover markers. Methods. A three-month, single-blinded, randomized, placebo-controlled clinical trial was conducted at the University hospital in Daegu, Republic of Korea. Fifty-two postmenopausal Korean women (older than 65 years with osteoporosis were randomly allocated to have either low energy UVB or placebo for 30 minutes a day for two weeks of treatment during winter. Laboratory analysis and physical examination before and 4, 8 and 12 weeks after treatment were carried out and BMD was measured before and 8 and 12 weeks after treatment. The effects of time and treatment interaction between these two groups were evaluated by repeated-measure two-factor analysis, and subgroup analysis was performed to examine UVB effect on the vitamin D insufficient group [serum 25(OHD3 concentration <30 ng/mL]. Results. In vitamin D insufficient group, the effect of UVB irradiation on vitamin D and bone ALP as well as additional benefit on bone formation was confirmed. The vitamin D insufficient group showed statistically significant increment in serum 25(OHD3 compared with the normal group (p<0.05. However, there was no significant difference between two groups in the other bone turnover markers, such as serum calcium, PTH-C, serum osteocalcin, serum CTX and BMD. Conclusion. Low-energy-short-term UVB radiation for postmenopausal women may be of use in vitamin D

  17. A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation

    Directory of Open Access Journals (Sweden)

    Nikolis A

    2016-05-01

    Full Text Available Andreas Nikolis,1 Steven Bernstein,2 Brian Kinney,3 Nicolo Scuderi,4 Shipra Rastogi,5 John S Sampalis6 1Victoria Park, Plastic Surgery Section, Westmount, QC, Canada; 2Dermatology Department, University of Montreal Health Centre, Montreal, QC, Canada; 3Department of Plastic Surgery, USC School of Medicine, Beverley Hills, CA, USA; 4Department of Plastic and Reconstructive Surgery, La Sapienza, Rome, Italy; 5KLOX Technologies, Laval, 6JSS Medical Research, Montreal, QC, Canada Purpose: Many treatment modalities exist to counteract the effects of cutaneous aging. Ablative methods have been the mainstay for nonsurgical facial rejuvenation. In recent years, nonablative techniques have been developed with the aim of achieving facial rejuvenation without epidermal damage. Light-emitting diode (LED photorejuvenation is a novel nonablative technique that induces collagen synthesis through biophotomodulatory pathways. Materials and methods: A single-center, randomized, single-blinded, placebo-controlled, split-faced clinical trial was designed. Thirty-two patients were enrolled for a 12-week study. Patients were randomized into one of four groups: Group A, treatment with KLOX-001 gel formulation and white LED (placebo light; Group B, treatment with a placebo/base gel (no active chromophore formulation and KLOX LED light; Group C, treatment with KLOX-001 gel formulation and KLOX LED light; and Group D, treatment with the standard skin rejuvenating treatment (0.1% retinol-based cream. Patients received treatment at weeks 0, 1, 2, and 3, and returned to the clinic at weeks 4, 8, and 12 for clinical assessments performed by an independent, blinded committee of physicians using subjective clinician assessment scales. Tolerability, adverse outcomes, and patient satisfaction were also assessed. Results: Analysis demonstrated that the KLOX LED light with KLOX placebo/base gel and the KLOX LED light + KLOX-001 gel formulation groups were superior to standard of

  18. Impact of Moringa oleifera lam. Leaf powder supplementation versus nutritional counseling on the body mass index and immune response of HIV patients on antiretroviral therapy: a single-blind randomized control trial.

    Science.gov (United States)

    Tshingani, Koy; Donnen, Philippe; Mukumbi, Henri; Duez, Pierre; Dramaix-Wilmet, Michèle

    2017-08-22

    To achieve effective antiretroviral therapy (ART) outcomes, adherence to an antiretroviral regimen and a good immunometabolic response are essential. Food insecurity can act as a real barrier to adherence to both of these factors. Many people living with human immunodeficiency virus (PLHIV) treated with ART in the Democratic Republic of the Congo (DRC) are faced with nutritional challenges. A significant proportion are affected by under nutrition, which frequently leads to therapeutic failure. Some HIV care facilities recommend supplementation with Moringa oleifera (M.O.) Lam. leaf powder to combat marginal and major nutritional deficiencies. This study aims to assess the impact of M.O. Lam. leaf powder supplementation compared to nutritional counseling on the nutritional and immune status of PLHIV treated with ART. A single-blind randomized control trial was carried out from May to September 2013 at an outpatient clinic for HIV-infected patients in Kinshasa (DRC). Sixty adult patients who were at stable HIV/AIDS clinical staging 2, 3 or 4 according to the World Health Organization (WHO), and were undergoing ART were recruited. After random allocation, 30 patients in the Moringa intervention group (MG) received the M.O. Lam. leaf powder daily over 6 months, and 30 in the control group (CG) received nutritional counseling over the same period. Changes in the body mass index (BMI) were measured monthly and biological parameters were measured upon admission and at the end of the study for the patients in both groups. The two study groups were similar in terms of long-term nutritional exposure, sociodemographic, socioeconomic, clinical, and biological features. At 6 months follow-up, patients in the MG exhibited a significantly greater increase in BMI and albumin levels than those in the CG. The interaction between the sociodemographic, clinical, and biological characteristics of patients in the two groups was not significant, with the exception of professional

  19. Safety and tolerability of conserved region vaccines vectored by plasmid DNA, simian adenovirus and modified vaccinia virus ankara administered to human immunodeficiency virus type 1-uninfected adults in a randomized, single-blind phase I trial.

    Directory of Open Access Journals (Sweden)

    Emma-Jo Hayton

    Full Text Available HIV-1 vaccine development has advanced slowly due to viral antigenic diversity, poor immunogenicity and recently, safety concerns associated with human adenovirus serotype-5 vectors. To tackle HIV-1 variation, we designed a unique T-cell immunogen HIVconsv from functionally conserved regions of the HIV-1 proteome, which were presented to the immune system using a heterologous prime-boost combination of plasmid DNA, a non-replicating simian (chimpanzee adenovirus ChAdV-63 and a non-replicating poxvirus, modified vaccinia virus Ankara. A block-randomized, single-blind, placebo-controlled phase I trial HIV-CORE 002 administered for the first time candidate HIV-1- vaccines or placebo to 32 healthy HIV-1/2-uninfected adults in Oxford, UK and elicited high frequencies of HIV-1-specific T cells capable of inhibiting HIV-1 replication in vitro. Here, detail safety and tolerability of these vaccines are reported.Local and systemic reactogenicity data were collected using structured interviews and study-specific diary cards. Data on all other adverse events were collected using open questions. Serum neutralizing antibody titres to ChAdV-63 were determined before and after vaccination.Two volunteers withdrew for vaccine-unrelated reasons. No vaccine-related serious adverse events or reactions occurred during 190 person-months of follow-up. Local and systemic events after vaccination occurred in 27/32 individuals and most were mild (severity grade 1 and predominantly transient (<48 hours. Myalgia and flu-like symptoms were more strongly associated with MVA than ChAdV63 or DNA vectors and more common in vaccine recipients than in placebo. There were no intercurrent HIV-1 infections during follow-up. 2/24 volunteers had low ChAdV-63-neutralizing titres at baseline and 7 increased their titres to over 200 with a median (range of 633 (231-1533 post-vaccination, which is of no safety concern.These data demonstrate safety and good tolerability of the pSG2

  20. Efficacy of Intra-articular Injection of a Newly Developed Plasma Rich in Growth Factor (PRGF) Versus Hyaluronic Acid on Pain and Function of Patients with Knee Osteoarthritis: A Single-Blinded Randomized Clinical Trial

    Science.gov (United States)

    Raeissadat, Seyed Ahmad; Rayegani, Seyed Mansoor; Ahangar, Azadeh Gharooee; Abadi, Porya Hassan; Mojgani, Parviz; Ahangar, Omid Gharooi

    2017-01-01

    Background and objectives: Knee osteoarthritis is the most common joint disease. We aimed to compare the efficacy and safety of intra-articular injection of a newly developed plasma rich in growth factor (PRGF) versus hyaluronic acid (HA) on pain and function of patients with knee osteoarthritis. Methods: In this single-blinded randomized clinical trial, patients with symptomatic osteoarthritis of knee were assigned to receive 2 intra-articular injections of our newly developed PRGF in 3 weeks or 3 weekly injections of HA. Our primary outcome was the mean change from baseline until 2 and 6 months post intervention in scores of visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. We used analysis of variance for repeated-measures statistical test. Results: A total of 69 patients entered final analysis. The mean age of patients was 58.2 ± 7.41 years and 81.2% were women. In particular, total WOMAC index decreased from 42.9 ± 13.51 to 26.8 ± 13.45 and 24.4 ± 16.54 at 2 and 6 months in the newly developed PRGF group (within subjects P = .001), and from 38.8 ± 12.62 to 27.8 ± 11.01 and 27.4 ± 11.38 at 2 and 6 months in the HA group (within subjects P = .001), respectively (between subjects P = .631). There was no significant difference between PRGF and HA groups in patients’ satisfaction and minor complications of injection, whereas patients in HA group reported significantly lower injection-induced pain. Conclusions: In 6 months follow up, our newly developed PRGF and HA, both are effective options to decrease pain and improvement of function in patients with symptomatic mild to moderate knee osteoarthritis. PMID:29051707

  1. Efficacy of Intra-articular Injection of a Newly Developed Plasma Rich in Growth Factor (PRGF) Versus Hyaluronic Acid on Pain and Function of Patients with Knee Osteoarthritis: A Single-Blinded Randomized Clinical Trial.

    Science.gov (United States)

    Raeissadat, Seyed Ahmad; Rayegani, Seyed Mansoor; Ahangar, Azadeh Gharooee; Abadi, Porya Hassan; Mojgani, Parviz; Ahangar, Omid Gharooi

    2017-01-01

    Knee osteoarthritis is the most common joint disease. We aimed to compare the efficacy and safety of intra-articular injection of a newly developed plasma rich in growth factor (PRGF) versus hyaluronic acid (HA) on pain and function of patients with knee osteoarthritis. In this single-blinded randomized clinical trial, patients with symptomatic osteoarthritis of knee were assigned to receive 2 intra-articular injections of our newly developed PRGF in 3 weeks or 3 weekly injections of HA. Our primary outcome was the mean change from baseline until 2 and 6 months post intervention in scores of visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. We used analysis of variance for repeated-measures statistical test. A total of 69 patients entered final analysis. The mean age of patients was 58.2 ± 7.41 years and 81.2% were women. In particular, total WOMAC index decreased from 42.9 ± 13.51 to 26.8 ± 13.45 and 24.4 ± 16.54 at 2 and 6 months in the newly developed PRGF group (within subjects P  = .001), and from 38.8 ± 12.62 to 27.8 ± 11.01 and 27.4 ± 11.38 at 2 and 6 months in the HA group (within subjects P  = .001), respectively (between subjects P  = .631). There was no significant difference between PRGF and HA groups in patients' satisfaction and minor complications of injection, whereas patients in HA group reported significantly lower injection-induced pain. In 6 months follow up, our newly developed PRGF and HA, both are effective options to decrease pain and improvement of function in patients with symptomatic mild to moderate knee osteoarthritis.

  2. Efficacy of Intra-articular Injection of a Newly Developed Plasma Rich in Growth Factor (PRGF Versus Hyaluronic Acid on Pain and Function of Patients with Knee Osteoarthritis: A Single-Blinded Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Seyed Ahmad Raeissadat

    2017-10-01

    Full Text Available Background and objectives: Knee osteoarthritis is the most common joint disease. We aimed to compare the efficacy and safety of intra-articular injection of a newly developed plasma rich in growth factor (PRGF versus hyaluronic acid (HA on pain and function of patients with knee osteoarthritis. Methods: In this single-blinded randomized clinical trial, patients with symptomatic osteoarthritis of knee were assigned to receive 2 intra-articular injections of our newly developed PRGF in 3 weeks or 3 weekly injections of HA. Our primary outcome was the mean change from baseline until 2 and 6 months post intervention in scores of visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, and Lequesne index. We used analysis of variance for repeated-measures statistical test. Results: A total of 69 patients entered final analysis. The mean age of patients was 58.2 ± 7.41 years and 81.2% were women. In particular, total WOMAC index decreased from 42.9 ± 13.51 to 26.8 ± 13.45 and 24.4 ± 16.54 at 2 and 6 months in the newly developed PRGF group (within subjects P  = .001, and from 38.8 ± 12.62 to 27.8 ± 11.01 and 27.4 ± 11.38 at 2 and 6 months in the HA group (within subjects P  = .001, respectively (between subjects P  = .631. There was no significant difference between PRGF and HA groups in patients’ satisfaction and minor complications of injection, whereas patients in HA group reported significantly lower injection-induced pain. Conclusions: In 6 months follow up, our newly developed PRGF and HA, both are effective options to decrease pain and improvement of function in patients with symptomatic mild to moderate knee osteoarthritis.

  3. Nutrient-rich dairy proteins improve appendicular skeletal muscle mass and physical performance, and attenuate the loss of muscle strength in older men and women subjects: a single-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Alemán-Mateo H

    2014-09-01

    Full Text Available Heliodoro Alemán-Mateo,1 Virginia Ramírez Carreón,1 Liliana Macías,1 Humberto Astiazaran-García,1 Ana Cristina Gallegos-Aguilar,1 José Rogelio Ramos Enríquez2 1Coordinación de Nutrición, Centro de Investigación en Alimentación y Desarrollo, A.C., 2Laboratorio de Análisis Clínicos e Investigación, Departamento de Ciencias Químico Biológicas, Universidad de Sonora, Hermosillo, Mexico Background: At present, it is unknown whether the use of nutrient-rich dairy proteins improves the markers of sarcopenia syndrome. Therefore, our proposal was to investigate whether ­adding 210 g of ricotta cheese daily would improve skeletal muscle mass, handgrip strength, and ­physical performance in non-sarcopenic older subjects.Subjects and methods: This was a single-blind randomized clinical trial that included two homogeneous, randomized groups of men and women over 60 years of age. Participants in the intervention group were asked to consume their habitual diet but add 210 g of ricotta cheese (IG/HD + RCH, while the control group was instructed to consume only their habitual diet (CG/HD. Basal and 12-week follow-up measurements included appendicular skeletal muscle mass (ASMM by dual-energy X-ray absorptiometry, handgrip strength by a handheld dynamometer, and physical performance using the short physical performance battery (SPPB and the stair-climb power test (SCPT. The main outcomes were relative changes in ASMM, strength, SPPB, and SCPT.Results: ASMM increased in the IG/HD + RCH (0.6±3.5 kg, but decreased in the CG/HD (–1.0±2.6. The relative change between groups was statistically significant (P=0.009. The relative change in strength in both groups was negative, but the loss of muscle strength was more pronounced in CG/HD, though in this regard statistical analysis found only a tendency (P=0.07. The relative change in the balance-test scores was positive for the IG/HD + RCH, while in the CG/HD it was negative, as those individuals had

  4. Lysine clonixinate versus dipyrone (metamizole for the acute treatment of severe migraine attacks: a single-blind, randomized study Clonixinato de lisina versus dipirona (metamizol para o tratamento agudo de uma crise intensa de enxaqueca: estudo monocego e randomizado

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    Abouch Valenty Krymchantowski

    2008-06-01

    Full Text Available BACKGROUND AND OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAID are effective to treat migraine attacks. Lysine clonixinate (LC and dipyrone (metamizol have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. METHOD: Thirty patients (28 women, 2 men, aged 18 to 48 years with migraine according the International Headache Society (IHS (2004 were studied. The patients were randomized into 2 groups when presenting to an emergency department with a severe migraine attack. The study was single-blind. Headache intensity, nausea, photophobia and side effects were evaluated at 0, 30, 60 and 90 minutes after the drug administration. Rectal indomethacin as rescue medication (RM was available after 2 hours and its use compared between groups. RESULTS: All patients completed the study. At 30 minutes, 0% of the dipyrone group 13% of the LC group were pain free (p=0.46. At 60 and 90 minutes, 2 (13% and 5 (33% patients from the dipyrone group and 11 (73% and 13 (86.7% patients from the LC group were pain free (pCONTEXTO E OBJETIVO: Antiinflamatórios não esteroidais (AINE são eficazes no tratamento de crises de enxaqueca. O objetivo deste estudo foi comparar a eficácia e a tolerabilidade das apresentações injetáveis do clonixinato de lisina (CL e da dipirona no tratamento de crises intensas de enxaqueca. MÉTODO: Trinta pacientes (28 mulheres, 2 homens, com idades entre 18 e 48 anos e enxaqueca de acordo com a Classificação Internacional de Cefaléias (2004 foram estudados. Os pacientes foram randomizados em 2 grupos ao se apresentarem em uma unidade de emergência, com uma crise intensa de enxaqueca. O desenho do estudo foi monocego. A intensidade da cefaléia, a presença de náusea e fotofobia e os efeitos colaterais foram avaliados e comparados na administração das drogas e após 30

  5. Effects of oral contraceptives containing ethinylestradiol with either drospirenone or levonorgestrel on various parameters associated with well-being in healthy women: a randomized, single-blind, parallel-group, multicentre study.

    Science.gov (United States)

    Kelly, Sue; Davies, Emyr; Fearns, Simon; McKinnon, Carol; Carter, Rick; Gerlinger, Christoph; Smithers, Andrew

    2010-01-01

    The combined oral contraceptive Yasmin (drospirenone 3 mg plus ethinylestradiol 30 microg [DRSP 3 mg/EE 30 microg]) has been shown to be a well tolerated and effective combination that provides high contraceptive reliability and good cycle control. Furthermore, DRSP 3 mg/EE 30 microg has been shown to have a positive effect on premenstrual symptoms and well-being/health-related quality of life, and to improve the skin condition of women with acne. To date, however, there have been relatively few studies that have compared the effects of DRSP 3 mg/EE 30 microg on the general well-being of women with those of other oral contraceptives. To compare the impact of DRSP 3 mg/EE 30 microg with that of levonorgestrel 150 microg/EE 30 microg (LNG 150 microg/EE 30 microg; Microgynon 30) on various parameters associated with well-being in healthy female subjects. This was a randomized, single-blind, parallel-group, multicentre study conducted using 21/7-day regimens of DRSP 3 mg/EE 30 microg and LNG 150 microg/EE 30 microg over seven cycles. Efficacy parameters included: changes in Menstrual Distress Questionnaire (MDQ) normative T scores; the proportion of subjects with acne; and menstrual symptoms. Cycle control and subjective well-being parameters were also assessed. Treatment with DRSP 3 mg/EE 30 microg had similar beneficial effects on symptoms of water retention and impaired concentration to LNG 150 microg/EE 30 microg, but was significantly better in alleviating negative affect symptoms during the menstrual phase (median difference in MDQ T score -3; p = 0.027; Wilcoxon rank sum test). The proportion of subjects with acne decreased from approximately 55% to approximately 45% in the DRSP 3 mg/EE 30 microg group, but remained static at approximately 60% in the LNG 150 microg/EE 30 microg group. Somatic and psychological symptoms occurred at the greatest intensity and for most subjects during the menstrual phase of the cycle in both groups. Both drugs had similar cycle

  6. Sucralfate versus cimetidine in reflux esophagitis. A single-blind multicenter study

    NARCIS (Netherlands)

    Hameeteman, W.; v d Boomgaard, D. M.; Dekker, W.; Schrijver, M.; Wesdorp, I. C.; Tytgat, G. N.

    1987-01-01

    A single-blind randomized multicenter study was performed in 42 patients with endoscopically documented reflux esophagitis. Patients were randomly given 400 mg cimetidine q.i.d. or a suspension of 1 g sucralfate q.i.d. for a period of 8 weeks. Forty patients were evaluated after 8 weeks. Symptomatic

  7. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  8. Continuous activation of PpIX by daylight is as effective as and less painful than conventional photodynamic therapy for actinic keratoses; a randomized, controlled, single-blinded study

    DEFF Research Database (Denmark)

    Wiegell, S.R.; Hædersdal, Merete; Philipsen, P.A.

    2008-01-01

    of the face and scalp were treated with MAL-PDT in two symmetrical areas. One area was illuminated by red LED light (37 J cm(-2)) after 3-h incubation with MAL under occlusive dressing. The other area was treated with daylight for 2.5 h after the MAL cream had been under occlusion for half an hour. Results We...... found no significant difference in the treatment effect between the two treatments (P = 0.13), with a reduction of AK lesions of 79% in the daylight area compared with 71% in the LED area. Treatment response in the daylight area did not depend on the intensity of the daylight. Illumination with LED...... of porphyrins during its formation. Objectives The objective of this randomized controlled study was to compare response rates and adverse effects after methyl aminolevulinate (MAL)-PDT using conventional red light-emitting diode (LED) light vs. daylight. Patients/methods Twenty-nine patients with AK...

  9. Assessment of the rate of premolar extraction space closure in the maxillary arch with the AcceleDent Aura appliance vs no appliance in adolescents: A single-blind randomized clinical trial.

    Science.gov (United States)

    Miles, Peter; Fisher, Elizabeth; Pandis, Nikolaos

    2018-01-01

    The purpose of this 2-arm parallel trial was to assess the effect of the AcceleDent Aura appliance (OrthoAccel Technologies, Houston, Tex) on the rate of maxillary premolar extraction space closure in adolescent patients. Forty Class II adolescents treated with full fixed appliances and maxillary premolar extractions participated in this randomized clinical trial. They were recruited in a private practice and treated by 1 clinician. Randomization was accomplished in blocks of 10 patients assigned to either a no-appliance group or the AcceleDent Aura appliance group with the allocations concealed in opaque, sealed envelopes. Both the operator and the outcome assessor were blinded; however, it was not feasible to blind the patients. Models were taken of the maxillary arch at the start of space closure and just before complete space closure. The space was measured parallel to the occlusal plane from the cusp tips of the teeth mesial and distal to the extraction spaces. There was no clinically (0.05 mm per month; 95% confidence interval [CI], -0.24, 0.34) or statistically significant difference in the rate of space closure (P = 0.74). In both the univariable and multivariable analyses, the mean rate of tooth movement was slower by 0.13 mm per month (95% CI, -.26, .005) on the left side compared with the right side, but this was not statistically significant (P = 0.06). The AcceleDent Aura appliance had no effect on the rate of maxillary premolar extraction space closure. Only a few participants were considered to be good compliers with the appliance. However, the rate of space closure in the good compliers was similar to the overall group and did not appear to influence the result. This trial was not registered. The protocol was not published before trial commencement. Copyright © 2017 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

  10. Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial.

    Science.gov (United States)

    Hofland, Jan; Ouattara, Alexandre; Fellahi, Jean-Luc; Gruenewald, Matthias; Hazebroucq, Jean; Ecoffey, Claude; Joseph, Pierre; Heringlake, Matthias; Steib, Annick; Coburn, Mark; Amour, Julien; Rozec, Bertrand; Liefde, Inge de; Meybohm, Patrick; Preckel, Benedikt; Hanouz, Jean-Luc; Tritapepe, Luigi; Tonner, Peter; Benhaoua, Hamina; Roesner, Jan Patrick; Bein, Berthold; Hanouz, Luc; Tenbrinck, Rob; Bogers, Ad J J C; Mik, Bert G; Coiffic, Alain; Renner, Jochen; Steinfath, Markus; Francksen, Helga; Broch, Ole; Haneya, Assad; Schaller, Manuella; Guinet, Patrick; Daviet, Lauren; Brianchon, Corinne; Rosier, Sebastien; Lehot, Jean-Jacques; Paarmann, Hauke; Schön, Julika; Hanke, Thorsten; Ettel, Joachym; Olsson, Silke; Klotz, Stefan; Samet, Amir; Laurinenas, Giedrius; Thibaud, Adrien; Cristinar, Mircea; Collanges, Olivier; Levy, François; Rossaint, Rolf; Stevanovic, Ana; Schaelte, Gereon; Stoppe, Christian; Hamou, Nora Ait; Hariri, Sarah; Quessard, Astrid; Carillion, Aude; Morin, Hélène; Silleran, Jacqueline; Robert, David; Crouzet, Anne-Sophie; Zacharowski, Kai; Reyher, Christian; Iken, Sonja; Weber, Nina C; Hollmann, Marcus; Eberl, Susanne; Carriero, Giovanni; Collacchi, Daria; Di Persio, Alessandra; Fourcade, Olivier; Bergt, Stefan; Alms, Angela

    2017-12-01

    Ischemic myocardial damage accompanying coronary artery bypass graft surgery remains a clinical challenge. We investigated whether xenon anesthesia could limit myocardial damage in coronary artery bypass graft surgery patients, as has been reported for animal ischemia models. In 17 university hospitals in France, Germany, Italy, and The Netherlands, low-risk elective, on-pump coronary artery bypass graft surgery patients were randomized to receive xenon, sevoflurane, or propofol-based total intravenous anesthesia for anesthesia maintenance. The primary outcome was the cardiac troponin I concentration in the blood 24 h postsurgery. The noninferiority margin for the mean difference in cardiac troponin I release between the xenon and sevoflurane groups was less than 0.15 ng/ml. Secondary outcomes were the safety and feasibility of xenon anesthesia. The first patient included at each center received xenon anesthesia for practical reasons. For all other patients, anesthesia maintenance was randomized (intention-to-treat: n = 492; per-protocol/without major protocol deviation: n = 446). Median 24-h postoperative cardiac troponin I concentrations (ng/ml [interquartile range]) were 1.14 [0.76 to 2.10] with xenon, 1.30 [0.78 to 2.67] with sevoflurane, and 1.48 [0.94 to 2.78] with total intravenous anesthesia [per-protocol]). The mean difference in cardiac troponin I release between xenon and sevoflurane was -0.09 ng/ml (95% CI, -0.30 to 0.11; per-protocol: P = 0.02). Postoperative cardiac troponin I release was significantly less with xenon than with total intravenous anesthesia (intention-to-treat: P = 0.05; per-protocol: P = 0.02). Perioperative variables and postoperative outcomes were comparable across all groups, with no safety concerns. In postoperative cardiac troponin I release, xenon was noninferior to sevoflurane in low-risk, on-pump coronary artery bypass graft surgery patients. Only with xenon was cardiac troponin I release less than with total intravenous

  11. The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial).

    Science.gov (United States)

    Clausen, Brian; Holsgaard-Larsen, Anders; Søndergaard, Jens; Christensen, Robin; Andriacchi, Thomas P; Roos, Ewa M

    2014-11-15

    Knee osteoarthritis (OA) is a mechanically driven disease, and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief, indicating that pharmacologic pain relief may be positively associated with disease progression. Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable. The knee-joint load is influenced by functional alignment of the trunk, pelvis, and lower-limb segments with respect to the knee, as well as the ground-reaction force generated during movement. Neuromuscular exercise can influence knee load and decrease knee pain. It includes exercises to improve balance, muscle activation, functional alignment, and functional knee stability. The primary objective of this randomized controlled trial (RCT) is to investigate the efficacy of a NEuroMuscular EXercise (NEMEX) therapy program, compared with optimized analgesics and antiinflammatory drug use, on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis. One hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated (1:1) to one of two 8-week treatments, either (a) NEMEX therapy twice a week or (b) information on the recommended use of analgesics and antiinflammatory drugs (acetaminophen and oral NSAIDs) via a pamphlet and video materials. The primary outcome is change in knee load during walking (the Knee Index, a composite score of the first external peak total reaction moment on the knee joint from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures, in addition to changes in self-reported pain, function, health status, and quality of life. These findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use

  12. Comparing the effects of balance training with and without cognitive tasks on the quality of life and balance performance in community-dwelling older adults: a single-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ehsan Sinaei

    2016-12-01

    Full Text Available Background: Aging process can deteriorate the ability to maintain balance, specifically under dual-task conditions. Thus far, different methods of exercises therapy have been applied to improve balance performance of older adults. The present study was designed to compare the effects of two protocols of balance training on the quality of life (QoL and balance performance in older adults with mild balance impairments. Methods: Twenty-four older adults over 60 years old were allocated randomly into single-task (n=12 and dual-task (n=12 exercise groups. Single-task group received routine balance exercises, over a four-week period and dual-task group was treated by the same exercise program plus a cognitive task. QoL and balance status were assessed by the Short-Form Health Survey (SF-36 and Fullerton Advanced Balance scale (FAB questionnaires, before and after the interventions. Results: After four weeks of training, balance performance and some factors of QoL improved significantly in both groups (P<0.05. However, there were no significant differences in any of the variables between the two groups. Conclusion: Balance exercises, under both single- and dual-task conditions can improve the balance level and some aspects of QoL in older adults with mild balance impairments, with no priority of one group over another.

  13. Comparison of the effects of water- and land-based exercises on the physical function and quality of life in community-dwelling elderly people with history of falling: a single-blind, randomized controlled trial.

    Science.gov (United States)

    Oh, SeJun; Lim, Jong-Min; Kim, Yushin; Kim, MinSeock; Song, WoonGang; Yoon, BumChul

    2015-01-01

    The purpose of this study was to identify the effects of water-based exercises on the physical functions and quality of life (QOL) in community-dwelling elderly people with history of falling. Participants were randomly assigned to the water-based exercise group (n=34) or land-based exercise groups (n=32). To identify the effects on physical functions, muscle strength, flexibility, and mobility were measured. QOL and fear of falling were evaluated using the Short Form 36-item questionnaire and the modified falls efficacy scale (M-FES). The measurements were performed before and after the 10-week training period. Within-group analysis indicated that hip abduction and adduction strength improved significantly in both groups (p=0.005; p=0.007). However, no statistically significant within-group differences were found in the back scratch test (p=0.766) and chair sit-and-reach test (p=0.870). QOL was significantly different in both groups (health transition: p=0.014, physical functioning: pwater-based exercises are beneficial to improve the QOL, as well as physical activities, of community-dwelling elderly compared with land-based exercise. Water-based exercises would be useful to improve physical and psychological health in the elderly people with history of falling. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  14. Evaluation of group versus individual physiotherapy following lower limb intra-muscular Botulinum Toxin-Type A injections for ambulant children with cerebral palsy: A single-blind randomized comparison trial.

    Science.gov (United States)

    Thomas, Rachel E; Johnston, Leanne M; Sakzewski, Leanne; Kentish, Megan J; Boyd, Roslyn N

    2016-01-01

    This study aimed to evaluate efficacy of group (GRP) versus individual (IND) physiotherapy rehabilitation following lower limb intramuscular injections of Botulinum Toxin-Type A (BoNT-A) for ambulant children with cerebral palsy (CP). Following lower limb BoNT-A injections, 34 children were randomly allocated to GRP (n=17; mean age 7y8m SD 2.0; 13 males; Gross Motor Function Classification System (GMFCS) I=5, II=8, III=4) or IND physiotherapy (n=17; mean age 8y7m SD 2.0; 11 males; GMFCS I=9, II=5, III=3). Primary outcomes were the Canadian Occupational Performance Measure (COPM) and Edinburgh Visual Gait Score (EVGS) assessed at baseline, 10 and 26 weeks post intervention. There were no baseline differences between groups. GRP intervention had greater, but not clinically meaningful, improvement in COPM satisfaction (estimated mean difference EMD 1.7, 95% CI 0.4-3.1; pphysiotherapy (either GRP or IND) with an additional indirect dose (median 16 episodes) of individualized home programme activities following lower limb BoNT-A injections, however, was inadequate to drive clinically meaningful changes in lower limb motor outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Noncorticosteroid Combination Shampoo versus 1% Ketoconazole Shampoo for the Management of Mild-to-Moderate Seborrheic Dermatitis of the Scalp: Results from a Randomized, Investigator-Single-Blind Trial Using Clinical and Trichoscopic Evaluation.

    Science.gov (United States)

    Dall'Oglio, Federica; Lacarrubba, Francesco; Verzì, Anna Elisa; Micali, Giuseppe

    2016-02-01

    The aim of this study was to assess the efficacy and tolerability of a combination noncorticosteroid, antiinflammatory/antifungal shampoo versus 1% ketoconazole shampoo in the treatment of mild-to-moderate scalp seborrheic dermatitis (SD). Twenty patients were randomized to using the combination shampoo (group A, 10 patients) or the 1% ketoconazole shampoo (group B, 10 patients) 3 times a week every other day for 8 weeks. Efficacy was evaluated by measuring the degree of scaling and pruritus by clinical and trichoscopic examination using a 4-point scale. Additionally, a physician global assessment (PGA) was assessed at the end of the study. At 4 weeks, there was a significant reduction of scaling from baseline for both groups, while pruritus showed a significant reduction only for group A. After 8 weeks, there was a significant reduction of scaling and pruritus for both groups. PGA showed a complete response in 90% of the cases in both groups. The results of our study demonstrate that the combination noncorticosteroid, antiinflammatory/antifungal shampoo represents an alternative approach to standard topical treatment for scalp SD. A noncorticosteroid shampoo may be equally safe and effective as ketoconazole shampoo for scalp SD, and trichoscopy provides accurate and reliable quantifiable data to assist in therapeutic monitoring.

  16. A single-blinded randomized controlled study to assess the efficacy of twice daily application of sinecatechins 15% ointment when used sequentially with cryotherapy in the treatment of external genital warts.

    Science.gov (United States)

    On, Shelbi C Jim; Linkner, Rita V; Haddican, Madelaine; Yaroshinsky, Alex; Gagliotti, Matthew; Singer, Giselle; Goldenberg, Gary

    2014-11-01

    To evaluate the efficacy of sequential therapy of cryotherapy and sinecatechins 15% ointment BID versus cryotherapy alone in treatment of external genital warts (EGW). Forty-two subjects with at least two EGW lesions underwent cryotherapy to all lesions. One week following cryotherapy, subjects were randomized 1:1 to receive either no additional treatment or treatment with sinecatechins 15% ointment BID up to 16 weeks or until complete clearance. The total number of visible baseline and new EGW were recorded at each visit. Subjects were followed for a total of 65 weeks post-treatment. There was a significant reduction in mean number of lesions from baseline after 16 weeks of treatment in the cryotherapy-sinecatechins ointment group compared to cryotherapy alone (-5.0 lesions vs -2.1 lesions respectively, P=0.07). Cryotherapy plus sinecatechins 15% ointment BID resulted in a significant improvement in the reduction of EGW compared to cryotherapy alone. Clinicaltrials.gov registration identifier: NCT02147353.

  17. Combined effects of cerebellar transcranial direct current stimulation and transcutaneous spinal direct current stimulation on robot-assisted gait training in patients with chronic brain stroke: A pilot, single blind, randomized controlled trial.

    Science.gov (United States)

    Picelli, Alessandro; Chemello, Elena; Castellazzi, Paola; Filippetti, Mirko; Brugnera, Annalisa; Gandolfi, Marialuisa; Waldner, Andreas; Saltuari, Leopold; Smania, Nicola

    2018-01-01

    Preliminary evidence showed additional effects of anodal transcranial direct current stimulation over the damaged cerebral hemisphere combined with cathodal transcutaneous spinal direct current stimulation during robot-assisted gait training in chronic stroke patients. This is consistent with the neural organization of locomotion involving cortical and spinal control. The cerebellum is crucial for locomotor control, in particular for avoidance of obstacles, and adaptation to novel conditions during walking. Despite its key role in gait control, to date the effects of transcranial direct current stimulation of the cerebellum have not been investigated on brain stroke patients treated with robot-assisted gait training. To evaluate the effects of cerebellar transcranial direct current stimulation combined with transcutaneous spinal direct current stimulation on robot-assisted gait training in patients with chronic brain stroke. After balanced randomization, 20 chronic stroke patients received ten, 20-minute robot-assisted gait training sessions (five days a week, for two consecutive weeks) combined with central nervous system stimulation. Group 1 underwent on-line cathodal transcranial direct current stimulation over the contralesional cerebellar hemisphere + cathodal transcutaneous spinal direct current stimulation. Group 2 received on-line anodal transcranial direct current stimulation over the damaged cerebral hemisphere + cathodal transcutaneous spinal direct current stimulation. The primary outcome was the 6-minute walk test performed before, after, and at follow-up at 2 and 4 weeks post-treatment. The significant differences in the 6-minute walk test noted between groups at the first post-treatment evaluation (p = 0.041) were not maintained at either the 2-week (P = 0.650) or the 4-week (P = 0.545) follow-up evaluations. Our preliminary findings support the hypothesis that cathodal transcranial direct current stimulation over the contralesional

  18. Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study

    International Nuclear Information System (INIS)

    Kimura, Hiroaki; Yamamoto, Norio; Shirai, Toshiharu; Nishida, Hideji; Hayashi, Katsuhiro; Tanzawa, Yoshikazu; Takeuchi, Akihiko; Igarashi, Kentaro; Inatani, Hiroyuki; Shimozaki, Shingo; Kato, Takashi; Aoki, Yu; Higuchi, Takashi; Tsuchiya, Hiroyuki

    2015-01-01

    The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT 3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV

  19. Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study.

    Science.gov (United States)

    Kimura, Hiroaki; Yamamoto, Norio; Shirai, Toshiharu; Nishida, Hideji; Hayashi, Katsuhiro; Tanzawa, Yoshikazu; Takeuchi, Akihiko; Igarashi, Kentaro; Inatani, Hiroyuki; Shimozaki, Shingo; Kato, Takashi; Aoki, Yu; Higuchi, Takashi; Tsuchiya, Hiroyuki

    2015-03-01

    The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV. © 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  20. A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women

    Directory of Open Access Journals (Sweden)

    Kallol K Roy

    2017-01-01

    Full Text Available Study Objective: To compare the operative and reproductive outcome of hysteroscopic myomectomy using unipolar resectoscope versus bipolar resectoscope in patients with infertility and menorrhagia. Design: Randomized, prospective, parallel, comparative, single-blinded study. Design Classification: Canadian Task Force classification I. Setting: Tertiary care institute. Patients: Sixty women with submucous myoma and infertility. Interventions: Hysteroscopic myomectomy performed with unipolar resectoscope or bipolar resectoscope. Measurements: Primary outcome measures were the pregnancy-related indicators. Secondary outcome measures were the operative parameters, harmful outcomes related to the procedure, and comparison of improvement levels in the menstrual pattern after surgery between the two groups. Main Results: A total of 60 patients were randomized into two groups of equal size. Baseline characteristics were not significantly different between the two groups. Reduction in sodium level from pre- to postsurgery was significantly (P = 0.001 higher in the unipolar group. Nine patients (30% in the unipolar group had hyponatremia in the postoperative period compared to none in the bipolar group (P = 0.002. However, there was no significant difference in the other operative parameters between the two groups. In both the groups, a significant improvement in the menstrual symptoms was observed after myomectomy. Pregnancy-related outcomes were similar in both the groups. Conclusion: The use of bipolar resectoscope for hysteroscopic myomectomy is associated with lesser risk of hyponatremia compared to unipolar resectoscope. Bipolar resectoscopic myomectomy is found to be an effective and safer alternative to unipolar resectoscopy with similar reproductive outcome.

  1. Brief motivational interview and educational brochure in emergency room settings for adolescents and young adults with alcohol-related problems: a randomized single-blind clinical trial Intervenção motivacional breve e brochura educacional em pronto-socorro para adolescentes e adultos jovens com problemas relacionados ao álcool: um ensaio clínico simples-cego randomizado

    Directory of Open Access Journals (Sweden)

    Maria Luiza Segatto

    2011-09-01

    Full Text Available OBJECTIVE: To evaluate the effectiveness of brief motivational interviewing and an educational brochure when delivered in emergency room to reduce alcohol abuse and related problems among adolescents and young adults. METHOD: A randomized single-blind clinical trial with a three-month follow-up was carried out at three emergency rooms from October 2004 to November 2005; subjects assessed were 16-25 years old treated for alcohol related events up to 6 hours after consumption. Socio-demographic data, quantity, frequency and negative consequences of alcohol consumption, motivation to change habits and future risk perception were evaluated. Statistical analysis was performed on subjects who completed follow-up (completers. ANCOVA model was used to analyze the difference between the intervention groups with statistical significance level α = 5% and confidence interval (CI of 95%. RESULTS: 186 subjects formed the initial sample, being 175 included and randomized to the educational brochure group (n = 88 or motivational interviewing group (n = 87. Follow-up assessment was performed in 85.2% of the sample. No significant difference between groups was observed. However, significant reductions (p OBJETIVO: Avaliar a efetividade da entrevista motivacional breve e de uma brochura educativa quando aplicadas em prontos-socorros para reduzir o abuso e problemas relacionados ao álcool entre os jovens. MÉTODO: Um ensaio clínico randomizado simples-cego com três meses de seguimento foi realizado em três prontos-socorros de outubro de 2004 a novembro de 2005, com indivíduos de 16-25 anos tratados por eventos relacionados ao álcool com até 6 horas após o consumo. Dados sociodemográficos, quantidade, frequência e consequências negativas, motivação para mudanças de hábitos e percepção para riscos do consumo de álcool foram avaliados. A análise estatística foi realizada em indivíduos que completaram o seguimento (completados. Modelo de ANCOVA

  2. Brief motivational interview and educational brochure in emergency room settings for adolescents and young adults with alcohol related problems: a randomized single blind clinical trial Intervenção motivacional breve e brochura educacional em pronto-socorro para adolescentes e adultos jovens com problemas relacionados ao álcool: um ensaio clínico simples cego randomizado

    Directory of Open Access Journals (Sweden)

    Maria Luiza Segatto

    2011-01-01

    Full Text Available OBJECTIVE: To evaluate the effectiveness of brief motivational interviewing and an educational brochure when delivered in emergency room to reduce alcohol abuse and related problems among adolescents and young adults. METHOD: a randomized single blind clinical trial with a 3 month follow-up was carried out at three emergency rooms from October 2004 to November 2005; subjects assessed were 16-25 years old treated for alcohol related events up to 6 hours after consumption. Socio-demographic data, quantity, frequency and negative consequences of alcohol consumption, motivation to change habits and future risk preception were evaluated. Statistical analysis was performed on subjects who completed follow up (completers. ANCOVA model was used to analyze the difference between the intervention groups with statistical significance level α = 5% and Confidence Interval (CI 95%. RESULTS: 186 subjects formed the initial sample, being n = 175 included and randomized to educational brochure group (n = 88 or motivational interviewing group (n = 87. Follow-up assessment was performed in 85.2% sample. No significant difference between groups was observed. However, significant reductions (p OBJETIVO: Avaliar a efetividade da entrevista motivacional breve e de uma brochura educativa quando aplicadas em prontos-socorros para reduzir o abuso e problemas relacionados ao álcool entre os jovens. MÉTODO: Um ensaio clínico randomizado simples-cego com três meses de seguimento foi realizado em três prontos-socorros de outubro de 2004 a novembro de 2005, com indivíduos de 16-25 anos tratados por eventos relacionados ao álcool com até 6 horas após o consumo. Dados sociodemográficos, quantidade, frequência e consequências negativas, motivação para mudanças de hábitos e percepção para riscos do consumo de álcool foram avaliados. A análise estatística foi realizada em indivíduos que completaram o seguimento (completados. Modelo de ANCOVA foi utilizado

  3. A Prospective, Randomized Trial in the Emergency Department of Suggestive Audio-Therapy under Deep Sedation for Smoking Cessation.

    Science.gov (United States)

    Rodriguez, Robert M; Taylor, Opal; Shah, Sushma; Urstein, Susan

    2007-08-01

    In a sample of patients undergoing procedural deep sedation in the emergency department (ED), we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. We asked subjects about their smoking, including desire to quit (0-10 numerical scale) and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone) or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 +/- 2.6 and mean cigarettes per day was 17.5 +/- 12.1. We successfully contacted 69 (62%) patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: -22.0% to 18.8%). Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: -8.7% to 35.6%). Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

  4. Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Introduction Succinylcholine and rocuronium are widely used to facilitate rapid sequence induction (RSI) intubation in intensive care. Concerns relate to the side effects of succinylcholine and to slower onset and inferior intubation conditions associated with rocuronium. So far, succinylcholine and rocuronium have not been compared in an adequately powered randomized trial in intensive care. Accordingly, the aim of the present study was to compare the incidence of hypoxemia after rocuronium or succinylcholine in critically ill patients requiring an emergent RSI. Methods This was a prospective randomized controlled single-blind trial conducted from 2006 to 2010 at the University Hospital of Basel. Participants were 401 critically ill patients requiring emergent RSI. Patients were randomized to receive 1 mg/kg succinylcholine or 0.6 mg/kg rocuronium for neuromuscular blockade. The primary outcome was the incidence of oxygen desaturations defined as a decrease in oxygen saturation ≥ 5%, assessed by continuous pulse oxymetry, at any time between the start of the induction sequence and two minutes after the completion of the intubation. A severe oxygen desaturation was defined as a decrease in oxygen saturation ≥ 5% leading to a saturation value of ≤ 80%. Results There was no difference between succinylcholine and rocuronium regarding oxygen desaturations (succinylcholine 73/196; rocuronium 66/195; P = 0.67); severe oxygen desaturations (succinylcholine 20/196; rocuronium 20/195; P = 1.0); and extent of oxygen desaturations (succinylcholine -14 ± 12%; rocuronium -16 ± 13%; P = 0.77). The duration of the intubation sequence was shorter after succinycholine than after rocuronium (81 ± 38 sec versus 95 ± 48 sec; P = 0.002). Intubation conditions (succinylcholine 8.3 ± 0.8; rocuronium 8.2 ± 0.9; P = 0.7) and failed first intubation attempts (succinylcholine 32/200; rocuronium 36/201; P = 1.0) did not differ between the groups. Conclusions In critically ill

  5. Use of ready-made insoles in the treatment of lesser metatarsalgia: a prospective randomized controlled trial.

    Science.gov (United States)

    Kelly, A; Winson, I

    1998-04-01

    Two insoles designed to treat primary lesser metatarsalgia were compared in terms of their effect on plantar pressures and the subjective symptom relief. A prospective single blind randomized trial of 8 weeks' treatment in 46 feet in 33 patients was performed. Subjective outcome measures were visual analogue pain scores and estimated compliance. Objective outcome measures were dynamic plantar pressures using the Musgrave Footprint System. In group 1 (Viscoped), 6 of 18 patients rated themselves much improved or somewhat improved, and in group 2 (Langer) the proportion was 12 of 15 (P = 0.02). Reported mean compliance was 16% higher in the Langer group. Plantar forefoot pressure was lowered by the insoles in all cases. The reduction was significantly greater (P < 0.001) in group 2, both in absolute pressure and as a percentage of initial pressure. Group 2 (Langer) was significantly better in terms of reduction of peak metatarsal pressure. All the subjective outcome measures were better for the group 2 (Langer).

  6. Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

    Science.gov (United States)

    Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

    2014-07-01

    A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  7. Inspiratory muscle training in bronchiectasis patients: a prospective randomized controlled study.

    Science.gov (United States)

    Liaw, Mei-Yun; Wang, Yi-Hsi; Tsai, Yu-Chin; Huang, Kuo-Tung; Chang, Pei-Wen; Chen, Yung-Che; Lin, Meng-Chih

    2011-06-01

    To investigate the efficacy and feasibility of home-based inspiratory muscle training in patients with bronchiectasis. A prospective, single-blind, randomized, controlled study. Outpatient clinic of a tertiary care medical centre. Twenty-six patients with bronchiectasis were randomly divided into inspiratory muscle training and control groups. In the inspiratory muscle training group (n = 13), the training programme started with an intensity of 30% maximal inspiratory pressure (MIP), which was increased by 2 cmH(2)O each week, for 30 minutes daily, 5 days a week for eight weeks. The control group (n = 13) did not receive inspiratory muscle training. Main outcome measures included spirometry, resting oxyhaemoglobin saturation by pulse oximetry (SpO(2)), lowest SpO(2) and Borg Scale during 6-minute walking tests, 6-minute walking distance (6MWD), 6-minute walking work (6M(work)), MIP, maximal expiratory pressure (MEP) and St George's Respiratory Questionnaire. There were significant differences in change from baseline in 6MWD (411.9 (133.5) vs. 473.2 (117.2) m, P = 0.021), 6M(work) (21 051.0 (8286.7) vs. 23 915.5 (8343.0) kg-m, P = 0.022), MIP (60.8 (21.8) vs. 84.6 (29.0) cmH(2)O, P = 0.004), and MEP (72.3 (31.1) vs. 104.2 (35.7) cmH(2)O, P = 0.004) in the inspiratory muscle training group. Significant improvements in both MIP (23.8 (25.3) vs. 2.3 (16.4) cmH(2)O, adjusted P-value = 0.005) and MEP (31.9 (30.8) vs. 11.5 (20.8) cmH(2)O, adjusted P-value = 0.038) levels after adjusting for age by linear regression analysis were observed between groups. An eight-week home-based inspiratory muscle training is feasible and effective in improving both inspiratory and expiratory muscle strength, but has no effect on respiratory function and quality of life in patients with bronchiectasis.

  8. A prospective randomized trial of Kotase ® (Bromelain + Trypsin) in ...

    African Journals Online (AJOL)

    International Journal of Medicine and Health Development. Journal Home · ABOUT THIS ... A prospective randomized trial of Kotase® (Bromelain + Trypsin) in the management of post-operative abdominal wounds at the University of Nigeria Teaching Hospital Enugu, Nigeria. Emmanuel R Ezeome, Aloy E Aghaji ...

  9. A single-blinded randomised clinical trial of permissive underfeeding in patients requiring parenteral nutrition.

    Science.gov (United States)

    Owais, Anwar Elias; Kabir, Syed Irfan; Mcnaught, Clare; Gatt, Marcel; MacFie, John

    2014-12-01

    The importance of adequate nutritional support is well established, but characterising what 'adequate nutrition' represents remains contentious. In recent years there has been increasing interest in the concept of 'permissive underfeeding' where patients are intentionally prescribed less nutrition than their calculated requirements. The aim of this study was to evaluate the effect of permissive underfeeding on septic and nutrition related morbidity in patients requiring short term parenteral nutrition (PN). This was a single-blinded randomised clinical trial of 50 consecutive patients requiring parenteral nutritional support. Patients were randomized to receive either normocaloric or hypocaloric feeding (respectively 100% vs. 60% of estimated requirements). The primary end point was septic complications. Secondary end points included the metabolic, physiological and clinical outcomes to the two feeding protocols. Permissive underfeeding was associated with fewer septic complications (3 vs. 12 patients; p = 0.003), and a lower incidence of the systemic inflammatory response syndrome (9 vs. 16 patients; p = 0.017). Permissively underfed patients had fewer feed related complications (2 vs. 9 patients; p = 0.016). Permissive underfeeding in patients requiring short term PN appears to be safe and may results in reduced septic and feed-related complications. NCT01154179 TRIAL REGISTRY: http://clinicaltrials.gov/ct2/show/NCT01154179. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  10. Use of Play Therapy in Nursing Process: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Sezici, Emel; Ocakci, Ayse Ferda; Kadioglu, Hasibe

    2017-03-01

    Play therapy is a nursing intervention employed in multidisciplinary approaches to develop the social, emotional, and behavioral skills of children. In this study, we aim to determine the effects of play therapy on the social, emotional, and behavioral skills of pre-school children through the nursing process. A single-blind, prospective, randomized controlled study was undertaken. The design, conduct, and reporting of this study adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The participants included 4- to 5-year-old kindergarten children with no oral or aural disabilities and parents who agreed to participate in the study. The Pre-school Child and Family Identification Form and Social Competence and the Behavior Evaluation Scale were used to gather data. Games in the play therapy literature about nursing diagnoses (fear, social disturbance, impaired social interactions, ineffective coping, anxiety), which were determined after the preliminary test, constituted the application of the study. There was no difference in the average scores of the children in the experimental and control groups in their Anger-Aggression (AA), Social Competence (SC), and Anxiety-Withdrawal (AW) scores beforehand (t = 0.015, p = .988; t = 0.084, p = .933; t = 0.214, p = .831, respectively). The difference between the average AA and SC scores in the post-test (t = 2.041, p = .045; t = 2.692, p = .009, respectively), and the retests were statistically significant in AA and SC average scores in the experimental and control groups (t = 4.538, p = .000; t = 4.693; p = .000, respectively). In AW average scores, no statistical difference was found in the post-test (t = 0.700, p = .486), whereas in the retest, a significant difference was identified (t = 5.839, p = .000). Play therapy helped pre-school children to improve their social, emotional, and behavioral skills. It also provided benefits for the children to decrease their fear and anxiety levels, to improve

  11. Prospective randomized crossover study of a new closed-loop control system versus pressure support during weaning from mechanical ventilation.

    Science.gov (United States)

    Clavieras, Noémie; Wysocki, Marc; Coisel, Yannael; Galia, Fabrice; Conseil, Matthieu; Chanques, Gerald; Jung, Boris; Arnal, Jean-Michel; Matecki, Stefan; Molinari, Nicolas; Jaber, Samir

    2013-09-01

    Intellivent is a new full closed-loop controlled ventilation that automatically adjusts both ventilation and oxygenation parameters. The authors compared gas exchange and breathing pattern variability of Intellivent and pressure support ventilation (PSV). In a prospective, randomized, single-blind design crossover study, 14 patients were ventilated during the weaning phase, with Intellivent or PSV, for two periods of 24 h in a randomized order. Arterial blood gases were obtained after 1, 8, 16, and 24 h with each mode. Ventilatory parameters were recorded continuously in a breath-by-breath basis during the two study periods. The primary endpoint was oxygenation, estimated by the calculation of the difference between the PaO2/FIO2 ratio obtained after 24 h of ventilation and the PaO2/FIO2 ratio obtained at baseline in each mode. The variability in the ventilatory parameters was also evaluated by the coefficient of variation (SD to mean ratio). There were no adverse events or safety issues requiring premature interruption of both modes. The PaO2/FIO2 (mean ± SD) ratio improved significantly from 245 ± 75 at baseline to 294 ± 123 (P = 0.03) after 24 h of Intellivent. The coefficient of variation of inspiratory pressure and positive end-expiratory pressure (median [interquartile range]) were significantly higher with Intellivent, 16 [11-21] and 15 [7-23]%, compared with 6 [5-7] and 7 [5-10]% in PSV. Inspiratory pressure, positive end-expiratory pressure, and FIO2 changes were adjusted significantly more often with Intellivent compared with PSV. Compared with PSV, Intellivent during a 24-h period improved the PaO2/FIO2 ratio in parallel with more variability in the ventilatory support and more changes in ventilation settings.

  12. A Prospective, Randomized Trial in The Emergency Department Of Suggestive Audio-Therapy Under Deep Sedation for Smoking Cessation

    Directory of Open Access Journals (Sweden)

    Shah, Sushma

    2007-08-01

    Full Text Available Objectives: In a sample of patients undergoing procedural deep sedation in the emergency department (ED, we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. Methods: We asked subjects about their smoking, including desire to quit (0-10 numerical scale and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. Results: One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 ± 2.6 and mean cigarettes per day was 17.5 ± 12.1. We successfully contacted 69 (62% patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: –22.0% to 18.8%. Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: –8.7% to 35.6%. Conclusion: Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

  13. Qualitative bacteriology in malignant wounds--a prospective, randomized, clinical study to compare the effect of honey and silver dressings

    DEFF Research Database (Denmark)

    Lund-Nielsen, Betina; Adamsen, Lis; Gottrup, Finn

    2011-01-01

    . A prospective, randomized, single-blind controlled clinical study was conducted to evaluate the bacteriology of malignant wounds and compare the effect of a honey-coated (Group A) to a silver-coated (Group B) dressing on the qualitative bacteriology of malignant wounds. All wound interventions were performed...... years, range 47-92) consented to participate and completed the 4-week study. The majority were women (88%) with breast cancer (79%). No statistically significant differences were found between the type and number of different wound pathogens in the wounds during the course of the study or between Group...... were identified. Sixty-one percent (61%) of wounds decreased in size following treatment, but no significant differences were observed between the type and variety of wound pathogens and whether wound size decreased. Although quantitative bacteriological changes may have occurred, the possible...

  14. Botulinum toxin in the treatment of orofacial tardive dyskinesia : A single blind study

    NARCIS (Netherlands)

    Slotema, Christina W.; van Harten, Peter N.; Bruggeman, Richard; Hoek, Hans W.

    2008-01-01

    Objective: Orofacial tardive dyskinesia (OTD) is difficult to treat and Botulinium Toxin A (BTA) may be an option. Methods: In a single blind (raters were blind) study (N= 12, duration 33 weeks) OTD was treated with Botulinum Toxin A in three consecutive sessions with increasing dosages. The

  15. Unilateral pallidotomy in Parkinson's disease : a randomised, single-blind, multicentre trial

    NARCIS (Netherlands)

    de Bie, RMA; de Haan, RJ; Nijssen, PCG; Rutgers, AWF; Beute, GN; Haaxma, R; Schmand, B; Staal, MJ; Speelman, J.D.

    1999-01-01

    Background The results of several cohort studies suggest that patients with advanced Parkinson's disease would benefit from unilateral pallidotomy. We have assessed the efficacy of unilateral pallidotomy in a randomised, single-blind, multicentre trial. Methods We enrolled 37 patients with advanced

  16. The starting dose of levothyroxine in primary hypothyroidism treatment: a prospective, randomized, double-blind trial

    NARCIS (Netherlands)

    Roos, Annemieke; Linn-Rasker, Suzanne P.; van Domburg, Ron T.; Tijssen, Jan P.; Berghout, Arie

    2005-01-01

    BACKGROUND: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. METHODS: We conducted a prospective, randomized,

  17. Intrapartum amnioinfusion in women with oligohydramniosis. A prospective randomized trial.

    Science.gov (United States)

    Persson-Kjerstadius, N; Forsgren, H; Westgren, M

    1999-02-01

    To evaluate the effects of amnioinfusion in oligohydramniosis. During a 20-month period, patients at term with oligohydramniosis (amniotic fluid index less than 5 cm) at Huddinge University and Norrköping Hospitals were recruited for a prospective randomized study to evaluate amnioinfusion. Informed consent was obtained from 112 patients who met the entry criteria. Sixty subjects were randomized to amnioinfusion and 52 to the control group. Outcome parameters included fetal heart rate abnormalities, mode of delivery, Apgar score, pH in umbilical artery blood and need for neonatal intensive care. The cesarean section rate was significantly reduced in the amnio-infusion group (29% versus 13%, p=0.043). No difference in time from randomization to delivery was detected between the two groups. The frequency of ominous fetal heart rate tracings with a cervical dilatation of 0-3 cm was the same in the two groups. The frequency of such heart rate patterns after amnioinfusion was significantly lower than in the control group. Neonatal outcome, pH in the umbilical artery blood and need for neonatal intensive care did not differ between the two groups. The present study confirms the findings of other authors that amnioinfusion effectively reduces the number of cesarean sections in cases of oligohydramniosis.

  18. HIMALAIA (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA) : a randomized single- blind controlled trial of induced hypertension vs. no induced hypertension in the treatment of delayed cerebral ischemia after subarachnoid hemorrhage

    NARCIS (Netherlands)

    Gathier, C. S.; van den Bergh, W. M.; Slooter, A. J. C.

    RationaleDelayed cerebral ischemia (DCI) is a major complication after aneurysmal subarachnoid hemorrhage (SAH). One option to treat delayed cerebral ischemia is to use induced hypertension, but its efficacy on the eventual outcome has not been proven in a randomized clinical trial. This article

  19. HIMALAIA (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA): a randomized single-blind controlled trial of induced hypertension vs. no induced hypertension in the treatment of delayed cerebral ischemia after subarachnoid hemorrhage

    NARCIS (Netherlands)

    Gathier, C. S.; van den Bergh, W. M.; Slooter, A. J. C.; Algra, Ale; Beute, Gus N.; Coert, Bert A.; Dankbaar, Jan-Willem; Dippel, Diederik; Dirven, Clemens M. F.; Gathier, Celine S.; Horn, Janneke; van der Jagt, Mathieu; Kesecioglu, Jozef; van Kooten, Fop; van der Lugt, Aad; Muller, Marcella C. A.; Oldenbeuving, Annemarie W.; van der Pol, Bram; Regli, Luca; Rinkel, Gabriel J. E.; Roks, Gerwin; van der Schaaf, Irene C.; Slooter, Arjen J. C.; Vandertop, W. Peter; Verweij, Bon H.

    2014-01-01

    Delayed cerebral ischemia (DCI) is a major complication after aneurysmal subarachnoid hemorrhage (SAH). One option to treat delayed cerebral ischemia is to use induced hypertension, but its efficacy on the eventual outcome has not been proven in a randomized clinical trial. This article describes

  20. HIMALAIA (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA): a randomized single-blind controlled trial of induced hypertension vs. no induced hypertension in the treatment of delayed cerebral ischemia after subarachnoid hemorrhage.

    Science.gov (United States)

    Gathier, C S; van den Bergh, W M; Slooter, A J C

    2014-04-01

    Delayed cerebral ischemia (DCI) is a major complication after aneurysmal subarachnoid hemorrhage (SAH). One option to treat delayed cerebral ischemia is to use induced hypertension, but its efficacy on the eventual outcome has not been proven in a randomized clinical trial. This article describes the design of the HIMALAIA trial (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA), designed to assess the effectiveness of induced hypertension on neurological outcome in patients with DCI after SAH. To investigate whether induced hypertension improves the functional outcome in patients with delayed cerebral ischemia after SAH. The HIMALAIA trial is a multicenter, singe-blinded, randomized controlled trial in patients with DCI after a recent SAH. Eligible patients will be randomized to either induced hypertension (n = 120) or to no induced hypertension (n = 120). In selected centers, the efficacy of induced hypertension in augmenting cerebral blood flow will be measured by means of cerebral perfusion computerized tomography scanning. Follow-up assessments will be performed at 3 and 12 months after randomization by trial nurses who are blinded to the treatment allocation and management. We will include patients during five years. The primary outcome is the proportion of subarachnoid hemorrhage patients with delayed cerebral ischemia with poor outcome three-months after randomization, defined as a modified Rankin scale of more than 3. Secondary outcome measures are related to treatment failure, functional outcome, adverse events, and cerebral hemodynamics. The HIMALAIA trial is registered at clinicaltrials.gov under identifier NCT01613235. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

  1. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  2. Selective decontamination in pediatric liver transplants. A randomized prospective study.

    Science.gov (United States)

    Smith, S D; Jackson, R J; Hannakan, C J; Wadowsky, R M; Tzakis, A G; Rowe, M I

    1993-06-01

    Although it has been suggested that selective decontamination of the digestive tract (SDD) decreases postoperative aerobic Gram-negative and fungal infections in orthotopic liver transplantation (OLT), no controlled trials exist in pediatric patients. This prospective, randomized controlled study of 36 pediatric OLT patients examines the effect of short-term SDD on postoperative infection and digestive tract flora. Patients were randomized into two groups. The control group received perioperative parenteral antibiotics only. The SDD group received in addition polymyxin E, tobramycin, and amphotericin B enterally and by oropharyngeal swab postoperatively until oral intake was tolerated (6 +/- 4 days). Indications for operation, preoperative status, age, and intensive care unit and hospital length of stay were no different in SDD (n = 18) and control (n = 18) groups. A total of 14 Gram-negative infections (intraabdominal abscess 7, septicemia 5, pneumonia 1, urinary tract 1) developed in the 36 patients studied. Mortality was not significantly different in the two groups. However, there were significantly fewer patients with Gram-negative infections in the SDD group: 3/18 patients (11%) vs. 11/18 patients (50%) in the control group, P < 0.001. There was also significant reduction in aerobic Gram-negative flora in the stool and pharynx in patients receiving SDD. Gram-positive and anaerobic organisms were unaffected. We conclude that short-term postoperative SDD significantly reduces Gram-negative infections in pediatric OLT patients.

  3. Pulmonary gas exchange impairment following tourniquet deflation: a prospective, single-blind clinical trial.

    Science.gov (United States)

    Lin, Lina; Wang, Liangrong; Bai, Yu; Zheng, Liupu; Zhao, Xiyue; Xiong, Xiangqing; Jin, Lida; Ji, Wei; Wang, Wantie

    2010-06-09

    The tourniquet has been considered as a recognized cause of limb ischemia/reperfusion injury in orthopedic surgery resulting in a transient neutrophil, monocyte activation, and enhanced neutrophil transendothelial migration with potential remote tissue injury. This study investigated the effect of unilateral tourniquet application within a safe time limit on pulmonary function and the roles of lipid peroxidation and systemic inflammatory response. Thirty patients undergoing unilateral lower extremity surgery with or without tourniquet were equally divided into a control group with no tourniquet (Group C) and a tourniquet (Group T). Arterial partial pressure of oxygen (P(a)O(2)), arterial-alveolar oxygen tension ratio (a/A ratio), alveolar-arterial oxygen difference (A-aDO(2)) and respiratory index, plasma malondialdehyde, serum interleukin (IL) -6 and IL-8 levels were measured immediately before and 1 hour after tourniquet inflation/operation beginning, 0.5, 2, 6, and 24 hours after tourniquet deflation/operation ending. The results represented no significant changes in Group C with regard to either blood gas variables or levels of circulating mediators, while blood gas variable changes of greater A-aDO(2) and respiratory index and lower PaO2 and a/A ratio were shown at 6 hours following tourniquet deflation. The levels of malondialdehyde, IL-6, and IL-8 were increased over baseline values from 2 to 24 hours following tourniquet deflation in Group T. We concluded that tourniquet application within a safe time limit may cause pulmonary gas exchange impairment several hours after tourniquet deflation, where lipid peroxidation and systemic inflammatory response may be involved. Copyright 2010, SLACK Incorporated.

  4. Resistant metatarsus adductus: prospective randomized trial of casting versus orthosis.

    Science.gov (United States)

    Herzenberg, John E; Burghardt, Rolf D

    2014-03-01

    Metatarsus adductus is a common pediatric foot deformity related to intrauterine molding. It is usually a mild deformity that responds well to simple observation or minimal treatment with a home program of stretching. Resistant cases may need a more aggressive approach such as serial casting or special bracing to avoid the need for surgical intervention. We compared clinical outcomes using serial casting with orthoses for resistant metatarsus adductus. We prospectively treated 27 infants (43 feet) between the ages 3 and 9 months who failed home stretching treatment. Patients were randomized to either serial plaster casting or Bebax orthoses. Footprints and simulated weight-bearing anteroposterior and lateral view radiographs were made at entry and follow-up. There was no statistical difference between casting and Bebax for the following parameters: age at study entry, length of treatment, number of clinic visits, follow-up, and follow-up maintenance treatments. Both groups showed improvement in footprint and radiographic measurements post-treatment, without worsening of heel valgus. The Bebax group had greater improvement in the footprint heel bisector measurement than the casting group. The Bebax treatment requires more active parental cooperation. A simulated cost analysis of materials and office visit charges, however, revealed that Bebax treatment was significantly less expensive, about half the cost of casting. Because of the cost savings and virtually identical clinical results, we recommend the Bebax orthosis for resistant metatarsus in pre-walking infants with parents who are compliant. Other considerations include specific insurance plans, which may pay for casts but not orthoses.

  5. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-12-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.

  6. Controlled single-blind clinical evaluation of low-dose mammographic screen: film systems

    International Nuclear Information System (INIS)

    Sickles, E.A.; Genant, H.K.

    1979-01-01

    The ability of five low-dose mammographic screen-film systems to portray normal and abnormal breast structures was evaluated in parallel with a study of physical image properties. Single-blind evaluations of the visibility of normal breast architecture, mass lesions, and calcifications were made on the mammograms of 100 patients radiographed with each of the systems. There was increased noise and slightly poorer resolution of the faster recording systems, but there was no difference in final diagnostic impressions among the five systems. These results suggest that the faster systems will result in substantial dose reduction without sacrificing diagnostic accuracy

  7. Occlusion of the pancreatic duct versus pancreaticojejunostomy: a prospective randomized trial.

    NARCIS (Netherlands)

    K.T. Tran; C.H.J. van Eijck (Casper); V. di Carlo (Valerio); W.C.J. Hop (Wim); A. Zerbi (Alessandro); G. Balzano (Gianpaolo); J. Jeekel (Hans)

    2002-01-01

    textabstractOBJECTIVE: Using a prospective randomized study to assess postoperative morbidity and pancreatic function after pancreaticoduodenectomy with pancreaticojejunostomy and duct occlusion without pancreaticojejunostomy. SUMMARY BACKGROUND DATA: Postoperative complications

  8. Sotalol vs metoprolol for ventricular rate control in patients with chronic atrial fibrillation who have undergone digitalization: a single-blinded crossover study.

    Science.gov (United States)

    Kochiadakis, G E; Kanoupakis, E M; Kalebubas, M D; Igoumenidis, N E; Vardakis, K E; Mavrakis, H E; Vardas, P E

    2001-01-01

    To compare the effects of sotalol and metoprolol on heart rate, during isotonic (ITE) and isometric (IME) exercise and daily activities, in digitalized patients with chronic atrial fibrillation. The study had a randomized, single-blinded, crossover design. Twenty-three patients with chronic atrial fibrillation received placebo for 4 weeks, followed by a 4-week period of treatment with sotalol and metoprolol in random order. At the end of each period, the patients were assessed with 24-h ECG monitoring, a cardiopulmonary exercise test and a handgrip manoeuvre. Both agents produced a lower heart rate than placebo at rest and at all levels of isotonic exercise (P digitalized patients with atrial fibrillation. Sotalol is superior to metoprolol at submaximal exercise, resulting in better rate control during daily activities.

  9. Random forest predictive modeling of mineral prospectivity with small number of prospects and data with missing values in Abra (Philippines)

    Science.gov (United States)

    Carranza, Emmanuel John M.; Laborte, Alice G.

    2015-01-01

    Machine learning methods that have been used in data-driven predictive modeling of mineral prospectivity (e.g., artificial neural networks) invariably require large number of training prospect/locations and are unable to handle missing values in certain evidential data. The Random Forests (RF) algorithm, which is a machine learning method, has recently been applied to data-driven predictive mapping of mineral prospectivity, and so it is instructive to further study its efficacy in this particular field. This case study, carried out using data from Abra (Philippines), examines (a) if RF modeling can be used for data-driven modeling of mineral prospectivity in areas with a few (i.e., individual layers of evidential data. Furthermore, RF modeling can handle missing values in evidential data through an RF-based imputation technique whereas in WofE modeling values are simply represented by zero weights. Therefore, the RF algorithm is potentially more useful than existing methods that are currently used for data-driven predictive mapping of mineral prospectivity. In particular, it is not a purely black-box method like artificial neural networks in the context of data-driven predictive modeling of mineral prospectivity. However, further testing of the method in other areas with a few mineral occurrences is needed to fully investigate its usefulness in data-driven predictive modeling of mineral prospectivity.

  10. A single-blinded phenobarbital-controlled trial of levetiracetam as mono-therapy in dogs with newly diagnosed epilepsy.

    Science.gov (United States)

    Fredsø, N; Sabers, A; Toft, N; Møller, A; Berendt, M

    2016-02-01

    Treatment of canine epilepsy is problematic. Few antiepileptic drugs have proven efficacy in dogs and undesirable adverse effects and pharmacoresistance are not uncommon. Consequently, the need for investigation of alternative treatment options is ongoing. The objective of this study was to investigate the efficacy and tolerability of levetiracetam as mono-therapy in dogs with idiopathic epilepsy. The study used a prospective single-blinded parallel group design. Twelve client-owned dogs were included and were randomised to treatment with levetiracetam (30 mg/kg/day or 60 mg/kg/day divided into three daily dosages) or phenobarbital (4 mg/kg/day divided twice daily). Control visits were at days 30, 60 and then every 3 months for up to 1 year. Two or more seizures within 3 months led to an increase in drug dosage (levetiracetam: 10 mg/kg/day, phenobarbital: 1 mg/kg/day). Five of six levetiracetam treated dogs and one of six phenobarbital treated dogs withdrew from the study within 2-5 months due to insufficient seizure control. In the levetiracetam treated dogs there was no significant difference in the monthly number of seizures before and after treatment, whereas in the phenobarbital treated dogs there were significantly (P = 0.013) fewer seizures after treatment. Five phenobarbital treated dogs were classified as true responders (≥50% reduction in seizures/month) whereas none of the levetiracetam treated dogs fulfilled this criterion. Adverse effects were reported in both groups but were more frequent in the phenobarbital group. In this study levetiracetam was well tolerated but was not effective at the given doses as mono-therapy in dogs with idiopathic epilepsy. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. Familiar trespassers in histopathology: An obstacle in diagnosis? A single-blind study

    Directory of Open Access Journals (Sweden)

    P Shashikala

    2017-01-01

    Full Text Available Background: Histopathologists encounter strange structures in tissue sections that appear unrelated to tissues, and these artifacts may be misinterpreted and misdiagnosed as pathological lesions. These substances may either be present within the tissues or can get implanted into tissue during biopsy procedure or laboratory handling or processing. Aims: The aim of this study is to observe the microscopic appearance of different abnormal structures like commonly implanted food particles or easily incorporated substances during tissue processing with their probable histological misdiagnosis. Materials and Methods: Certain food particles, suture materials, wood pieces, insects, and filter paper were intentionally introduced in the tissue specimens of uterus and lung. Following routine processing and hematoxylin and eosin staining, the slides were subjected to single-blind study and viewed under light and polarizing microscope. Results: The vivid appearances of these structures lead to histological misdiagnosis. Conclusion: Knowledge and familiarity of these commonly encountered extraneous substances will help to prevent misinterpretation.

  12. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-11-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2–12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mg kg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mg kg−1 neostigmine, Group RS (n = 40 received 2 mg kg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients’ characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures. Resumo: Justificativa e objetivos: Os inibidores da acetilcolinesterase podem causar curarização residual no p

  13. Effectiveness of different memory training programs on improving hyperphagic behaviors of residents with dementia: a longitudinal single-blind study.

    Science.gov (United States)

    Kao, Chieh-Chun; Lin, Li-Chan; Wu, Shiao-Chi; Lin, Ker-Neng; Liu, Ching-Kuan

    2016-01-01

    Hyperphagia increases eating-associated risks for people with dementia and distress for caregivers. The purpose of this study was to compare the long-term effectiveness of spaced retrieval (SR) training and SR training combined with Montessori activities (SR + M) for improving hyperphagic behaviors of special care unit residents with dementia. The study enrolled patients with dementia suffering from hyperphagia resident in eight institutions and used a cluster-randomized single-blind design, with 46 participants in the SR group, 49 in the SR + M group, and 45 participants in the control group. For these three groups, trained research assistants collected baseline data on hyperphagic behavior, pica, changes in eating habits, short meal frequency, and distress to caregivers. The SR and SR + M groups underwent memory training over a 6-week training period (30 sessions), and a generalized estimating equation was used to compare data of all the three groups of subjects obtained immediately after the training period and at follow-ups 1 month, 3 months, and 6 months later. Results showed that the hyperphagic and pica behaviors of both the SR and SR + M groups were significantly improved (P<0.001) and that the effect lasted for 3 months after training. The improvement of fast eating was significantly superior in the SR + M group than in the SR group. The improvement in distress to caregivers in both intervention groups lasted only until the posttest. Improvement in changes in eating habits of the two groups was not significantly different from that of the control group. SR and SR + M training programs can improve hyperphagic behavior of patients with dementia. The SR + M training program is particularly beneficial for the improvement of rapid eating. Caregivers can choose a suitable memory training program according to the eating problems of their residents.

  14. Immediate effects of kinesiotaping on quadriceps muscle strength: a single-blind, placebo-controlled crossover trial.

    Science.gov (United States)

    Vercelli, Stefano; Sartorio, Francesco; Foti, Calogero; Colletto, Lorenzo; Virton, Domenico; Ronconi, Gianpaolo; Ferriero, Giorgio

    2012-07-01

    To investigate the immediate effects on maximal muscle strength of kinesiotaping (KT) applied to the dominant quadriceps of healthy subjects. Single-blind, placebo-controlled crossover trial. "Salvatore Maugeri" Foundation. With ethical approval and informed consent, a convenience sample of 36 healthy volunteers were recruited. Two subjects did not complete the sessions and were excluded from the analysis. Subjects were tested across 3 different sessions, randomly receiving 2 experimental KT conditions applied with the aim of enhancing and inhibiting muscle strength and a sham KT application. Quadriceps muscle strength was measured by means of an isokinetic maximal test performed at 60 and 180 degrees per second. Two secondary outcome measures were performed: the single-leg triple hop for distance to measure limb performance and the Global Rating of Change Scale (GRCS) to calculate agreement between KT application and subjective perception of strength. Compared with baseline, none of the 3 taping conditions showed a significant change in muscle strength and performance (all P > 0.05). Effect size was very low under all conditions (≤0.08). Very few subjects showed an individual change greater than the minimal detectable change. Global Rating of Change Scale scores demonstrated low to moderate agreement with the type of KT applied, but some placebo effects were reported independently of condition. Our findings indicated no significant effect in the maximal quadriceps strength immediately after the application of inhibition, facilitation, or sham KT. These results do not support the use of KT applied in this way to change maximal muscle strength in healthy people.

  15. Single-blind trial addressing the differential effects of two reflexology techniques versus rest, on ankle and foot oedema in late pregnancy.

    Science.gov (United States)

    Mollart, L

    2003-11-01

    This single-blind randomised controlled trial explored the differential effects of two different foot reflexology techniques with a period of rest on oedema-relieving effects and symptom relief in healthy pregnant women with foot oedema. Fifty-five women in the third trimester were randomly assigned to one of the three groups: a period of rest, 'relaxing' reflexology techniques or a specific 'lymphatic' reflexology technique for 15 min with pre- and post-therapy ankle and foot circumference measurements and participant questionnaire. There was no statistically significant difference in the circumference measurements between the three groups; however, the lymphatic technique reflexology group mean circumference measurements were all decreased. A significant reduction in the women's symptom mean measurements in all groups (preflexology techniques, relaxing reflexology techniques and a period of rest had a non-significant oedema-relieving effect. From the women's viewpoint, lymphatic reflexology was the preferred therapy with significant increase in symptom relief.

  16. Prospective randomized clinical studies involving reirradiation. Lessons learned

    International Nuclear Information System (INIS)

    Nieder, Carsten; Langendijk, Johannes A.; Guckenberger, Matthias; Grosu, Anca L.

    2016-01-01

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [de

  17. A single-blind trial of reflexology for irritable bowel syndrome.

    Science.gov (United States)

    Tovey, Philip

    2002-01-01

    BACKGROUND: Irritable bowel syndrome (IBS) is a significant problem for primary care, as treatment options are limited and it can frequently develop into a chronic condition. Complementary and alternative medicine, including reflexology, is being turned to increasingly in an attempt to manage symptoms. There are currently no studies which address the effectiveness of reflexology for IBS. Despite this, it continues to be advocated and used. AIM: To provide the first evidence on the effectiveness of reflexology in the management of the core defining symptoms of IBS. DESIGN OF STUDY: A single-blind trial carried out in primary care settings. SETTING: Thirty-four participants diagnosed with IBS on the basis of the Rome Criteria. METHOD: Participants were allocated to receive either a reflexology foot massage or a non-reflexology foot massage control group. RESULTS: On none of the three symptoms monitored--abdominal pain, constipation/diarrhoea, and abdominal distention--was there a statistically or clinically significant difference between reflexology and control groups. CONCLUSION: On the basis of these results there is nothing to suggest that reflexology produces any specific benefit for patients with IBS. There is currently no evidence to support its use. However this was one (relatively) small scale study; further research that, for example, assesses the impact of therapist (professional and lay) versus therapy, is still needed. PMID:11791811

  18. Prospective randomized clinical studies involving reirradiation. Lessons learned

    Energy Technology Data Exchange (ETDEWEB)

    Nieder, Carsten [Nordland Hospital, Department of Oncology and Palliative Medicine, Bodoe (Norway); University of Tromsoe, Department of Clinical Medicine, Faculty of Health Sciences, Tromsoe (Norway); Langendijk, Johannes A. [University Medical Centre Groningen, Department of Radiation Oncology, Groningen (Netherlands); Guckenberger, Matthias [University Hospital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Grosu, Anca L. [University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany)

    2016-10-15

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [German] Eine Rebestrahlung kann fuer viele Patienten mit rezidivierenden Malignomen eine nuetzliche Option bieten. Der Zweck dieser Studie bestand darin, alle in der juengeren Vergangenheit publizierten randomisierten Studien zu beurteilen, da deren methodische Staerken und Schwaechen, Ergebnisse und resultierende Implikationen bzw. offene Fragen die Planung kuenftiger Studien wesentlich beeinflussen koennen. Systematische Uebersicht aller zwischen 2000 und 2015 veroeffentlichten Studien (Literatursuche ueber PubMed, Scopus und Web of Science). Ausgewertet wurden 9 Studien, in die vor allem Patienten mit Kopf-Hals-Tumoren eingeschlossen waren. Im Median hatten 69 Patienten teilgenommen. Das

  19. Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein : A Prospective Randomized Controlled Trial

    NARCIS (Netherlands)

    Bakker, N. A.; Schieven, L. W.; Bruins, R. M. G.; van den Berg, M.; Hissink, R. J.

    2013-01-01

    Objectives: To determine if the duration of wearing compression stockings after endovenous laser ablation (EVLA) of the great saphenous vein (GSV) has influence on pain and quality of life. Methods: This was a prospective randomized controlled trial. Between December 2006 and February 2008, 109

  20. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  1. One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery : a prospective randomized trial

    NARCIS (Netherlands)

    Van der Steen, Annemarie; Detollenaere, Renee; Den Boon, Jan; Van Eijndhoven, Hugo

    For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization. We conducted a prospective randomized trial in which 179

  2. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    Abstract. Background: Recently, manufacturers have introduced bulk‑fill composite resins that reportedly can be placed in increments of 4 mm or greater. Objective: The purpose of this article was to report the results of 12 months prospective randomized clinical trial that evaluated the clinical performance of one ...

  3. Ultrasonic root-end preparation in apical surgery : a prospective randomized study

    NARCIS (Netherlands)

    de Lange, Jan; Putters, Thomas; Baas, Erik M.; van Ingen, Johan M.

    2007-01-01

    Objective. The purpose of this study was to evaluate the potential benefit of an ultrasonic device in apical surgery on the outcome of treatment. Study design. A randomized prospective design was used in a standardized treatment protocol. Patients were allocated to treatment with an ultrasonic

  4. A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

    African Journals Online (AJOL)

    2015-12-16

    Dec 16, 2015 ... prospective randomized clinical trial that evaluated the clinical performance of one high‑viscosity bulk‑fill composite resin in Class II cavities of posterior teeth. .... amount of glass ionomer needed was used to cover the calcium ...

  5. Nonoperative Treatment of Thoracic and Lumbar Spine Fractures : A Prospective Randomized Study of Different Treatment Options

    NARCIS (Netherlands)

    Stadhouder, Agnita; Buskens, Erik; Vergroesen, Diederik A.; Fidler, Malcolm W.; de Nies, Frank; Oner, F. C.

    Objectives: To evaluate and compare nonoperative treatment methods for traumatic thoracic and lumbar compression fractures and burst fractures. Design: Prospective randomized controlled trial with long-term follow-up. Setting: Two general hospitals in the Netherlands. Patients/Participants: Patients

  6. Ulcerative colitis patients with an inflammatory response upon mesalazine cannot be desensitized: a randomized study.

    Science.gov (United States)

    Buurman, Dorien J; De Monchy, Jan G R; Schellekens, Reinout C A; van der Waaij, Laurens A; Kleibeuker, Jan H; Dijkstra, Gerard

    2015-04-01

    Mesalazine is a key drug in the treatment of ulcerative colitis (UC). Intolerance to mesalazine has been described, including fever and gastrointestinal symptoms. Several case reports reported successful desensitization of patients with mesalazine intolerance. The aim was to assess the number of UC patients who are persistently intolerant to mesalazine after single-blinded rechallenge and to test the effectiveness of a rapid desensitization protocol in UC patients demonstrated mesalazine intolerance. This is a prospective, single-blind randomized study in UC patients who discontinued mesalazine because of intolerance. Patients with severe reactions were excluded. Eligible patients underwent a skin patch test with mesalazine followed by a single-blinded randomized crossover rechallenge with 500 mg mesalazine or placebo. Patients with symptoms upon rechallenge were admitted to the hospital for 3 days oral desensitization. Nine of the 37 identified UC patients who discontinued mesalazine because of intolerance were included. All nine patients had negative patch tests, seven patients had symptoms (fever, nausea, vomiting and diarrhea) within 2 h upon rechallenge. Four of these seven patients participated in the desensitization protocol and in none a successful desensitization could be performed. All four had an inflammatory intolerance reaction with rise in C-reactive protein. There were no elevations in serum tryptase or urinary-methylhistamine levels observed and no signs of immediate type allergic reactions, like urticaria, bronchial obstruction or anaphylaxis. We recommend not to rechallenge UC patients with an inflammatory response upon mesalazine and these patients will not benefit from a rapid desensitization protocol.

  7. Glove failure in elective thyroid surgery: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Dariusz Timler

    2015-06-01

    Full Text Available Objectives: To analyze perforation rate in sterile gloves used by surgeons in the operating theatre of the Department of Endocrinological and General Surgery of Medical University of Lodz. Material and Methods: Randomized and controlled trial. This study analyses the incidents of tears in sterile surgical gloves used by surgeons during operations on 3 types of thyroid diseases according to the 10th revision of International Statistical Classification of Diseases and Related Health Problems (ICD-10 codes. Nine hundred seventy-two pairs (sets of gloves were collected from 321 surgical procedures. All gloves were tested immediately following surgery using the water leak test (EN455-1 to detect leakage. Results: Glove perforation was detected in 89 of 972 glove sets (9.2%. Statistically relevant more often glove tears occurred in operator than the 1st assistant (p < 0.001. The sites of perforation were localized mostly on the middle finger of the non-dominant hand (22.5%, and the non-dominant ring finger (17.9%. Conclusions: This study has proved that the role performed by the surgeon during the procedure (operator, 1st assistant has significant influence on the risk of glove perforations. Nearly 90% of glove perforations are unnoticed during surgery.

  8. TVT versus TOT, 2-year prospective randomized study.

    Science.gov (United States)

    Wadie, Bassem S; El-Hefnawy, Ahmed S; Elhefnawy, Ahmed S

    2013-06-01

    To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT. Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare(®)) or TOT (Aris(®)). All women were seen 1 week, 3, 6, 12, 18, and 24 months. Seventy-one women completed 2-year follow-up. Median age was 47 (range 33-60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m(2). POP of any degree was seen in 50 % (35 women). At 1 year, pad test-negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT. Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.

  9. Efficacy of Arthroscopic Teaching Methods: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Robinson, Luke; Spanyer, Jonathon; Yenna, Zachary; Burchell, Patrick; Garber, Andrew; Riehl, John

    Arthroscopic education research recently has been focused on the use of skills labs to facilitate resident education and objective measure development to gauge technical skill. This study evaluates the effectiveness of three different teaching methods. Medical students were randomized into three groups. The first group received only classroom-based lecture. The second group received the same lecture and 28 minutes of lab-based hands-off arthroscopy instruction using a cadaver and arthroscopy setup. The final group received the same lecture and 7 minutes of hands-on arthroscopy instruction in the lab on a cadaver knee. The arthroscopic knee exam that followed simulated a diagnostic knee exam and subjects were measured on task completion and by the number of look downs. The number of look downs and the number of tasks completed did not achieve statistical significance between groups. Posttest survey results revealed that the hands-on group placed significantly more value on their educational experience as compared with the other two groups. (Journal of Surgical Orthopaedic Advances.

  10. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  11. Conventional versus computer-navigated TKA: a prospective randomized study.

    Science.gov (United States)

    Todesca, Alessandro; Garro, Luca; Penna, Massimo; Bejui-Hugues, Jacques

    2017-06-01

    The purpose of this study was to assess the midterm results of total knee arthroplasty (TKA) implanted with a specific computer navigation system in a group of patients (NAV) and to assess the same prosthesis implanted with the conventional technique in another group (CON); we hypothesized that computer navigation surgery would improve implant alignment, functional scores and survival of the implant compared to the conventional technique. From 2008 to 2009, 225 patients were enrolled in the study and randomly assigned in CON and NAV groups; 240 consecutive mobile-bearing ultra-congruent score (Amplitude, Valence, France) TKAs were performed by a single surgeon, 117 using the conventional method and 123 using the computer-navigated approach. Clinical outcome assessment was based on the Knee Society Score (KSS), the Hospital for Special Surgery Knee Score and the Western Ontario Mac Master University Index score. Component survival was calculated by Kaplan-Meier analysis. Median follow-up was 6.4 years (range 6-7 years). Two patients were lost to follow-up. No differences were seen between the two groups in age, sex, BMI and side of implantation. Three patients of CON group referred feelings of instability during walking, but clinical tests were all negative. NAV group showed statistical significant better KSS Score and wider ROM and fewer outliers from neutral mechanical axis, lateral distal femoral angle, medial proximal tibial angle and tibial slope in post-operative radiographic assessment. There was one case of early post-operative superficial infection (caused by Staph. Aureus) successfully treated with antibiotics. No mechanical loosening, mobile-bearing dislocation or patellofemoral complication was seen. At 7 years of follow-up, component survival in relation to the risk of aseptic loosening or other complications was 100 %. There were no implant revisions. This study demonstrates superior accuracy in implant positioning and statistical significant

  12. Effectiveness of different memory training programs on improving hyperphagic behaviors of residents with dementia: a longitudinal single-blind study

    Directory of Open Access Journals (Sweden)

    Kao CC

    2016-05-01

    Full Text Available Chieh-Chun Kao,1,2 Li-Chan Lin,3 Shiao-Chi Wu,4 Ker-Neng Lin,5,6 Ching-Kuan Liu7,8 1Department of Nursing, National Yang-Ming University, Taipei, 2Department of Nursing, Ching Kuo Institute of Management and Health, Keelung, 3Institute of Clinical Nursing, 4Institute of Health and Welfare Policy, National Yang-Ming University, 5Neurological Institute, Taipei Veterans General Hospital, Taipei, 6Department of Psychology, Soochow University, Taipei, Taiwan; 7Department of Neurology, Kaohsiung Medical University Hospital, 8Department of Neurology, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan Background: Hyperphagia increases eating-associated risks for people with dementia and distress for caregivers. The purpose of this study was to compare the long-term effectiveness of spaced retrieval (SR training and SR training combined with Montessori activities (SR + M for improving hyperphagic behaviors of special care unit residents with dementia. Methods: The study enrolled patients with dementia suffering from hyperphagia resident in eight institutions and used a cluster-randomized single-blind design, with 46 participants in the SR group, 49 in the SR + M group, and 45 participants in the control group. For these three groups, trained research assistants collected baseline data on hyperphagic behavior, pica, changes in eating habits, short meal frequency, and distress to caregivers. The SR and SR + M groups underwent memory training over a 6-week training period (30 sessions, and a generalized estimating equation was used to compare data of all the three groups of subjects obtained immediately after the training period and at follow-ups 1 month, 3 months, and 6 months later. Results: Results showed that the hyperphagic and pica behaviors of both the SR and SR + M groups were significantly improved (P<0.001 and that the effect lasted for 3 months after training. The improvement of fast eating was

  13. Brief report: Pilot single-blind placebo lead-in study of acamprosate in youth with autistic disorder.

    Science.gov (United States)

    Erickson, Craig A; Wink, Logan K; Early, Maureen C; Stiegelmeyer, Elizabeth; Mathieu-Frasier, Lauren; Patrick, Vanessa; McDougle, Christopher J

    2014-04-01

    An excitatory/inhibitory (E:I) imbalance marked by enhanced glutamate and deficient gamma-aminobutyric acid (GABA) neurotransmission may contribute to the pathophysiology of autism spectrum disorders (ASD). We report on the first single-blind placebo lead-in trial of acamprosate, a drug with putative mechanisms restoring E:I imbalance, in twelve youth with ASD. We conducted a 12-week single-blind, placebo lead-in study of acamprosate in youth age 5-17 years with autistic disorder. Six of nine subjects who received active drug treatment were deemed treatment responders (defined by a score at final visit of "very much improved" or "much improved" on the Clinical Global Impressions Improvement scale) and ≥25% improvement on the Aberrant Behavior Checklist Social Withdrawal subscale. Future larger-scale dose finding studies of acamprosate in ASD may be warranted given this preliminary indication of benefit.

  14. Evaluation of homoeopathic treatment in polycystic ovary syndrome: A single-blind, randomised, placebo-controlled pilot study

    OpenAIRE

    Chetna Deep Lamba; Praveen Oberai; Raj K Manchanda; Padmalaya Rath; P Hima Bindu; Maya Padmanabhan

    2018-01-01

    Background and Objectives: This study was conducted with the primary objective of evaluating efficacy of Homoeopathy in establishing the menstrual regularity with improvement in either ultrasonological findings or hirsutism/acne. The quality of life was also assessed using polycystic ovary syndrome questionnaire (PCOSQ). Materials and Methods: A single-blind, randomised, placebo-controlled pilot study was conducted from February 2014 to May 2015 at two research centres. The cases fulfilling t...

  15. Gemcitabine and treatment of diffuse large B-cell lymphoma in relapsed or refractory elderly patients: A prospective randomized trial in Algeria

    Directory of Open Access Journals (Sweden)

    Aribi Mourad

    2010-01-01

    Full Text Available Context: Support for non-Hodgkin′s lymphoma (NHL with large cells that is refractory or relapsed after first-line chemotherapy poses a greater therapeutic problem with bone marrow transplant therapy or when old age is a contra-indication for high-dose chemotherapy, especially among developing countries such as Algeria. Aim: To show that the regimen, including gemcitabine, could be more effective in treating elderly patients with diffuse large B-cell lymphoma (DLBCL in relapse / refractory, without complete remission, when compared with the ESHAP (etoposide, cisplatine, solumedrol, aracytine regimen. Materials and Methods: Ninety-six patients in the age group of 60-70 years were volunteers for a prospective randomized single-blind study, carried out for three years. Patients were divided into two groups by the drawing of lots. The first group (GA, n = 48, relapse; n = 27 [56.3%], refractory; n = 21 [43.7%] received treatment with ESHAP protocol and the second one (GB, n = 48, relapse; n = 28 [58%], refractory; n = 20 [42%] with GPD (gemcitabine, dexamethasone, cisplatine protocol. Results: The overall response rates and mean survival at three years were significantly higher among patients subjected to GPD treatment compared with those subjected to ESHAP treatment (63% vs. 55%, P = 0.01 and 20.5% [95% CI 16.5-24.5] vs. 11.8% [8.9-14.6], respectively. Additionally, three-year progression-free and event-free survival rates were 20.5% (16.3-24 and 19.7% (15.9-23.5, respectively, for the GPD regimen and 10.9% (8.2-13.7 and 11.1% (95% CI 8.5-13.7, respectively, for the ESHAP regimen. Moreover, the GPD regimen was associated with improving overall survival (RR=2.02, 95% CI 1.59-2.56; P = 0.000, event-free survival (2.03, 1.64-2.52; P < 0.001 and progression-free survival (1.86, 1.46-2.37; P < 0.001. Conclusion: In cases of contra-indication for high-dose chemotherapy for elderly patients with DLBCL, without complete remission, the Gemcitabine

  16. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial.

    Science.gov (United States)

    Enander, Jesper; Andersson, Erik; Mataix-Cols, David; Lichtenstein, Linn; Alström, Katarina; Andersson, Gerhard; Ljótsson, Brjánn; Rück, Christian

    2016-02-02

    To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. A 12 week single blind parallel group randomised controlled trial. Academic medical centre. 94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥ 20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial. Participants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks. The primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥ 30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial. BDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference -7.1 points, 95% confidence interval -9.8 to -4.4), depression (MADRS-S group difference -4.5 points, -7.5 to -1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high. CBT can be delivered safely via the internet to patients with body

  17. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population.

    Science.gov (United States)

    Di Biase, Luigi; Tung, Roderick; Szili-Torok, Tamás; Burkhardt, J David; Weiss, Peter; Tavernier, Rene; Berman, Adam E; Wissner, Erik; Spear, William; Chen, Xu; Neužil, Petr; Skoda, Jan; Lakkireddy, Dhanunjaya; Schwagten, Bruno; Lock, Ken; Natale, Andrea

    2017-04-01

    Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction. This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation. The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation. Clinicaltrials.gov identifier: NCT02637947.

  18. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

    Directory of Open Access Journals (Sweden)

    Parker Melissa J

    2012-06-01

    Full Text Available Abstract Background When planning a randomized controlled trial (RCT, investigators must select randomization and allocation procedures based upon a variety of factors. While third party randomization is cited as being among the most desirable randomization processes, many third party randomization procedures are neither feasible nor cost-effective for small RCTs, including pilot RCTs. In this study we present our experience with a third party randomization and allocation procedure that utilizes current technology to achieve randomization in a rapid, reliable, and cost-effective manner. Methods This method was developed by the investigators for use in a small 48-participant parallel group RCT with four study arms. As a nested study, the reliability of this randomization procedure was prospectively evaluated in this cohort. The primary outcome of this nested study was the proportion of subjects for whom allocation information was obtained by the Research Assistant within 15 min of the initial participant randomization request. A secondary outcome was the average time for communicating participant group assignment back to the Research Assistant. Descriptive information regarding any failed attempts at participant randomization as well as costs attributable to use of this method were also recorded. Statistical analyses included the calculation of simple proportions and descriptive statistics. Results Forty-eight participants were successfully randomized and group allocation instruction was received for 46 (96% within 15 min of the Research Assistant placing the initial randomization request. Time elapsed in minutes until receipt of participant allocation instruction was Mean (SD 3.1 +/− 3.6; Median (IQR 2 (2,3; Range (1–20 for the entire cohort of 48. For the two participants for whom group allocation information was not received by the Research Assistant within the 15-min pass threshold, this information was obtained following a second

  19. Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors

    NARCIS (Netherlands)

    K.T. Tran; H.G. Smeenk; C.H.J. van Eijck (Casper); G. Kazemier (Geert); W.C.J. Hop (Wim); J.W. Greve (Jan Willem); O.T. Terpstra (Onno); J.A. Zijlstra (Jan); P. Klinkert; J. Jeekel (Hans)

    2004-01-01

    textabstractOBJECTIVE: A prospective randomized multicenter study was performed to assess whether the results of pylorus-preserving pancreaticoduodenectomy (PPPD) equal those of the standard Whipple (SW) operation, especially with respect to duration of surgery, blood loss,

  20. Prospective randomized trial of sclerotherapy vs standard treatment for epistaxis due to hereditary hemorrhagic telangiectasia.

    Science.gov (United States)

    Boyer, Holly; Fernandes, Patricia; Le, Chap; Yueh, Bevan

    2015-05-01

    Our previous studies have demonstrated the tolerability and low side-effect profile of office-based sclerotherapy with sodium tetradecyl sulfate (STS) for treating recurrent epistaxis due to hereditary hemorrhagic telangiectasia (HHT). The objective of this study was to use a prospective randomized trial to determine the effectiveness of sclerotherapy with STS vs standard treatment. This prospective randomized trial (conducted from November 1, 2011, through January 31, 2014) involved 17 patients with recurrent epistaxis due to HHT. We defined standard treatment as continuation of any treatment that the patient had previously undergone, such as moisturization, packing, and cautery. We used a crossover design, so study participants were randomized to either sclerotherapy or standard treatment during the first time period, and then to the other during the second period. The primary outcome measure was frequency and severity of epistaxis, as measured by the epistaxis severity score (ESS). The ESS is a 10-point scale, with higher scores corresponding to more bleeding. After controlling for treatment order, bleeding was substantially better controlled after sclerotherapy; the ESS after sclerotherapy was nearly one point lower than after standard treatment (-0.95, 1-sided p = 0.027). Treatment order, baseline ESS, the number of lesions, moisturization practices, and a history of previous blood transfusions did not significantly affect the results. This trial demonstrated that sclerotherapy with STS (vs standard treatment) significantly reduced epistaxis due to HHT. © 2015 ARS-AAOA, LLC.

  1. Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

    2017-06-01

    The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p e-learning, a fact that encourages the use of e-learning in oncology. REBECU1111-1142-1963.

  2. A prospective randomized comparison of curved array and radial echoendoscopy in patients with esophageal cancer

    DEFF Research Database (Denmark)

    Siemsen, Mette; Svendsen, Lars Bo; Knigge, Ulrich

    2003-01-01

    BACKGROUND: Both curved array and radial scanning echoendoscopy are used for locoregional staging of cancer arising in the esophagus or cardia. The accuracy of TNM staging of these malignancies by curved array and radial EUS was compared in a prospective, randomized study. METHODS: Patients...... with cancer of the esophagus or cardia were examined by both curved array and radial echoendoscopy in randomized order by the same endosonographer in an unblinded fashion. The staging results and the examination time for the two echoendoscopies were compared and statistically analyzed, and finally compared......, respectively, 15 and 12 minutes (pcancer of the esophagus or cardia. The choice of echoendoscope for TNM staging in patients with these malignancies is, therefore, a question...

  3. The Ex-PRESS glaucoma shunt versus trabeculectomy in open-angle glaucoma: a prospective randomized study

    NARCIS (Netherlands)

    de Jong, Leo A. M. S.

    2009-01-01

    The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma. This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a

  4. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  5. Lysine clonixinate versus dipyrone (metamizole) for the acute treatment of severe migraine attacks: a single-blind, randomized study

    OpenAIRE

    Krymchantowski,Abouch Valenty; Carneiro,Henrique; Barbosa,Jackeline; Jevoux,Carla

    2008-01-01

    BACKGROUND AND OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Lysine clonixinate (LC) and dipyrone (metamizol) have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. METHOD: Thirty patients (28 women, 2 men), aged 18 to 48 years with migraine according the International Headache Societ...

  6. Comparison of simultaneous and sequential administration of fentanyl-propofol for surgical abortion: a randomized single-blinded controlled trial.

    Science.gov (United States)

    Gao, Wei; Sha, Baoyong; Zhao, Yuan; Fan, Zhe; Liu, Lin; Shen, Xin

    2017-08-01

    Propofol lipid emulsion (PLE) is a nanosized sedative, and it is used with a combination of salted antalgic prodrug, fentanyl citrate (FC). To illustrate the synergistic effect of mixing, we compared the sedation/analgesia resulting from simultaneous and sequential administration in surgically induced abortion (No. ChiCTR-IPC-15006153). Simultaneous group showed lower bispectral index, blood pressure, and heart rate, when cannula was inserted into the uterus. It also showed less frequency of hypertension, sinus tachycardia, movement, pain at the injection site, and additional FC. Therefore, premixing of PLE and FC enhanced the sedation and analgesia; stabilized the hemodynamics; lessened the incidence of movement and injection pain; and reduced the requirement of drugs.

  7. A Randomized, Single-Blind, Substitution Study of OROS Methylphenidate (Concerta) in ADHD Adults Receiving Immediate Release Methylphenidate

    Science.gov (United States)

    Spencer, Thomas J.; Mick, Eric; Surman, Craig B. H.; Hammerness, Paul; Doyle, Robert; Aleardi, Megan; Kotarski, Meghan; Williams, Courtney G.; Biederman, Joseph

    2011-01-01

    Objective: The main aim of this study was to examine the efficacy, tolerability, and compliance of an extended-release formulation of methylphenidate (OROS-MPH) in adults with ADHD receiving immediate-release methylphenidate (IR-MPH). Method: Participants were outpatient adults with ADHD who were stable on IR-MPH-administered TID. Participants…

  8. Adding magnesium sulfate to bupivacaine in transversus abdominis plane block for laparoscopic cholecystectomy: A single blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    K Al-Refaey

    2016-01-01

    Conclusion: Adding MgSo4 as an adjuvant to bupivacaine in TAP block; during anesthesia for LC; improved postoperative analgesia in the form of increased duration, decreased analgesic requirements and PONV.

  9. Effect of Hominis placenta Pharmacopuncture on the Dysmenorrhea (A Pilot study, Single blind, Randomized, Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Su-Min Kim

    2008-09-01

    Full Text Available Objective : This study was designed to evaluate the effect of Hominis placenta Pharmacopuncture treatment on Dysmenorrhea of Women. Methods : 49 subjects who were suffering from dysmenorrhea volunteered to answer the MMP(Measure of Menstrual Pain and MSSL(Menstrual Symptom Severity List questionnaire. They were divided into two groups, a Hominis placenta Pharmacopuncture treatment group(Experiment al group, n=25 and a Normal Saline(N/S treatment group(Control group, n=24. The two groups were injected on the CV4, S36, Sp9 and Sp6 acupuncture point. They were treated totally five times depending on the individual menstruation cycles. The scores of MMP and MSSL were measured overall three times before and after the menstruation cycle. The collected data were analyzed as paired t-test, independent t-test using SPSS 12.0 WIN Program. Results : As a result of the evaluation by MMP and MSSL, a significant improvement on dysmenorrhea was made in the two groups(p<0.05, and both scores of Experiment group were decreased more than Control group. But there was no significant difference between the two groups. Conclusions : The Hominis placenta Pharmacopuncture treatment and the Normal Saline treatment were effective in decreasing the symptom of Dysmenorrhea.

  10. Efficacy and safety of a new microneedle patch for skin brightening: A Randomized, split-face, single-blind study.

    Science.gov (United States)

    Park, Kui Young; Kwon, Hyun Jung; Lee, Changjin; Kim, Daegun; Yoon, Jun Jin; Kim, Myeong Nam; Kim, Beom Joon

    2017-09-01

    Although microneedles are one of the best transdermal drug delivery systems for active compounds, few clinical trials have examined the safety and efficacy of brightening microneedle patches. To determine the efficacy and safety of a newly developed whitening microneedle patch. A split-face study was designed for efficacy assessment with 34 Korean women applying the tested product (a whitening microneedle patch) on one cheek and a control whitening essence on the other. We objectively measured changes in melanin index values and skin brightness by mexameter and chromameter. Each participant also used global assessment to determine skin whitening. In addition, 55 participants were selected for primary skin irritation tests and repeated insult patch tests for safety assessments. Mean skin brightness and melanin indexes improved (Pmicroneedle patch was effective and safe for skin brightening and would be a promising functional cosmetic product. © 2017 Wiley Periodicals, Inc.

  11. Prospective, randomized evaluation of a personal digital assistant-based research tool in the emergency department

    Directory of Open Access Journals (Sweden)

    Dinizio Anthony

    2008-01-01

    Full Text Available Abstract Background Personal digital assistants (PDA offer putative advantages over paper for collecting research data. However, there are no data prospectively comparing PDA and paper in the emergency department. The aim of this study was to prospectively compare the performance of PDA and paper enrollment instruments with respect to time required and errors generated. Methods We randomized consecutive patients enrolled in an ongoing prospective study to having their data recorded either on a PDA or a paper data collection instrument. For each method, we recorded the total time required for enrollment, and the time required for manual transcription (paper onto a computer database. We compared data error rates by examining missing data, nonsensical data, and errors made during the transcription of paper forms. Statistical comparisons were performed by Kruskal-Wallis and Poisson regression analyses for time and errors, respectively. Results We enrolled 68 patients (37 PDA, 31 paper. Two of 31 paper forms were not available for analysis. Total data gathering times, inclusive of transcription, were significantly less for PDA (6:13 min per patient compared to paper (9:12 min per patient; p Conclusion Using a PDA-based data collection instrument for clinical research reduces the time required for data gathering and significantly improves data integrity.

  12. A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

    Science.gov (United States)

    McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

    2001-05-01

    Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically

  13. Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study.

    Science.gov (United States)

    Hafer, Carsten; Golla, Paulina; Gericke, Marion; Eden, Gabriele; Beutel, Gernot; Schmidt, Julius J; Schmidt, Bernhard M W; De Reys, Stef; Kielstein, Jan T

    2016-01-01

    Therapeutic plasma exchange (TPE) is either performed using a highly permeable filter with standard multifunctional renal replacement equipment (mTPE) or a centrifugation device (cTPE). Although both techniques are well established in clinical practice, performance of these two modes of TPE was never compared in a prospective randomized fashion. Thus we aimed to compare two commercially available therapeutic apheresis systems: mTPE (Octonova with Plasmaflo filter) and cTPE (Spectra Optia apheresis system). Twenty-one patients (age 51.6 ± 13.5 years; 10 F/11 M; BMI 25.1 ± 5.0 kg/m(2)) were enrolled in this randomized, prospective, paired, crossover study performed in the Hannover Medical School, Germany. First treatment (either mTPE or cTPE) was chosen by an online randomization list. The primary endpoints were plasma removal efficiency with 1.2× of the total plasma volume exchanged. Secondary endpoints were total amount of plasma substances removed, such as IgG and fibrinogen. Further, the treatment effect on platelet count and complications were evaluated. Despite a comparable volume of the processed plasma, mTPE treatment time was 10.5 % longer than cTPE treatment time (p centrifugal procedures were conducted using flow rates that could easily be obtained using peripheral access, plasma removal efficiency was significantly higher and treatment time was significantly lower in cTPE as compared to mTPE. Despite this lower treatment time, the decline in markers of procedure efficacy was comparable. Especially in centers performing many procedures per year, cTPE in contrast to mTPE can reduce treatment time without compromising treatment efficacy.

  14. A prospective, randomized study addressing the need for physical simulation following virtual simulation

    International Nuclear Information System (INIS)

    Valicenti, Richard K.; Waterman, Frank M.; Corn, Benjamin W.; Curran, Walter J.

    1997-01-01

    Purpose: To accurately implement a treatment plan obtained by virtual or CT simulation, conventional or physical simulation is still widely used. To evaluate the need for physical simulation, we prospectively randomized patients to undergo physical simulation or no additional simulation after virtual simulation. Methods and Materials: From July 1995 to September 1996, 75 patients underwent conformal four-field radiation therapy planning for prostate cancer with a commercial grade CT simulator. The patients were randomized to undergo either port filming immediately following physical simulation or port filming alone. The precision of implementing the devised plan was evaluated by comparing simulator radiographs and/or port films against the digitally reconstructed radiographs (DRRs) for x, y, and z displacements of the isocenter. Changes in beam aperture were also prospectively evaluated. Results: Thirty-seven patients were randomized to undergo physical simulation and first day port filming, and 38 had first day treatment verification films only without a physical simulation. Seventy-eight simulator radiographs and 195 first day treatment port films were reviewed. There was no statistically significant reduction in treatment setup error (>5 mm) if patients underwent physical simulation following virtual simulation. No patient required a resimulation, and there was no significant difference in changes of beam aperture. Conclusions: Following virtual simulation, physical simulation may not be necessary to accurately implement the conformal four-field technique. Because port filming appears to be sufficient to assure precise and reliable execution of a devised treatment plan, physical simulation may be eliminated from the process of CT based planning when virtual simulation is available

  15. Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

    Science.gov (United States)

    Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

    2012-10-01

    Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

  16. Prospective randomized trial compares suction versus water seal for air leaks.

    Science.gov (United States)

    Cerfolio, R J; Bass, C; Katholi, C R

    2001-05-01

    Surgeons treat air leaks differently. Our goal was to evaluate whether it is better to place chest tubes on suction or water seal for stopping air leaks after pulmonary surgery. A second goal was to evaluate a new classification system for air leaks that we developed. Patients were prospectively randomized before surgery to receive suction or water seal to their chest tubes on postoperative day (POD) #2. Air leaks were described and quantified daily by a classification system and a leak meter. The air-leak meter scored leaks from 1 (least) to 7 (greatest). The group randomized to water seal stayed on water seal unless a pneumothorax developed. On POD #2, 33 of 140 patients had an air leak. Eighteen patients had been preoperatively randomized to water seal and 15 to suction. Air leaks resolved in 12 (67%) of the water seal patients by the morning of POD #3. All 6 patients whose air leak did not stop had a leak that was 4/7 or greater (p leak meter. Of the 15 patients randomized to suction, only 1 patient's air leak (7%) resolved by the morning of POD #3. The randomization aspect of the trial was ended and statistical analysis showed water seal was superior (p = 0.001). The remaining 14 patients were then placed to water seal and by the morning of POD #4, 13 patients' leaks had stopped. Of the 32 total patients placed to seal, 7 (22%) developed a pneumothorax and 6 of these 7 patients had leaks that were 4/7 or greater (p = 0.001). Placing chest tubes on water seal seems superior to wall suction for stopping air leaks after pulmonary resection. However, water seal does not stop expiratory leaks that are 4/7 or greater. Pneumothorax may occur when chest tubes are placed on seal with leaks this large.

  17. Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

    Science.gov (United States)

    Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

    2002-05-01

    Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

  18. Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.

    Science.gov (United States)

    Adams, Lindsay B; Chang, Craig; Pope, Janet; Kim, Yeonsoo; Liu, Pei; Yates, Amy

    2016-05-01

    Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.

  19. Tolerance and diagnostic accuracy of an abbreviated adenosine infusion for myocardial scintigraphy: a randomized, prospective study.

    Science.gov (United States)

    Treuth, M G; Reyes, G A; He, Z X; Cwajg, E; Mahmarian, J J; Verani, M S

    2001-01-01

    The objectives of this study were 2-fold: (1) to determine the tolerance of adenosine perfusion tomography with the use of an abbreviated (3-minute) infusion in comparison to the standard (6-minute) infusion, and (2) to assess the relative diagnostic accuracy of a 3-minute adenosine infusion in patients referred for arteriography. An abbreviated adenosine infusion may decrease the frequency and duration of side effects and be a more cost-effective alternative. We prospectively randomized 599 patients undergoing adenosine myocardial perfusion tomography to either a 3-minute or 6-minute adenosine infusion at 140 microg/kg per minute. Among the 599 enrolled patients, 142 subsequently underwent coronary angiography. Patients randomized to the 3-minute adenosine infusion tolerated the procedure better than those randomized to the standard infusion (P <.01). Flushing, headache, neck pain, and atrioventricular block were all significantly less frequent (P <.01) with the abbreviated infusion. Moreover, patients receiving the abbreviated infusion had less hypotension and tachycardia (P <.05). The sensitivity of the test for detection of coronary artery disease was 88% for both the 3- and 6-minute infusions. In patients with abnormal scan results, perfusion defect size was slightly larger in those receiving a 6-minute infusion versus those receiving a 3-minute infusion (P =.05). An abbreviated 3-minute adenosine infusion, in combination with perfusion tomography, has similar sensitivity for detection of coronary artery disease and is better tolerated than the standard 6-minute infusion.

  20. Randomized prospective study comparing vancomycin with teicoplanin in the treatment of infections associated with Hickman catheters.

    Science.gov (United States)

    Smith, S R; Cheesbrough, J; Spearing, R; Davies, J M

    1989-08-01

    In 72 episodes of suspected or proven Hickman-catheter-associated infection occurring in 59 patients with various hematological disorders, patients were assigned to treatment with either vancomycin or teicoplanin in a randomized nonblinded prospective study. Of 60 episodes evaluable for response, 28 were treated with vancomycin and 32 were treated with teicoplanin. Sixteen infective episodes were microbiologically documented in the vancomycin group, and twenty-one were microbiologically documented in the teicoplanin group. Microbiologically and clinically documented infections treated with vancomycin had an 80% response rate, compared with a 69% response rate for those treated with teicoplanin (P = 0.316). Adverse events occurred in nine (25%) of the episodes in the vancomycin group, compared with three (8%) in the teicoplanin group (P = 0.044). Teicoplanin may provide an effective alternative to vancomycin in the treatment of Hickman-catheter-associated infection in patients with hematological malignancies.

  1. Prospective, Randomized, Multinational Study of Prostatic Urethral Lift Versus Transurethral Resection of the Prostate

    DEFF Research Database (Denmark)

    Sønksen, Jens; Barber, Neil J; Speakman, Mark J

    2015-01-01

    BACKGROUND: Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral...... lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial...... at 10 European centers involving 80 men with BPH LUTS. INTERVENTION: PUL or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation...

  2. Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, V.; Kaur, I.; Kumar, B. [Postgraduate Institute of Medicinal Education & Research, Chandigarh (India)

    2003-10-01

    Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

  3. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study

    DEFF Research Database (Denmark)

    Hauerberg, J.; Kosteljanetz, M.; Bøge-Rasmussen, Torben

    2008-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE: To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage. SUMMARY...... by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery. RESULTS: There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain...... adjacent disc degeneration or spondylosis were the same in both groups. CONCLUSION: This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc...

  4. Targeted physiotherapy for patellofemoral joint osteoarthritis: A protocol for a randomised, single-blind controlled trial

    Science.gov (United States)

    Crossley, Kay M; Vicenzino, Bill; Pandy, Marcus G; Schache, Anthony G; Hinman, Rana S

    2008-01-01

    Background The patellofemoral joint (PFJ) is one compartment of the knee that is frequently affected by osteoarthritis (OA) and is a potent source of OA symptoms. However, there is a dearth of evidence for compartment-specific treatments for PFJ OA. Therefore, this project aims to evaluate whether a physiotherapy treatment, targeted to the PFJ, results in greater improvements in pain and physical function than a physiotherapy education intervention in people with symptomatic and radiographic PFJ OA. Methods 90 people with PFJ OA (PFJ-specific history, signs and symptoms and radiographic evidence of PFJ OA) will be recruited from the community and randomly allocated into one of two treatments. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of physiotherapy (8 individual sessions over 12 weeks, as well as a home exercise program 4 times/week) compared to a physiotherapist-delivered OA education control treatment (8 individual sessions over 12 weeks). Physiotherapy treatment will consist of (i) quadriceps muscle retraining; (ii) quadriceps and hip muscle strengthening; (iii) patellar taping; (iv) manual PFJ and soft tissue mobilisation; and (v) OA education. Resistance and dosage of exercises will be tailored to the participant's functional level and clinical state. Primary outcomes will be evaluated by a blinded examiner at baseline, 12 weeks and 9 months using validated and reliable pain, physical function and perceived global effect scales. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models, including respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction. Conclusion This RCT is targeting PFJ OA, an important sub-group of knee OA patients, with a specifically designed conservative intervention. The project's outcome will influence PFJ OA rehabilitation, with the potential to reduce

  5. Targeted physiotherapy for patellofemoral joint osteoarthritis: A protocol for a randomised, single-blind controlled trial

    Directory of Open Access Journals (Sweden)

    Schache Anthony G

    2008-09-01

    Full Text Available Abstract Background The patellofemoral joint (PFJ is one compartment of the knee that is frequently affected by osteoarthritis (OA and is a potent source of OA symptoms. However, there is a dearth of evidence for compartment-specific treatments for PFJ OA. Therefore, this project aims to evaluate whether a physiotherapy treatment, targeted to the PFJ, results in greater improvements in pain and physical function than a physiotherapy education intervention in people with symptomatic and radiographic PFJ OA. Methods 90 people with PFJ OA (PFJ-specific history, signs and symptoms and radiographic evidence of PFJ OA will be recruited from the community and randomly allocated into one of two treatments. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of physiotherapy (8 individual sessions over 12 weeks, as well as a home exercise program 4 times/week compared to a physiotherapist-delivered OA education control treatment (8 individual sessions over 12 weeks. Physiotherapy treatment will consist of (i quadriceps muscle retraining; (ii quadriceps and hip muscle strengthening; (iii patellar taping; (iv manual PFJ and soft tissue mobilisation; and (v OA education. Resistance and dosage of exercises will be tailored to the participant's functional level and clinical state. Primary outcomes will be evaluated by a blinded examiner at baseline, 12 weeks and 9 months using validated and reliable pain, physical function and perceived global effect scales. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models, including respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction. Conclusion This RCT is targeting PFJ OA, an important sub-group of knee OA patients, with a specifically designed conservative intervention. The project's outcome will influence PFJ OA rehabilitation, with the

  6. Co-ingestion of carbohydrate and whey protein isolates enhance PGC-1α mRNA expression: a randomised, single blind, cross over study

    Directory of Open Access Journals (Sweden)

    Hill Karen M

    2013-02-01

    Full Text Available Abstract Background Whey protein isolates (WPI supplementation is known to improve resistance training adaptations. However, limited information is available on the effects of WPI plus carbohydrate (CHO supplementation on endurance training adaptations. Method Six endurance trained male cyclists and triathletes (age 29 ± 4 years, weight 74 ± 2 kg, VO2 max 63 ± 3 ml oxygen. kg-1. Min-1, height 183 ± 5 cm; mean ± SEM were randomly assigned to one of two dietary interventions in a single blind cross over design; CHO or CHO + WPI. Each dietary intervention was followed for 16 days which included the last 2 days having increased CHO content, representing a CHO loading phase. The dietary interventions were iso-caloric and carbohydrate content matched. On completion of the dietary intervention, participants performed an exercise bout, consisting of cycling for 60 min at 70% VO2 max, followed by time trial to exhaustion at 90% VO2 max and recovered in the laboratory for 6 hours. Blood samples and muscle biopsies were taken at various time points at rest and through the exercise trial and recovery. Results Compared to CHO, CHO + WPI increased plasma insulin during recovery at 180 mins (P Conclusion This study showed co-ingestion of CHO + WPI may have beneficial effects on recovery and adaptations to endurance exercise via, increased insulin response and up regulation of PGC-1α mRNA expression.

  7. The Effect of Isomaltulose Together with Green Tea on Glycemic Response and Antioxidant Capacity: A Single-Blind, Crossover Study in Healthy Subjects.

    Science.gov (United States)

    Suraphad, Passakorn; Suklaew, Phim On; Ngamukote, Sathaporn; Adisakwattana, Sirichai; Mäkynen, Kittana

    2017-05-06

    Isomaltulose, a naturally-occurring isomer of sucrose, is commonly used as an alternative sweetener in foods and beverages. The goal of this study was to determine the effect of isomaltulose together with green tea on postprandial plasma glucose and insulin concentration, as well as antioxidant capacity in healthy subjects. In a randomized, single-blind, crossover study, 15 healthy subjects (eight women and seven men; ages 23.5 ± 0.7 years; with body mass index of 22.6 ± 0.4 kg/m²) consumed five beverages: (1) 50 g sucrose in 400 mL water; (2) 50 g isomaltulose in 400 mL of water; (3) 400 mL of green tea; (4) 50 g sucrose in 400 mL of green tea; and (5) 50 g isomaltulose in 400 mL of green tea. Incremental area under postprandial plasma glucose, insulin, ferric reducing ability of plasma (FRAP) and malondialdehyde (MDA) concentration were determined during 120 min of administration. Following the consumption of isomaltulose, the incremental 2-h area under the curve (AUC 0-2 h ) indicated a higher reduction of postprandial glucose (43.4%) and insulin concentration (42.0%) than the consumption of sucrose. The addition of green tea to isomaltulose produced a greater suppression of postprandial plasma glucose (20.9%) and insulin concentration (37.7%). In accordance with antioxidant capacity, consumption of sucrose (40.0%) and isomaltulose (28.7%) caused the reduction of green tea-induced postprandial increases in FRAP. A reduction in postprandial MDA after drinking green tea was attenuated when consumed with sucrose (34.7%) and isomaltulose (17.2%). In conclusion, green tea could enhance the reduction of postprandial glucose and insulin concentration when consumed with isomaltulose. In comparison with sucrose, isomaltulose demonstrated less alteration of plasma antioxidant capacity after being consumed with green tea.

  8. Continuous spinal anesthesia versus combined spinal epidural block for major orthopedic surgery: prospective randomized study

    Directory of Open Access Journals (Sweden)

    Luiz Eduardo Imbelloni

    Full Text Available CONTEXT AND OBJECTIVES: In major orthopedic surgery of the lower limbs, continuous spinal anesthesia (CSA and combined spinal epidural anesthesia (CSE are safe and reliable anesthesia methods. In this prospective randomized clinical study, the blockading properties and side effects of CSA were compared with single interspace CSE, among patients scheduled for major hip or knee surgery. DESIGN AND SETTING: Prospective clinical study conducted at the Institute for Regional Anesthesia, Hospital de Base, São José do Rio Preto. METHODS: 240 patients scheduled for hip arthroplasty, knee arthroplasty or femoral fracture treatment were randomly assigned to receive either CSA or CSE. Blockades were performed in the lateral position at the L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor blockade, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and postdural puncture headache (PDPH were recorded. At the end of the surgery, the catheter was removed and cerebrospinal fluid leakage was evaluated. RESULTS: Seven patients were excluded (three CSA and four CSE. There was significantly lower incidence of paresthesia in the CSE group. The resultant sensory blockade level was significantly higher with CSE. Complete motor blockade occurred in 110 CSA patients and in 109 CSE patients. Arterial hypotension was observed significantly more often in the CSE group. PDPH was observed in two patients of each group. CONCLUSION: Our results suggest that both CSA and CSE provided good surgical conditions with low incidence of complications. The sensory blockade level and hemodynamic changes were lower with CSA.

  9. Peyton's four-step approach for teaching complex spinal manipulation techniques - a prospective randomized trial.

    Science.gov (United States)

    Gradl-Dietsch, Gertraud; Lübke, Cavan; Horst, Klemens; Simon, Melanie; Modabber, Ali; Sönmez, Tolga T; Münker, Ralf; Nebelung, Sven; Knobe, Matthias

    2016-11-03

    The objectives of this prospective randomized trial were to assess the impact of Peyton's four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG) or a control group, which received conventional teaching (CG). Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC) exam) and practical skills (Objective Structured Practical Examination (OSPE)) with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Peyton's approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

  10. Malignant astrocytoma: hyperfractionated and standard radiotherapy with chemotherapy in a randomized prospective clinical trial

    International Nuclear Information System (INIS)

    Payne, D.G.; Simpson, W.J.; Keen, C.; Platts, M.E.

    1982-01-01

    A prospective randomized trial of 157 patients with malignant astrocytomas (Grade III or IV) was carried out at a single institution. The minimization technique ensured balanced distribution of prognostic factors between the treatment groups. All received oral lomustine (CCNU, 80 mg/m 2 ) six weekly and hydroxyurea (HU, 3.5 gm/m 2 over 5 days) three weekly, for one year or until recurrence, with doses adjusted for myelosuppression. Patients were randomized to daily (5000 rad in 25 fractions (fr) in 5 weeks) or Q3h (every 3 hours) Cobalt 60 irradiation (3600-4000 rad in 36-40 fr of 100 rad each, given 4 fr per day at 3-hour intervals over two weeks). Steroid therapy (up to 16 mg day dexamethasone) was permitted. Complications were moderate and equivalent in the two groups. No significant survival or toxicity differences were seen between the two groups. Age, initial performance status, and extent of surgical resection were found to be significant (P<0.01) prognostic factors for survival. Median survival of the whole group was 48 weeks with a minimum follow-up of one year. There was no advantage to large radiation fields. The hyperfractionation and daily regimes had similar efficacy and toxicity. Hyperfractionation with chemotherapy offers a useful alternative approach in the management of this disease

  11. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study.

    Science.gov (United States)

    El-Awadi, Saleh; El-Nakeeb, Ayman; Youssef, Tamer; Fikry, Amir; Abd El-Hamed, Tito M; Ghazy, Hosam; Foda, Elyamany; Farid, Mohamed

    2009-02-01

    Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necessitating blood transfusions to 7 (12.72%) patients in OC group. The time to resume diet was 18.36+8.18 h in LC group which is significantly earlier than in OC group 47.84+14.6h P<0.005. Hospital stay was significantly longer in OC group than LC group (6+1.74 days versus 1.87+1.11 days) P<0.01 with low postoperative morbidity. LC in cirrhotics is still complicated and highly difficult which associates with significant morbidity compared with that of patients without cirrhosis. However, it offers lower morbidity, shorter operative time; early resume dieting with less need for blood transfusion and reducing hospital stay than OC.

  12. PRK and butterfly LASEK: prospective, randomized, contralateral eye comparison of epithelial healing and ocular discomfort.

    Science.gov (United States)

    Ghanem, Vinícius C; Souza, Giselle C; Souza, Denise C; Viese, Juliana M Z; Weber, Sarah L P; Kara-José, Newton

    2008-06-01

    To compare corneal reepithelialization, pain scores, ocular discomfort, and tear production after photorefractive keratectomy (PRK) and butterfly laser epithelial keratomileusis (LASEK). This prospective, randomized, double-masked study comprised 102 eyes of 51 patients who underwent laser refractive surgery. Each patient was randomized to have one eye operated on with PRK and the other with butterfly LASEK. Patients were followed for 1 year. The mean reepithelialization time in the PRK group was 4.35+/-0.48 days (range: 4 to 5 days) and 4.75+/-0.72 days (range: 4 to 6 days) in the butterfly LASEK group (PPRK was noted (3.31+/-4.09 vs 4.43+/-4.27; P=.18). Schirmer test values were significantly reduced from preoperative levels through 12 months with both PRK (23.6+/-8.1 vs 19.4+/-10.1; P<.002) and butterfly LASEK (22.4+/-8.7 vs 18.9+/-9.7; P=.01); however, no difference between groups was noted at any time. Photorefractive keratectomy showed a modest but statistically significant shorter reepithelialization time and a tendency towards lower pain scores than butterfly LASEK. The reepithelialization time was strongly associated with the duration of surgery in both techniques. A similar reduction of Schirmer test values was observed up to 1 year postoperatively in both groups.

  13. Custom vs conventional PRK: a prospective, randomized, contralateral eye comparison of postoperative visual function.

    Science.gov (United States)

    Mifflin, Mark D; Hatch, Bryndon B; Sikder, Shameema; Bell, James; Kurz, Christopher J; Moshirfar, Majid

    2012-02-01

    To determine whether VISX S4 (VISX Inc) custom photorefractive keratectomy (PRK) results in better visual outcomes than VISX S4 conventional PRK. Photorefractive keratectomy was performed on 80 eyes from 40 patients in this randomized, prospective, contralateral eye study. Dominant eyes were randomized to one group with the fellow eye receiving the alternate treatment. Primary outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), contrast sensitivity, and root-mean-square (RMS) higher order aberrations. Mean UDVA was -0.023±0.099 (20/19) in the custom group and -0.044±0.080 (20/18) in the conventional group 6 months after surgery (P=.293). Mean CDVA was -0.073±0.067 (20/17) in the custom group and -0.079±0.071 (20/17) in the conventional group 6 months after surgery (P=.659). Total higher order aberration RMS and spherical aberration increased in both groups compared to preoperative values (PPRK were shown to be safe and effective with excellent visual acuity and contrast sensitivity performance at 6 and 12 months. Conventional PRK induced more coma than custom PRK; however, this did not seem to correlate with clinical outcomes. Copyright 2012, SLACK Incorporated.

  14. Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

    Science.gov (United States)

    Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

    2010-01-01

    To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

  15. Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical

    Directory of Open Access Journals (Sweden)

    Aline Cristine Gomes

    2017-05-01

    Full Text Available Objectives The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo or single-file reciprocating (Reciproc systems were used. Materials and Methods Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS, ranging from ‘least possible discomfort’ (1 to ‘greatest possible discomfort’ (10. The Wilcoxon signed-rank test was used to determine significant differences at p< 0.05. Results Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660. Conclusions Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

  16. Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

    Science.gov (United States)

    Chen, Wen-Jun; Yuan, Shao-Fei; Yan, Qing-Yuan; Xiong, Jian-Ping; Wang, Sen-Ming; Zheng, Wei-E; Zhang, Wu; Sun, Hong-Yu; Chen, Hua; Wu, Li-Li

    2012-02-01

    The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE). A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups. Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05). In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.

  17. Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

    2013-03-01

    Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  18. Improving Prospective Memory in Persons With Parkinson Disease: A Randomized Controlled Trial.

    Science.gov (United States)

    Foster, Erin R; McDaniel, Mark A; Rendell, Peter G

    2017-05-01

    Prospective memory (PM) is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause PM deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions (IIs) is an encoding strategy that may improve PM in this population. To determine the effect of IIs on PM performance in PD. This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (n = 62) performed a computerized PM test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either IIs or a rehearsal (RR) encoding strategy. PM performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared with time-based cues. In addition, IIs resulted in a larger effect than RR for the nonrepeated tasks. Strategies that support full encoding of PM cues and actions can improve PM performance among people with PD, particularly for tasks with cues that are readily available in the environment. IIs may be more effective than RR for nonrepeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage PM impairment could improve function and quality of life and significantly affect clinical care for people with PD.

  19. Randomized prospective study of olecranon fracture fixation: cable pin system versus tension band wiring.

    Science.gov (United States)

    Liu, Q-H; Fu, Z-G; Zhou, J-L; Lu, T; Liu, T; Shan, L; Liu, Y; Bai, L

    2012-01-01

    This prospective, randomized study compared the effectiveness of the cable pin system (CPS) versus tension band wiring (TBW) for olecranon fracture fixation. Patients with acute transverse or slight oblique olecranon fractures were randomly divided into two groups: one fixed by CPS and the other by TBW. Clinical outcome data were collected and analysed following a mean duration of 21 months. The mean ± SD fracture healing time was significantly shorter in the CPS group (n = 30; 9.73 ± 2.02 weeks) compared with the TBW group (n = 32; 11.13 ± 2.21 weeks). One patient in the CPS group and seven patients in the TBW group experienced postoperative complications; this difference was statistically significant. The mean ± SD Mayo Elbow Performance Score in the CPS group was significantly higher (88.67 ± 6.42) than that in the TBW group (80.78 ± 11.99). Logistic regression analysis showed an association between fixation method and fracture healing time, complications and elbow function. Internal fixation by CPS is an effective method for olecranon fracture and is associated with a shorter healing time, fewer complications and better function than TBW.

  20. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  1. Prophylactic amnioinfusion in preganancies complicated by chorioamnionitis: a prospective randomized trial.

    Science.gov (United States)

    Parilla, B V; McDermott, T M

    1998-01-01

    The objective of this article is to prospectively investigate the efficacy of amnioinfusion as a means to reduce febrile morbidity in pregnancies complicated by chorioamnionitis. All laboring patients with a temperature > or =100.1 degrees F were approached for study participation. Exclusion criteria included amnionitis diagnosed at greater than 8 cm dilation, multiple gestation, placental abruption, or a nonreassuring fetal heart rate tracing. Consenting patients were randomized to receive antibiotics (ampicillin or penicillin with gentamicin) and acetaminophen with or without amnioinfusion. All patients received intrauterine pressure catheter placement. For study patients, normal saline at room temperature was infused at 10 mL/min for 60 min, then 3 mL/min until delivery. Postpartum endometritis was defined as a temperature = 100.4 degrees F accompanied by uterine tenderness more than 12 hr after delivery. Statistical analysis was performed using the Student's t-test for continuous data and Chi-square for discrete variables. Thirty-six patients were enrolled, and complete data were available for 34 patients (17 in each group). There were no differences between groups with respect to maternal age, gravidity, race, or gestational age. There were also no differences between groups in duration of rupture of membranes, temperature at randomization, interval from randomization to delivery, cesarean section rate, or umbilical cord arterial pH. The mean temperature at the time of delivery was 99.8+/-0.9 degrees F for the amnioinfusion group versus 100.5+/-1.0 degrees F for the control group (p=0.046). Three of 17 amnioinfusion patients and 3 of 17 control patients had postpartum endometritis. There was 1 neonatal infection in the treatment group and no neonatal infections among the control patients. Prophylactic amnioinfusion was associated with a decline in temperature at the time of delivery. No untoward effects from the amnioinfusion were identified.

  2. EFFECTIVENESS OF ROCABADO'S TECHNIQUE FOR SUBJECTS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION - A SINGLE BLIND STUDY

    Directory of Open Access Journals (Sweden)

    Niha Siraj Mulla

    2015-02-01

    Full Text Available Background:A temporo-mandibular joint dysfunction or TMD is a group of conditions characterized by pain in the muscles of mastication, the temporo-mandiblar joint or both. Rocabado has described techniques includes the Rocabado’s manipulation and Rocabado’s exercises which have both been individually advocated for treatment of TMD. The purpose of study is to determine the effectiveness of Rocabado’s techniques on TMJ dysfunction symptoms, pain, TMJ Range of Motion (ROM and jaw functional limitation for subjects with temporo-mandibular joint dysfunction. Method: Pre to post test experimental study design, subjects with temporo-mandibular joint dysfunction randomized into two groups with 15 subjects into each group with total of 30 subjects in Study and control group, respectively. The study group received the Rocabado’s technique which consisted of Rocabado’s non-thrust TMJ manipulation and Rocabado’s exercises along with conventional TMJ exercises and the control group received only conventional TMJ exercises. The exercises were performed for 6 times per each session, six times in a day, one session under supervision and remaining five sessions by the subject at home for 6 days in a week for duration of 2 weeks. The outcome measurements such as VAS for pain, TMJ ROM, Fonseca’s questionnaire rating for TMJ dysfunction symptoms and jaw function limitation score (JFLS was measured before and after two weeks of intervention. Results: Comparative analysis, using Independent ‘t’ test and Mann Whitney U- test found that the means of VAS, TMJ ROM, Fonseca’s questionnaire and JFLS scores showed statistically significant difference (p <0.05 when the pre-intervention means and post-intervention means were compared between two groups. Conclusion: It is concluded that Rocabado’s technique found to have statistically and clinically significant added effect with conventional TMJ exercises shown greater percentage of improvements obtained

  3. Gentamicin-collagen sponge reduces sternal wound complications after heart surgery : A controlled, prospectively randomized, double-blind study

    NARCIS (Netherlands)

    Schimmer, Christoph; Oezkur, Mehmet; Sinha, Bhanu; Hain, Johannes; Gorski, Armin; Hager, Benjamin; Leyh, Rainer

    Objective: Prophylactic retrosternal placement of a gentamicin-collagen sponge has been the subject of several recent clinical studies and is a matter of controversy. The present study is the first controlled, prospective, randomized, double-blind, single-center study to investigate the efficacy of

  4. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  5. Immediate loading versus immediate provisionalization of maxillary single-tooth replacements: a prospective randomized study with BioComp implants

    NARCIS (Netherlands)

    Lindeboom, Jerome A.; Frenken, Joost W.; Dubois, Leander; Frank, Michael; Abbink, Ingmar; Kroon, Frans H.

    2006-01-01

    PURPOSE: The aim of this prospective randomized study was to evaluate the clinical outcome of immediately loaded solid plasma sprayed (TPS) BioComp (BioComp Industries BV, Vught, The Netherlands) implants versus immediate provisionalized but non-loaded BioComp implants in the anterior and premolar

  6. EFFICACY OF SPINAL-CORD STIMULATION AS ADJUVANT THERAPY FOR INTRACTABLE ANGINA-PECTORIS - A PROSPECTIVE, RANDOMIZED CLINICAL-STUDY

    NARCIS (Netherlands)

    DEJONGSTE, MJL; HAUTVAST, RWM; HILLEGE, HL; LIE, KI

    Objectives. In a prospective, randomized study with an 8-week follow-up period, we evaluated the efficacy of spinal cord stimulation an exercise capacity and quality of life in patients with intractable angina. Background. Despite important achievements in therapy for ischemic heart disease, there

  7. Preoperative therapeutic exercise in frail elderly scheduled for total hip replacement: A randomized pilot trial

    NARCIS (Netherlands)

    Hoogeboom, T.J.; Dronkers, J.J.; Ende, C.H.M. van den; Oosting, E.; Meeteren, N.L.U. van

    2010-01-01

    Objective: To evaluate the feasibility and preliminary effectiveness of therapeutic exercise before total hip replacement in frail elderly. Design: A single-blind, randomized clinical pilot trial. Setting: Outpatient physiotherapy department. Subjects: Frail elderly with hip osteoarthritis awaiting

  8. YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

    Science.gov (United States)

    Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

    2011-03-01

    To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of

  9. Preoperative Radiotherapy in Resectable Rectal Cancer: A Prospective Randomized Study of Two Different Approaches

    International Nuclear Information System (INIS)

    EITTA, M.A.; EL- WAHIDI, G.F.; FOUDA, M.A.; ABO EL-NAGA, E.M.; GAD EL-HAK, N.

    2010-01-01

    Preoperative radiotherapy in resectable rectal cancer has a number of potential advantages, most importantly reducing local recurrence, increasing survival and down-staging effect. Purpose: This prospective study was designed to compare between two different approaches of preoperative radiotherapy, either short course or long course radiotherapy. The primary endpoint is to evaluate the local recurrence rate, overall survival (OS) and disease free survival (DFS). The secondary endpoint is to evaluate down staging, treatment toxicity and ability to do sphincter sparing procedure (SSP), aiming at helping in the choice of the optimal treatment modality. Patients and Methods: This is a prospective randomized study of patients with resectable rectal cancer who presented to the department of Clinical Oncology and Nuclear Medicine, Mansoura University during the time period between June 2007 and September 2009. These patients received preoperative radiotherapy and were randomized into two arms: Arm 1, short course (SCRT) 25Gy/week/5 fractions followed by surgery within one week, and arm 2, long course preoperative radiotherapy (LCRT) 45Gy/5 weeks/25 fractions followed by surgery after 4-6 weeks. Adjuvant chemotherapy was given 4-6 weeks after surgery according to the postoperative pathology. Results: After a median follow-up of 18 months (range 6 to 28 months), we studied the patterns of recurrence. Three patients experienced local recurrence (LR), two out of 14 (14.2%) in arm 1 and one out of 15 patients (6.7%) in arm 2, (p=0.598). Three patients developed distant metastases [two in arm 1 (14.2%) and one in arm 2 (6.7%), p=0.598]. Two-year OS rate was 64±3% and 66±2%, (p= 0.389), and the 2-year DFS rate was 61±2% and 83±2% for arms 1 and 2, respectively (p=0.83). Tumor (T) downstaging was more achieved in LCRT arm with a statistically significant difference, but did not reach statistical significance in node (N) down-staging. SSP was more available in LCRT but with no

  10. Exercise training and weight loss, not always a happy marriage: single blind exercise trials in females with diverse BMI.

    Science.gov (United States)

    Jackson, Matthew; Fatahi, Fardin; Alabduljader, Kholoud; Jelleyman, Charlotte; Moore, Jonathan P; Kubis, Hans-Peter

    2018-04-01

    Individuals show high variability in body weight responses to exercise training. Expectations and motivation towards effects of exercise on body weight might influence eating behaviour and could conceal regulatory mechanisms. We conducted 2 single-blind exercise trials (4 weeks (study 1) and 8 weeks (study 2)) with concealed objectives and exclusion of individuals with weight loss intention. Circuit exercise training programs (3 times a week (45-90 min), intensity 50%-90% peak oxygen uptake for 4 and 8 weeks) were conducted. Thirty-four females finished the 4-week intervention and 36 females the 8-week intervention. Overweight/obese (OV/OB) and lean female participants' weight/body composition responses were assessed and fasting and postprandial appetite hormone levels (PYY, insulin, amylin, leptin, ghrelin) were measured before and after the intervention for understanding potential contribution to individuals' body weight response to exercise training (study 2). Exercise training in both studies did not lead to a significant reduction of weight/body mass index (BMI) in the participants' groups; however, lean participants gained muscle mass. Appetite hormones levels were significantly (p training did not lead to weight loss in female participants, while a considerable proportion of variance in body weight response to training could be explained by individuals' appetite hormone levels and BMI.

  11. The role of auditory feedback in music-supported stroke rehabilitation: A single-blinded randomised controlled intervention.

    Science.gov (United States)

    van Vugt, F T; Kafczyk, T; Kuhn, W; Rollnik, J D; Tillmann, B; Altenmüller, E

    2016-01-01

    Learning to play musical instruments such as piano was previously shown to benefit post-stroke motor rehabilitation. Previous work hypothesised that the mechanism of this rehabilitation is that patients use auditory feedback to correct their movements and therefore show motor learning. We tested this hypothesis by manipulating the auditory feedback timing in a way that should disrupt such error-based learning. We contrasted a patient group undergoing music-supported therapy on a piano that emits sounds immediately (as in previous studies) with a group whose sounds are presented after a jittered delay. The delay was not noticeable to patients. Thirty-four patients in early stroke rehabilitation with moderate motor impairment and no previous musical background learned to play the piano using simple finger exercises and familiar children's songs. Rehabilitation outcome was not impaired in the jitter group relative to the normal group. Conversely, some clinical tests suggests the jitter group outperformed the normal group. Auditory feedback-based motor learning is not the beneficial mechanism of music-supported therapy. Immediate auditory feedback therapy may be suboptimal. Jittered delay may increase efficacy of the proposed therapy and allow patients to fully benefit from motivational factors of music training. Our study shows a novel way to test hypotheses concerning music training in a single-blinded way, which is an important improvement over existing unblinded tests of music interventions.

  12. Restricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adults: a randomised, parallel-group, multicentre, single-blind controlled trial.

    Science.gov (United States)

    Doig, Gordon S; Simpson, Fiona; Heighes, Philippa T; Bellomo, Rinaldo; Chesher, Douglas; Caterson, Ian D; Reade, Michael C; Harrigan, Peter W J

    2015-12-01

    Equipoise exists regarding the benefits of restricting caloric intake during electrolyte replacement for refeeding syndrome, with half of intensive care specialists choosing to continue normal caloric intake. We aimed to assess whether energy restriction affects the duration of critical illness, and other measures of morbidity, compared with standard care. We did a randomised, multicentre, single-blind clinical trial in 13 hospital intensive care units (ICUs) in Australia (11 sites) and New Zealand (two sites). Adult critically ill patients who developed refeeding syndrome within 72 h of commencing nutritional support in the ICU were enrolled and allocated to receive continued standard nutritional support or protocolised caloric restriction. 1:1 computer-based randomisation was done in blocks of variable size, stratified by enrolment serum phosphate concentration (>0·32 mmol/L vs ≤0·32 mmol/L) and body-mass index (BMI; >18 kg/m(2)vs ≤18 kg/m(2)). The primary outcome was the number of days alive after ICU discharge, with 60 day follow-up, in a modified intention-to-treat population of all randomly allocated patients except those mistakenly enrolled. Days alive after ICU discharge was a composite outcome based on ICU length of stay, overall survival time, and mortality. The Refeeding Syndrome Trial was registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR number 12609001043224). Between Dec 3, 2010, and Aug 13, 2014, we enrolled 339 adult critically ill patients: 170 were randomly allocated to continued standard nutritional support and 169 to protocolised caloric restriction. During the 60 day follow-up, the mean number of days alive after ICU discharge in 165 assessable patients in the standard care group was 39·9 (95% CI 36·4-43·7) compared with 44·8 (95% CI 40·9-49·1) in 166 assessable patients in the caloric restriction group (difference 4·9 days, 95% CI -2·3 to 13·6, p=0·19). Nevertheless, protocolised caloric

  13. Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure

    Directory of Open Access Journals (Sweden)

    Tojo Katsuyoshi

    2008-05-01

    Full Text Available Abstract Background The large clinical trials proved that Basal-Bolus (BB insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. Methods In PROBE (Prospective, Randomized, Open, Blinded-Endpoint design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range age: 64.5(56.8~71.0years with secondary failure of sulfonylurea (SU were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group, and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. Results After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3 → 7.4(6.9~8.7%, p Conclusion Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. Trial registration Current Controlled Trials number, NCT00348231

  14. Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

    Science.gov (United States)

    Al-Tamimi, Yahia Z; Bhargava, Deepti; Feltbower, Richard G; Hall, Gregory; Goddard, Anthony J P; Quinn, Audrey C; Ross, Stuart A

    2012-03-01

    A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome. Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit. Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively). Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage. URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

  15. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study.

    Science.gov (United States)

    Tuakli-Wosornu, Yetsa A; Terry, Alon; Boachie-Adjei, Kwadwo; Harrison, Julian R; Gribbin, Caitlin K; LaSalle, Elizabeth E; Nguyen, Joseph T; Solomon, Jennifer L; Lutz, Gregory E

    2016-01-01

    To determine whether single injections of autologous platelet-rich plasma (PRP) into symptomatic degenerative intervertebral disks will improve participant-reported pain and function. Prospective, double-blind, randomized controlled study. Outpatient physiatric spine practice. Adults with chronic (≥6 months), moderate-to-severe lumbar diskogenic pain that was unresponsive to conservative treatment. Participants were randomized to receive intradiskal PRP or contrast agent after provocative diskography. Data on pain, physical function, and participant satisfaction were collected at 1 week, 4 weeks, 8 weeks, 6 months, and 1 year. Participants in the control group who did not improve at 8 weeks were offered the option to receive PRP and subsequently followed. Functional Rating Index (FRI), Numeric Rating Scale (NRS) for pain, the pain and physical function domains of the 36-item Short Form Health Survey, and the modified North American Spine Society (NASS) Outcome Questionnaire were used. Forty-seven participants (29 in the treatment group, 18 in the control group) were analyzed by an independent observer with a 92% follow-up rate. Over 8 weeks of follow-up, there were statistically significant improvements in participants who received intradiskal PRP with regards to pain (NRS Best Pain) (P = .02), function (FRI) (P = .03), and patient satisfaction (NASS Outcome Questionnaire) (P = .01) compared with controls. No adverse events of disk space infection, neurologic injury, or progressive herniation were reported following the injection of PRP. Participants who received intradiskal PRP showed significant improvements in FRI, NRS Best Pain, and NASS patient satisfaction scores over 8 weeks compared with controls. Those who received PRP maintained significant improvements in FRI scores through at least 1 year of follow-up. Although these results are promising, further studies are needed to define the subset of participants most likely to respond to biologic intradiskal

  16. Prospective, randomized, controlled trial using best-selling smoking-cessation book.

    Science.gov (United States)

    Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David

    2017-07-01

    Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

  17. Tamsulosin versus tadalafil as a medical expulsive therapy for distal ureteral stones: A prospective randomized study.

    Science.gov (United States)

    Kc, Hari Bahadur; Shrestha, Anil; Acharya, Ganesh Bhakta; Basnet, Robin Bahadur; Shah, Arvind Kumar; Shrestha, Parash Mani

    2016-09-01

    This study aimed to compare the safety and efficacy of tamsulosin and tadalafil as medical expulsive therapy for distal ureteral stones. This prospective randomized study was conducted at the Department of Urology of Bir Hospital over a period of 12 months in patients with distal ureteral stones sized 5 to 10 mm. Patients were randomly divided into 2 groups: group A received tamsulosin 0.4 mg and group B received tadalafil 10 mg at bedtime for 2 weeks. Stone expulsion rate, number of ureteric colic episodes and pain score, analgesic requirements, and adverse drug effects were noted in both groups. Statistical analyses were performed by using Student t-test and chi-square test. Altogether 85 patients, 41 in group A and 44 in group B, were enrolled in the study. The patients' average age was 31.72±12.63 years, and the male-to-female ratio was 1.5:1. Demographic profiles, stone size, and baseline investigations were comparable between the 2 groups. The stone expulsion rate was significantly higher in the tadalafil group than in the tamsulosin group (84.1% vs. 61.0%, p=0.017). Although the occurrence of side effects was higher with tadalafil, this difference was not significant (p=0.099). There were no serious adverse effects. Tadalafil has a significantly higher stone expulsion rate than tamsulosin when used as a medical expulsive therapy for distal ureteral stones sized 5-10 mm. Both drugs are safe, effective, and well tolerated with minor side effects.

  18. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  19. Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial.

    Science.gov (United States)

    Hamlin, Katharine; Munro, Christopher; Barker, Scott L; McKenna, Sean; Kumar, Kapil

    2018-01-01

    Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

  20. Vapocoolant Anesthesia for Cosmetic Facial Rejuvenation Injections: A Randomized, Prospective, Split-Face Trial.

    Science.gov (United States)

    Zeiderman, Matthew R; Kelishadi, Shahrooz Sean; Tutela, John Paul; Rao, Arun; Chowdhry, Saeed; Brooks, Ronald M; Wilhelmi, Bradon J

    2018-01-01

    Background: Minimally invasive cosmetic procedures are the most commonly performed aesthetic techniques by plastic surgeons. Patients are interested in a pain-free experience. Surgeons desire patient satisfaction and time-efficient utilization of office staff and resources. Clinical evidence exists for use of vapocoolant technology to reduce pain associated with intravenous cannulation in the pediatric population and in hemodialysis patients. Applying vapocoolant technology to facial rejuvenation is a novel approach to decrease pain associated with neurotoxin or filler injection. Methods: A randomized, prospective study was conducted, testing 15 subjects receiving filler injections and another 15 patients receiving neurotoxin injections using a split-face model. The vapocoolant spray used was composed of a 95:5 ratio of 1,1,1,3,3-pentafluoropropane and 1,1,1,2-tetrafluoroethane. Within each group, individual patients randomly received injection (filler or neurotoxin) alone versus injection (filler or neurotoxin) plus vapocoolant on an equivalent half of his or her face. An independent examiner recorded from each patient on a scale of 1 to 10 perceived pain for injection alone versus injection plus vapocoolant spray. Results were calculated as a percentage change of pain scores experienced after injection for each person between the control (nonvapocoolant) and treatment (vapocoolant) sides of the face. Results: Vapocoolant spray at the time of cosmetic facial injections leads to a 59% decrease in perceived pain score with neurotoxin injections (range, 0%-100% change) and 64% decrease in perceived pain score with filler injections (range, 0%-100% change). These results were statistically significant with P reduces pain associated with facial rejuvenation procedures.

  1. Timing of urinary catheter removal after uncomplicated total abdominal hysterectomy: a prospective randomized trial.

    Science.gov (United States)

    Ahmed, Magdy R; Sayed Ahmed, Waleed A; Atwa, Khaled A; Metwally, Lobna

    2014-05-01

    To assess whether immediate (0h), intermediate (after 6h) or delayed (after 24h) removal of an indwelling urinary catheter after uncomplicated abdominal hysterectomy can affect the rate of re-catheterization due to urinary retention, rate of urinary tract infection, ambulation time and length of hospital stay. Prospective randomized controlled trial conducted at Suez Canal University Hospital, Egypt. Two hundred and twenty-one women underwent total abdominal hysterectomy for benign gynecological diseases and were randomly allocated into three groups. Women in group A (73 patients) had their urinary catheter removed immediately after surgery. Group B (81 patients) had the catheter removed 6h post-operatively while in group C (67 patients) the catheter was removed after 24h. The main outcome measures were the frequency of urinary retention, urinary tract infections, ambulation time and length of hospital stay. There was a significantly higher number of urinary retention episodes requiring re-catheterization in the immediate removal group compared to the intermediate and delayed removal groups (16.4% versus 2.5% and 0% respectively). Delayed urinary catheter removal was associated with a higher incidence of urinary tract infections (15%), delayed ambulation time (10.3h) and longer hospital stay (5.6 days) compared to the early (1.4%, 4.1h and 3.2 days respectively) and intermediate (3.7%, 6.8h and 3.4 days respectively) removal groups. Removal of the urinary catheter 6h postoperatively appears to be more advantageous than early or late removal in cases of uncomplicated total abdominal hysterectomy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  2. Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces.

    Science.gov (United States)

    Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

    2015-01-01

    To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Assil Eye Institute, Beverly Hills, CA, USA. Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (Ptransverse system vs torsional (Ptransverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient.

  3. Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

    Science.gov (United States)

    Pakarinen, Harri J; Flinkkilä, Tapio E; Ohtonen, Pasi P; Hyvönen, Pekka H; Lakovaara, Martti T; Leppilahti, Juhana I; Ristiniemi, Jukka Y

    2011-12-01

    This study was designed to assess whether transfixion of an unstable syndesmosis is necessary in supination-external rotation (Lauge-Hansen SE/Weber B)-type ankle fractures. A prospective study of 140 patients with unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures was done. After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixion with 3.5-mm tricortical screws or no syndesmotic fixation. Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of followup. Twenty four (17%) of 140 patients had positive standardized 7.5-Nm ER stress tests after malleolar fixation. The stress view was positive three times on tibiotalar clear space, seven on tibiofibular clear space, and 14 times on both tibiotalar and tibiofibular clear spaces. There was no significant difference between the two randomization groups with regards to Olerud-Molander functional score, VAS scale measuring pain and function, or RAND 36-Item Health Survey pain or physical function at 1 year. Relevant syndesmotic injuries are rare in supination-external rotation ankle fractures, and syndesmotic transfixion with a screw did not influence the functional outcome or pain after the 1-year followup compared with no fixation.

  4. Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Evandro Pereira Palacio

    2016-02-01

    Full Text Available ABSTRACT OBJECTIVE: To evaluate the effects of platelet-rich plasma (PRP infiltration in patients with lateral epicondylitis of the elbow, through analysis of the Disabilities of the Arm, Shoulder and Hand (DASH and Patient-Rated Tennis Elbow Evaluation (PRTEE questionnaires. METHODS: Sixty patients with lateral epicondylitis of the elbow were prospectively randomized and evaluated after receiving infiltration of three milliliters of PRP, or 0.5% neocaine, or dexamethasone. For the scoring process, the patients were asked to fill out the DASH and PRTEE questionnaires on three occasions: on the day of infiltration and 90 and 180 days afterwards. RESULTS: Around 81.7% of the patients who underwent the treatment presented some improvement of the symptoms. The statistical tests showed that there was evidence that the cure rate was unrelated to the substance applied (p = 0.62. There was also intersection between the confidence intervals of each group, thus demonstrating that the proportions of patients whose symptoms improved were similar in all the groups. CONCLUSION: At a significance level of 5%, there was no evidence that one treatment was more effective than another, when assessed using the DASH and PRTEE questionnaires.

  5. Percutaneous CT-guided lung biopsy: sequential versus spiral scanning. A randomized prospective study

    International Nuclear Information System (INIS)

    Ghaye, B.; Dondelinger, R.F.; Dewe, W.

    1999-01-01

    The aim of this study was to evaluate in a prospective and randomized study spiral versus sequential scanning in the guidance of percutaneous lung biopsy. Fifty thoracic lesions occurring in 48 patients were biopsied by a senior and a junior operator. Six different time segments of the procedure were measured. Scanning mode versus length of procedure, pathological results, irradiation and complications were evaluated. Total duration of the procedure and of the first sampling was significantly longer with spiral CT for the senior operator (p < 0.004). No significant time difference was observed for the junior operator. Diameter of the lesion, depth of location, position of the patient and needle entry site did not influence the results. The sensitivity was 90.9, specificity 100, positive predictive value 100 and negative predictive value 60 % for spiral CT, and 94.7, 100, 100 and 85.7 % for sequential CT, respectively. Eleven pneumothoraces and ten perinodular hemorrhages were seen with spiral CT and six and ten, respectively, with sequential CT. The mean dose of irradiation was 4027 mAs for spiral CT and 2358 mAs for conventional CT. Spiral CT does neither reduce procedure time nor the rate of complications. Pathological results do not differ compared with sequential CT, and total dose of irradiation is higher with spiral scanning. (orig.)

  6. Frequency format diagram and probability chart for breast cancer risk communication: a prospective, randomized trial

    Directory of Open Access Journals (Sweden)

    Wahner-Roedler Dietlind

    2008-10-01

    Full Text Available Abstract Background Breast cancer risk education enables women make informed decisions regarding their options for screening and risk reduction. We aimed to determine whether patient education regarding breast cancer risk using a bar graph, with or without a frequency format diagram, improved the accuracy of risk perception. Methods We conducted a prospective, randomized trial among women at increased risk for breast cancer. The main outcome measurement was patients' estimation of their breast cancer risk before and after education with a bar graph (BG group or bar graph plus a frequency format diagram (BG+FF group, which was assessed by previsit and postvisit questionnaires. Results Of 150 women in the study, 74 were assigned to the BG group and 76 to the BG+FF group. Overall, 72% of women overestimated their risk of breast cancer. The improvement in accuracy of risk perception from the previsit to the postvisit questionnaire (BG group, 19% to 61%; BG+FF group, 13% to 67% was not significantly different between the 2 groups (P = .10. Among women who inaccurately perceived very high risk (≥ 50% risk, inaccurate risk perception decreased significantly in the BG+FF group (22% to 3% compared with the BG group (28% to 19% (P = .004. Conclusion Breast cancer risk communication using a bar graph plus a frequency format diagram can improve the short-term accuracy of risk perception among women perceiving inaccurately high risk.

  7. Thermal welding versus cold knife tonsillectomy: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Metin Yilmaz

    2012-05-01

    Full Text Available This is a prospective randomized study conducted in a group of children who underwent two methods of tonsillectomy: thermal welding or cold knife tonsillectomy. Parameters, such as postoperative pain scores, intraoperative blood loss, operation time, and postoperative bleeding rates, were analyzed to find out which technique is better. Ninety-one children (aged between 2 years and 13 years with recurrent tonsillitis, obstructive sleep apnea syndrome, or both were included in the study. According to the type of tonsillectomy procedure, the patients were divided into two groups: cold knife and thermal welding procedure. The two groups were compared on the basis of postoperative pain scores, intraoperative blood loss, operation time, and postoperative bleeding. Fifty-seven patients underwent thermal welding tonsillectomy and 34 had cold knife tonsillectomy. The mean pain score in thermal welding group was significantly lower (p<0.001. There was no remarkable blood loss intraoperatively in the thermal welding procedure. The operation time was not significantly different between two groups. No postoperative bleeding was encountered in the thermal welding group. Compared with the cold knife technique, thermal welding was found to be a relatively new and safe technique for tonsillectomy as it results in significantly less postoperative pain and no remarkable blood loss.

  8. Perioperative hyperoxygenation and wound site infection following surgery for acute appendicitis: a randomized, prospective, controlled trial.

    Science.gov (United States)

    Bickel, Amitai; Gurevits, Michael; Vamos, Ronny; Ivry, Simon; Eitan, Arieh

    2011-04-01

    To assess the influence of hyperoxygenation on surgical site infection by using the most homogeneous study population. A randomized, prospective, controlled trial. Department of surgery in a government hospital. A total of 210 patients who underwent open surgery for acute appendicitis. In the study group, patients received 80% oxygen during anesthesia, followed by high-flow oxygen for 2 hours in the recovery room. The control group received 30% oxygen, as usual. Open appendectomy via incision in the right lower quadrant of the abdomen. Surgical site infection, mainly assessed by the ASEPSIS (additional treatment, serous discharge, erythema, purulent discharge, separation of deep tissues, isolation of bacteria, and stay in hospital prolonged >14 days) system score. Surgical site infections were recorded in 6 of 107 patients (5.6%) in the study group vs 14 of 103 patients (13.6%) in the control group (P = .04). Significant differences in the ASEPSIS score were also found. The mean hospital stay was longer in the control group (2.92 days) compared with the study group (2.51 days) (P = .01). The use of supplemental oxygen is advantageous in operations for acute appendicitis by reducing surgical site infection rate and hospital stay. clinicaltrials.gov Identifier: NCT01002365.

  9. Prospective, randomized, controlled trial of polymer cable ties versus standard wire closure of midline sternotomy.

    Science.gov (United States)

    Marasco, Silvana F; Fuller, Louise; Zimmet, Adam; McGiffin, David; Seitz, Michael; Ch'ng, Stephanie; Gangahanumaiah, Shivanand; Bailey, Michael

    2018-04-16

    Midline sternotomy remains the most common access incision for cardiac operations. Traditionally, the sternum is closed with stainless steel wires. Wires are well known to stretch and break, however, leading to pain, nonunion, and potential deep sternal wound infection. We hypothesized that biocompatible plastic cable ties would achieve a more rigid sternal fixation, reducing postoperative pain and analgesia requirements. A prospective, randomized study compared the ZIPFIX (De Puy Synthes, West Chester, Pa) sternal closure system (n = 58) with standard stainless steel wires (n = 60). Primary outcomes were pain and analgesia requirements in the early postoperative period. Secondary outcome was sternal movement, as assessed by ultrasound at the postoperative follow-up visit. Groups were well matched in demographic and operative variables. There were no significant differences between groups in postoperative pain, analgesia, or early ventilatory requirements. Patients in the ZIPFIX group had significantly more movement in the sternum and manubrium on ultrasound at 4 weeks. ZIPFIX sternal cable ties provide reliable closure but no demonstrable benefit in this study in pain or analgesic requirements relative to standard wire closure after median sternotomy. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

  10. Prospective, randomized, blinded evaluation of donor semen quality provided by seven commercial sperm banks.

    Science.gov (United States)

    Carrell, Douglas T; Cartmill, Deborah; Jones, Kirtly P; Hatasaka, Harry H; Peterson, C Matthew

    2002-07-01

    To evaluate variability in donor semen quality between seven commercial donor sperm banks, within sperm banks, and between intracervical insemination and intrauterine insemination. Prospective, randomized, blind evaluation of commercially available donor semen samples. An academic andrology laboratory. Seventy-five cryopreserved donor semen samples were evaluated. Samples were coded, then blindly evaluated for semen quality. Standard semen quality parameters, including concentration, motility parameters, World Health Organization criteria morphology, and strict criteria morphology. Significant differences were observed between donor semen banks for most semen quality parameters analyzed in intracervical insemination samples. In general, the greatest variability observed between banks was in percentage progressive sperm motility (range, 8.8 +/- 5.8 to 42.4 +/- 5.5) and normal sperm morphology (strict criteria; range, 10.1 +/- 3.3 to 26.6 +/- 4.7). Coefficients of variation within sperm banks were generally high. These data demonstrate the variability of donor semen quality provided by commercial sperm banks, both between banks and within a given bank. No relationship was observed between the size or type of sperm bank and the degree of variability. The data demonstrate the lack of uniformity in the criteria used to screen potential semen donors and emphasize the need for more stringent screening criteria and strict quality control in processing samples.

  11. Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study.

    Science.gov (United States)

    Patel, Jay N; Spanyer, Jonathon M; Smith, Langan S; Huang, Jiapeng; Yakkanti, Madhusudhan R; Malkani, Arthur L

    2014-08-01

    The purpose of this study was to compare the efficacy of topical Tranexamic Acid (TXA) versus Intravenous (IV) Tranexamic Acid for reduction of blood loss following primary total knee arthroplasty (TKA). This prospective randomized study involved 89 patients comparing topical administration of 2.0g TXA, versus IV administration of 10mg/kg. There were no differences between the two groups with regard to patient demographics or perioperative function. The primary outcome measure, perioperative change in hemoglobin level, showed a decrease of 3.06 ± 1.02 in the IV group and 3.42 ± 1.07 in the topical group (P = 0.108). There were no statistical differences between the groups in preoperative hemoglobin level, lowest postoperative hemoglobin level, or total drain output. One patient in the topical group required blood transfusion (P = 0.342). Based on our study, topical Tranexamic Acid has similar efficacy to IV Tranexamic Acid for TKA patients. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. Small bowel preparations for capsule endoscopy with mannitol and simethicone: a prospective, randomized, clinical trial.

    Science.gov (United States)

    Chen, Hong-bin; Huang, Yue; Chen, Su-yu; Song, Hui-wen; Li, Xiao-lin; Dai, Dong-lin; Xie, Jia-tia; He, Song; Zhao, Yuan-yuan; Huang, Chun; Zhang, Sheng-jun; Yang, Lin-na

    2011-04-01

    There is no consensus concerning small bowel preparation before capsule endoscopy (CE). This study evaluated the effects of 4 regimens on small bowel cleansing and diagnostic yield. Patients were randomly divided into 4 groups. Group A consumed a clear liquid diet after lunch on the day before CE, followed by overnight fasting. Group B took 250 mL 20% mannitol and 1 L 0.9% saline orally at 05:00 hours on the day of the procedure. In group C, the same regimen was taken at 20:00 hours on the day before and at 05:00 hours on the day of CE. In group D, in addition to the group C regimen, 20 mL oral simethicone was taken 30 minutes before CE. Two hundred patients were prospectively enrolled, and 7 were excluded from the final analysis because of incomplete small bowel transit. No significant difference was noted among the 4 groups for small bowel transit time. Bowel preparation in group D was significantly better than for the other regimens for overall cleansing of the proximal small bowel, and showed improved overall cleansing of the distal small bowel when compared with 10-hours overnight fasting. Pathological lesions of the proximal and distal small bowel were, respectively, achieved in 82 and 74 patients, mostly distributed in group D. Small bowel preparation that involves split-dose oral mannitol plus single-dose simethicone for CE can improve mucosal visualization and subsequent diagnostic yield when compared with 10-hours overnight fasting.

  13. Topical sucralfate for pain after oral CO2 laser surgery: a prospective, randomized, controlled trial.

    Science.gov (United States)

    Guo, Chau-Shiang; Chuang, Hui-Ching; Chien, Chih-Yen

    2012-01-01

    The aim of this study was to assess the effect of topical sucralfate on postoperative pain scores and other secondary outcomes including the frequency and duration of analgesic use and postoperative bleeding episodes after CO(2) laser treatment of oral leukoplakia. In this prospective trial, a total of 80 patients were randomized into the sucralfate group (n = 40) or the control group (n = 40). Postoperative pain scores, the frequency and duration of analgesic requirements, and postoperative wound bleeding episodes were compared between the 2 groups from the operative day to postoperative day 6. Patients in the sucralfate group experienced significantly less postoperative pain on postoperative days 1 and 2. Although there was no significant difference in frequency and duration of analgesic use between the 2 groups, a trend toward lower frequency and fewer days of analgesic use in the sucralfate group was observed. This study demonstrated the efficacy of topical sucralfate application in diminishing postoperative pain after CO(2) laser therapy for oral leukoplakia. Topical sucralfate can be considered a feasible adjuvant medication for the control of pain after CO(2) laser treatment of oral leukoplakia. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. The efficiency of sucralfate in corrosive esophagitis: a randomized, prospective study.

    Science.gov (United States)

    Gümürdülü, Yüksel; Karakoç, Emre; Kara, Banu; Taşdoğan, Burçak Evren; Parsak, Cem Kaan; Sakman, Gürhan

    2010-03-01

    Ingestion of a chemical agent is a serious problem, and several treatment protocols to prevent stricture formation have been proposed. We conducted a randomized prospective study to evaluate the effectiveness of oral intensive sucralfate plus conventional therapy compared to conventional therapy alone. Fifteen patients with stage 2b and 3 corrosive esophagitis admitted to our gastroenterology, general surgery and intensive care units between 2004 and 2007 were included. Patients were divided into two groups. The patients in the first group (n=8) received intensive sucralfate therapy plus conventional therapy, while the other group (n=7) received only conventional therapy. We performed upper endoscopic procedures on days: 0, 21, 45, 90 and 180 to identify the emergent complications. In the first group, only one patient had stricture formation, allowing passage of a 9.2 mm endoscope and causing no dysphagia, on day 45. There was no progression in the stricture on follow-ups at the 3rd and 6th months. In the second group, 6 patients had stricture formation causing narrowing and dysphagia. Intensive sucralfate therapy may decrease the frequency of stricture formation in patients with advanced corrosive esophagitis. Further studies with large groups of patients are required to confirm our findings.

  15. [Do double gloves protect against contamination during cannulation of blood vessels? A prospective randomized study].

    Science.gov (United States)

    Szarpak, Łukasz; Kurowski, Andrzej

    2014-01-01

    Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient. Thus they protect the assistance provider from hand skin contamination with potentially infectious biological materials. The aim of the study was to evaluate the occurrence of pierce, perforations or damage of medical gloves during cannulation of blood vessels. In the prospective randomized study 303 pairs of gloves, used during cannulation of blood vessels under simulated resuscitation, were analyzed. Gloves were tested by the water leak test. The water test revealed 44 cases of damage to the gloves used during cannulation of blood vessels. Significant differences were noted in the frequency of damage to both the outer and single pairs of gloves and the inner pair of gloves. The study showed that the use of double gloves provides a higher level of security for a paramedic than the use of a single pair of gloves, however, double gloves reduce the manual dexterity of a paramedic. A large number of damages to gloves are not noticed by medical personnel during surgery.

  16. Behavioral measures to reduce non-adherence in renal transplant recipients: a prospective randomized controlled trial.

    Science.gov (United States)

    Garcia, Márcia Fátima Faraldo Martinez; Bravin, Ariane Moyses; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; Nga, Hong Si; Takase, Henrique Mochida; de Andrade, Luis Gustavo Modelli

    2015-11-01

    Solid-organ transplant recipients present a high rate of non-adherence to drug treatment. Few interventional studies have included approaches aimed at increasing adherence. The objective of this study was to evaluate the impact of an educational and behavioral strategy on treatment adherence of kidney transplant recipients. In a randomized prospective study, incident renal transplant patients (n = 111) were divided into two groups: control group (received usual transplant patient education) and treatment group (usual transplant patient education plus ten additional weekly 30-min education/counseling sessions about immunosuppressive drugs and behavioral changes). Treatment adherence was assessed using ITAS adherence questionnaire after 3 months. Renal function at 3, 6, and 12 months, and the incidence of transplant rejection were evaluated. The non-adherence rates were 46.4 and 14.5 % in the control and treatment groups (p = 0.001), respectively. The relative risk for non-adherence was 2.59 times (CI 1.38-4.88) higher in the control group. Multivariate analysis demonstrated a 5.84 times (CI 1.8-18.8, p = 0.003) higher risk of non-adherence in the control group. There were no differences in renal function and rejection rates between groups. A behavioral and educational strategy addressing the patient's perceptions and knowledge about the anti-rejection drugs significantly improved the short-term adherence to immunosuppressive therapy.

  17. TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized trial.

    Science.gov (United States)

    Krofta, Ladislav; Feyereisl, Jaroslav; Otcenásek, Michal; Velebil, Petr; Kasíková, Eva; Krcmár, Michal

    2010-02-01

    A study was conducted to compare the efficacy and complications of TVT and TVT-O. This study is a prospective randomized trial involving 300 women with primary SUI; 149 received TVT, and 151 patients were treated with TVT-O. At the 1 year follow-up, 141 TVT patients and 147 TVT-O patients (dropout, 5.3% and 2.6%) were evaluated using urodynamic studies, validated questionnaires, and a 1-h pad test. The mean operating time was shorter in the TVT-O group (p 0.05). Inner thigh discomfort was reported by 5.4% of TVT-O patients. In the TVT and the TVT-O groups, respectively, 90.1% and 88.4% women were objectively cured. The satisfaction with the surgical outcome reflects the significant decrease in the questionnaire mean symptom scores in both groups. Postoperative de novo urgency was significantly more common in the TVT-O patients (p = 0.015). The groups showed comparable objective and subjective cure rates.

  18. Colon and rectal surgery for cancer without mechanical bowel preparation: one-center randomized prospective trial.

    Science.gov (United States)

    Scabini, Stefano; Rimini, Edoardo; Romairone, Emanuele; Scordamaglia, Renato; Damiani, Giampiero; Pertile, Davide; Ferrando, Valter

    2010-04-30

    Mechanical bowel preparation is routinely done before colon and rectal surgery, aimed at reducing the risk of postoperative infectious complications. The aim of the study was to assess whether elective colon and rectal surgery can be safely performed without preoperative mechanical bowel preparation. Patients undergoing elective colon and rectal resections with primary anastomosis were prospectively randomized into two groups. Group A had mechanical bowel preparation with polyethylene glycol before surgery, and group B had their surgery without preoperative mechanical bowel preparation. Patients were followed up for 30 days for wound, anastomotic, and intra-abdominal infectious complications. Two hundred forty four patients were included in the study, 120 in group A and 124 in group B. Demographic characteristics, type of surgical procedure and type of anastomosis did not significantly differ between the two groups. There was no difference in the rate of surgical infectious complications between the two groups but the overall infectious complications rate was 20.0% in group A and 11.3% in group B (p .05). Wound infection (p = 0.18), anastomotic leak (p = 0.52), and intra-abdominal abscess (p = 0.36) occurred in 9.2%, 5.8%, and 5.0% versus 4.8%, 4.0%, and 2.4%, respectively. No mechanical bowel preparation seems to be safe also in rectal surgery. These results suggest that elective colon and rectal surgery may be safely performed without mechanical preparation.

  19. [Ambulatory laparoscopic cholecystectomy by minilaparoscopy versus traditional multiport ambulatory laparoscopic cholecystectomy. Prospective randomized trial].

    Science.gov (United States)

    Planells Roig, Manuel; Arnal Bertomeu, Consuelo; Garcia Espinosa, Rafael; Cervera Delgado, Maria; Carrau Giner, Miguel

    2016-02-01

    Difference analysis of ambulatorization rate, pain, analgesic requirements and daily activities recovery in patients undergoing laparoscopic cholecystectomy with standard multiport access (CLMP) versus a minilaparoscopic, 3mm size, technique. Prospective randomized trial of 40 consecutive patients undergoing laparoscopic cholecystectomy. Comparison criteria included predictive ultrasound factors of difficult cholecystectomy, previous history of complicated biliary disease and demographics. Results are analyzed in terms of ambulatorization rate, pain, analgesic requirements, postoperative recovery, technical difficulty, hemorrhage intensity, overnight stay, readmission rate and total or partial conversion. Both procedures were similar in surgery time, technical score and hemorrhage score. MLC was associated with similar ambulatorization rate, 85%, and over-night stay 15%, with only 15% partial conversion rate. MLC showed less postoperative pain (P=.026), less analgesic consumption (P=.006) and similar DAR (P=.879). MLC is similar to CLMP in terms of ambulatorization with less postoperative pain and analgesic requirements without differences in postoperative recovery. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. Comparison of natural drainage group and negative drainage groups after total thyroidectomy: prospective randomized controlled study.

    Science.gov (United States)

    Woo, Seung Hoon; Kim, Jin Pyeong; Park, Jung Je; Shim, Hyun Seok; Lee, Sang Ha; Lee, Ho Joong; Won, Seong Jun; Son, Hee Young; Kim, Rock Bum; Son, Young-Ik

    2013-01-01

    The aim of this study was to compare a negative pressure drain with a natural drain in order to determine whether a negative pressure drainage tube causes an increase in the drainage volume. Sixty-two patients who underwent total thyroidectomy for papillary thyroid carcinoma (PTC) were enrolled in the study between March 2010 and August 2010 at Gyeongsang National University Hospital. The patients were prospectively and randomly assigned to two groups, a negative pressure drainage group (n=32) and natural drainage group (n=30). Every 3 hours, the volume of drainage was checked in the two groups until the tube was removed. The amount of drainage during the first 24 hours postoperatively was 41.68 ± 3.93 mL in the negative drain group and 25.3 ± 2.68 mL in the natural drain group (pdrain group was 35.19 ± 4.26 mL and natural drain groups 21.53 ± 2.90 mL (pdrain may increase the amount of drainage during the first 24-48 hours postoperatively. Therefore, it is not necessary to place a closed suction drain when only a total thyroidectomy is done.

  1. Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

    Science.gov (United States)

    Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

    2014-05-01

    To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total

  2. Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

    Science.gov (United States)

    Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

    2018-01-01

    Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0

  3. Treatment for non-thyroidal illness syndrome in advanced chronic kidney disease: a single-blind controlled study.

    Science.gov (United States)

    Yan, Wenjun; Wang, Lijuan; Huang, Tianlun; Xu, Gaosi

    2017-08-01

    Non-thyroidal illness syndrome (NTIS) is common among patients with advanced chronic kidney disease (CKD) and is strongly associated with poor prognosis. However, it remains unclear in how to correct this disorder and this study aimed to evaluate the effectiveness of sodium bicarbonate (SB) and N-acetyl-cysteine (NAC) for correcting NTIS status. Patients with CKD stage 3-4 were single-blind, placebo-controlled treated with placebo, SB, or NAC for 18 weeks. The primary end points were the correction of NTIS and the occurrence of end-stage renal disease (ESRD). The secondary point was the change in estimated glomerular filtration rate (eGFR) after the follow-up. The Kaplan-Meier survival analysis showed significant lower correcting ratio of NTIS in control group compared with SB group [Hazard ratio (HR) 0.19, 95 % confidence interval (CI) 0.04-0.89, p = 0.035] and NAC group (HR 0.09, 95 % CI 0.02-0.38, p = 0.001), and increased ESRD risk in control group than in SB group (HR 1.97, 95 % CI 1.02-3.84, p = 0.045) and NAC group (HR 5.50, 95 % CI 2.23-13.57, p < 0.001). The Cox regression analysis demonstrated significantly different effectiveness of placebo, SB and NAC on NTIS correction and ESRD risk, p < 0.05, respectively. Variance analysis displayed a greater reduction in eGFR in controls than in SB (p = 0.044) and NAC group (p < 0.001). SB and NAC are effective in promoting the recovery from NTIS status and delaying the deterioration of renal function in advanced CKD patients.

  4. Evaluation of homoeopathic treatment in polycystic ovary syndrome: A single-blind, randomised, placebo-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Chetna Deep Lamba

    2018-01-01

    Full Text Available Background and Objectives: This study was conducted with the primary objective of evaluating efficacy of Homoeopathy in establishing the menstrual regularity with improvement in either ultrasonological findings or hirsutism/acne. The quality of life was also assessed using polycystic ovary syndrome questionnaire (PCOSQ. Materials and Methods: A single-blind, randomised, placebo-controlled pilot study was conducted from February 2014 to May 2015 at two research centres. The cases fulfilling the eligibility criteria were enrolled (n = 60 and randomised to either the homoeopathic intervention (HI (n = 30 or identical placebo (P (n = 30 with uniform lifestyle modification (LSM for 6 months. Results: The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18 in HI + LSM group and none (n = 0 in control group (P = 0.001. Statistically significant difference (P = 0.016 was observed in reduction of intermenstrual duration (from 76.1 ± 37.7 to 46.6 ± 38.7 days in HI + LSM in comparison to placebo + LSM group (from 93.0 ± 65.2 to 93.9 ± 96.2 days. In PCOSQ, also, significant improvement was observed in HI group in domains of weight, fertility, emotions and menstrual problems (P < 0.05 with no difference in body hair (P = 0.708. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated medicine (n = 12, 40%. Conclusion: HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.

  5. Home-based step training using videogame technology in people with Parkinson's disease: a single-blinded randomised controlled trial.

    Science.gov (United States)

    Song, Jooeun; Paul, Serene S; Caetano, Maria Joana D; Smith, Stuart; Dibble, Leland E; Love, Rachelle; Schoene, Daniel; Menant, Jasmine C; Sherrington, Cathie; Lord, Stephen R; Canning, Colleen G; Allen, Natalie E

    2018-03-01

    To determine whether 12-week home-based exergame step training can improve stepping performance, gait and complementary physical and neuropsychological measures associated with falls in Parkinson's disease. A single-blinded randomised controlled trial. Community (experimental intervention), university laboratory (outcome measures). Sixty community-dwelling people with Parkinson's disease. Home-based step training using videogame technology. The primary outcomes were the choice stepping reaction time test and Functional Gait Assessment. Secondary outcomes included physical and neuropsychological measures associated with falls in Parkinson's disease, number of falls over six months and self-reported mobility and balance. Post intervention, there were no differences between the intervention ( n = 28) and control ( n = 25) groups in the primary or secondary outcomes except for the Timed Up and Go test, where there was a significant difference in favour of the control group ( P = 0.02). Intervention participants reported mobility improvement, whereas control participants reported mobility deterioration-between-group difference on an 11-point scale = 0.9 (95% confidence interval: -1.8 to -0.1, P = 0.03). Interaction effects between intervention and disease severity on physical function measures were observed ( P = 0.01 to P = 0.08) with seemingly positive effects for the low-severity group and potentially negative effects for the high-severity group. Overall, home-based exergame step training was not effective in improving the outcomes assessed. However, the improved physical function in the lower disease severity intervention participants as well as the self-reported improved mobility in the intervention group suggest home-based exergame step training may have benefits for some people with Parkinson's disease.

  6. Multicenter prospective randomized study comparing the technique of using a bovine pericardium biological prosthesis reinforcement in parietal herniorrhaphy (Tutomesh TUTOGEN) with simple parietal herniorrhaphy, in a potentially contaminated setting.

    Science.gov (United States)

    Nedelcu, Marius; Verhaeghe, Pierre; Skalli, Mehdi; Champault, Gerard; Barrat, Christophe; Sebbag, Hugues; Reche, Fabian; Passebois, Laurent; Beyrne, Daniel; Gugenheim, Jean; Berdah, Stephane; Bouayed, Amine; Michel Fabre, Jean; Nocca, David

    2016-03-01

    The use of parietal synthetic prosthetic reinforcement material in potentially contaminated settings is not recommended, as there is a risk that the prosthesis may become infected. Thus, simple parietal herniorrhaphy, is the conventional treatment, even though there is a significant risk that the hernia may recur. Using new biomaterials of animal origin presently appears to offer a new therapeutic solution, but their effectiveness has yet to be demonstrated. The purpose of this multicenter prospective randomized single-blind study was to compare the surgical treatment of inguinal hernia or abdominal incisional hernia by simple parietal herniorrhaphy without prosthetic reinforcement (Group A), with Tutomesh TUTOGEN biological prosthesis reinforcement parietal herniorrhaphy (Group B), in a potentially contaminated setting. We examined early postoperative complications in the first month after the operation, performed an assessment after one year of survival without recurrence and analyzed the quality of life and pain of the patients (using SF-12 health status questionnaire and Visual Analog Pain Scale) at 1, 6, and 12 months, together with an economic impact study. Hundred and thirty four patients were enrolled between January 2009 and October 2010 in 20 French hospitals. The groups were comparable with respect to their enrollment characteristics, their history, types of operative indications and procedures carried out. At one month post-op, the rate of infectious complications (n(A) = 11(18.33%) vs. n(B) = 12(19.05%), p = 0.919) was not significantly different between the two groups. The assessment after one year of survival without recurrence revealed that survival was significantly greater in Group B (Group A recurrence: 10, Group B: 3; p = 0.0475). No difference in the patients' quality of life was demonstrated at 1, 6, or 12 months. However, at the 1 month follow-up, the "perceived health" rating seemed better in the group with Tutomesh (p

  7. Comparative analysis of conventional and eversion carotid endarterectomy: Prospective randomized study

    Directory of Open Access Journals (Sweden)

    Marković Dragan M.

    2008-01-01

    Full Text Available INTRODUCTION Studies completed in the last decade of the 20th century showed benefits of carotid endarterectomy in the prevention of stroke in patients with a high-grade stenosis of the internal carotid artery. OBJECTIVE The aim of this prospective, randomized study was the comparison of early and long-term results between the conventional and eversion carotid endarterectomy, and literature review. METHOD By the method of random choice, 103 patients were operated on using the eversion carotid endarterectomy and 98 patients using the conventional technique. Operative treatment was carried out under general anaesthesia. Following the clammping of the carotid artery, retrograde blood pressure was determined by a direct puncture of the internal carotid artery above the stenotic lesions. In patients with retrograde pressure below 20 mm Hg intraluminal shunting was routinely performed. Early results were estimated (during the first seven postoperative days based on mortality, central neurological complications (stroke, TIA and cranial or cervical nerve lesions. Long-term results were estimated (after at least two years based on long-term survival rate, central neurological complications (stroke, TIA and the incidence of haemodynamically significant restenosis of the carotid artery treated by endarterectomy. RESULTS The average time of clamming of the internal carotid artery in the eversion carotid anderectomy group was 5.36 minutes shorter than in the group treated by the conventional technique. Student's t-test showed a statistically highly significant difference in the time needed for clamming of the internal carotid artery between the two groups. The average duration of eversion endarterectomy (82 minutes was most often 19 minutes shorter than the duration of the conventional endarterectomy (101 minutes. Student's t-test showed a statistically highly significant difference in the average length of surgeries. The distal intimal fixation was more

  8. Optimal scheme of postoperative chemoradiotherapy in rectal cancer: phase III prospective randomized trial

    International Nuclear Information System (INIS)

    Kim, Young Seok; Kim, Jong Hoon; Choi, Eun Kyung

    2002-01-01

    To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, patterns of failure, toxicities in early and late radiotherapy groups using a phase III randomized prospective clinical trial. From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm I)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU 375 mg/m 2 /day, leucovorin 20 mg/m 2 , IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were 78.3% and 68.7% in arm I, and 78.4% and 67.5% in arm II. The local recurrence rate was 6.6% and 6.4% (ρ = 0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms (23.8% and 29.5%, ρ = 0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in 63.0% and 58.2% of the respective arms (ρ = N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only 1.3% and 2.6% of patients in each respective arm. There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed

  9. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  10. A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors

    Directory of Open Access Journals (Sweden)

    Cinnamon S. Bloss

    2016-01-01

    Full Text Available Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers–some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program–making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large

  11. Early loading of plalatal implants (ortho-type II a prospective multicenter randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gedrange Tomasz

    2007-09-01

    Full Text Available Abstract Background In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage. Methods/Design The intended study is designed as a prospective, multicenter randomized controlled trial (RCT, comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland. 124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard, whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement. The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone

  12. Phase II prospective randomized trial of weight loss prior to radical prostatectomy.

    Science.gov (United States)

    Henning, Susanne M; Galet, Colette; Gollapudi, Kiran; Byrd, Joshua B; Liang, Pei; Li, Zhaoping; Grogan, Tristan; Elashoff, David; Magyar, Clara E; Said, Jonathan; Cohen, Pinchas; Aronson, William J

    2017-12-04

    Obesity is associated with poorly differentiated and advanced prostate cancer and increased mortality. In preclinical models, caloric restriction delays prostate cancer progression and prolongs survival. We sought to determine if weight loss (WL) in men with prostate cancer prior to radical prostatectomy affects tumor apoptosis and proliferation, and if WL effects other metabolic biomarkers. In this Phase II prospective trial, overweight and obese men scheduled for radical prostatectomy were randomized to a 5-8 week WL program consisting of standard structured energy-restricted meal plans (1200-1500 Kcal/day) and physical activity or to a control group. The primary endpoint was apoptotic index in the radical prostatectomy malignant epithelium. Secondary endpoints were proliferation (Ki67) in the radical prostatectomy tissue, body weight, body mass index (BMI), waist to hip ratio, body composition, and serum PSA, insulin, triglyceride, cholesterol, testosterone, estradiol, leptin, adiponectin, interleukin 6, interleukin 8, insulin-like growth factor 1, and IGF binding protein 1. In total 23 patients were randomized to the WL intervention and 21 patients to the control group. Subjects in the intervention group had significantly more weight loss (WL:-3.7 ± 0.5 kg; Control:-1.6 ± 0.5 kg; p = 0.007) than the control group and total fat mass was significantly reduced (WL:-2.1 ± 0.4; Control: 0.1 ± 0.3; p = 0.015). There was no significant difference in apoptotic or proliferation index between the groups. Among the other biomarkers, triglyceride, and insulin levels were significantly decreased in the WL compared with the control group. In summary, this short-term WL program prior to radical prostatectomy resulted in significantly more WL in the intervention vs. the control group and was accompanied by significant reductions in body fat mass, circulating triglycerides, and insulin. However, no significant changes were observed in malignant

  13. Computer-Assisted Training as a Complement in Rehabilitation of Patients With Chronic Vestibular Dizziness-A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Brandt, Michael Smærup; Gro¨nvall, Erik; Larsen, Simon B.

    2015-01-01

    Objective To compare a computer exercise program with conservative home-training following printed instructions in the rehabilitation of elderly patients with vestibular dysfunction. Design Single-blind, randomized, controlled trial. Setting Geriatric Department, Aarhus University Hospital...

  14. Treatment of lateral epicondilitis using three different local injection modalities: a randomized prospective clinical trial.

    Science.gov (United States)

    Dogramaci, Yunus; Kalaci, Aydiner; Savaş, Nazan; Duman, I Gokhan; Yanat, A Nedim

    2009-10-01

    To determine the effectiveness of three different local injection modalities in the treatment of lateral epicondilitis. In a prospective randomized study on lateral epicondilitis, 75 patients were divided into three equal groups A, B and C (n = 25) and were treated using three different method of local injection. The patients in group A were treated with local injection of a steroid (1 mL triamcinolone) combined with local anaesthetic (1 mL lidocaine), those in group B were treated with injection of local anaesthetic (1 mL lidocaine) combined with peppering technique and those in group C with local injection of a steroid (1 mL triamcinolone) combined with local anaesthetic (1 mL lidocaine) and peppering technique. The outcome was defined by measuring the elbow pain during the activity using a 10-cm visual analogue scale (VAS) and satisfaction with the treatment using a scoring system based on the criteria of the Verhaar et al. at 3 weeks and 6 months after the injection and compared with the pre-treatment condition. There were significant (P = 0.006) differences in the successful outcomes between the three groups at 6 months. In group C in which local steroid + peppering injection technique were used; excellent results were obtained in 84% of patients comparing to 36% and 48% for patients in groups A and B, respectively. The successful outcomes were statistically higher in group C comparing to group A (P = 0.002) and group B (P = 0.011). In all groups, there was a significantly lower pain (VAS) at the 3-week and 6-month follow-ups comparing to the pre-treatment condition. VAS measured at 6-month follow-up were significantly lower in group C comparing to other groups (P = 0.002). In the treatment of lateral epicondilitis, combination of corticosteroid injections with peppering is more effective than corticosteroid injections or peppering injections alone and produces better clinical results.

  15. A randomized prospective pilot trial of Web-delivered epilepsy stigma reduction communications in young adults.

    Science.gov (United States)

    Sajatovic, Martha; Herrmann, Lynn K; Van Doren, Jamie R; Tatsuoka, Curtis; Welter, Elisabeth; Perzynski, Adam T; Bukach, Ashley; Needham, Kelley; Liu, Hongyan; Berg, Anne T

    2017-11-01

    Epilepsy is a common neurological condition that is often associated with stigmatizing attitudes and negative stereotypes among the general public. This randomized controlled trial (RCT) tested two new communication approaches targeting epilepsy stigma versus an education-alone approach. Two brief stigma-reduction videos were developed, informed by community stakeholder input; one highlighted role competency in people with epilepsy; the other highlighted social inclusion of people with epilepsy. A control video was also developed. A Web-based survey using a prospective RCT design compared effects of experimental videos and control on acceptability, perceived impact, epilepsy knowledge, and epilepsy stigma. Epilepsy knowledge and stigma were measured with the Epilepsy Knowledge Questionnaire (EKQ) and Attitudes and Beliefs about Living with Epilepsy (ABLE), respectively. A total of 295 participants completed the study. Mean age was 23.1 (standard deviation = 3.27) years; 59.0% were male, and 71.4% were white. Overall, respondents felt videos impacted their epilepsy attitudes. EKQ scores were similar across videos, with a trend for higher knowledge in experimental videos versus control (p = 0.06). The role competency and control videos were associated with slightly better perceived impact on attitudes. There were no differences between videos on ABLE scores (p = 0.568). There were subgroup differences suggesting that men, younger individuals, whites, and those with personal epilepsy experience had more stigmatizing attitudes. This RCT tested communication strategies to improve knowledge and attitudes about epilepsy. Although this initial effort will require follow-up, we have demonstrated the acceptability, feasibility, and potential of novel communication strategies to target epilepsy stigma, and a Web-based approach for assessing them. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  16. Comparative evaluation of left ventricular mass regression after aortic valve replacement: a prospective randomized analysis

    Directory of Open Access Journals (Sweden)

    Kiessling Arndt H

    2011-10-01

    Full Text Available Abstract Background We assessed the hemodynamic performance of various prostheses and the clinical outcomes after aortic valve replacement, in different age groups. Methods One-hundred-and-twenty patients with isolated aortic valve stenosis were included in this prospective randomized randomised trial and allocated in three age-groups to receive either pulmonary autograft (PA, n = 20 or mechanical prosthesis (MP, Edwards Mira n = 20 in group 1 (age 75. Clinical outcomes and hemodynamic performance were evaluated at discharge, six months and one year. Results In group 1, patients with PA had significantly lower mean gradients than the MP (2.6 vs. 10.9 mmHg, p = 0.0005 with comparable left ventricular mass regression (LVMR. Morbidity included 1 stroke in the PA population and 1 gastrointestinal bleeding in the MP subgroup. In group 2, mean gradients did not differ significantly between both populations (7.0 vs. 8.9 mmHg, p = 0.81. The rate of LVMR and EF were comparable at 12 months; each group with one mortality. Morbidity included 1 stroke and 1 gastrointestinal bleeding in the stentless and 3 bleeding complications in the MP group. In group 3, mean gradients did not differ significantly (7.8 vs 6.5 mmHg, p = 0.06. Postoperative EF and LVMR were comparable. There were 3 deaths in the stented group and no mortality in the stentless group. Morbidity included 1 endocarditis and 1 stroke in the stentless compared to 1 endocarditis, 1 stroke and one pulmonary embolism in the stented group. Conclusions Clinical outcomes justify valve replacement with either valve substitute in the respective age groups. The PA hemodynamically outperformed the MPs. Stentless valves however, did not demonstrate significantly superior hemodynamics or outcomes in comparison to stented bioprosthesis or MPs.

  17. Prophylactic beclomethasone spray to the skin during postoperative radiotherapy of carcinoma breast: a prospective randomized study

    International Nuclear Information System (INIS)

    Shukla, P.N.; Gairola, M.; Mohanti, B.K.; Rath, G.K.

    2006-01-01

    Background and aims: Radiation induced wet desquamation of skin in carcinoma breast patients is a painful condition. In this study topical beclomethasone dipropionate spray was used as prophylaxis with the purpose of reducing risk of the wet desquamation of skin in irradiated field. Materials and methods: sixty patients of carcinoma breast were planned for postoperative loco regional radiotherapy (50 Gy in 25 fraction over five weeks) were prospectively randomized into two groups (1) steroid group-patients were advised to use beclomethasone dipropionate spray in irradiated axilla from day one of radiotherapy, (2) control group-patients were not allowed to use any topical agent in irradiated area. Radiation induced skin reaction was noted in terms of erythema, dry desquamation and wet desquamation weekly till end of prescribed 50Gy dose of the radiation therapy. Statistical method: Chi-square test was used to see the statistical significance of the difference in wet desquamation between two arms of the study. Chi-square value and P-value was calculated for the difference of wet desquamation in two study arms. Result: In steroid group 4/30 (13.33%) patients developed wet desquamation of the axillary skin at the end of the radiotherapy. For the control group, this figure was 11/30 (36.66%). The difference in wet desquamation of the axillary skin in the two groups was statistically significant (P-value=0.0369). Conclusion: Topical steroid (beclomethasone dipropionate spray) for skin during radiotherapy significantly reduces the risk of wet desquamation of the skin. (author)

  18. Prospective randomized comparison of mitomycin C application in endoscopic and external dacryocystorhinostomy.

    Science.gov (United States)

    Mudhol, Rekha R; Zingade, N D; Mudhol, R S; Harugop, Anil S; Das, Amal T

    2013-08-01

    The aim of the study is to compare the subjective (relief of symptoms) and objective (endoscopic visualization of ostium patency at the time of syringing) outcomes at the end of two procedures-Endonasal DCR versus External DCR with Mitomycin C and to assess the role of Mitomycin C in maintaining patency of nasolacrimal drainage system. Prospective randomized comparative study was performed. Thirty-five patients were enrolled in each endoscopic and external dacryocystorhinostomy groups with Mitomycin C (MMC) application. The 37 eyes underwent endonasal DCR (28 unilateral primary eyes + 1 bilateral primary eyes + 5 unilateral revision eyes + 1 bilateral revision eye) while 35 eyes underwent external DCR (34 unilateral primary eyes + 1 unilateral revision eye). Mitomycin C 0.2 mg/ml was applied intra-operatively for 5 min to the ostium site at the end of endonasal or external DCR procedure. Objective assessment by syringing at the end of 1 year in the endonasal group showed 35 eyes (94%) were patent, 1 (3%) was partially blocked and 1(3%) was completely blocked; while in external group all 35 eyes (100%) were patent. Endoscopic visualization of the ostium at the time of syringing showed only one eye (3%) in the endonasal group was blocked while all the other eyes in both groups were patent. Both groups had a mean follow-up of 6-36 months. No complications were associated with use of Mitomycin C. In conclusion, intra-operative use of Mitomycin C in both endoscopic DCR and external DCR is safe and effective in increasing the success rate.

  19. Partial splenic embolization using polyvinyl alcohol particles for hypersplenism in cirrhosis: A prospective randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Zhu Kangshun [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: zhksh010@163.com; Meng Xiaochun [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: mengxiaochun1972@163.com; Li Zhengran [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: andyreede@21cn.com; Huang Mingsheng [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: laom502@tom.com; Guan Shouhai [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: guanshouhai@163.com; Jiang Zaibo [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: jiangzaibo@yahoo.com.cn; Shan Hong [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: gzshsums@public.guangzhou.gd.cn

    2008-04-15

    Purpose: To prospectively evaluate the efficacy and safety of partial splenic embolization (PSE) using polyvinyl alcohol (PVA) particles for hypersplenism in cirrhosis, as compared to PSE using gelfoam particles. Materials and methods: PSE was performed in 60 consecutive patients with hypersplenism caused by cirrhosis. The patients were randomly assigned into 2 groups: gelfoam group, 32 patients received PSE using gelfoam particles as the embolic material; PVA group, 28 patients received PSE using PVA particles. The follow-up contents included peripheral blood cell counts (leukocyte, platelet and red blood cell) and complications associated with PSE. Results: Prior to PSE, there was no significant difference between the two groups in sex, age, Child-Pugh grade, the extent of embolization and peripheral blood cell counts. After PSE, no matter in which group, leukocyte and platelet counts kept significantly higher than pre-PSE during the 3-year follow-up period (P < .0001), but the post-PSE improvement of leukocyte and platelet counts was significantly better in PVA group than in gelfoam group (P < .05). Red blood cell counts showed no remarkable changes after PSE (P > .05). Severe complications occurred in 8 patients (25.0%) in gelfoam group and 6 patients (21.4%) in PVA group (P > .05), but the degree of abdominal pain was higher in the latter than in the former (P < .05). Among 17 patients who received more than 70% embolization of spleen, 10 (58.8%) developed severe complications, while among 43 patients who received 70% or less embolization of spleen, only four (9.3%) had severe complications. This difference was statistically significant (P < .05). Conclusion: PVA particles could be used as the embolic material in PSE; in comparison with PSE using gelfoam particles, PSE using PVA particles can achieve even better efficacy in alleviating hypersplenism, but the extent of embolization should be strictly limited to not more than 70% of splenic volume.

  20. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Christos Asteriou

    2016-01-01

    Full Text Available Background: Postoperative morbidity and inhospital length of stay are considered major determinants of total health care expenditure associated with thoracic operations. The aim of this study was to prospectively evaluate the role of video-assisted thoracic surgery (VATS compared to mini-muscle-sparing thoracotomy in facilitating early recovery and hospital discharge after pulmonary sublobar wedge resections. Patients and Methods: A total number of 120 patients undergoing elective pulmonary sublobar wedge resection were randomly assigned to VATS (n = 60 or mini-muscle-sparing thoracotomy (n = 60. The primary endpoint was time to hospital discharge. Postoperative complications, cardiopulmonary morbidity and 30-day mortality served as secondary endpoints. Results: Patients' baseline demographic and clinical data did not differ among study arms as well as the number of pulmonary segments resected and the morphology of the nodular lesions. Total hospital stay was significantly shorter in patients assigned to the thoracoscopic technique as opposed to those who were operated using the mini-muscle-sparing thoracotomy approach (4 ± 0.6 versus 4.4 ± 0.6 days respectively, P = 0.006. Multivariate analysis revealed that VATS approach was inversely associated with longer inhospital stay whereas the number of resected segments was positively associated with an increased duration of hospitalization. Patients in the VATS group were less likely to develop atelectasis (≥1 lobe compared to those who underwent thoracotomy (0% versus 6.7% respectively, P = 0.042. Kaplan-Meier analysis revealed similar 30-day mortality rates in both study arms (Log-rank P = 0.560. Conclusion: VATS was associated with shorter duration of hospitalization positively affecting the patients' quality of life and satisfaction. Significant suppression of the total cost of recovery after thoracoscopic pulmonary resections is expected.

  1. Influence of Gender on the Performance of Cardiopulmonary Rescue Teams: A Randomized, Prospective Simulator Study.

    Science.gov (United States)

    Amacher, Simon Adrian; Schumacher, Cleo; Legeret, Corinne; Tschan, Franziska; Semmer, Norbert Karl; Marsch, Stephan; Hunziker, Sabina

    2017-07-01

    Little is known about the influence of gender on resuscitation performance which may improve future education in resuscitation. The aim of this study was to compare female and male rescuers in regard to cardiopulmonary resuscitation and leadership performance. Prospective, randomized simulator study. High-fidelity patient simulator center of the medical ICU, University Hospitals Basel (Switzerland). Two hundred sixteen volunteer medical students (108 females and 108 males) of two Swiss universities in teams of three. None. We analyzed data on the group and the individual level separately. The primary outcome on the group level was the hands-on time within the first 180 seconds after the onset of the cardiac arrest. Compared with male-only teams, female-only teams showed less hands-on time (mean ± SD) (87 ± 41 vs 109 ± 33 s; p = 0.037) and a longer delay before the start of chest compressions (109 ± 77 vs 70 ± 56 s; p = 0.038). Additionally, female-only teams showed a lower leadership performance in different domains and fewer unsolicited cardiopulmonary resuscitation measures compared with male-only teams. On the individual level, which was assessed in mixed teams only, female gender was associated with a lower number of secure leadership statements (3 ± 2 vs 5 ± 3; p = 0.027). Results were confirmed in regression analysis adjusted for team composition. We found important gender differences, with female rescuers showing inferior cardiopulmonary resuscitation performance, which can partially be explained by fewer unsolicited cardiopulmonary resuscitation measures and inferior female leadership. Future education of rescuers should take gender differences into account.

  2. Prospective, randomized comparative study between single-port laparoscopic appendectomy and conventional laparoscopic appendectomy.

    Science.gov (United States)

    Villalobos Mori, Rafael; Escoll Rufino, Jordi; Herrerías González, Fernando; Mias Carballal, M Carmen; Escartin Arias, Alfredo; Olsina Kissler, Jorge Juan

    2014-01-01

    Laparoscopic appendectomy is probably the technique of choice in acute appendicitis. Single port laparoscopic surgery (SILS) has been proposed as an alternative technique. The objective of this study is to compare the safety and efficacy of SILS against conventional laparoscopic appendectomy (LA). From January 2011 to September 2012, 120 patients with acute appendicitis were prospectively randomized; 60 for SILS and 60 for LA. Patients between 15 to 65 years were selected, with onset of symptoms less than 48h. We compared BMI, surgery time, start of oral intake, hospital stay, postoperative pain, pathology and costs. The median age, BMI, sex and time of onset of symptoms to diagnosis were similar. There were no statistically significant differences in the operative time, start of oral intake or hospital stay. There was a significant difference in postoperative pain being higher in SILS (4±1.3) than in LA (3.3±0.5) with a P=.004. Flemonous appendicitis predominated in both groups in a similar percentage. A total of 3 cases with intra-abdominal abscess (SILS 2, LA 1) required readmission and resolved spontaneously with intravenous antibiotic treatment. One case of SILS required assistance by a 5mm trocar in the RLC for drainage placement. The cost was higher in SILS due the single port device. SILS appendectomy is safe, effective and has similar results to LA in selected patients, and although the cost is greater, the long term results will determine the future of this technique. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

  3. Next-generation narrow band imaging system for colonic polyp detection: a prospective multicenter randomized trial.

    Science.gov (United States)

    Horimatsu, Takahiro; Sano, Yasushi; Tanaka, Shinji; Kawamura, Takuji; Saito, Shoichi; Iwatate, Mineo; Oka, Shiro; Uno, Koji; Yoshimura, Kenichi; Ishikawa, Hideki; Muto, Manabu; Tajiri, Hisao

    2015-07-01

    Previous studies have yielded conflicting results on the colonic polyp detection rate with narrow-band imaging (NBI) compared with white-light imaging (WLI). We compared the mean number of colonic polyps detected per patient for NBI versus WLI using a next-generation NBI system (EVIS LUCERA ELITE; Olympus Medical Systems) used with standard-definition (SD) colonoscopy and wide-angle (WA) colonoscopy. this study is a 2 × 2 factorial, prospective, multicenter randomized controlled trial. this study was conducted at five academic centers in Japan. patients were allocated to one of four groups: (1) WLI with SD colonoscopy (H260AZI), (2) NBI with SD colonoscopy (H260AZI), (3) WLI with WA colonoscopy (CF-HQ290), and (4) NBI with WA colonoscopy (CF-HQ290). the mean numbers of polyps detected per patient were compared between the four groups: WLI with/without WA colonoscopy and NBI with/without WA colonoscopy. Of the 454 patients recruited, 431 patients were enrolled. The total numbers of polyps detected by WLI with SD, NBI with SD, WLI with WA, and NBI with WA were 164, 176, 188, and 241, respectively. The mean number of polyps detected per patient was significantly higher in the NBI group than in the WLI group (2.01 vs 1.56; P = 0.032). The rate was not higher in the WA group than in the SD group (1.97 vs 1.61; P = 0.089). Although WA colonoscopy did not improve the polyp detection, next-generation NBI colonoscopy represents a significant improvement in the detection of colonic polyps.

  4. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial.

    Science.gov (United States)

    Angioli, Roberto; De Cicco Nardone, Carlo; Plotti, Francesco; Cafà, Ester Valentina; Dugo, Nella; Damiani, Patrizio; Ricciardi, Roberto; Linciano, Francesca; Terranova, Corrado

    2014-01-01

    To investigate the effects of music on anxiety and perception of pain during office hysteroscopy. Prospective randomized trial (Canadian Task Force classification I). Major university medical center. Three hundred fifty-six patients were enrolled between July 2012 and January 2013. Hysteroscopy was performed in a dedicated ambulatory room, using vaginoscopy and without any type of anesthesia. A Bettocchi hysteroscope 5 mm in diameter was used. All procedures were performed by the same surgeon, a gynecologist with special interest in hysteroscopy. Data collected included age, body mass index, number of vaginal deliveries, educational achievement level, and history of endometrial surgery (curettage and/or hysteroscopy). For each patient, vital parameters such as blood pressure, heart rate, and respiratory rate were recorded 15 minutes before the procedure and during hysteroscopy after traversing the cervix. Wait time before surgery and the duration of the procedure were also recorded. A completed Italian version of the state anxiety questionnaire (State-Trait Anxiety Inventory) and a visual analog scale (VAS) were administered to each patient before and after the procedure. The t test and Mann-Whitney U test was used when appropriate to compare the 2 groups. Statistical significance was accepted at p = .05. During surgery, systolic blood pressure and heart rate were significantly lower in the music group compared with the no music group. Women in the music group experienced significantly lower anxiety after hysteroscopy and less pain during the procedure, and a significant decrease in both anxiety and pain scores after hysteroscopy. Postoperative State-Trait Anxiety Inventory form Y1 and VAS scores were significantly lower in the music group. Music can be useful as a complementary method to control anxiety and reduce perception of pain. The patient is more relaxed and experiences less discomfort. Copyright © 2014. Published by Elsevier Inc.

  5. EFFECTIVENESS OF MUSCLE STRETCHING IN OCCUPATION RELATED CHRONIC MECHANICAL LOW BACK PAIN IN COMMUNITY NURSES –A SINGLE BLIND STUDY

    OpenAIRE

    Khwairakpam Zhimina Devi; Sai Kumar. N; Vinod Babu. K; V.R. Ayyappan

    2014-01-01

    Background and Objective: Stretching of Lower Back Muscle, Hamstring and Tensor Fasciae Latae have an immediate effect on Chronic Lower Back Pain. Hence the purpose is to find the short term effect of stretching of Lower Back Muscle, Hamstring and Tensor Fasciae Latae on intensity of low back pain, flexibility and functional disability in occupation related Chronic Mechanical Low Back Pain in Community Nurses. Method: Single blind experimental study design, 40 subjects with Chronic mechani...

  6. A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

    OpenAIRE

    Stefan Landgraeber; Henning Quitmann; Sebastian Güth; Marcel Haversath; Wojciech Kowalczyk; Andrés Kecskeméthy; Hansjörg Heep; Marcus Jäger

    2013-01-01

    There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and ...

  7. Influence of the pneumatic tourniquet on patella tracking in total knee arthroplasty: a prospective randomized study in 100 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Toftgaard Jensen, T

    2005-01-01

    One hundred consecutive patients with osteoarthritis of the knee joint and scheduled for primary total knee arthroplasty performed in a bloodless field were prospectively randomized to have the tourniquet inflated on either straight leg or maximally flexed knee. There was no difference in the num...... deflation led to better patella tracking and saved 5 (31%) of 16 releases with no difference between groups. We recommend tourniquet deflation and reevaluation of patella tracking before performing lateral release in patellar maltracking....

  8. Ketamine as an Adjunct to Postoperative Pain Management in Opioid Tolerant Patients After Spinal Fusions: A Prospective Randomized Trial

    OpenAIRE

    Urban, Michael K.; Ya Deau, Jacques T.; Wukovits, Barbara; Lipnitsky, Jane Y.

    2007-01-01

    Management of acute postoperative pain is challenging, particularly in patients with preexisting narcotic dependency. Ketamine has been used at subanesthetic doses as a N-methyl d-aspartate (NMDA) receptor antagonist to block the processing of nociceptive input in chronic pain syndromes. This prospective randomized study was designed to assess the use of ketamine as an adjunct to acute pain management in narcotic tolerant patients after spinal fusions. Twenty-six patients for 1–2 level poster...

  9. Tissue welding tonsillectomy provides an enhanced recovery compared to that after monopolar electrocautery technique in adults: a prospective randomized clinical trial.

    Science.gov (United States)

    Silvola, Juha; Salonen, Aarre; Nieminen, Jouko; Kokki, Hannu

    2011-02-01

    We have compared tonsillectomy (TE) with tissue welding (TW) technology using a specially designed forceps versus conventional monopolar electrocautery to evaluate whether this new technology may improve recovery after TE. This was a single-blind, randomized clinical trial with two parallel groups. Sixty healthy adult day-surgery patients were allocated into the TW-TE group (n = 31) and the monopolar electrocautery-TE group (n = 29). We recorded intraoperative events and short- and long-term recovery for 2 weeks postoperatively. The patients and study nurses evaluating patients during recovery were blinded to the operation method used. All patients in the TW-TE group completed the study as per protocol, but in the monopolar electrocautery-TE group, there was one drop-out in the hospital and another after discharge. There was no difference in the perioperative parameters and early recovery between the two groups. After discharge, recovery was significantly faster in the TW group than in the monopolar group: (1) the duration of postoperative pain was 2 days shorter, and (2) activities of normal daily living were less affected, and (3) the need for hospital contacts after discharge, and (4) the incidence of postoperative bleeding was less in the TW group than that in the monopolar group. No patients in the TW group developed secondary bleeding versus three patients in the monopolar group requiring electrocautery to control bleeding. In conclusion; our results indicate that, TW technique may provide reduced pain, faster recovery, and fewer complications compared to electrocautery TE.

  10. Photorefractive keratectomy versus laser in situ keratomileusis for moderate to high myopia. A randomized prospective study.

    Science.gov (United States)

    Hersh, P S; Brint, S F; Maloney, R K; Durrie, D S; Gordon, M; Michelson, M A; Thompson, V M; Berkeley, R B; Schein, O D; Steinert, R F

    1998-08-01

    This report presents the results of a randomized clinical trial of photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). A randomized, prospective multicenter clinical trial. A total of 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. The mean preoperative manifest refraction spherical equivalent was -9.23 diopters (D) in the PRK group and -9.30 D in the LASIK group. All patients received a one-pass, multizone excimer laser ablation as part of either a PRK or LASIK procedure using the Summit Apex excimer laser. Attempted corrections ranged from 6.00 to 15.00 D. Data on uncorrected and spectacle-corrected visual acuity, predictability,and stability of refraction, corneal haze, and flap complications were analyzed. Patients were observed for up to 6 months. One day after surgery, 0 (0.0%) and 3 (4.5%) eyes in the PRK group saw 20/20 and 20/40 or better uncorrected, respectively, while 7 (10%) and 48 (68.6%) eyes in the LASIK group saw 20/20 and 20/40 or better, respectively. At 6 months after PRK, 13 (19.1%) and 45 (66.2%) eyes saw 20/20 and 20/40 or better, respectively, while after LASIK, 16 (26.2%) and 34 (55.7%) eyes saw 20/20 and 20/40 or better, respectively (odds ratio = 0.56 for likelihood of uncorrected visual acuity PRK vs. LASIK, 95% confidence interval [CI] = 0.31-1.19). After PRK, 39 eyes (57.4%) were within 1.0 D of attempted correction compared with 24 eyes (40.7%) in the LASIK group (odds ratio = 0.50 for likelihood fo undercorrection 1.0 D for PRK vs. LASIK, 95% CI = 0.24-1.04); however, the standard deviation of the predictability was similar between groups: 1.01 D for PRK and 1.22 D for LASIK. From months 1 to 6, there was an average regression of 0.89 D in the PRK group and 0.55 D in the LASIK group. After PRK, eight eyes (11.8%) had a decrease in spectacle-corrected visual acuity of two Snellen lines or more; after LASIK, two eyes (3.2%) had a decrease of two lines or more

  11. Soothing and anti-itch effect of quercetin phytosome in human subjects: a single-blind study

    Directory of Open Access Journals (Sweden)

    Maramaldi G

    2016-02-01

    Full Text Available Giada Maramaldi,1 Stefano Togni,1 Ivan Pagin,1 Luca Giacomelli,2 Roberta Cattaneo,3 Roberto Eggenhöffner,2 Samuele E Burastero4 1Indena S.p.A, Milan, 2Department of Surgical Sciences and Integrated Diagnostics, School of Medicine, Genova University, Genoa, 3Abich Srl, Verbania, 4San Raffaele Scientific Institute, Milan, ItalyBackground: We evaluated the ability of quercetin, a natural antioxidant formulated in a specific delivery system, to reduce skin inflammation induced by a variety of stimuli, including UV radiation, stimulation with a histamine solution, or contact with chemical irritants. In particular, we tested the soothing and anti-itch effect of Quercevita®, 1% cream for external use, a formulation characterized by a phospholipids-based delivery system.Patients and methods: The study was a monocentric, single blind trial that enrolled a group of 30 healthy volunteers. The back of each subject was examined to identify four quadrants with no previous skin damage or naevi that were treated in order to induce a controlled and reversible form of skin stress. The areas were treated as follows: no product; Quercevita® 1% cream, 2 mg/cm2; placebo; positive control (a commercially available topical formulation containing 1% dexchlorpheniramine.Results: Only quercetin phospholipids 1% and dexchlorpheniramine 1% achieved a significant reduction in erythema with comparable results: (–10.05% [P=0.00329] for quercetin phospholipids 1% vs –14.05% [P=0.00046] for the positive control. Moreover, quercetin phospholipids 1% and dexchlorpheniramine 1% were both associated with a significant decrease in mean wheal diameter: (–13.25% and –12.23% for dexchlorpheniramine 1%, respectively. Similar findings were reported for the other tested parameters.Conclusion: Quercetin has a skin protective effect against damage caused by a variety of insults, including UV radiation, histamine, or contact with toxic chemical compounds. Indeed, quercetin is able

  12. Comparative prospective randomized trial: laparoscopic versus open common bile duct exploration

    Directory of Open Access Journals (Sweden)

    Vladimir Grubnik

    2011-06-01

    Full Text Available Introduction: Single-stage laparoscopic procedures for common bile duct (CBD stones are an alternative treatmentoption to two-stage endo-laparoscopic treatment and to open choledocholithotomy. Several reports have demonstratedthe feasibility, safety, efficiency and cost-effectiveness of laparoscopic techniques.Aim: To analyse the safety and benefits of laparoscopic compared to open common bile duct (CBD exploration.Material and methods: The prospective randomized trial included a total of 256 patients with CBD stones operated from2005 to 2009 in a single centre. The male/female ratio was 82/174, with a median age 62.3 ±5.8 years (range 27 to 87years. There were two groups of patients. Group I: laparoscopic CBD exploration (138 patients. Group II: open CBD exploration(118 patients. Patient comorbidity was assessed by means of the American Society of Anesthesiologists (ASA classification;ASA II – 109 patients, ASA III – 59 patients. Bile duct stones were visualized preoperatively by means of US examinationin 129 patients, by means of ERCP in 26 patients, and by magnetic resonance cholangiopancreatography (MRCPin 72 patients. Preoperative evaluation was done through medical history, biochemical tests and ultrasonography.Results: The mean duration of laparoscopic procedures was 82 min (range 40-160 min. The mean duration of openprocedures was 90 min (range 60-150 min. Mean blood loss was much lower in the laparoscopic group than in theopen group (20 ±2 v.s 285 ±27, p < 0.01. Postoperative complications were observed in 7 patients of the laparoscopicgroup and in 15 patients in the open group (p < 0.01. Laparoscopic common bile duct exploration was performedthrough a trans-cystic approach in 76 patients and via choledochotomy in 62 patients. The transcystic approach wassuccessful in 76 patients (74.5%. External drainage was used in 25 (32.8% patients with the transcystic approach.Conclusions: Laparoscopic CBD exploration can be performed with

  13. Multidisciplinary intervention reducing readmissions in medical inpatients: a prospective, non-randomized study

    Directory of Open Access Journals (Sweden)

    Torisson G

    2013-09-01

    Full Text Available Gustav Torisson,1 Lennart Minthon,1 Lars Stavenow,2 Elisabet Londos1 1Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, 2Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden Background: The purpose of this study was to examine whether a multidisciplinary intervention targeting drug-related problems, cognitive impairment, and discharge miscommunication could reduce readmissions in a general hospital population. Methods: This prospective, non-randomized intervention study was carried out at the department of general internal medicine at a tertiary university hospital. Two hundred medical inpatients living in the community and aged over 60 years were included. Ninety-nine patients received interventions and 101 received standard care. Control/intervention allocation was determined by geographic selection. Interventions consisted of a comprehensive medication review, improved discharge planning, post-discharge telephone follow-up, and liaison with the patient's general practitioner. The main outcome measures recorded were readmissions and hospital nights 12 months after discharge. Separate analyses were made for 12-month survivors and from an intention-to-treat perspective. Comparative analyses were made between groups as well as within groups over time. Results: After 12 months, survivors in the control group had 125 readmissions in total, compared with 58 in the intervention group (Mann–Whitney U test, P = 0.02. For hospital nights, the numbers were 1,228 and 492, respectively (P = 0.009. Yearly admissions had increased from the previous year in the control group from 77 to 125 (Wilcoxon signed-rank test, P = 0.002 and decreased from 75 to 58 in the intervention group (P = 0.25. From the intention-to-treat perspective, the same general pattern was observed but was not significant (1,827 versus 1,008 hospital nights, Mann–Whitney test, P = 0.054. Conclusion: A multidisciplinary approach

  14. Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

    Science.gov (United States)

    Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

    2012-04-01

    The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

  15. Intrathecal pressure monitoring and cerebrospinal fluid drainage in acute spinal cord injury: a prospective randomized trial.

    Science.gov (United States)

    Kwon, Brian K; Curt, Armin; Belanger, Lise M; Bernardo, Arlene; Chan, Donna; Markez, John A; Gorelik, Stephen; Slobogean, Gerard P; Umedaly, Hamed; Giffin, Mitch; Nikolakis, Michael A; Street, John; Boyd, Michael C; Paquette, Scott; Fisher, Charles G; Dvorak, Marcel F

    2009-03-01

    Ischemia is an important factor in the pathophysiology of secondary damage after traumatic spinal cord injury (SCI) and, in the setting of thoracoabdominal aortic aneurysm repair, can be the primary cause of paralysis. Lowering the intrathecal pressure (ITP) by draining CSF is routinely done in thoracoabdominal aortic aneurysm surgery but has not been evaluated in the setting of acute traumatic SCI. Additionally, while much attention is directed toward maintaining an adequate mean arterial blood pressure (MABP) in the acute postinjury phase, little is known about what is happening to the ITP during this period when spinal cord perfusion pressure (MABP - ITP) is important. The objectives of this study were to: 1) evaluate the safety and feasibility of draining CSF to lower ITP after acute traumatic SCI; 2) evaluate changes in ITP before and after surgical decompression; and 3) measure neurological recovery in relation to the drainage of CSF. Twenty-two patients seen within 48 hours of injury were prospectively randomized to a drainage or no-drainage treatment group. In all cases a lumbar intrathecal catheter was inserted for 72 hours. Acute complications of headache/nausea/vomiting, meningitis, or neurological deterioration were carefully monitored. Acute Spinal Cord Injury motor scores were documented at baseline and at 6 months postinjury. On insertion of the catheter, mean ITP was 13.8 +/- 1.3 mm Hg (+/- SD), and it increased to a mean peak of 21.7 +/- 1.5 mm Hg intraoperatively. The difference between the starting ITP on catheter insertion and the observed peak intrathecal pressure after decompression was, on average, an increase of 7.9 +/- 1.6 mm Hg (p drainage group was 30.6 +/- 2.3 mm Hg, which was significantly higher than the peak intraoperative ITP (p = 0.0098). During the same period, the peak recorded ITP in patients randomized to receive drainage was 28.1 +/- 2.8 mm Hg, which was not statistically higher than the peak intraoperative ITP (p = 0.15). The

  16. Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer : Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

    NARCIS (Netherlands)

    Khankari, Nikhil K.; Shu, Xiao Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Eeles, Rosalind A.; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei; Blalock, Kendra; Campbell, Peter T.; Casey, Graham; Conti, David V.; Edlund, Christopher K.; Figueiredo, Jane; James Gauderman, W.; Gong, Jian; Green, Roger C.; Harju, John F.; Harrison, Tabitha A.; Jacobs, Eric J.; Jenkins, Mark A.; Jiao, Shuo; Li, Li; Lin, Yi; Manion, Frank J.; Moreno, Victor; Mukherjee, Bhramar; Raskin, Leon; Schumacher, Fredrick R.; Seminara, Daniela; Severi, Gianluca; Stenzel, Stephanie L.; Thomas, Duncan C.; Hopper, John L.; Southey, Melissa C.; Makalic, Enes; Schmidt, Daniel F.; Fletcher, Olivia; Peto, Julian; Gibson, Lorna; dos Santos Silva, Isabel; Ahsan, Habib; Whittemore, Alice; Waisfisz, Quinten; Meijers-Heijboer, Hanne; Adank, Muriel; van der Luijt, Rob B.; Uitterlinden, Andre G.; Hofman, Albert; Meindl, Alfons; Schmutzler, Rita K.; Müller-Myhsok, Bertram; Lichtner, Peter; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Chang-Claude, Jenny; Hein, Rebecca; Dahmen, Norbert; Beckman, Lars; Crisponi, Laura; Hall, Per; Czene, Kamila; Irwanto, Astrid; Liu, Jianjun; Easton, Douglas F.; Turnbull, Clare; Rahman, Nazneen; Eeles, Rosalind; Kote-Jarai, Zsofia; Muir, Kenneth; Giles, Graham; Neal, David; Donovan, Jenny L.; Hamdy, Freddie C.; Wiklund, Fredrik; Gronberg, Henrik; Haiman, Christopher; Schumacher, Fred; Travis, Ruth; Riboli, Elio; Hunter, David; Gapstur, Susan; Berndt, Sonja; Chanock, Stephen; Han, Younghun; Su, Li; Wei, Yongyue; Hung, Rayjean J.; Brhane, Yonathan; McLaughlin, John; Brennan, Paul; McKay, James D.; Rosenberger, Albert; Houlston, Richard S.; Caporaso, Neil; Teresa Landi, Maria; Heinrich, Joachim; Wu, Xifeng; Ye, Yuanqing; Christiani, David C.

    2016-01-01

    Background: Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using

  17. Cognitive behavioural therapy with optional graded exercise therapy in patients with severe fatigue with myotonic dystrophy type 1: a multicentre, single-blind, randomised trial.

    Science.gov (United States)

    Okkersen, Kees; Jimenez-Moreno, Cecilia; Wenninger, Stephan; Daidj, Ferroudja; Glennon, Jeffrey; Cumming, Sarah; Littleford, Roberta; Monckton, Darren G; Lochmüller, Hanns; Catt, Michael; Faber, Catharina G; Hapca, Adrian; Donnan, Peter T; Gorman, Gráinne; Bassez, Guillaume; Schoser, Benedikt; Knoop, Hans; Treweek, Shaun; van Engelen, Baziel G M

    2018-06-18

    Myotonic dystrophy type 1 is the most common form of muscular dystrophy in adults and leads to severe fatigue, substantial physical functional impairment, and restricted social participation. In this study, we aimed to determine whether cognitive behavioural therapy optionally combined with graded exercise compared with standard care alone improved the health status of patients with myotonic dystrophy type 1. We did a multicentre, single-blind, randomised trial, at four neuromuscular referral centres with experience in treating patients with myotonic dystrophy type 1 located in Paris (France), Munich (Germany), Nijmegen (Netherlands), and Newcastle (UK). Eligible participants were patients aged 18 years and older with a confirmed genetic diagnosis of myotonic dystrophy type 1, who were severely fatigued (ie, a score of ≥35 on the checklist-individual strength, subscale fatigue). We randomly assigned participants (1:1) to either cognitive behavioural therapy plus standard care and optional graded exercise or standard care alone. Randomisation was done via a central web-based system, stratified by study site. Cognitive behavioural therapy focused on addressing reduced patient initiative, increasing physical activity, optimising social interaction, regulating sleep-wake patterns, coping with pain, and addressing beliefs about fatigue and myotonic dystrophy type 1. Cognitive behavioural therapy was delivered over a 10-month period in 10-14 sessions. A graded exercise module could be added to cognitive behavioural therapy in Nijmegen and Newcastle. The primary outcome was the 10-month change from baseline in scores on the DM1-Activ-c scale, a measure of capacity for activity and social participation (score range 0-100). Statistical analysis of the primary outcome included all participants for whom data were available, using mixed-effects linear regression models with baseline scores as a covariate. Safety data were presented as descriptives. This trial is registered

  18. A randomized, prospective cross-over trial comparing methylene blue-directed biopsy and conventional random biopsy for detecting intestinal metaplasia and dysplasia in Barrett's esophagus.

    Science.gov (United States)

    Ragunath, K; Krasner, N; Raman, V S; Haqqani, M T; Cheung, W Y

    2003-12-01

    The value of methylene blue-directed biopsies (MBDB) in detecting specialized intestinal metaplasia and dysplasia in Barrett's esophagus remains unclear. The aim of this study was to compare the accuracy of MBDB with random biopsy in detecting intestinal metaplasia and dysplasia in patients with Barrett's esophagus. A prospective, randomized, cross-over trial was undertaken to compare MBDB with random biopsy in patients with Barrett's esophagus segments 3 cm or more in length without macroscopic evidence of dysplasia or cancer. Dysplasia was graded as: indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia, or carcinoma, and was reported in a blinded fashion. Fifty-seven patients were recruited, 44 of whom were male. A total of 1,269 biopsies were taken (MBDB-651, random biopsie-618). Analysis of the results by per-biopsy protocol showed that the MBDB technique diagnosed significantly more specialized intestinal metaplasia (75 %) compared to the random biopsy technique (68 %; P = 0.032). The sensitivity and specificity rates of MBDB for diagnosing specialized intestinal metaplasia were 91 % (95 % CI, 88 - 93 %) and 43 % (95 % CI, 36 - 51 %), respectively. The sensitivity and specificity rates of MBDB for diagnosing dysplasia or carcinoma were 49 % (95 % CI, 38 - 61 %) and 85 % (95 % CI, 82 - 88 %), respectively. There were no significant differences in the diagnosis of dysplasia and carcinoma - MBDB 12 %, random biopsy 10 %. The methylene blue staining pattern appeared to have an influence on the detection of specialized intestinal metaplasia and dysplasia/carcinoma. Dark blue staining was associated with increased detection of specialized intestinal metaplasia (P biopsies. Although MBDB prolongs the endoscopy procedure slightly, it is a safe and well-tolerated procedure. Further clinical studies on the MBDB technique exclusively in endoscopically normal dysplastic Barrett's esophagus are needed.

  19. Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial.

    Science.gov (United States)

    Ostlie, Daniel J; Juang, David; Aguayo, Pablo; Pettiford-Cunningham, Janine P; Erkmann, Erin A; Rash, Diane E; Sharp, Susan W; Sharp, Ronald J; St Peter, Shawn D

    2012-06-01

    The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P burns results. Copyright © 2012 Elsevier Inc. All rights reserved.

  20. Treatment of benign esophageal stricture by Eder-Puestow or balloon dilators: a comparison between randomized and prospective nonrandomized trials.

    Science.gov (United States)

    Yamamoto, H; Hughes, R W; Schroeder, K W; Viggiano, T R; DiMagno, E P

    1992-03-01

    To determine whether the natural history of strictures is affected by the type of dilator used to treat newly diagnosed peptic strictures, we designed a prospective randomized trial to compare the results after Eder-Puestow or Medi-Tech balloon dilation. We entered 31 patients into the trial. We also prospectively followed up all 92 nonrandomized patients who underwent their first dilation for a benign stricture during the same period as the prospective randomized trial. The nonrandomized patients also underwent dilation with either the Eder-Puestow or the balloon technique at the discretion of the gastroenterologist performing the endoscopy. We found no statistically significant differences in the immediate or long-term results of the two methods among the randomized, nonrandomized, and overall combined groups. All but 1 of the 123 patients had immediate relief of dysphagia. Within each group of patients, the probability of remaining free of dysphagia 1 year after the initial dilation was approximately 20%, and the probability of not requiring a second dilation was approximately 65% with either technique. Major (esophageal rupture) and minor (bleeding or chest pain) complications occurred in 1% and 5% of the patients and 0.4% and 3% of the total dilation procedures, respectively. The esophageal rupture and four of six minor complications occurred after repeated dilations. Five of the six minor complications occurred with use of the Eder-Puestow dilators. We conclude that Eder-Puestow and balloon dilations of benign esophageal strictures are associated with similar outcomes, but repeated dilations and the Eder-Puestow technique may be associated with an increased risk of complications.

  1. BLEEDING PEPTIC ULCER, NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND HELICOBACTER PYLORI INFECTION – A PROSPECTIVE, CONTROLLED, RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    Pavel Skok

    2002-06-01

    Full Text Available Background. The explanation of peptic ulcer etiology has changed significantly in the past decade after the clarification of the significance of Helicobacter pylori infection.Aim. To evaluate the effectiveness of Helicobacter pylori eradication in patients with hemorrhaging peptic ulcer and patients with peptic ulcer without complications.Study ethics. The study was approved in 1998 by the Medical Ethics Committee of the Republic of Slovenia (No. 90/09/98.Type of study. Prospective, controlled and randomized study, carried out between 1998–2000.Patients and methods. The study included 80 patients (50 male and 30 female, av.age 57.5 years, SD ± 17.1, range 22– 80 in which endoscopy confirmed hemorrhage from peptic ulcer of stomach or duodenum and Helicobacter pylori infection. In all cases endoscopic hemostasis was performed: injection sclerotherapy with diluted adrenalin 1:10,000 and 1% polidocanol or argon plasma coagulation. The control group was made up of 80 patients (50 male and 30 female, av.age 56.8 years, SD ± 16.8, range 19–80 with peptic ulcer of stomach or duodenum and Helicobacter pylori infection. Infection was confirmed by a rapid urease test and histologic investigation of the gastric mucosa. In all cases the recommended drug combinations were used in the treatment of the infection: a proton pump inhibitor, omeprazol (4 weeks, and combination of antibiotics, claritromycin and metronidazole or with regard to the antibiogram (1 week. The therapeutic success was ascertained endoscopically four weeks after inclusion in the study. Infection eradication was confirmed by the rapid urease test and histologic investigation of the gastric mucosa.Results. Four weeks after inclusion in the study the success of infection eradication was 92.5% in the study group, in the control group it was 91.3% (p > 0.05. In 6 patients (7.5%, 6/ 80 from the study group and in 7 (8.8%, 7/80 from the control group we introduced a replacement treatment

  2. Comparison of self-citation by peer reviewers in a journal with single-blind peer review versus a journal with open peer review.

    Science.gov (United States)

    Levis, Alexander W; Leentjens, Albert F G; Levenson, James L; Lumley, Mark A; Thombs, Brett D

    2015-12-01

    Some peer reviewers may inappropriately, or coercively request that authors include references to the reviewers' own work. The objective of this study was to evaluate whether, compared to reviews for a journal with single-blind peer review, reviews for a journal with open peer review included (1) fewer self-citations; (2) a lower proportion of self-citations without a rationale; and (3) a lower ratio of proportions of citations without a rationale in self-citations versus citations to others' work. Peer reviews for published manuscripts submitted in 2012 to a single-blind peer review journal, the Journal of Psychosomatic Research, were previously evaluated (Thombs et al., 2015). These were compared to publically available peer reviews of manuscripts published in 2012 in an open review journal, BMC Psychiatry. Two investigators independently extracted data for both journals. There were no significant differences between journals in the proportion of all reviewer citations that were self-citations (Journal of Psychosomatic Research: 71/225, 32%; BMC Psychiatry: 90/315, 29%; p=.50), or in the proportion of self-citations without a rationale (Journal of Psychosomatic Research: 15/71, 21%; BMC Psychiatry: 12/90, 13%; p=.21). There was no significant difference between journals in the proportion of self-citations versus citations to others' work without a rationale (p=.31). Blind and open peer review methodologies have distinct advantages and disadvantages. The present study found that, in reasonably similar journals that use single-blind and open review, there were no substantive differences in the pattern of peer reviewer self-citations. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Effectiveness of a low-cost virtual reality system for children with developmental delay: a preliminary randomised single-blind controlled trial.

    Science.gov (United States)

    Salem, Yasser; Gropack, Stacy Jaffee; Coffin, Dale; Godwin, Ellen M

    2012-09-01

    Physical and occupational therapists have started to use the Nintendo Wii™ gaming system with adults and children as part of their regular treatment. Despite the growing use of the Wii and trend towards evidence-based practice, limited evidence is available on the effectiveness of virtual reality using the Wii for children with developmental delay. The purpose of this study was to determine the feasibility and preliminary effectiveness of a low-cost gaming system for young children with developmental delay. Single-blind, randomised controlled trial. Forty children with developmental delay (age 39 to 58 months) who attended a segregated or integrated preschool participated in this study. All children's parents read and signed an informed consent form approved by the institutional review board. Children were assigned at random to an experimental (Wii) group (n=20) or a control group (n=20). Two weekly sessions for 10 weeks using Nintendo Wii Sports™ and Nintendo Wii Fit™, including balance, strength training and aerobics games. Participants were evaluated 1 week before and 1 week after the programme by a blinded investigator. Primary outcomes were gait speed, timed up and go test, single leg stance test, five-times-sit-to-stand test, timed up and down stairs test, 2-minute walk test and grip strength. The Gross Motor Function Measure (GMFM) was used to assess gross motor skills. The two groups were homogenous regarding all parameters at baseline. The Wii training was feasible and enjoyable for those in the experimental group. There were no adverse effects or injuries reported over 267 training sessions. Comparison of groups following the intervention indicated that the experimental group showed significant improvements compared with the control group in single leg stance test {mean difference 1.03 [standard deviation (SD) 1.7], 95% confidence interval (CI) 0.2 to 1.9; P=0.017}, right grip strength [mean difference 1.11 (SD 1.84), 95% CI 0.15 to 2.06; P=0

  4. Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

    Science.gov (United States)

    Raunest, J; Löhnert, J

    1990-01-01

    A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

  5. The analgesic effect of dexketoprofen when added to lidocaine for intravenous regional anaesthesia: a prospective, randomized, placebo-controlled study.

    Science.gov (United States)

    Yurtlu, S; Hanci, V; Kargi, E; Erdoğan, G; Köksal, B G; Gül, Ş; Okyay, R D; Ayoğlu, H; Turan, I Ö

    2011-01-01

    This prospective, randomized, placebo-controlled study evaluated the effects of dexketoprofen as an adjunct to lidocaine in intravenous regional anaesthesia (IVRA) or as a supplemental intravenous (i.v.) analgesic. Patients scheduled for elective hand or forearm soft-tissue surgery were randomly divided into three groups. All 45 patients received 0.5% lidocaine as IVRA. Dexketoprofen was given either i.v. or added into the IVRA solution and the control group received an equal volume of saline both i.v. and as part of the IVRA. The times of sensory and motor block onset, recovery time and postoperative analgesic consumption were recorded. Compared with controls, the addition of dexketoprofen to the IVRA solution resulted in more rapid onset of sensory and motor block, longer recovery time, decreased intra- and postoperative pain scores and decreased paracetamol use. It is concluded that coadministration of dexketoprofen with lidocaine in IVRA improves anaesthetic block and decreases postoperative analgesic requirements.

  6. A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

    Science.gov (United States)

    Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

    2011-01-01

    A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

  7. Safety and efficacy of dual-lead thalamic deep brain stimulation for patients with treatment-refractory multiple sclerosis tremor: a single-centre, randomised, single-blind, pilot trial.

    Science.gov (United States)

    Oliveria, Seth F; Rodriguez, Ramon L; Bowers, Dawn; Kantor, Daniel; Hilliard, Justin D; Monari, Erin H; Scott, Bonnie M; Okun, Michael S; Foote, Kelly D

    2017-09-01

    Efficacy in previous studies of surgical treatments of refractory multiple sclerosis tremor using lesioning or deep brain stimulation (DBS) has been variable. The aim of this study was to investigate the safety and efficacy of dual-lead thalamic DBS (one targeting the ventralis intermedius-ventralis oralis posterior nucleus border [the VIM lead] and one targeting the ventralis oralis anterior-ventralis oralis posterior border [the VO lead]) for the treatment of multiple sclerosis tremor. We did a single centre, single-blind, prospective, randomised pilot trial at the University of Florida Center for Movement Disorders and Neurorestoration clinic (Gainesville, FL, USA). We recruited adult patients with a clinical diagnosis of multiple sclerosis tremor refractory to previous medical therapy. Before surgery to implant both leads, we randomly assigned patients (1:1) to receive 3 months of optimised single-lead DBS-either VIM or VO. We did the randomisation with a computer-generated sequence, using three blocks of four patients, and independent members of the Center did the assignment. Patients and all clinicians other than the DBS programming nurse were masked to the choice of lead. Patients underwent surgery 1 month after their baseline visit for implantation of the dual lead DBS system. A pulse generator and two extension cables were implanted in a second surgery 3-4 weeks later. Patients then received an initial 3-month period of continuous stimulation of either the VIM or VO lead followed by blinded safety assessment of their tremor with the Tolosa-Fahn-Marin Tremor Rating Scale (TRS) during optimised VIM or VO lead stimulation at the end of the 3 months. After this visit, both leads were activated in all patients for an additional 3 months, and optimally programmed during serial visits as dictated by a prespecified programming algorithm. At the 6-month follow-up visit, TRS score was measured, and mood and psychological batteries were administered under four

  8. Combined impact of negative lifestyle factors on cardiovascular risk in children: a randomized prospective study

    OpenAIRE

    Meyer, Ursina; Schindler, Christian; Bloesch, Tamara; Schmocker, Eliane; Zahner, Lukas; Puder, Jardena J; Kriemler, Susi

    2014-01-01

    PURPOSE: Negative lifestyle factors are known to be associated with increased cardiovascular risk (CVR) in children, but research on their combined impact on a general population of children is sparse. Therefore, we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after 4 years. METHODS: Of the 540 randomly selected 6- to 13-year-old children, 502 children participated in a baseline health assessment, and ...

  9. A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma.

    Science.gov (United States)

    Singh, Amit Kumar; Suryanarayanan, Bhaskar; Choudhary, Ajay; Prasad, Akhila; Singh, Sachin; Gupta, Laxmi Narayan

    2014-01-01

    Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, 246 patients with CSDH were assessed for eligibility. Among 200 patients fulfilling the eligibility criteria, 100 each were assigned to "drain group" (drain inserted into the subdural space following BHD) and "without drain group" (subdural drain was not inserted following BHD) using random allocation software. The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery. Recurrence occurred in 9 of 100 patients with a drain, and 26 of 100 patients in without drain group (P = 0.002). The mortality was 5% in patients with drain and 4% in patients without drain group (P = 0.744). The medical and surgical complications were comparable between the two study groups. Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications.

  10. Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

    Science.gov (United States)

    Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

    2012-01-01

    The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

  11. Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

    Science.gov (United States)

    Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

    2015-12-01

    To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  12. Use of cinacalcet in nephrolithiasis associated with normocalcemic or hypercalcemic primary hyperparathyroidism: results of a prospective randomized pilot study

    Directory of Open Access Journals (Sweden)

    Simone Brardi

    2015-03-01

    Full Text Available Objectives: To evaluate, by means of a prospective randomized study, the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant. Materials and Methods: Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism (4 hypercalcemics and 6 normocalcemics, equally divided between males and females, were randomly but not blindly addressed to treatment with potassium citrate and allopurinol, or to the same therapeutic regimen in combination with cinacalcet. The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone (PTH within normal limits while enabling the maintenance of adequate calcemic values. All study participants were given the same diet based on a reduction in sodium intake, oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration. After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it, conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet. Follow up was continued for a second period of observation of the same duration of the first. Results: At the end of the period of treatment with cinacalcet, for both variants of hyperparathyroidism, a statistically significant reduction in the overall number and in the diameter of renal stones was found. Conclusions: This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake, in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism.

  13. Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

    Directory of Open Access Journals (Sweden)

    Natalie L Rasgon

    Full Text Available The objective of this study was to examine the effects of estrogen-based hormone therapy (HT on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5 at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+ or discontinue (HT- therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET. Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE-based HT, as well as women who continued conjugated equine estrogen (CEE-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE. Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease.ClinicalTrials.gov NCT00097058.

  14. Effect of knee joint icing on knee extension strength and knee pain early after total knee arthroplasty: a randomized cross-over study

    DEFF Research Database (Denmark)

    Holm, Bente; Husted, Henrik; Kehlet, Henrik

    2012-01-01

    Objective: To investigate the acute effect of knee joint icing on knee extension strength and knee pain in patients shortly after total knee arthroplasty.Design: A prospective, single-blinded, randomized, cross-over study.Setting: A fast-track orthopaedic arthroplasty unit at a university hospital.......Participants: Twenty patients (mean age 66 years; 10 women) scheduled for primary unilateral total knee arthroplasty.Interventions: The patients were treated on two days (day 7 and day 10) postoperatively. On one day they received 30 minutes of knee icing (active treatment) and on the other day they received 30...... minutes of elbow icing (control treatment). The order of treatments was randomized.Main outcome measures: Maximal knee extension strength (primary outcome), knee pain at rest and knee pain during the maximal knee extensions were measured 2-5 minutes before and 2-5 minutes after both treatments...

  15. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  16. Effects of Aromatherapy Massage on Pregnant Women's Stress and Immune Function: A Longitudinal, Prospective, Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Pao-Ju; Chou, Cheng-Chen; Yang, Luke; Tsai, Yu-Lun; Chang, Yue-Cune; Liaw, Jen-Jiuan

    2017-10-01

    This study's aims are to examine the effects of aromatherapy massage on women's stress and immune function during pregnancy. This longitudinal, prospective, randomized controlled trial recruited 52 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the intervention (n = 24) or control (n = 28) group using Clinstat block randomization. The intervention group received 70 min of aromatherapy massage with 2% lavender essential oil every other week (10 times in total) for 20 weeks; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A (IgA) levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation) and were analyzed using enzyme-linked immunosorbent assay. The pregnant women in the intervention group had lower salivary cortisol (p aromatherapy massage than those in the control group, which did not receive massage treatment. Comparing the long-term effects of aromatherapy massage on salivary IgA levels between groups at different times, the study found that the pretest salivary IgA levels at 32 (p = 0.002) and 36 (p aromatherapy massage could significantly decrease stress and enhance immune function in pregnant women. The findings can guide clinicians or midwives in providing aromatherapy massage to women throughout the pregnancy.

  17. High dose Senna or Poly Ethylene Glycol (PEG for elective colonoscopy preparation: a prospective randomized investigator-blinded clinical trial

    Directory of Open Access Journals (Sweden)

    Ahmad Shavakhi

    2011-01-01

    Full Text Available Background: The aim of this study was to determine the efficacy of two methods of colon preparation for colon cleansing in a randomized controlled trial. Methods: In this prospective randomized investigator-blinded trial, consecutive outpatients indicated for elective colonoscopy were randomized into two groups. Patients in Senna group took 24 tablets of 11 mg Senna in two divided doses 24 hour before colonoscopy. In Poly Ethylene Glycol (PEG group they solved 4 sachets in 4 liters of water the day before the procedure and were asked to drink 250 ml every 15 minutes. The overall quality of colon cleansing was evaluated using the Aronchick scoring scale. Difficulty of the procedure, patients′ tolerance and compliance and adverse events were also evaluated. Results: 322 patients were enrolled in the study. There was no significant difference in the quality of colon cleansing, patients′ tolerance, compliance and the difficulty of the procedure between two groups (p > 0.05. The incidence of adverse effects was similar between two groups except for abdominal pain that was more severe in Senna group (p < 0.05 and nausea and vomiting that was more common in PEG group (p < 0.05 Conclusions: In conclusion we deduce that Senna has the same efficacy and patient′s acceptance as Polyethylene glycol-electrolyte solution (PEG-ES and it could be prescribed as an alternative method for bowel preparation.

  18. Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

    Science.gov (United States)

    Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

    2012-05-01

    Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

  19. Epidemiology, epigenetics and the 'Gloomy Prospect': embracing randomness in population health research and practice.

    Science.gov (United States)

    Smith, George Davey

    2011-06-01

    Epidemiologists aim to identify modifiable causes of disease, this often being a prerequisite for the application of epidemiological findings in public health programmes, health service planning and clinical medicine. Despite successes in identifying causes, it is often claimed that there are missing additional causes for even reasonably well-understood conditions such as lung cancer and coronary heart disease. Several lines of evidence suggest that largely chance events, from the biographical down to the sub-cellular, contribute an important stochastic element to disease risk that is not epidemiologically tractable at the individual level. Epigenetic influences provide a fashionable contemporary explanation for such seemingly random processes. Chance events-such as a particular lifelong smoker living unharmed to 100 years-are averaged out at the group level. As a consequence population-level differences (for example, secular trends or differences between administrative areas) can be entirely explicable by causal factors that appear to account for only a small proportion of individual-level risk. In public health terms, a modifiable cause of the large majority of cases of a disease may have been identified, with a wild goose chase continuing in an attempt to discipline the random nature of the world with respect to which particular individuals will succumb. The quest for personalized medicine is a contemporary manifestation of this dream. An evolutionary explanation of why randomness exists in the development of organisms has long been articulated, in terms of offering a survival advantage in changing environments. Further, the basic notion that what is near-random at one level may be almost entirely predictable at a higher level is an emergent property of many systems, from particle physics to the social sciences. These considerations suggest that epidemiological approaches will remain fruitful as we enter the decade of the epigenome.

  20. Sympatho-vagal balance, as quantified by ANSindex, predicts post spinal hypotension and vasopressor requirement in parturients undergoing lower segmental cesarean section: a single blinded prospective observational study.

    Science.gov (United States)

    Prashanth, Anitha; Chakravarthy, Murali; George, Antony; Mayur, Rohini; Hosur, Rajathadri; Pargaonkar, Sumant

    2017-08-01

    Hypotension subsequent to spinal anesthesia occurs in a significant number of parturients undergoing lower segment caesarian section. Currently available methods to predict the incidence of hypotension, its severity and the outcome are sub-optimal. Many workers have used basal heart rate as one of the predictors. But using this method it is not possible to objectively analyze and predict the extent and severity of hypotension. We used an equipment measuring the level of sympatho-vagal balance, ANSiscope™, which derives these values from computed value of RR interval variability. We made a single measure of the value which was blinded to the patient and the anesthesiologist. We studied one hundred eight patients who underwent lower segment caesarian section under spinal anesthesia and found the variability of preoperative ANSindex (% activity displayed by the equipment) from 9 to 65 %. Higher ANSindex value was significantly associated with post spinal hypotension (p 0.017). A value of 24 % indicated the critical level above which hypotension appeared commonly. The ANSindex value might help anesthesiologist to anticipate and prepare for hypotension that is likely to ensue.

  1. Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts.

    Science.gov (United States)

    Lorello, David John; Peck, Michael; Albrecht, Marlene; Richey, Karen J; Pressman, Melissa A

    2014-01-01

    It is common practice to keep those patients with lower extremity autografts immobile until post-operative day (POD) 5. There is however inherent risks associated with even short periods of immobility. As of now there are no randomized controlled trials looking at early ambulation of patients with lower extremity autografts in the burn community.The objective of this study was to show that patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5. Thirty-one subjects who received autografts to the lower extremity were randomized after surgery into either the early ambulation group (EAG;17 subjects) or the standard treatment group (STG;14 subjects). Those subjects randomized to the EAG began ambulating with physical therapy on POD 1. Subjects in the STG maintained bed rest until POD 5. There was no difference in the number of patients with graft loss in either the EAG or STG on POD 5, and during any of the follow-up visits. No subjects required regrafting. There was a significant difference in the mean minutes of ambulation, with the EAG ambulating longer than the STG (EAG 23.4 minutes [SD 12.03], STG 14.1 [SD 9.00], P=.0235) on POD 5. Burn patients with lower extremity autografts can safely ambulate on POD 1 without fear of graft failure compared with those patients that remain on bed rest for 5 days.

  2. Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial

    International Nuclear Information System (INIS)

    Zissiadis, Yvonne; Harper, Emily; Kearney, Elizabeth

    2010-01-01

    Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients' anxiety levels. The secondary aim was to determine the impact of this information on patients' satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients' anxiety scores or

  3. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial.

    Science.gov (United States)

    Cherian, Jeffrey J; Bhave, Anil; Kapadia, Bhaveen H; Starr, Roland; McElroy, Mark J; Mont, Michael A

    2015-05-01

    Pneumatic unloader bracing with extension assists have been proposed as a non-operative modality that may delay the need for knee surgery by reducing pain and improving function. This prospective, randomized trial evaluated 52 patients who had knee osteoarthritis for changes in: (1) muscle strength; (2) objective functional improvements; (3); subjective functional improvements; (4) pain; (5) quality of life; and (6) conversion to total knee arthroplasty (TKA) compared to standard of care. Patient outcomes were evaluated at a minimum 3 months. Braced patient's demonstrated significant improvements in muscle strength, several functional tests, and patient reported outcomes when compared to the matched cohort. These results are encouraging and suggest that this device may represent a promising alternative to standard treatment methods for knee osteoarthritis. Copyright © 2014 Elsevier Inc. All rights reserved.

  4. Continuous vs. blocks of physiotherapy for motor development in children with cerebral palsy and similar syndromes: A prospective randomized study.

    Science.gov (United States)

    Brunner, Anne-Louise; Rutz, Erich; Juenemann, Stephanie; Brunner, Reinald

    2014-12-01

    To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy (CP). A prospective randomized cross-over design study compared the effect of regular physiotherapy (baseline) with blocks of physiotherapy alternating with no physiotherapy over one year. Thirty-nine institutionalized children with CP and clinically similar syndromes (6-16 years old, Gross Motor Function Classification Scale II-IV) were included. During the first scholastic year, group A received regular physiotherapy, group B blocks of physiotherapy and vice versa in the second year. The Gross Motor Function Measure 66 (GMFM-66) was the outcome measure. Thirteen children in each group completed the study. GMFM-66 improved (p Physiotherapy may be more effective when provided regularly rather than in blocks.

  5. Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

    2015-12-01

    There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Efficacy and safety of non-immersive virtual reality exercising in stroke rehabilitation (EVREST): a randomised, multicentre, single-blind, controlled trial.

    Science.gov (United States)

    Saposnik, Gustavo; Cohen, Leonardo G; Mamdani, Muhammad; Pooyania, Sepideth; Ploughman, Michelle; Cheung, Donna; Shaw, Jennifer; Hall, Judith; Nord, Peter; Dukelow, Sean; Nilanont, Yongchai; De Los Rios, Felipe; Olmos, Lisandro; Levin, Mindy; Teasell, Robert; Cohen, Ashley; Thorpe, Kevin; Laupacis, Andreas; Bayley, Mark

    2016-09-01

    Non-immersive virtual reality is an emerging strategy to enhance motor performance for stroke rehabilitation. There has been rapid adoption of non-immersive virtual reality as a rehabilitation strategy despite the limited evidence about its safety and effectiveness. Our aim was to compare the safety and efficacy of virtual reality with recreational therapy on motor recovery in patients after an acute ischaemic stroke. In this randomised, controlled, single-blind, parallel-group trial we enrolled adults (aged 18-85 years) who had a first-ever ischaemic stroke and a motor deficit of the upper extremity score of 3 or more (measured with the Chedoke-McMaster scale) within 3 months of randomisation from 14 in-patient stroke rehabilitation units from four countries (Canada [11], Argentina [1], Peru [1], and Thailand [1]). Participants were randomly allocated (1:1) by a computer-generated assignment at enrolment to receive a programme of structured, task-oriented, upper extremity sessions (ten sessions, 60 min each) of either non-immersive virtual reality using the Nintendo Wii gaming system (VRWii) or simple recreational activities (playing cards, bingo, Jenga, or ball game) as add-on therapies to conventional rehabilitation over a 2 week period. All investigators assessing outcomes were masked to treatment assignment. The primary outcome was upper extremity motor performance measured by total time to complete the Wolf Motor Function Test (WMFT) at the end of the 2 week intervention period, analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NTC01406912. The study was done between May 12, 2012, and Oct 1, 2015. We randomly assigned 141 patients: 71 received VRWii therapy and 70 received recreational activity. 121 (86%) patients (59 in the VRWii group and 62 in the recreational activity group) completed the final assessment and were included in the primary analysis. Each group improved WMFT performance time relative to

  7. A randomized, blinded, prospective clinical trial of postoperative rehabilitation in dogs after surgical decompression of acute thoracolumbar intervertebral disc herniation.

    Science.gov (United States)

    Zidan, Natalia; Sims, Cory; Fenn, Joe; Williams, Kim; Griffith, Emily; Early, Peter J; Mariani, Chris L; Munana, Karen R; Guevar, Julien; Olby, Natasha J

    2018-05-01

    Experimental evidence shows benefit of rehabilitation after spinal cord injury (SCI) but there are limited objective data on the effect of rehabilitation on recovery of dogs after surgery for acute thoracolumbar intervertebral disc herniations (TL-IVDH). Compare the effect of basic and intensive post-operative rehabilitation programs on recovery of locomotion in dogs with acute TL-IVDH in a randomized, blinded, prospective clinical trial. Thirty non-ambulatory paraparetic or paraplegic (with pain perception) dogs after decompressive surgery for TL-IVDH. Blinded, prospective clinical trial. Dogs were randomized (1:1) to a basic or intensive 14-day in-house rehabilitation protocol. Fourteen-day open field gait score (OFS) and coordination (regulatory index, RI) were primary outcomes. Secondary measures of gait, post-operative pain, and weight were compared at 14 and 42 days. Of 50 dogs assessed, 32 met inclusion criteria and 30 completed the protocol. There were no adverse events associated with rehabilitation. Median time to walking was 7.5 (2 - 37) days. Mean change in OFS by day 14 was 6.13 (confidence intervals: 4.88, 7.39, basic) versus 5.73 (4.94, 6.53, intensive) representing a treatment effect of -0.4 (-1.82, 1.02) which was not significant, P=.57. RI on day 14 was 55.13 (36.88, 73.38, basic) versus 51.65 (30.98, 72.33, intensive), a non-significant treatment effect of -3.47 (-29.81, 22.87), P = .79. There were no differences in secondary outcomes between groups. Early postoperative rehabilitation after surgery for TL-IVDH is safe but doesn't improve rate or level of recovery in dogs with incomplete SCI. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  8. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    International Nuclear Information System (INIS)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

    2017-01-01

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  9. The effect of tourniquet use on fixation quality in cemented total knee arthroplasty a prospective randomized clinical controlled RSA trial.

    Science.gov (United States)

    Molt, Mats; Harsten, Andreas; Toksvig-Larsen, Sören

    2014-03-01

    A concern that arises with any change in technique is whether it affects the long-term implant stability. The objective of this study was to evaluate the early migration, measured by radiostereometric analysis (RSA), and the functional outcome of the Triathlon™ cemented knee prosthesis, operated on with or without a tourniquet. During the last decades RSA has emerged as a way to assess prosthetic fixation and long time prognosis. The method has been used extensively in both hip and knee arthroplasty. This was a single centre prospective study including 60 patients randomized into two groups operated on either with or without tourniquet. RSA investigation was done within 2-3 days postoperatively after full weight bearing, and then at 3 months, 1 year and 2 years postoperatively. There were no differences between the groups regarding the translation along or rotation around the three coordinal axes, or in maximum total point motion (MTPM). At 2 years the mean MTPM (SD) was 0.71 mm (0.64) for the tourniquet-group and 0.53 mm (0.21) for the non-tourniquet-group. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability whether operated on with or without tourniquet. Level I. Article focus: A safety study for total knee replacement operated on with or without perioperative tourniquet regarding the prosthetic fixation. Strengths and limitations: Strength of this study is that it is a randomized prospective trial using an objective measuring tool. The sample size of 25-30 patients is reportedly sufficient for the screening of implants using RSA (1-3). Clinical trials NCT01604382, Ethics Committee approval D-nr: 144/20085. © 2013.

  10. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

    2017-03-15

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  11. Effects of epidural lidocaine analgesia on labor and delivery: A randomized, prospective, controlled trial

    Directory of Open Access Journals (Sweden)

    Nafisi Shahram

    2006-12-01

    Full Text Available Abstract Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic. Our study was conducted to answer the question: does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population? Method 395 healthy, nulliparous women, at term, presented in spontaneous labor with a singleton vertex presentation. These patients were randomized to receive analgesia either, epidural with bolus doses of 1% lidocaine or intravenous, with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters. The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded, in each patient. The total number of vacuum-assisted and cesarean deliveries were also measured. Results 197 women were randomized to the epidural group. 198 women were randomized to the single-dose intravenous meperidine group. There was no statistical difference in rates of vacuum-assisted delivery rate. Cesarean deliveries, as a consequence of fetal bradycardia or dystocia, did not differ significantly between the groups. Differences in the duration of the active-first and the second stages of labor were not statistically significant. The number of newborns with 1-min and 5-min Apgar scores less than 7, did not differ significantly between both analgesia groups. Conclusion Epidural analgesia with 1% lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate.

  12. 2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

    Science.gov (United States)

    Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

    2017-12-01

    3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

  13. rhBMP-2 for posterolateral instrumented lumbar fusion: a multicenter prospective randomized controlled trial.

    Science.gov (United States)

    Hurlbert, R John; Alexander, David; Bailey, Stewart; Mahood, James; Abraham, Ed; McBroom, Robert; Jodoin, Alain; Fisher, Charles

    2013-12-01

    Multicenter randomized controlled trial. To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft. In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion. Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively. One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007). The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.

  14. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

    Science.gov (United States)

    Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

    2018-06-01

    There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

  16. Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

    Science.gov (United States)

    Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

    2014-04-01

    To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

  17. Pharmacological strategies to reduce pruritus during postoperative epidural analgesia after lumbar fusion surgery - a prospective randomized trial in 150 patients

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    Robinson Yohan

    2011-05-01

    Full Text Available Abstract Background Epidural analgesia with bupivacain, epinephrine and fentanyl provides excellent pain control after lumbar fusion surgery, but pruritus and motor block are frequent side effects. Theoretically epidural ropivacain combined with oral oxycodone could decrease the incidence of these side effects. The two regimens were compared in a prospective randomized trial. Patients and methods 150 patients (87 women treated with posterior instrumented lumbar fusion were included. The mean age was 51 +/- 11 years. 76 were randomized to bupivacain, epinephrine and fentanyl (group B and 74 to ropivacain and oxycodone (group R. Pruritus, motor block and pain were measured 6 hours after surgery, thereafter 6 times per day for 5 days. Any pain breakthrough episode was registered whenever it occurred. Results The epidural treatment could be performed in 143 patients (72 in group B and 71 in group R. Disturbing pruritus occurred in 53 patients in group B compared to 12 in group R (p Conclusions Pruritus could be reduced with a combination of epidural ropivacain and oral oxycodone, at the price of a slightly higher pain level. Ropivacaine was not found to be superior to bupivacaine with regard to motor blocks.

  18. Stenting or not prior to extracorporeal shockwave lithotripsy for ureteral stones? Results of a prospective randomized study.

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    Sfoungaristos, Stavros; Polimeros, Nikolaos; Kavouras, Adamantios; Perimenis, Petros

    2012-06-01

    To determine the need for pre-treatment stenting in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for ureteral stones sized 4-10 mm. A prospective randomized study was conducted between September 2009 and March 2011. Included 156 patients randomized in stented and non-stented groups and underwent a maximum of 3 ESWL sessions. Radiographic follow-up was used to assess the stone fragmentation and clearance. Results were compared in terms of stone-free rates, post-treatment morbidity and complications. Overall efficacy was 76.9%. Stone-free rates were statistically significantly lower (P = 0.026) in the stented group (68.6%) compared to the non-stented ones (83.7%). Furthermore, stenting was significantly correlated with post-treatment lower urinary tract symptoms (P ≤ 0.001), need for more ESWL sessions (P = 0.019) and possibility for operation due to ESWL failure (P = 0.026). A multivariate analysis was conducted to identify the parameters which may predict complete stone removal after ESWL. Stone size (P = 0.026), stone location (P = 0.011) and stenting (P = 0.007) were the most significant factors. ESWL is an efficient and safe treatment for 4- to 10-mm ureteral stones. Pre-treatment stenting is limiting stone-free rates and is significantly influencing post-ESWL morbidity and quality of life in a negative manner, while it contributes minimally to the prophylaxis of complications.

  19. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial

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    Henzen Christoph

    2007-07-01

    Full Text Available Abstract Background: Lower respiratory tract infections like acute bronchitis, exacerbated chronic obstructive pulmonary disease and community-acquired pneumonia are often unnecessarily treated with antibiotics, mainly because of physicians' difficulties to distinguish viral from bacterial cause and to estimate disease-severity. The goal of this trial is to compare medical outcomes, use of antibiotics and hospital resources in a strategy based on enforced evidence-based guidelines versus procalcitonin guided antibiotic therapy in patients with lower respiratory tract infections. Methods and design: We describe a prospective randomized controlled non-inferiority trial with an open intervention. We aim to randomize over a fixed recruitment period of 18 months a minimal number of 1002 patients from 6 hospitals in Switzerland. Patients must be >18 years of age with a lower respiratory tract infections Discussion: Use of and prolonged exposure to antibiotics in lower respiratory tract infections is high. The proposed trial investigates whether procalcitonin-guidance may safely reduce antibiotic consumption along with reductions in hospitalization costs and antibiotic resistance. It will additionally generate insights for improved prognostic assessment of patients with lower respiratory tract infections. Trial registration: ISRCTN95122877

  20. [Assessment of nociceptive suppression in laparoscopic postoperative status: prospective, randomized and comparative study with a control group].

    Science.gov (United States)

    Jaime, A; Hernández-Favela, P; Zamora, R; Nava, E; Barroso, G; Kably, A

    2001-08-01

    In recent years endoscopic surgery has became a highly demanded procedure because it is an easy method for diagnosis and treatment in gynecological field. Post-operative pain is considered as a condition in the morbidity status. The objective of this study was to evaluate the nociceptive suppression in laparoscopic surgery. A prospective randomized trial was performed in order to evaluate this condition. A total of 45 patients were included. Three groups were randomized using two different anesthetics applied in the cult-de-sac and uterine-bladder union. Group A (n-15) received bupivacaine, group B (n = 15) ropivacaine and group C (control) saline solution was instilled. The pain was scored using the visual analog scale as same as blood pressure and heart rate in a 15 minute intervals in the recovery room. For study design there were no differences in age, weight, height and body mass index (EMI). The surgical and anesthetic times were similar among groups. However there were significant differences when pain was evaluated. For a less toxic effects and good preventive analgesia we recommend to use ropivacaine in the postoperative status.

  1. Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China.

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    He, Zhong; Chen, Rong; Zhou, Yingfang; Geng, Li; Zhang, Zhenyu; Chen, Shuling; Yao, Yanjun; Lu, Junli; Lin, Shouqing

    2009-05-20

    To investigate the efficacy and safety of VAC BNO 1095 extract in Chinese women suffering from moderate to severe premenstrual syndrome (PMS). Prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting three cycles, Eligible patients were randomly assigned into treatment or placebo groups and had treatment with VAC extract or placebo for up to three cycles. Efficacy was assessed using the Chinese version PMS-diary (PMSD) and PMTS. Two hundred and seventeen women were eligible to enter the treatment phase (TP) and were randomly assigned into the treatment group (108) or the placebo group (109), 208 provided the efficacy data (treatment 104, placebo 104), and 202 completed the treatment phase (treatment 101, placebo 101). The mean total PMSD score decreased from 29.23 at baseline (0 cycle) to 6.41 at the termination (3rd cycle) for the treatment group and from 28.14 at baseline (0 cycle) to 12.64 at the termination (3rd cycle) for the placebo group. The total PMSD score of 3rd cycle was significantly lower than the baseline in both groups (pVitex agnus castus (VAC BNO 1095 corresponding to 40mg herbal drug) is a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to severe PMS.

  2. Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

    Science.gov (United States)

    Hoffmann, Clement; Falzone, Elisabeth; Verret, Catherine; Pasquier, Pierre; Leclerc, Thomas; Donat, Nicolas; Jost, Daniel; Mérat, Stephane; Maurice, Guillaume de Saint; Lenoir, Bernard; Auroy, Yves; Tourtier, Jean-Pierre

    2013-09-01

    We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (β = 0.9 [95% confidence interval, 0.5-1.3]). An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

  3. Effectiveness of Topical Sucralfate in the Management of Pressure Ulcer in Hospitalized Patients: A Prospective, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Ala, Shahram; Saeedi, Majid; Gholipour, Afshin; Ahmadi, Motahareh; Asoodeh, Ali; Shiva, Afshin

    2018-04-10

    The aim of this study was to evaluate the effectiveness of topical sucralfate in the management of pressure ulcer (PU) in hospitalized patients. Forty hospitalized patients with stage II PU were included in this prospective, double-blind, randomized, placebo-controlled trial and were randomly divided into 2 groups receiving either sucralfate gel or placebo, on a daily basis. The patients were visited every day for 14 days, the ulcer was evaluated using the Pressure Ulcer Scale for Healing (PUSH) and changes to the measured scores over time were used as an indicator of wound healing. There were no statistically significant differences in any of the demographic characteristics between both groups. Both of the interventions reduced the average PUSH score, and at the end of the trial, all but 2 patients were healed. One in each group discontinued the trial because of exacerbation of the ulcer. No significant between-group difference in the average PUSH score reduction was observed (6.36 ± 2.11 vs. 5.89 ± 1.41, P = 0.42). Although the average healing time was less in the sucralfate group (6.05 ± 2.17 vs. 7.78 ± 3.42), the difference was not statistically significant (P = 0.07). Sucralfate gel does not improve healing of PU compared with placebo.

  4. Postoperative pain after foraminal enlargement in anterior teeth with necrosis and apical periodontitis: a prospective and randomized clinical trial.

    Science.gov (United States)

    Silva, Emmanuel João Nogueira Leal; Menaged, Karyne; Ajuz, Natasha; Monteiro, Maria Rachel Figueiredo Penalva; Coutinho-Filho, Tauby de Souza

    2013-02-01

    The aim of this randomized, controlled, prospective clinical study was to determine if foraminal enlargement instrumentation during endodontic treatment is associated with more postoperative pain compared with standard nonenlargement instrumentation. Forty volunteers with a single root canal were diagnosed with asymptomatic necrosis with apical periodontitis and randomized into 2 experimental groups (ie, the control group and the foraminal enlargement group). Endodontic treatment was performed in a single visit, and volunteers were instructed to record pain intensity (ie, none, slight, moderate, and severe). Scores from 1 to 4 were attributed to each kind of pain after 12, 24, and 48 hours. The Kolmogorov-Smirnov and Student's t tests were used to determine significant differences at P .05, Student's t test). Postoperative pain showed no statistically significant difference between the groups at any observation period (P > .05). Also, no significant difference was observed in the mean number of analgesic tablets used between the groups (P > .05). The foraminal enlargement and nonenlargement techniques resulted in the same postoperative pain and necessity for analgesic medication. This may suggest that the use of foraminal enlargement should be performed for endodontic treatment previsibility without increasing postoperative pain. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  5. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  6. Peyton’s four-step approach for teaching complex spinal manipulation techniques – a prospective randomized trial

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    Gertraud Gradl-Dietsch

    2016-11-01

    Full Text Available Abstract Background The objectives of this prospective randomized trial were to assess the impact of Peyton’s four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. Methods We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG or a control group, which received conventional teaching (CG. Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC exam and practical skills (Objective Structured Practical Examination (OSPE with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. Results There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Conclusions Peyton’s approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

  7. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

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    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  8. Sleep quality in patients with xerostomia: a prospective and randomized case-control study.

    Science.gov (United States)

    Lopez-Jornet, Pia; Lucero Berdugo, Maira; Fernandez-Pujante, Alba; C, Castillo Felipe; Lavella C, Zamora; A, Pons-Fuster; J, Silvestre Rangil; Silvestre, Francisco Javier

    2016-01-01

    Objectives To investigate sleep quality, anxiety/depression and quality-of-life in patients with xerostomia. Materials and methods This prospective, observational, cross-sectional study was conducted among a group of xerostomia patients (n = 30) compared with 30 matched control subjects. The following evaluation scales were used to assess the psychological profile of each patient: the Hospital Anxiety and Depression Scale, the Oral Health Impact Profile-14 (OHIP-14), the Xerostomia Inventory, the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Results The PSQI obtained 5.3 3 ± 1.78 for patients with xerostomia compared with 4.26 ± 1.01 for control subjects (p = 0.006); ESS obtained 5.7 ± 2.1 for test patients vs 4.4 0 ± 1 for control subjects (p = 0.010). Statistical regression analysis showed that xerostomia was significantly associated with depression (p = 0.027). Conclusions Patients with xerostomia exhibited significant decreases in sleep quality compared with control subjects.

  9. Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

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    Sudha Prathikanti

    Full Text Available Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI. At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72, and mean BDI score 22.4 (SD = 4.5. Twenty participants were