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Sample records for chronic whiplash trial

  1. Dry needling and exercise for chronic whiplash - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Souvlis Tina

    2009-12-01

    Full Text Available Abstract Background Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash. Method/Design A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1 dry-needling, advice and exercise or 2 sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted. Discussion This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash. Trial registration ACTRN12609000470291

  2. Melatonin for chronic whiplash syndrome with delayed melatonin onset randomised, placebo-controlled trial

    NARCIS (Netherlands)

    Wieringen, S. van; Jansen, T.; Smits, M.G.; Nagtegaal, J.E.; Coenen, A.M.L.

    2001-01-01

    Objective: To assess the influence of melatonin in patients with chronic whiplash syndrome and delayed melatonin onset. Design: Randomised, double-blind, placebo-controlled, parallel-group trial. One-week baseline was followed by a 4-week treatment period with either melatonin or placebo. In the ba

  3. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: Design of a randomised controlled trial

    DEFF Research Database (Denmark)

    Ris Hansen, Inge; Christensen, Robin Daniel Kjersgaard; Thomsen, Bente

    2011-01-01

    is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients......ABSTRACT: BACKGROUND: Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective...... with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline. METHODS: The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited...

  4. Mechanisms of chronic pain from whiplash injury.

    Science.gov (United States)

    Davis, Charles G

    2013-02-01

    This article is to provide insights into the mechanisms underlying chronic pain from whiplash injury. Studies show that injury produces plasticity changes of different neuronal structures that are responsible for amplification of nociception and exaggerated pain responses. There is consistent evidence for hypersensitivity of the central nervous system to sensory stimulation in chronic pain after whiplash injury. Tissue damage, detected or not by the available diagnostic methods, is probably the main determinant of central hypersensitivity. Different mechanisms underlie and co-exist in the chronic whiplash condition. Spinal cord hyperexcitability in patients with chronic pain after whiplash injury can cause exaggerated pain following low intensity nociceptive or innocuous peripheral stimulation. Spinal hypersensitivity may explain pain in the absence of detectable tissue damage. Whiplash is a heterogeneous condition with some individuals showing features suggestive of neuropathic pain. A predominantly neuropathic pain component is related to a higher pain/disability level.

  5. Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Letitia Campbell

    2015-10-01

    Discussion: This study will provide a definitive evaluation of the effects of adding trauma-focused cognitive behaviour therapy to physiotherapy exercise for individuals with chronic WAD and PTSD. This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have implications for both health and insurance policy makers in their decision-making regarding treatment options and funding.

  6. Risk factors for development and maintenance of chronic whiplash

    OpenAIRE

    Myrtveit, Solbjørg Makalani

    2015-01-01

    Background: After experiencing whiplash accidents, most individuals recover rapidly. Others, however, develop chronic whiplash, a condition characterized by long lasting neck pain, somatic complaints and symptoms of anxiety and depression. Individuals with chronic whiplash report the condition to reduce their quality of life and ability to work. As most individuals recover from whiplash accidents without needing medical attention, identifying those at risk of chronic complai...

  7. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hansen Inge

    2011-12-01

    Full Text Available Abstract Background Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline. Methods/Design The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control group or a combined pain management and training (interventiongroup. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36, Physical Component Summary (PCS. Secondary outcomes will be Global Perceived Effect (-5 to +5, Neck Disability Index (0-50, Patient Specific Functioning Scale (0-10, numeric rating scale for pain bothersomeness (0-10, SF-36 Mental Component Summary (MCS, TAMPA scale of Kinesiophobia (17-68, Impact of Event Scale (0-45, EuroQol (0

  8. The Effect of Neck-specific Exercise With, or Without a Behavioral Approach, on Pain, Disability, and Self-Efficacy in Chronic Whiplash-associated Disorders : A Randomized Clinical Trial

    OpenAIRE

    2015-01-01

    OBJECTIVES:: The aim of this study was to compare the effect on self-rated pain, disability and self-efficacy of three interventions for the management of chronic Whiplash Associated Disorders (WAD): physiotherapist-led neck-specific exercise, physiotherapist-led neck-specific exercise with the addition of a behavioral approach, or prescription of physical activity. METHODS:: Two hundred and sixteen volunteers with chronic WAD participated in this randomized, assessor blinded, clinical trial ...

  9. Satisfaction With the Outcome of Physical Therapist-Prescribed Exercise in Chronic Whiplash-Associated Disorders: Secondary Analysis of a Randomized Clinical Trial.

    Science.gov (United States)

    Ardern, Clare L; Peterson, Gunnel; Ludvigsson, Maria Landén; Peolsson, Anneli

    2016-08-01

    Study Design Secondary analysis of a randomized clinical trial. Background Patient perception of the benefits gained from treatment is important, yet satisfaction with the outcome of treatment for chronic whiplash-associated disorders (WADs) has not been investigated. Objectives To investigate whether satisfaction with the outcome of treatment for chronic WAD changed over time, and whether there were group differences. Methods Two hundred sixteen people with chronic WAD (66% women; mean age, 40.4 years) participated in a 3-month program of physical therapist-led neck-specific exercises with or without a behavioral approach, or received a prescription of general physical activity. The main outcome was satisfaction with the outcome of treatment, assessed at baseline and 3, 6, and 12 months later. Additional outcomes were enablement and expectation fulfillment. Results Satisfaction improved over time in the 3 groups (odds ratio = 1.15; 95% confidence interval: 1.10, 1.20; Pphysical activity. Enablement increased after completion of the intervention in all groups (Pphysical activity (P<.01). Conclusion Exercise interventions for chronic WAD led to increased satisfaction for 12 months following treatment that was unrelated to the type of exercise intervention received. Level of Evidence Therapy, level 1b. Registered January 22, 2012 at www.ClinicalTrials.gov (NCT01528579). J Orthop Sports Phys Ther 2016;46(8):640-649. Epub 3 Jul 2016. doi:10.2519/jospt.2016.6136.

  10. The anatomy and biomechanics of acute and chronic whiplash injury.

    Science.gov (United States)

    Siegmund, Gunter P; Winkelstein, Beth A; Ivancic, Paul C; Svensson, Mats Y; Vasavada, Anita

    2009-04-01

    Whiplash injury is the most common motor vehicle injury, yet it is also one of the most poorly understood. Here we examine the evidence supporting an organic basis for acute and chronic whiplash injuries and review the anatomical sites within the neck that are potentially injured during these collisions. For each proposed anatomical site--facet joints, spinal ligaments, intervertebral discs, vertebral arteries, dorsal root ganglia, and neck muscles--we present the clinical evidence supporting that injury site, its relevant anatomy, the mechanism of and tolerance to injury, and the future research needed to determine whether that site is responsible for some whiplash injuries. This article serves as a snapshot of the current state of whiplash biomechanics research and provides a roadmap for future research to better understand and ultimately prevent whiplash injuries.

  11. Burnout in Patients with Chronic Whiplash-Associated Disorders

    Science.gov (United States)

    Clementz, Gunilla; Borsbo, Bjorn; Norrbrink, Cecilia

    2012-01-01

    This study sought to assess burnout and its relation to pain, disability, mood and health-related quality of life in a group of patients with chronic whiplash-associated disorders (WAD). Forty-five patients with chronic WAD ([greater than or equal to] 3 months) referred to a multidisciplinary rehabilitation centre were included. A questionnaire…

  12. Chronic neck pain disability due to an acute whiplash injury

    NARCIS (Netherlands)

    Nederhand, Marc J.; Hermens, Hermie J.; IJzerman, Maarten J.; Turk, Dennis C.; Zilvold, Gerrit

    2003-01-01

    Several theories about musculoskeletal pain syndromes such as whiplash-associated disorder (WAD) suggest that pain and muscle activity interact and may contribute to the chronicity of symptoms. Studies using surface electromyography (sEMG) have demonstrated abnormal muscle activation patterns of the

  13. Altered Regional Cerebral Blood Flow in Chronic Whiplash Associated Disorders

    NARCIS (Netherlands)

    Vállez García, David; Doorduin, Janine; Willemsen, Antoon T.M.; Dierckx, Rudi A.j.o.; Otte, Andreas

    2016-01-01

    There is increasing evidence of central hyperexcitability in chronic whiplash-associated disorders (cWAD). However, little is known about how an apparently simple cervical spine injury can induce changes in cerebral processes. The present study was designed (1) to validate previous results showing a

  14. Chronic Neck Pain and Whiplash: A Case-Control Study of the Relationship between Acute Whiplash Injuries and Chronic Neck Pain

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    Michael D Freeman

    2006-01-01

    Full Text Available The authors undertook a case-control study of chronic neck pain and whiplash injuries in nine states in the United States to determine whether whiplash injuries contributed significantly to the population of individuals with chronic neck and other spine pain.

  15. A Combination of Gestalt Therapy, Rosen Body Work, and Cranio Sacral Therapy did not help in Chronic Whiplash-Associated Disorders (WAD - Results of a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2004-01-01

    Full Text Available The chronic state of whiplash-associated disorder (WAD might be understood as a somatization of existential pain. Intervention aimed to improve quality of life (QOL seemed to be a solution for such situations. The basic idea behind the intervention was holistic, restoring quality of life and relationship with self, in order to diminish tension in the locomotion system, especially the neck. A psychosomatic theory for WAD is proposed. Our treatment was a short 2-day course with teachings in philosophy of life, followed by 6 to 10 individual sessions in gestalt psychotherapy and body therapy (Rosen therapy and Cranio Sacral therapy, followed by a 1-day course approximately 2 months later, closing the intervention. Two independent institutions did the intervention and the assessments. In a randomized, clinically controlled setting, 87 chronic WAD patients were included with a median duration of 37 months from their whiplash accidents. One patient never started. Forty-three had the above intervention (female/male = 36/7, ages 22–49, median 37 years and another 43 were assigned to a nontreated control group (female/male = 35/8, ages 1848, median 38. Six had disability pension and 27 had pending medicolegal issues in each group. Effect variables were pain in neck, arm, and/or head; measures of quality of life and daily activities; as well as general physical or mental health. Wilcoxon test for between-groups comparisons with intention-to-treat analyses was conducted; the square curve paradigm testing for immediate improvements of health and quality of life was also used. The groups were comparable at baseline. From the intervention group, 11 dropped out during the intervention (4 of those later joined the follow-up investigation, 22 of the remaining 32 graduated the course, and 35 of the 43 controls did as well. Approximately 3 months later, we found no clinically relevant or significant increase in any effect measure. The above version of a quality

  16. Classification of Chronic Whiplash Associated Disorders With Artificial Neural Networks

    Science.gov (United States)

    2007-11-02

    question is how to analyse a multiple of features in an appropriate way. Different Artificial Neural Networks (ANN) have been developed during the past...sample IR-light, at 60 Hz, reflected by the retro-reflective markers. CLASSIFICATION OF CHRONIC WHIPLASH ASSOCIATED DISORDERS WITH ARTIFICIAL NEURAL NETWORKS F...Associated Disorders With Artificial Neural Networks Contract Number Grant Number Program Element Number Author(s) Project Number Task Number

  17. Neck collar, "act-as-usual" or active mobilization for whiplash injury? A randomized parallel-group trial

    DEFF Research Database (Denmark)

    Kongsted, Alice; Montvilas, Erisela Qerama; Kasch, Helge

    2007-01-01

    Study Design. Randomized, parallel-group trial. Objective. To compare the effect of 3 early intervention strategies following whiplash injury. Summary of Background Data. Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion......-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only. Methods. Participants were recruited from emergency units and general...... practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12...

  18. Managing Injuries of the Neck Trial (MINT: design of a randomised controlled trial of treatments for whiplash associated disorders

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    Williamson Esther M

    2007-01-01

    Full Text Available Abstract Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED, followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI, and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised.

  19. Chronic neck pain : An epidemiological, psychological and SPECT study with emphasis on whiplash-associated disorders

    OpenAIRE

    2006-01-01

    Chronic neck pain, a common cause of disability, seems to be the result of several interacting mechanisms. In addition to degenerative and inflammatory changes and trauma, psychological and psychosocial factors are also involved. One common type of trauma associated with chronic neck pain is whiplash injury; this sometimes results in whiplash-associated disorder (WAD), a controversial condition with largely unknown pathogenetic mechanisms. We studied the prevalence of chronic neck pain of tra...

  20. Incidence and predictors of chronic headache attributed to whiplash injury.

    Science.gov (United States)

    Obermann, M; Nebel, K; Riegel, A; Thiemann, D; Yoon, M-S; Keidel, M; Stude, P; Diener, Hc; Katsarava, Z

    2010-05-01

    We identified clinical, demographic and psychological predictive factors that may contribute to the development of chronic headache associated with mild to moderate whiplash injury [Quebec Task Force (QTF) ≤ II] and determined the incidence of this chronic pain state. Patients were recruited prospectively from six participating accident and emergency departments. While 4.6% of patients developed chronic headache attributed to whiplash injury according to the International Classification of Headache Disorders, 2nd edn criteria, 15.2% of patients complained about headache lasting > 42 days (QTF criteria). Predictive factors were pre-existing facial pain [odds ratio (OR) 9.7, 95% confidence interval (CI) 2.1, 10.4; P = 0.017], lack of confidence to recover completely (OR 5.5, 95% CI 2.0, 13.2; P = 0.005), sore throat (OR 5.0, 95% CI 1.5, 8.9; P = 0.013), medication overuse (OR 4.2, 95% CI 1.4, 12.3; P = 0.009), high Neck Disability Index (OR 4.0, 95% CI 1.3, 12.6; P = 0.019), hopelessness/anxiety (OR 3.8, 95% CI 1.3, 8.7; P = 0.024), and depression (OR 3.3, 95% CI 1.2, 9.4; P = 0.024). The lack of a control group limits the conclusions that can be drawn from this study. Identified predictors closely resemble those found in chronic primary headache disorders.

  1. Somatic symptoms beyond those generally associated with a whiplash injury are increased in self-reported chronic whiplash. A population-based cross sectional study: the Hordaland Health Study (HUSK

    Directory of Open Access Journals (Sweden)

    Myrtveit Solbjørg

    2012-08-01

    Full Text Available Abstract Background Chronic whiplash leads to considerable patient suffering and substantial societal costs. There are two competing hypothesis on the etiology of chronic whiplash. The traditional organic hypothesis considers chronic whiplash and related symptoms a result of a specific injury. In opposition is the hypothesis that chronic whiplash is a functional somatic syndrome, and related symptoms a result of society-induced expectations and amplification of symptoms. According to both hypotheses, patients reporting chronic whiplash are expected to have more neck pain, headache and symptoms of anxiety and depression than the general population. Increased prevalence of somatic symptoms beyond those directly related to a whiplash neck injury is less investigated. The aim of this study was to test an implication derived from the functional hypothesis: Is the prevalence of somatic symptoms as seen in somatization disorder, beyond symptoms related to a whiplash neck injury, increased in individuals self-reporting chronic whiplash? We further aimed to explore recall bias by comparing the symptom profile displayed by individuals self-reporting chronic whiplash to that among those self-reporting a non-functional injury: fractures of the hand or wrist. We explored symptom load, etiologic origin could not be investigated in this study. Methods Data from the Norwegian population-based “Hordaland Health Study” (HUSK, 1997–99; N = 13,986 was employed. Chronic whiplash was self-reported by 403 individuals and fractures by 1,746. Somatization tendency was measured using a list of 17 somatic symptoms arising from different body parts and organ systems, derived from the research criteria for somatization disorder (ICD-10, F45. Results Chronic whiplash was associated with an increased level of all 17 somatic symptoms investigated (p Conclusions The increased prevalence of somatic symptoms beyond symptoms expected according to the organic injury model

  2. Patients with chronic whiplash-associated disorders: relationship between clinical and psychological factors and functional health status.

    NARCIS (Netherlands)

    Schmitt, M.A.; Meeteren, N.L. van; Wijer, A. de; Genderen, F.R. van; Graaf, Y. van der; Helders, P.J.M.

    2009-01-01

    OBJECTIVES: To examine the relative contribution of cervical impairments and psychosocial factors to perceived disability among people with chronic whiplash-associated disorders. DESIGN: A total of 86 patients with chronic whiplash-associated disorders participated in this observational, cross-secti

  3. Pre- and post-operative gait analysis for evaluation of neck pain in chronic whiplash

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    Ginsburg Glen M

    2009-07-01

    Full Text Available Abstract Introduction Chronic neck pain after whiplash is notoriously refractory to conservative treatment, and positive radiological findings to explain the symptoms are scarce. The apparent disproportionality between subjective complaints and objective findings is significant for the planning of treatment, impairment ratings, and judicial questions on causation. However, failure to identify a symptom's focal origin with routine imaging studies does not invalidate the symptom per se. It is therefore of a general interest both to develop effective therapeutic strategies in chronic whiplash, and to establish techniques for objectively evaluation of treatment outcomes. Methods Twelve patients with chronic neck pain after whiplash underwent pre- and postoperative computerized 3D gait analysis. Results Significant improvement was found in all gait parameters, cervical range-of-motion, and self reported pain (VAS. Conclusion Chronic neck pain is associated with abnormal cervical spine motion and gait patterns. 3D gait analysis is a useful instrument to assess the outcome of treatment for neck pain.

  4. Altered motor control patterns in whiplash and chronic neck pain

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    Vasseljen Ottar

    2008-06-01

    Full Text Available Abstract Background Persistent whiplash associated disorders (WAD have been associated with alterations in kinesthetic sense and motor control. The evidence is however inconclusive, particularly for differences between WAD patients and patients with chronic non-traumatic neck pain. The aim of this study was to investigate motor control deficits in WAD compared to chronic non-traumatic neck pain and healthy controls in relation to cervical range of motion (ROM, conjunct motion, joint position error and ROM-variability. Methods Participants (n = 173 were recruited to three groups: 59 patients with persistent WAD, 57 patients with chronic non-traumatic neck pain and 57 asymptomatic volunteers. A 3D motion tracking system (Fastrak was used to record maximal range of motion in the three cardinal planes of the cervical spine (sagittal, frontal and horizontal, and concurrent motion in the two associated cardinal planes relative to each primary plane were used to express conjunct motion. Joint position error was registered as the difference in head positions before and after cervical rotations. Results Reduced conjunct motion was found for WAD and chronic neck pain patients compared to asymptomatic subjects. This was most evident during cervical rotation. Reduced conjunct motion was not explained by current pain or by range of motion in the primary plane. Total conjunct motion during primary rotation was 13.9° (95% CI; 12.2–15.6 for the WAD group, 17.9° (95% CI; 16.1–19.6 for the chronic neck pain group and 25.9° (95% CI; 23.7–28.1 for the asymptomatic group. As expected, maximal cervical range of motion was significantly reduced among the WAD patients compared to both control groups. No group differences were found in maximal ROM-variability or joint position error. Conclusion Altered movement patterns in the cervical spine were found for both pain groups, indicating changes in motor control strategies. The changes were not related to a

  5. Whiplash injuries.

    Science.gov (United States)

    Malanga, Gerard; Peter, Jason

    2005-10-01

    Whiplash injuries are very common and usually are associated with rear-end collisions. However, a whiplash injury can be caused by any event that results in hyperextension and flexion of the cervical spine. These injuries are of serious concern to all consumers due to escalating cost of diagnosis, treatment, insurance, and litigation. Most acute whiplash injury cases respond well to conservative treatments, which result in resolution of symptoms usually within weeks to a few months after the injury occurred. Chronic whiplash injuries often are harder to diagnose and treat and often result in poor outcomes. Current research shows that various structures in the cervical spine receive nociceptive innervation and potentially may be the cause of chronic pain symptoms. One potential pain generator showing promise is the facet or zygapophyseal joints. Various researchers have proven that these joints are injured during whiplash injuries and that diagnosis and temporary pain relief can be obtained with facet joint injections. The initial evaluation of any patient should follow an organized and stepwise approach, and more serious causes of neck pain must first be ruled out through the history, physical examination, and diagnostic testing. Treatment regimens should be evidence-based, focusing on treatments that have proven to be effective in treating acute and chronic whiplash injuries.

  6. Chronic neck pain disability due to an acute whiplash injury.

    Science.gov (United States)

    Nederhand, Marc J; Hermens, Hermie J; IJzerman, Maarten J; Turk, Dennis C; Zilvold, Gerrit

    2003-03-01

    Several theories about musculoskeletal pain syndromes such as whiplash-associated disorder (WAD) suggest that pain and muscle activity interact and may contribute to the chronicity of symptoms. Studies using surface electromyography (sEMG) have demonstrated abnormal muscle activation patterns of the upper trapezius muscles in the chronic stage of WAD (grade II). There are, however, no studies that confirm that these muscle reactions are initiated in the acute stage of WAD, nor that these muscle reactions persist in the transition from acute neck pain to chronic neck pain disability. We analyzed the muscle activation patterns of the upper trapezius muscles in a cohort of 92 subjects with acute neck pain due to a motor vehicle accident (MVA). This cohort was followed up in order to evaluate differences in muscular activation patterns between subjects who have recovered and those subjects who have not recovered following an acute WAD and developed chronic neck pain. sEMG parameters were obtained at 1, 4, 8, 12, and 24 weeks after an MVA. The level of muscle reactivity (the difference in pre- and post-exercise EMG levels) and the level of muscle activity during an isometric and a dynamic task were used as EMG parameters. The results revealed no elevated muscle reactivity either in the acute stage, or during the follow-up period. The results of both the isometric and dynamic task, showed statistically significant different EMG levels between four neck pain disability subgroups (analysis of variance reaching P-levels of 0.000), with an inverse relationship between the level of neck pain disability and EMG level. Furthermore, follow-up assessments of the EMG level during these two tasks, did not show a time related change. In conclusion, in subjects with future disability, the acute stage is characterized by a reorganization of the muscular activation of neck and shoulder muscles, possibly aimed at minimizing the use of painful muscles. This change of motor control, is in

  7. Cervical Muscle Dysfunction in the Chronic Whiplash Associated Disorder Grade II (WAD-II)

    NARCIS (Netherlands)

    Nederhand, Marc J.; IJzerman, Maarten J.; Hermens, Hermie J.; Baten, Chris T.M.; Zilvold, Gerrit

    2000-01-01

    Study Design: In a cross-sectional study, surface electromyography measurements of the upper trapezius muscles were obtained during different functional tasks in patients with a chronic whiplash associated disorder Grade II and healthy control subjects. - Objectives: To investigate whether muscle d

  8. Cervical Muscle Dysfunction in Chronic Whiplash-Associated Disorder Grade 2: The Relevance of the Trauma

    NARCIS (Netherlands)

    Nederhand, Marc J.; Hermens, Hermie J.; IJzerman, Maarten J.; Turk, Dennis C.; Zilvold, Gerrit

    2002-01-01

    Study Design. Surface electromyography measurements of the upper trapezius muscles were performed in patients with a chronic whiplash-associated disorder Grade 2 and those with nonspecific neck pain. Objective. To determine the etiologic relation between acceleration–deceleration trauma and the pre

  9. A combination of gestalt therapy, Rosen Body Work, and Cranio Sacral therapy did not help in chronic whiplash-associated disorders (WAD)--results of a randomized clinical trial.

    Science.gov (United States)

    Ventegodt, Søren; Merrick, Joav; Andersen, Niels Jørgen; Bendix, Tom

    2004-12-10

    The chronic state of whiplash-associated disorder (WAD) might be understood as a somatization of existential pain. Intervention aimed to improve quality of life (QOL) seemed to be a solution for such situations. The basic idea behind the intervention was holistic, restoring quality of life and relationship with self, in order to diminish tension in the locomotion system, especially the neck. A psychosomatic theory for WAD is proposed. Our treatment was a short 2-day course with teachings in philosophy of life, followed by 6-10 individual sessions in gestalt psychotherapy and body therapy (Rosen therapy and Cranio Sacral therapy), followed by a 1-day course approximately 2 months later, closing the intervention. Two independent institutions did the intervention and the assessments. In a randomized, clinically controlled setting, 87 chronic WAD patients were included with a median duration of 37 months from their whiplash accidents. One patient never started. Forty-three had the above intervention (female/male = 36/7, ages 22-49, median 37 years) and another 43 were assigned to a nontreated control group (female/male = 35/8, ages 18-48, median 38). Six had disability pension and 27 had pending medicolegal issues in each group. Effect variables were pain in neck, arm, and/or head; measures of quality of life and daily activities; as well as general physical or mental health. Wilcoxon test for between-groups comparisons with intention-to-treat analyses was conducted; the square curve paradigm testing for immediate improvements of health and quality of life was also used. The groups were comparable at baseline. From the intervention group, 11 dropped out during the intervention (4 of those later joined the follow-up investigation), 22 of the remaining 32 graduated the course, and 35 of the 43 controls did as well. Approximately 3 months later, we found no clinically relevant or significant increase in any effect measure. The above version of a quality of life

  10. Implementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT: protocol of a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Trudy Rebbeck

    2016-04-01

    Discussion: This research is significant as it will be the first study to address the heterogeneity of whiplash by implementing a clinical pathway of care that matches evidence-based interventions to projected risk of poor recovery. The results of this trial have the potential to change clinical practice for WAD, thereby maximising treatment effects, improving patient outcomes, reducing costs and maintaining the compulsory third party system.

  11. A Research Synthesis of Therapeutic Interventions for Whiplash-Associated Disorder (WAD: Part 4 – Noninvasive Interventions for Chronic WAD

    Directory of Open Access Journals (Sweden)

    Robert W Teasell

    2010-01-01

    Full Text Available Whiplash-associated disorder (WAD represents a significant public health problem, resulting in substantial social and economic costs throughout the industrialized world. While many treatments have been advocated for patients with WAD, scientific evidence supporting their effectiveness is often lacking. A systematic review was conducted to evaluate the strength of evidence for various WAD therapies. Multiple databases (including Web of Science, EMBASE and PubMed were searched to identify all studies published from January 1980 through March 2009 that evaluated the effectiveness of any clearly defined treatment for acute (less than two weeks, subacute (two to 12 weeks or chronic (longer than 12 weeks WAD. The present article, the fourth in a five-part series, evaluates the evidence for noninvasive interventions initiated during the chronic phase of WAD. Twenty-two studies that met the inclusion criteria were identified, 12 of which were randomized controlled trials with ‘good’ overall methodological quality (median Physiotherapy Evidence Database score of 6. For the treatment of chronic WAD, there is evidence to suggest that exercise programs are effective in relieving whiplash-related pain, at least over the short term. While the majority of a subset of nine studies supported the effectiveness of interdisciplinary interventions, the two randomized controlled trials provided conflicting results. Finally, there was limited evidence, consisting of one supportive case series each, that both manual joint manipulation and myofeedback training may provide some benefit. Based on the available research, exercise programs were the most effective noninvasive treatment for patients with chronic WAD, although many questions remain regarding the relative effectiveness of various exercise regimens.

  12. Pre- and post-operative gait analysis for evaluation of neck pain in chronic whiplash

    OpenAIRE

    Ginsburg Glen M; Nystrom Ake; Stuberg Wayne; Dejong Stacey

    2009-01-01

    Abstract Introduction Chronic neck pain after whiplash is notoriously refractory to conservative treatment, and positive radiological findings to explain the symptoms are scarce. The apparent disproportionality between subjective complaints and objective findings is significant for the planning of treatment, impairment ratings, and judicial questions on causation. However, failure to identify a symptom's focal origin with routine imaging studies does not invalidate the symptom per se. It is t...

  13. Imaging Chronic Pain and Inflammation : Positron Emission Tomography Studies of Whiplash Associated Disorder

    OpenAIRE

    2008-01-01

    This thesis is on chronic neck pain after a rear impact car injury, so called whiplash associated disorder (WAD). Three empirical studies using positron emission tomography (PET) with different radioligands have been performed. The first study evaluated resting state regional cerebral blood flow (rCBF) in WAD patients and in healthy, pain-free controls, by use of oxygen-15 labeled water. Patients had heightened resting rCBF bilaterally in the posterior parahippocampal and the posterior cingul...

  14. Chronic neck pain. An epidemiological, psychological and SPECT study with emphasis on whiplash-associated disorders.

    Science.gov (United States)

    Guez, Michel

    2006-02-01

    Chronic neck pain, a common cause of disability, seems to be the result of several interacting mechanisms. In addition to degenerative and inflammatory changes and trauma, psychological and psychosocial factors are also involved. One common type of trauma associated with chronic neck pain is whiplash injury; this sometimes results in whiplash-associated disorder (WAD), a controversial condition with largely unknown pathogenetic mechanisms. We studied the prevalence of chronic neck pain of traumatic and non-traumatic origin and compared the prevalence of, sociodemographic data, self-perceived health, workload and chronic low-back pain in these groups. In a ready-made questionnaire (MONICA study), we added questions about cervical spine and low-back complaints. 6,000 (72%) completed a self-administered questionnaire. 43% reported neck pain: 48% of women and 38% of men. Women of working age had more neck pain than retired women, a phenomenon not seen in men. 19% of the studied population suffered from chronic neck pain and it was more frequent in women. A history of neck trauma was common in those with chronic neck pain. Those with a history of neck trauma perceived their health worse and were more often on sick-leave. About 50% of those with traumatic and non-traumatic chronic neck pain also had chronic low-back pain. We assessed the subjective and objective neuropsychological functioning in 42 patients with chronic neck pain, 21 with a whiplash trauma, and 21 without previous neck trauma. Despite cognitive complaints, the WAD patients had normal neuropsychological functioning, but the WAD group especially had deviant MMPI results-indicating impaired coping ability and somatization. WAD patients had no alterations in cerebral blood-flow pattern, as measured by rCBF-SPECT and SPM analysis, compared to healthy controls. This contrasts with the non-traumatic group with chronic neck pain, which showed marked blood-flow changes. The blood-flow changes in the non

  15. Altered thermal sensitivity in facial skin in chronic whiplash-associated disorders

    Institute of Scientific and Technical Information of China (English)

    Birgitta Haggman-Henrikson; Ewa Lampa; Erik Nordh

    2013-01-01

    There is a close functional relationship between the jaw and neck regions and it has been suggested that trigeminal sensory impairment can follow whiplash injury. Inclusion of manageable routines for valid assessment of the facial sensory capacity is thus needed for comprehensive evaluations of patients exposed to such trauma. The present study investigated facial thermal thresholds in patients with chronic whiplash-associated disorders (WADs) with both a qualitative method and quantitative sensory testing (QST). Ten women with pain and dysfunction following a whiplash injury were compared to 10 healthy age-matched women. Thermal detection thresholds were assessed by qualitative chair-side testing and by QST according to the method-of-limits. Seven test sites in the facial skin (overlying each trigeminal branch bilaterally, and the midpoint of the chin) were examined. The detection warm and cold thresholds were defined as the mean values of 10 individual thresholds. For the WAD patients, the qualitative assessment demonstrated both reduced and increased sensitivity compared to the healthy, whereas QST systematically showed significantly higher detection thresholds (i.e., decreased sensitivity) for both cold and warm stimuli. For the individuals who were assessed as having increased sensitivity in the qualitative assessment, the QST displayed either normal or higher thresholds, i.e., decreased sensitivity. The results suggest that QST is more sensitive for detecting thermal sensory disturbances in the face than a qualitative method. The impaired thermal sensitivity among the patients corroborates the notion of altered thermal detection capacity induced by WAD-related pain.

  16. Elevated [11C]-D-deprenyl uptake in chronic Whiplash Associated Disorder suggests persistent musculoskeletal inflammation.

    Directory of Open Access Journals (Sweden)

    Clas Linnman

    Full Text Available There are few diagnostic tools for chronic musculoskeletal pain as structural imaging methods seldom reveal pathological alterations. This is especially true for Whiplash Associated Disorder, for which physical signs of persistent injuries to the neck have yet to be established. Here, we sought to visualize inflammatory processes in the neck region by means Positron Emission Tomography using the tracer (11C-D-deprenyl, a potential marker for inflammation. Twenty-two patients with enduring pain after a rear impact car accident (Whiplash Associated Disorder grade II and 14 healthy controls were investigated. Patients displayed significantly elevated tracer uptake in the neck, particularly in regions around the spineous process of the second cervical vertebra. This suggests that whiplash patients have signs of local persistent peripheral tissue inflammation, which may potentially serve as a diagnostic biomarker. The present investigation demonstrates that painful processes in the periphery can be objectively visualized and quantified with PET and that (11C-D-deprenyl is a promising tracer for these purposes.

  17. Increased neck muscle activity and impaired balance among females with whiplash-related chronic neck pain

    DEFF Research Database (Denmark)

    Juul-Kristensen, Birgit; Clausen, Brian; Ris Hansen, Inge

    2013-01-01

    To investigate neck muscle activity and postural control in patients with whiplash-associated disorder compared with healthy controls.......To investigate neck muscle activity and postural control in patients with whiplash-associated disorder compared with healthy controls....

  18. Patients with chronic whiplash-associated disorders. Relationship between clinical and psychological factors and functional health status

    NARCIS (Netherlands)

    Schmitt, M.A.; Meeteren, N.L. van; Wijer, A. de; Genderen, F.R. van; Graaf, Y.D. van; Helders, P.J.

    2009-01-01

    Schmitt MA, van Meeteren NL, de Wijer A, van Genderen FR, van der Graaf Y, Helders PJ: Patients with chronic whiplash-associated disorders: Relationship between clinical and psychological factors and functional health status. Am J Phys Med Rehabil 2009;88:231-238. Objectives: To examine the relative

  19. Maintaining a balance: a focus group study on living and coping with chronic whiplash-associated disorder

    Directory of Open Access Journals (Sweden)

    Ihlebæk Camilla

    2010-07-01

    Full Text Available Abstract Background There is little qualitative insight into how persons with chronic Whiplash-Associated Disorder cope on a day to day basis. This study seeks to identify the symptoms persons with Whiplash-Associated Disorder describe as dominating and explore their self-initiated coping strategies. Methods Qualitative study using focus groups interviews. Fourteen Norwegian men and women with Whiplash-Associated Disorder (I or II were recruited to participate in two focus groups. Data were analyzed according to a phenomenological approach, and discussed within the model of Cognitive Activation Theory of Stress (CATS. Results Participants reported neck and head pain, sensory hypersensitivity, and cognitive dysfunction following their whiplash injury. Based on the intensity of symptoms, participants divided everyday life into good and bad periods. In good periods the symptoms were perceived as manageable. In bad periods the symptoms intensified and took control of the individual. Participants expressed a constant notion of trying to balance their three main coping strategies; rest, exercise, and social withdrawal. In good periods participants experienced coping by expecting good results from the strategies they used. In bad periods they experienced no or negative relationships between their behavioral strategies and their complaints. Conclusions Neck and head pain, sensory hypersensitivity, and cognitive dysfunction were reported as participants' main complaints. A constant notion of balancing between their three main coping strategies; rest, exercise, and social withdrawal, was described.

  20. A Research Synthesis of Therapeutic Interventions for Whiplash-Associated Disorder (WAD: Part 5 – Surgical and Injection-Based Interventions for Chronic WAD

    Directory of Open Access Journals (Sweden)

    Robert W Teasell

    2010-01-01

    Full Text Available Whiplash-associated disorder (WAD represents a significant public health problem, resulting in substantial social and economic costs throughout the industrialized world. While many treatments have been advocated for patients with WAD, scientific support regarding their effectiveness is often lacking. A systematic review was conducted to evaluate the strength of evidence associated with various WAD therapies. Multiple databases (including Web of Science, EMBASE and PubMed were searched to identify all studies published from January 1980 through March 2009 that evaluated the effectiveness of any well-defined treatment for acute (less than two weeks, subacute (two to 12 weeks or chronic (more than 12 weeks WAD. The present article, the fifth in a five-part series, evaluates the evidence for surgical and injection-based interventions initiated during the chronic phase of WAD. Twenty-five studies were identified that met the inclusion criteria, six of which were randomized controlled trials with ‘good’ overall methodological quality (median Physiotherapy Evidence Database score of 7.5. For the treatment of chronic WAD, there was moderate evidence supporting radiofrequency neurotomy as an effective treatment for whiplash-related pain, although relief is not permanent. Sterile water injections have been demonstrated to be superior to saline injections; however, it is not clear whether this treatment is actually beneficial. There was evidence supporting a wide range of other interventions (eg, carpal tunnel decompression with each of these evaluated by a single nonrandomized controlled trial. There is contradictory evidence regarding the effectiveness of botulinum toxin injections, and cervical discectomy and fusion. The evidence is not yet strong enough to establish the effectiveness of any of these treatments; of all the invasive interventions for chronic WAD, radiofrequency neurotomy appears to be supported by the strongest evidence. Further

  1. Protocol for an economic evaluation alongside the University Health Network Whiplash Intervention Trial: cost-effectiveness of education and activation, a rehabilitation program, and the legislated standard of care for acute whiplash injury in Ontario

    Directory of Open Access Journals (Sweden)

    van der Velde Gabrielle

    2011-07-01

    Full Text Available Abstract Background Whiplash injury affects 83% of persons in a traffic collision and leads to whiplash-associated disorders (WAD. A major challenge facing health care decision makers is identifying cost-effective interventions due to lack of economic evidence. Our objective is to compare the cost-effectiveness of: 1 physician-based education and activation, 2 a rehabilitation program developed by Aviva Canada (a group of property and casualty insurance providers, and 3 the legislated standard of care in the Canadian province of Ontario: the Pre-approved Framework Guideline for Whiplash developed by the Financial Services Commission of Ontario. Methods/Design The economic evaluation will use participant-level data from the University Health Network Whiplash Intervention Trial and will be conducted from the societal perspective over the trial's one-year follow-up. Resource use (costs will include all health care goods and services, and benefits provided during the trial's 1-year follow-up. The primary health effect will be the quality-adjusted life year. We will identify the most cost-effective intervention using the incremental cost-effectiveness ratio and incremental net-benefit. Confidence ellipses and cost-effectiveness acceptability curves will represent uncertainty around these statistics, respectively. A budget impact analysis will assess the total annual impact of replacing the current legislated standard of care with each of the other interventions. An expected value of perfect information will determine the maximum research expenditure Canadian society should be willing to pay for, and inform priority setting in, research of WAD management. Discussion Results will provide health care decision makers with much needed economic evidence on common interventions for acute whiplash management. Trial Registration http://ClinicalTrials.gov identifier NCT00546806 [Trial registry date: October 18, 2007; Date first patient was randomized: February

  2. Assessment of driving-related performance in chronic whiplash using an advanced driving simulator.

    Science.gov (United States)

    Takasaki, Hiroshi; Treleaven, Julia; Johnston, Venerina; Rakotonirainy, Andry; Haines, Andrew; Jull, Gwendolen

    2013-11-01

    Driving is often nominated as problematic by individuals with chronic whiplash associated disorders (WAD), yet driving-related performance has not been evaluated objectively. The purpose of this study was to test driving-related performance in persons with chronic WAD against healthy controls of similar age, gender and driving experience to determine if driving-related performance in the WAD group was sufficiently impaired to recommend fitness to drive assessment. Driving-related performance was assessed using an advanced driving simulator during three driving scenarios; freeway, residential and a central business district (CBD). Total driving duration was approximately 15min. Five driving tasks which could cause a collision (critical events) were included in the scenarios. In addition, the effect of divided attention (identify red dots projected onto side or rear view mirrors) was assessed three times in each scenario. Driving performance was measured using the simulator performance index (SPI) which is calculated from 12 measures. z-Scores for all SPI measures were calculated for each WAD subject based on mean values of the control subjects. The z-scores were then averaged for the WAD group. A z-score of ≤-2 indicated a driving failing grade in the simulator. The number of collisions over the five critical events was compared between the WAD and control groups as was reaction time and missed response ratio in identifying the red dots. Seventeen WAD and 26 control subjects commenced the driving assessment. Demographic data were comparable between the groups. All subjects completed the freeway scenario but four withdrew during the residential and eight during the CBD scenario because of motion sickness. All scenarios were completed by 14 WAD and 17 control subjects. Mean z-scores for the SPI over the three scenarios was statistically lower in the WAD group (-0.3±0.3; P0.05). Assessment of driving in an advanced driving simulator for approximately 15min revealed

  3. Chronic Mechanical Neck Pain in Adults Treated by Manual Therapy: A Systematic Review of Change Scores in Randomized Controlled Trials of a Single Session

    OpenAIRE

    Vernon, Howard; Humphreys, Barry Kim

    2008-01-01

    We report a systematic analysis of group change scores of subjects with chronic neck pain not due to whiplash and without headache or arm pain, in randomized clinical trials of a single session of manual therapy. A comprehensive literature search of clinical trials of chronic neck pain treated with manual therapies up to December 2006 was conducted. Trials that scored above 60% on the PEDro Scale were included. Change scores were analyzed for absolute, percentage change and effect size (ES) w...

  4. [Assessment of whiplash and cervical spine injury].

    Science.gov (United States)

    Marx, P

    2011-12-01

    Formulating an expert opinion on whiplash injuries requires that consideration be given to biomechanical, orthopedic, neurological, psychiatric and medicolegal aspects. The greatest difficulties are encountered in cases of mild whiplash where patients complain of constant pain without any physical correlative. Diverse assessments and principles for approving a claim are reflected in the fact that the prevalence of chronic spine pain after whiplash injuries (late whiplash syndrome) varies between 16% and 71% in different countries, and the proportion of whiplash injuries involved in petitions for compensation differs greatly across Europe (UK 75%, Germany 47%, Finland 8.5% and France 3% of all personal injuries).Important biomechanical, orthopedic, neurological, psychiatric and medicolegal aspects of expert testimony on whiplash associated disorders (WAD) are delineated.

  5. Chronic whiplash and central sensitization; an evaluation of the role of a myofascial trigger points in pain modulation

    Directory of Open Access Journals (Sweden)

    Freeman Michael D

    2009-04-01

    Full Text Available Abstract Objective it has been established that chronic neck pain following whiplash is associated with the phenomenon of central sensitization, in which injured and uninjured parts of the body exhibit lowered pain thresholds due to an alteration in central pain processing. it has furthermore been hypothesized that peripheral sources of nociception in the muscles may perpetuate central sensitization in chronic whiplash. the hypothesis explored in the present study was whether myofascial trigger points serve as a modulator of central sensitization in subjects with chronic neck pain. Design controlled case series. Setting outpatient chronic pain clinic. Subjects seventeen patients with chronic and intractable neck pain and 10 healthy controls without complaints of neck pain. Intervention symptomatic subjects received anesthetic infiltration of myofascial trigger points in the upper trapezius muscles and controls received the anesthetic in the thigh. Outcome measures: pre and post injection cervical range of motion, pressure pain thresholds (ppt over the infraspinatus, wrist extensor, and tibialis anterior muscles. sensitivity to light (photophobia and subjects' perception of pain using a visual analog scale (vas were also evaluated before and after injections. only the ppt was evaluated in the asymptomatic controls. Results immediate (within 1 minute alterations in cervical range of motion and pressure pain thresholds were observed following an average of 3.8 injections with 1–2 cc of 1% lidocaine into carefully identified trigger points. cervical range of motion increased by an average of 49% (p = 0.000 in flexion and 44% (p = 0.001 in extension, 47% (p = 0.000 and 28% (p Conclusion the present data suggest that myofascial trigger points serve to perpetuate lowered pain thresholds in uninjured tissues. additionally, it appears that lowered pain thresholds associated with central sensitization can be immediately reversed, even when associated

  6. Subjective health complaints in patients with chronic Whiplash Associated Disorders (WAD. Relationships with physical, psychological, and collision associated factors

    Directory of Open Access Journals (Sweden)

    Camilla Ihlebæk

    2009-10-01

    Full Text Available  Aims: Investigate subjective health complaints (SHC in chronic whiplash associated disorder (WAD, grade I & II patients, and to identify physical, psychological, and collision associated factors that might be associated with high levels of comorbidity. Method: During the years 2000-2002 171 chronic WAD patients filled in questionnaires and underwent physical examination. The prevalence of SHC was recorded and compared with a representative sample of the Norwegian population (n=1014. Results: The chronic WAD patients reported higher number of subjective health complaints (median: 9 than the general population (median: 5. They showed significantly higher risk of reporting all musculoskeletal complaints, palpitation, heat flushes, sleep problems, tiredness, dizziness, anxiety, depression, breathing difficulties, chest pain, coughing, heartburn, gas discomfort, and obstipation. The patients with the highest level of comorbid subjective health complaints also reported more function loss, reading difficulties, poorer quality of life, higher psychological distress, higher use of medication, and less optimism about their situation. There were no differences however, in any collision factors or physical meassures recorded by physiotherapists between the high, medium and low comorbidity groups. Conclusion: The high comorbidity of other complaints, the strong relationships between degree of comorbidity and psychological factors, and the lack of relationships between degree of comorbidity and collision factors and physical tests, suggest that chronic WAD is best understood as a syndrome and not simply as a neck injury. Sensitization is suggested as a possible psychobiological mechanism

  7. The relationship between chronic whiplash-associated disorder and post-traumatic stress: attachment-anxiety may be a vulnerability factor

    Directory of Open Access Journals (Sweden)

    Tonny Elmose Andersen

    2011-01-01

    Full Text Available Background: In more than 90% of whiplash accidents a good explanation regarding the association between trauma mechanism, organic pathology, and persistent symptoms has failed to be provided. Objective: We predicted that the severity of chronic whiplash-associated disorder (WAD, measured as number of whiplash symptoms, pain duration, pain-related disability, and degree of somatisation would be associated with the number of post-traumatic stress disorder symptoms (PTSD. Secondly, we expected attachment-anxiety to be a vulnerability factor in relation to both PTSD and WAD. Design: Data were collected from 1,349 women and 360 men suffering from WAD from the Danish Society for Polio, Traffic, and Accident Victims. The PTSD symptoms were measured by the Harvard Trauma Questionnaire. All three core PTSD clusters were included: re-experiencing, avoidance, and hyperarousal. Attachment security was measured along the two dimensions, attachment-anxiety and attachment-avoidance, by the Revised Adult Attachment Scale. Results: PTSD symptoms were significantly related to the severity of WAD. In particular, the PTSD clusters of avoidance and hyperarousal were associated with the number of whiplash symptoms, disability, and somatisation. Attachment-anxiety was significantly related to PTSD symptoms and somatisation but not to pain and disability. A co-morbidity of 38.8% was found between the PTSD diagnosis and WAD, and about 20% of the sample could be characterised as securely attached. Conclusions: The PTSD clusters of avoidance and hyperarousal were significantly associated with severity of WAD. The study emphasises the importance of assessing PTSD symptomatology after whiplash injury. Furthermore, it highlights that attachment theory may facilitate the understanding of why some people are more prone to develop PTSD and WAD than others.For abstract or full text in other languages, please see Supplementary files under Reading Tools online

  8. Are smooth pursuit eye movements altered in chronic whiplash-associated disorders? A cross-sectional study

    DEFF Research Database (Denmark)

    Kongsted, Alice; Jørgensen, L V; Bendix, T

    2007-01-01

    To evaluate whether smooth pursuit eye movements differed between patients with long-lasting whiplash-associated disorders and controls when using a purely computerized method for the eye movement analysis.......To evaluate whether smooth pursuit eye movements differed between patients with long-lasting whiplash-associated disorders and controls when using a purely computerized method for the eye movement analysis....

  9. Whiplash and Whiplash Associated Disorder (WAS)

    Science.gov (United States)

    ... pain is occasionally seen and is quite common after whiplash and may be caused by injury to the ... for you.) Treatment of whiplash The treatment of ... who do not get better after about 12 weeks require specialized treatment, often from ...

  10. Surgical fasciectomy of the trapezius muscle combined with neurolysis of the Spinal accessory nerve; results and long-term follow-up in 30 consecutive cases of refractory chronic whiplash syndrome

    Directory of Open Access Journals (Sweden)

    Freeman Michael

    2010-04-01

    Full Text Available Abstract Background Chronic problems from whiplash trauma generally include headache, pain and neck stiffness that may prove refractory to conservative treatment modalities. As has previously been reported, such afflicted patients may experience significant temporary relief with injections of local anesthetic to painful trigger points in muscles of the shoulder and neck, or lasting symptomatic improvement through surgical excision of myofascial trigger points. In a subset of patients who present with chronic whiplash syndrome, the clinical findings suggest an affliction of the spinal accessory nerve (CN XI, SAN by entrapment under the fascia of the trapezius muscle. The present study was undertaken to assess the effectiveness of SAN neurolysis in chronic whiplash syndrome. Methods A standardized questionnaire and a linear visual-analogue scale graded 0-10 was used to assess disability related to five symptoms (pain, headache, insomnia, weakness, and stiffness before, and one year after surgery in a series of thirty consecutive patients. Results The preoperative duration of symptoms ranged from seven months to 13 years. The following changes in disability scores were documented one year after surgery: Overall pain decreased from 9.5 +/- 0.9 to 3.2 +/- 2.6 (p Conclusions Entrapment of the spinal accessory nerve and/or chronic compartment syndrome of the trapezius muscle may cause chronic debilitating pain after whiplash trauma, without radiological or electrodiagnostic evidence of injury. In such cases, surgical treatment may provide lasting relief.

  11. Acute whiplash associated disorders (WAD

    Directory of Open Access Journals (Sweden)

    Kumar S

    2011-04-01

    Full Text Available Khushnum Pastakia, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, SA, Australia Date of preparation: 27th January 2011Conflict of interest: None declaredBackground: Whiplash-associated disorder (WAD is the term given for the collection of symptoms affecting the neck that are triggered by an accident with an acceleration–deceleration mechanism such as a motor vehicle accident. The incidence of whiplash injury varies greatly between different parts of the world with significant monetary burden on the individual as well as the wider community.Objective: Which treatments are best for reducing pain and disability experience in acute WADs?Level of evidence: Clinical practice guidelines, systematic reviews, meta-analysis, randomized controlled trials.Search sources: PubMed, Cochrane Library, Medline, EMBASE, AUST health, AMED.Outcomes: From the patient perspective the main outcomes considered are pain and disability.Consumer summary: Whiplash-associated disorders include a range of symptoms related to the neck and head. They commonly occur after motor vehicle accidents or diving mishaps. There is good evidence to suggest that active exercise, acting as usual and combination therapy are the most effective treatment choices in an acute presentation.Keywords: whiplash, neckpain, pain levels, multimodel therapy

  12. Multivariate analysis of ultrasound-recorded dorsal strain sequences: Investigation of dynamic neck extensions in women with chronic whiplash associated disorders

    Science.gov (United States)

    Peolsson, Anneli; Peterson, Gunnel; Trygg, Johan; Nilsson, David

    2016-08-01

    Whiplash Associated Disorders (WAD) refers to the multifaceted and chronic burden that is common after a whiplash injury. Tools to assist in the diagnosis of WAD and an increased understanding of neck muscle behaviour are needed. We examined the multilayer dorsal neck muscle behaviour in nine women with chronic WAD versus healthy controls during the entire sequence of a dynamic low-loaded neck extension exercise, which was recorded using real-time ultrasound movies with high frame rates. Principal component analysis and orthogonal partial least squares were used to analyse mechanical muscle strain (deformation in elongation and shortening). The WAD group showed more shortening during the neck extension phase in the trapezius muscle and during both the neck extension and the return to neutral phase in the multifidus muscle. For the first time, a novel non-invasive method is presented that is capable of detecting altered dorsal muscle strain in women with WAD during an entire exercise sequence. This method may be a breakthrough for the future diagnosis and treatment of WAD.

  13. Does cervical kyphosis relate to symptoms following whiplash injury?

    Science.gov (United States)

    Johansson, Mats Peter; Baann Liane, Martin Skogheim; Bendix, Tom; Kasch, Helge; Kongsted, Alice

    2011-08-01

    The mechanisms for developing long-lasting neck pain after whiplash injuries are still largely unrevealed. In the present study it was investigated whether a kyphotic deformity of the cervical spine, as opposed to a straight or a lordotic spine, was associated with the symptoms at baseline, and with the prognosis one year following a whiplash injury. MRI was performed in 171 subjects about 10 d after the accident, and 104 participated in the pain recording at 1-year follow-up. It was demonstrated that postures as seen on MRI can be reliably categorized and that a straight spine is the most frequent appearance of the cervical spine in supine MRI. In relation to symptoms it was seen that a kyphotic deformity was associated with reporting the highest intensities of headache at baseline, but not with an increased risk of long-lasting neck pain or headache. In conclusion, a kyphotic deformity is not significantly associated with chronic whiplash associated pain. Moreover, it is a clear clinical implication that pain should not be ascribed to a straight spine on MRI. We suggest that future trials on cervical posture focus upon the presence of kyphotic deformity rather than just on the absence of lordosis.

  14. Are early MRI findings correlated with long-lasting symptoms following whiplash injury? A prospective trial with 1-year follow-up

    DEFF Research Database (Denmark)

    Kongsted, Alice; Sorensen, Joan; Andersen, Hans

    2008-01-01

    prospectively followed cohorts are needed to identify possible clinically relevant MRI findings. The objective of this trial was to evaluate (1) the predictive value of cervical MRI after whiplash injuries and (2) the value of repeating MRI examinations after 3 months including sequences with flexion...... and extension of the cervical spine. Participants were included after rear-end or frontal car collisions. Patients with fractures or dislocations diagnosed by standard procedures at the emergency unit were not included. MRI scans of the cervical spine were performed at baseline and repeated after 3 months....... Clinical follow-ups were performed after 3 and 12 months. Outcome parameters were neck pain, headache, neck disability and working ability. A total of 178 participants had a cervical MRI scan on average 13 days after the injury. Traumatic findings were observed in seven participants. Signs of disc...

  15. StressModEx – Physiotherapist-led Stress Inoculation Training integrated with exercise for acute whiplash injury: study protocol for a randomised controlled trial

    OpenAIRE

    Carrie Ritchie; Justin Kenardy; Rob Smeets; Michele Sterling

    2015-01-01

    Introduction: Whiplash associated disorders are the most common non-hospitalised injuries following a road traffic crash. Up to 50% of individuals who experience a whiplash injury will not fully recover and report ongoing pain and disability. Most recovery, if it occurs, takes place in the first 2-3 months post injury, indicating that treatment provided in the early stages is critical to long-term outcome. However, early management approaches for people with acute whiplash associated disorder...

  16. A three-group study, internet-based, face-to-face based and standard- management after acute whiplash associated disorders (WAD – choosing the most efficient and cost-effective treatment: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bring Annika

    2009-07-01

    contribute to the creation of a cost-effective behavioural medicine approach to management of acute Whiplash Associated Disorders. The results of this study will answer an important question; on what extent and how should these patients be treated at acute stage and how much does the best management cost. Trial registration number Current Controlled Trials ISRCTN61531337

  17. Correlations between coping styles and symptom expectation for whiplash injury.

    Science.gov (United States)

    Ferrari, Robert; Russell, Anthony S

    2010-11-01

    In pain conditions, active coping has been found to be associated with less severe depression, increased activity level, and less functional impairment. Studies indicate that Canadians have a high expectation for chronic pain following whiplash injury. Expectation of recovery has been shown to predict recovery in whiplash victims. The objective of this study was to compare both the expectations and the coping style for whiplash injury in injury-naive subjects. The Vanderbilt Pain Management Inventory was administered to university students. Subjects who had not yet experienced whiplash injury were given a vignette concerning a neck sprain (whiplash injury) in a motor vehicle collision and were asked to indicate how likely they were to have thoughts or behaviors indicated in the coping style questionnaire. Subjects also completed expectation questionnaires regarding whiplash injury. Subjects (57%) held an expectation of chronic pain after whiplash injury. The mean active coping style score was 28.5±6.6 (40 is the maximum score for active coping). The mean passive coping style score was 28.5±6.6 (50 is the maximum score for passive coping). Those with high passive coping styles had a higher mean expectation score. The correlation between passive coping style score and expectation score was 0.62, while the correlation between active coping style score and expectation was -0.48. Both expectations and coping styles may interact or be co-modifiers in the outcomes of whiplash injury in whiplash victims. Further studies of coping style as an etiologic factor in the chronic whiplash syndrome are needed.

  18. Subgroups based on thermal and pressure pain thresholds in women with chronic whiplash display differences in clinical presentation – an explorative study

    Directory of Open Access Journals (Sweden)

    Börsbo B

    2012-11-01

    Full Text Available Björn Börsbo,1,2 Gunilla M Liedberg,3 Mia Wallin,1,3 Björn Gerdle1,41Department of Medicine and Health Sciences, University of Linköping, Linköping, Sweden; 2Clinical Department of Rehabilitation Medicine, County Hospital Ryhov, Jönköping, Sweden; 3Department of Social and Welfare Studies, University of Linköping, Norrköping, Sweden; 4Pain and Rehabilitation Centre, UHL, Östergötland County Council, Linköping, SwedenPurpose: To investigate the presence of subgroups in chronic whiplash-associated disorders (WAD based on pain thresholds for pressure (PPT, cold (CPT, and heat (HPT and to compare these subgroups with respect to symptomatology, disability, and health aspects. Methods: Two groups of female subjects – patients with chronic WAD (n = 28 and healthy controls (CON; n = 29 – were investigated. Quantitative sensory testing (QST for thermal thresholds and algometry for PPT at four sites in the body (over the trapezius and tibialis anterior bilaterally were determined. Habitual pain intensities, psychological strain, disability, and health aspects were registered using a questionnaire.Results: A cluster analysis based on PPT, CPT, and HPT identified two subgroups of chronic WAD: one sensitive subgroup (s-WAD; n = 21, and one less sensitive subgroup (ls-WAD; n = 6. S-WAD displayed widespread hyperalgesia, whereas ls-WAD had localized hyperalgesia in the neck area, with tendencies to supernormal values in remote areas of the body. Generally, s-WAD had a significantly worse situation than the CON with respect to symptomatology, disability, and health aspects. The ls-WAD group was intermediary between s-WAD and CON in these aspects.Conclusion: Different explanations, eg, severity of the pain condition per se, etiological factors, and pre-trauma differences in pain sensitivity, may exist for the differences in pain thresholds between the two subgroups. Future research should investigate the role of pain thresholds in the chronic

  19. Biomechanics of whiplash injury

    Institute of Scientific and Technical Information of China (English)

    CHEN Hai-bin; King H YANG; WANG Zheng-guo

    2009-01-01

    Despite a large number of rear-end collisions on the road and a high frequency of whiplash injuries reported, the mechanism of whiplash injuries is not completely understood. One of the reasons is that the injury is not necessarily accompanied by obvious tissue damage detectable by X-ray or MRI. An extensive series of biomechanics studies, including injury epidemiology, neck kinematics,facet capsule ligament mechanics, injury mechanisms and injury criteria, were undertaken to help elucidate these whiplash injury mechanisms and gain a better understanding of cervical facet pain. These studies provide the following evidences to help explain the mechanisms of the whiplash injury: (1) Whiplash injuries are generally considered to be a soft tissue injury of the neck with symptoms such as neck pain and stiffness, shoulder weakness, dizziness, headache and memory loss, etc. (2) Based on kinematical studies on the cadaver and volunteers, there are three distinct periods that have the potential to cause injury to the neck. In the first stage, flexural deformation of the neck is observed along with a loss of cervical lordosis; in the second stage, the cervical spine assumes an S-shaped curve as the lower vertebrae begin to extend and gradually cause the upper vertebrae to extend; during the final stage, the entire neck is extended due to the extension moments at both ends. (3)The in vivo environment afforded by rodent models of injury offers particular utility for linking mechanics, nociception and behavioral outcomes. Experimental findings have examined strains across the facet joint as a mechanism of whiplash injury, and suggested a capsular strain threshold or a vertebral distraction threshold for whiplash-related injury,potentially producing neck pain. (4) Injuries to the facet capsule region of the neck are a major source of post-crash pain. There are several hypotheses on how whiplash-associated injury may occur and three of these injuries are related to strains within

  20. Biomechanics of whiplash injury.

    Science.gov (United States)

    Chen, Hai-bin; Yang, King H; Wang, Zheng-guo

    2009-10-01

    Despite a large number of rear-end collisions on the road and a high frequency of whiplash injuries reported, the mechanism of whiplash injuries is not completely understood. One of the reasons is that the injury is not necessarily accompanied by obvious tissue damage detectable by X-ray or MRI. An extensive series of biomechanics studies, including injury epidemiology, neck kinematics, facet capsule ligament mechanics, injury mechanisms and injury criteria, were undertaken to help elucidate these whiplash injury mechanisms and gain a better understanding of cervical facet pain. These studies provide the following evidences to help explain the mechanisms of the whiplash injury: (1) Whiplash injuries are generally considered to be a soft tissue injury of the neck with symptoms such as neck pain and stiffness, shoulder weakness, dizziness, headache and memory loss, etc. (2) Based on kinematical studies on the cadaver and volunteers, there are three distinct periods that have the potential to cause injury to the neck. In the first stage, flexural deformation of the neck is observed along with a loss of cervical lordosis; in the second stage, the cervical spine assumes an S-shaped curve as the lower vertebrae begin to extend and gradually cause the upper vertebrae to extend; during the final stage, the entire neck is extended due to the extension moments at both ends. (3) The in vivo environment afforded by rodent models of injury offers particular utility for linking mechanics, nociception and behavioral outcomes. Experimental findings have examined strains across the facet joint as a mechanism of whiplash injury, and suggested a capsular strain threshold or a vertebral distraction threshold for whiplash-related injury, potentially producing neck pain. (4) Injuries to the facet capsule region of the neck are a major source of post-crash pain. There are several hypotheses on how whiplash-associated injury may occur and three of these injuries are related to strains

  1. Whiplash and its treatment

    NARCIS (Netherlands)

    Scholten-Peeters, G.G.M.

    2004-01-01

    Background: Active interventions show beneficial effect on recovery for patients with Whiplash-Associated Disorders grade 1 and 2. However, it is unclear who of the care providers in primary care is best able to provide these active treatment strategies. Methods: The objective of the study was to co

  2. Long-term Labour Market Performance of Whiplash Claimants

    DEFF Research Database (Denmark)

    Leth-Petersen, Søren; Rotger, Gabriel Pons

    financial incentive to not reduce earnings. This suggests that moderate injuries tend to be chronic, and that compensation-seeking behaviour is not the main explanation for this group. We find that claimants with chronic WADs used more health care in the year prior to the whiplash than claimants with non...

  3. The diagnosis and treatment of nonspecific neck pain and whiplash.

    Science.gov (United States)

    Binder, A

    2007-03-01

    Nonspecific (simple) neck pain is the commonest cause of neck symptoms and results from postural and mechanical causes. It includes pain following whiplash injury provided there is no bony injury or objective neurological deficit. The anatomy of the cervical spine is described, with the degenerative changes that are seen in patients with nonspecific neck pain, but also occur with ageing. The poor correlation between the degree of degeneration and presence and severity of symptoms is noted. A lack of specific pathology is also a feature of whiplash. The epidemiology, clinical presentation, investigation, and complications of nonspecific neck pain are described with a discussion of the controversial aspects of natural history, prognosis and therapy. Chronic whiplash is very common in some countries, but nonexistent in other countries and the factors which might explain this difference are considered. There is a great need for better quality studies to explore pathogenesis, natural history and factors including therapy that influence outcome.

  4. An attempt of early detection of poor outcome after whiplash

    Directory of Open Access Journals (Sweden)

    Sebastien LAPORTE

    2016-10-01

    Full Text Available The main concern with whiplash is that a large proportion of whiplash patients experience disabling symptoms or whiplash associated disorders (WAD for months if not years following the accident. Therefore, identifying early prognostic factors of WAD development is important as WAD have widespread clinical and economic consequences.In order to tackle that question, our study was specifically aimed at combining several methods of investigation in the same WAD patients at the acute stage and six months later. Our longitudinal, open, prospective, multi-center study included 38 whiplash patients, and 13 healthy volunteers matched for age, gender, and socio-economic status with the whiplash group. Whiplash patients were evaluated 15 to 21 days after road accident, and 6 months later. At each appointment, patients underwent a neuropsychological evaluation, a full clinical neurological examination, neurophysiological and postural tests, oto-neurological tests, cervical spine cord Magnetic Resonance Imaging (MRI with tractography (DTI. At 6-month, whiplash patients were categorized into two subgroups based on the results of the Diagnostic and Statistical Manual of Mental Disorders as having either favourable or unfavourable progression (an unfavourable classification corresponding to the presence of Post-Concussion Symptom PCS and we searched retrospectively for early prognostic factors of WAD predicting the passage to chronicity. We found that patients displaying high level of catastrophizing at the acute stage and /or post-traumatic stress disorder associated with either abnormalities in head or trunk kinematics, abnormal test of the otolithic function and at the Equitest or a combination of these syndromes, turned to chronicity. That is, the association of a neuropsychological disorder with a somatic one was sufficient to explain the passage to chronicity. This study suggests that low-grade whiplash patients should be submitted as early as possible

  5. Definition, klassifikation og epidemiologi ved whiplash

    DEFF Research Database (Denmark)

    Jensen, Troels Staehelin; Kasch, Helge; Bach, Flemming Winther

    2010-01-01

    A whiplash trauma is caused by an acceleration-deceleration force transferring its energy to the cervical spine. Whiplash-associated disorder (WAD) refers to the symptoms that develop after a whiplash injury. The prognosis is favorable with recovery in over 90% of the injured subjects. In a fract......A whiplash trauma is caused by an acceleration-deceleration force transferring its energy to the cervical spine. Whiplash-associated disorder (WAD) refers to the symptoms that develop after a whiplash injury. The prognosis is favorable with recovery in over 90% of the injured subjects...

  6. An Attempt of Early Detection of Poor Outcome after Whiplash

    Science.gov (United States)

    Laporte, Sebastien; Wang, Danping; Lecompte, Jennyfer; Blancho, Sophie; Sandoz, Baptiste; Feydy, Antoine; Lindberg, Pavel; Adrian, Julien; Chiarovano, Elodie; de Waele, Catherine; Vidal, Pierre-Paul

    2016-01-01

    The main concern with whiplash is that a large proportion of whiplash patients experience disabling symptoms or whiplash-associated disorders (WAD) for months if not years following the accident. Therefore, identifying early prognostic factors of WAD development is important as WAD have widespread clinical and economic consequences. In order to tackle that question, our study was specifically aimed at combining several methods of investigation in the same WAD patients at the acute stage and 6 months later. Our longitudinal, open, prospective, multi-center study included 38 whiplash patients, and 13 healthy volunteers matched for age, gender, and socio-economic status with the whiplash group. Whiplash patients were evaluated 15–21 days after road accident, and 6 months later. At each appointment, patients underwent a neuropsychological evaluation, a full clinical neurological examination, neurophysiological and postural tests, oto-neurological tests, cervical spine cord magnetic resonance imaging (MRI) with tractography (DTI). At 6 months, whiplash patients were categorized into two subgroups based on the results of the Diagnostic and Statistical Manual of Mental Disorders as having either favorable or unfavorable progression [an unfavorable classification corresponding to the presence of post-concussion symptom (PCS)] and we searched retrospectively for early prognostic factors of WAD predicting the passage to chronicity. We found that patients displaying high level of catastrophizing at the acute stage and/or post-traumatic stress disorder associated with either abnormalities in head or trunk kinematics, abnormal test of the otolithic function and at the Equitest or a combination of these syndromes, turned to chronicity. This study suggests that low-grade whiplash patients should be submitted as early as possible after the trauma to neuropsychological and motor control tests in a specialized consultation. In addition, they should be evaluated by a neuro

  7. An Attempt of Early Detection of Poor Outcome after Whiplash.

    Science.gov (United States)

    Laporte, Sebastien; Wang, Danping; Lecompte, Jennyfer; Blancho, Sophie; Sandoz, Baptiste; Feydy, Antoine; Lindberg, Pavel; Adrian, Julien; Chiarovano, Elodie; de Waele, Catherine; Vidal, Pierre-Paul

    2016-01-01

    The main concern with whiplash is that a large proportion of whiplash patients experience disabling symptoms or whiplash-associated disorders (WAD) for months if not years following the accident. Therefore, identifying early prognostic factors of WAD development is important as WAD have widespread clinical and economic consequences. In order to tackle that question, our study was specifically aimed at combining several methods of investigation in the same WAD patients at the acute stage and 6 months later. Our longitudinal, open, prospective, multi-center study included 38 whiplash patients, and 13 healthy volunteers matched for age, gender, and socio-economic status with the whiplash group. Whiplash patients were evaluated 15-21 days after road accident, and 6 months later. At each appointment, patients underwent a neuropsychological evaluation, a full clinical neurological examination, neurophysiological and postural tests, oto-neurological tests, cervical spine cord magnetic resonance imaging (MRI) with tractography (DTI). At 6 months, whiplash patients were categorized into two subgroups based on the results of the Diagnostic and Statistical Manual of Mental Disorders as having either favorable or unfavorable progression [an unfavorable classification corresponding to the presence of post-concussion symptom (PCS)] and we searched retrospectively for early prognostic factors of WAD predicting the passage to chronicity. We found that patients displaying high level of catastrophizing at the acute stage and/or post-traumatic stress disorder associated with either abnormalities in head or trunk kinematics, abnormal test of the otolithic function and at the Equitest or a combination of these syndromes, turned to chronicity. This study suggests that low-grade whiplash patients should be submitted as early as possible after the trauma to neuropsychological and motor control tests in a specialized consultation. In addition, they should be evaluated by a neuro

  8. Do whiplash patients differ from other patients with non-specific neck pain regarding pain, function or prognosis?

    Science.gov (United States)

    Verhagen, Arianne P; Lewis, Martyn; Schellingerhout, Jasper M; Heymans, Martijn W; Dziedzic, Krysia; de Vet, Henrica C W; Koes, Bart W

    2011-10-01

    We evaluated whether patients with self-reported whiplash differed in perceived pain, functional limitation and prognosis from patients with other painful neck complaints. Data from three Dutch trials and an English trial were used all evaluating conservative treatment in neck pain patients in primary care. All patients had non-specific neck pain. Information on any trauma or injury came from self-report at baseline. We compared frequencies of baseline variables and outcome at short-term and long term for whiplash and non-trauma neck pain patients separately. The total study population consisted of 804 neck pain patients. Of these patients 133 reported (16.5%) that an injury was the cause of their neck pain. In all trials there were 17-18% more male patients in the whiplash group. At follow-up pain decreased between 12 and 28%, function 10%, and 25-50% of patients recovered in all trials. Post-treatment improvements in pain, function and recovery were comparable between whiplash and non-trauma patients. We also found no different prognostic factors between whiplash and non-trauma patients. Overall we found in a population with mild to moderate pain no clinically relevant differences between patients with self-reported whiplash and patients with other painful neck complaints. The findings suggest that whiplash patients with mild to moderate pain should not be considered a specific subgroup of patients with non-specific neck pain.

  9. Definition, klassifikation og epidemiologi ved whiplash

    DEFF Research Database (Denmark)

    Jensen, Troels Staehelin; Kasch, Helge; Bach, Flemming Winther

    2010-01-01

    A whiplash trauma is caused by an acceleration-deceleration force transferring its energy to the cervical spine. Whiplash-associated disorder (WAD) refers to the symptoms that develop after a whiplash injury. The prognosis is favorable with recovery in over 90% of the injured subjects...

  10. Cognitive complaints in patients after whiplash injury: the impact of malingering

    Science.gov (United States)

    Schmand, B; Lindeboom, J; Schagen, S; Heijt, R; Koene, T; Hamburger, H

    1998-01-01

    OBJECTIVES—The validity of memory and concentration complaints that are often reported after a whiplash trauma is controversial. The prevalence of malingering or underperformance in post-whiplash patients, and its impact on their cognitive test results were studied.
METHODS—The Amsterdam short term memory (ASTM) test, a recently developed malingering test, was used as well as a series of conventional memory and concentration tests. The study sample was a highly selected group of patients, who were examined either as part of a litigation procedure (n=36) or in the normal routine of an outpatient clinic (n=72).
RESULTS—The prevalence of underperformance, as defined by a positive score on the malingering test, was 61% (95% CI: 45-77) in the context of litigation, and 29% (95% CI: 18-40) in the outpatient clinic (p=0.003). Furthermore, the scores on the memory and concentration test of malingering post-whiplash patients (n=43) and non-malingering post-whiplash patients (n=65) were compared with the scores of patients with closed head injury (n=20) and normal controls (n=46). The malingering post-whiplash patients scored as low as the patients with closed head injury on most tests.
CONCLUSIONS—The prevalence of malingering or cognitive underperformance in late post-whiplash patients is substantial, particularly in litigation contexts. It is not warranted to explain the mild cognitive disorders of whiplash patients in terms of brain damage, as some authors have done. The cognitive complaints of non-malingering post-whiplash patients are more likely a result of chronic pain, chronic fatigue, or depression.

 PMID:9527145

  11. The outcome of control groups in clinical trials of conservative treatments for chronic mechanical neck pain: a systematic review

    Directory of Open Access Journals (Sweden)

    Hagino Carol

    2006-07-01

    Full Text Available Abstract Background Chronic neck pain is highly prevalent in Western societies, with about 15% of females and 10% of males suffering with it at any time. The course of untreated chronic neck pain patients in clinical trials has not been well-defined and the placebo effect has not been clarified. Methods A systematic review of RCT's of conservative treatments for chronic mechanical neck pain was conducted. Studies were excluded if they did not include a control group, if they involved subjects with whiplash injuries, a predominance of headache or arm pain associated with chronic neck pain and if only one treatment was reported. Only studies scoring 3–5 out of 5 on the Jadad Scale for quality were included in the final analysis. Data on change in pain scores of subjects in both placebo (PL as well as no-treatment (NT control groups were analyzed. Mean changes in pain scores as well as effect sizes were calculated, summarized and compared between these groups. Results Twenty (20 studies, 5 in the NT group and 15 in the PL group, with outcome intervals ranging from 1–52 weeks were included in the final analysis. The mean [95% CI] effect size of change in pain ratings in the no-treatment control studies at outcome points up to 10 weeks was 0.18 [-0.05, 0.41] and for outcomes from 12–52 weeks it was 0.4 [0.12, 0.68]. In the placebo control groups it was 0.50 [0.10, 0.90] at up to 10 weeks and 0.33. [-1.97, 2.66] at 12–24 weeks. None of the comparisons between the no-treatment and placebo groups were statistically significant. Conclusion It appears that the changes in pain scores in subjects with chronic neck pain not due to whiplash who are enrolled in no-treatment and placebo control groups were similarly small and not significantly different. As well, they do not appear to increase over longer-term follow-up.

  12. Chronic mechanical neck pain in adults treated by manual therapy: a systematic review of change scores in randomized controlled trials of a single session.

    Science.gov (United States)

    Vernon, Howard; Humphreys, Barry Kim

    2008-01-01

    We report a systematic analysis of group change scores of subjects with chronic neck pain not due to whiplash and without headache or arm pain, in randomized clinical trials of a single session of manual therapy. A comprehensive literature search of clinical trials of chronic neck pain treated with manual therapies up to December 2006 was conducted. Trials that scored above 60% on the PEDro Scale were included. Change scores were analyzed for absolute, percentage change and effect size (ES) whenever possible. Nine trials were identified: 6 for spinal manipulation, 4 for spinal mobilization or non-manipulative manual therapy (2 overlapping trials), and 1 trial using ischemic compression. No trials were identified for massage therapy or manual traction. Four manipulation trials (five groups) reported mean immediate changes in 100-mm VAS of -18.94 (9.28) mm. ES for these changes ranged from .33 to 2.3. Two mobilization trials reported immediate VAS changes of -11.5 and -4 mm (ES of .36 and .22, respectively); one trial reported no difference in immediate pain scores versus sham mobilization. The ischemic compression study showed statistically significant immediate decreases in 100-mm pain VAS (average = -14.6 mm). There is moderate-to-high quality evidence that immediate clinically important improvements are obtained from a single session of spinal manipulation. The evidence for mobilization is less substantial, with fewer studies reporting smaller immediate changes. There is insufficient evidence for ischemic compression to draw conclusions. There is no evidence for a single session of massage or manual traction for chronic neck pain.

  13. Functional health status in subjects after a motor vehicle accident, with emphasis on whiplash associated disorders: Design of a descriptive, prospective inception cohort study

    NARCIS (Netherlands)

    Schmitt, Manfred; Meeteren, N.L. van; Wijer, A. de; Helders, P.J.M.; Graaf, Y. van der

    2008-01-01

    BACKGROUND: The clinical consequences of whiplash injuries resulting from a motor vehicle accident (MVA) are poorly understood. Thereby, there is general lack of research on the development of disability in patients with acute and chronic Whiplash Associated Disorders. METHODS/DESIGN: The objective

  14. Functional health status in subjects after a motor vehicle accident, with emphasis on whiplash associated disorders : design of a descriptive, prospective inception cohort study

    NARCIS (Netherlands)

    Schmitt, Maarten A.; van Meeteren, Nico L. U.; de Wijer, Anton; Helders, Paul J. M.; van der Graaf, Yolanda

    2008-01-01

    Background: The clinical consequences of whiplash injuries resulting from a motor vehicle accident (MVA) are poorly understood. Thereby, there is general lack of research on the development of disability in patients with acute and chronic Whiplash Associated Disorders. Methods/Design: The objective

  15. Temporomandibular disorders after whiplash injury

    DEFF Research Database (Denmark)

    Kasch, Helge; Hjorth, Tine; Svensson, Peter

    2002-01-01

    patients compared with a matched control group. The aim of the present study was to assess pain and sensorimotor function in the craniofacial region in an unselected group of patients sustaining a motor vehicle accident involving a rear collision. Methods: Prospectively, 19 acute whiplash patients exposed......Aims: Whiplash injury to the neck, is often considered a significant risk factor for development of temporomandibular disorders (TMD), and has been proposed to produce internal derangements of the temporomandibular joint (TMJ). Few studies however have examined TMD-related pain in acute whiplash...... diagnostic criteria. Participants underwent structured interviews, filled out the McGill Pain Questionnaire (MPQ), and bad their masticatory system examined by a trained dentist, blinded to their diagnosis. Pain detection threshold (PDT) to pressure stimuli, and maximal voluntary occlusal force (MVOF) were...

  16. Ph+ CML in early chronic phase | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available the trial The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia... protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia (CML) i

  17. Behandling af gener efter whiplash

    DEFF Research Database (Denmark)

    Rittig-Rasmussen, Bjarne; Kongsted, Alice; Carstensen, Tina Birgitte;

    2010-01-01

    Treatment of whiplash-associated disorders starts with a thorough clinical examination, which may be repeated after 1-3 weeks. For optimal results it is essential that the patient receives clear information about the condition and that any pain is treated effectively with analgesics. Risk factors...

  18. The fear-avoidance model in whiplash injuries.

    Science.gov (United States)

    Nieto, Rubén; Miró, Jordi; Huguet, Anna

    2009-05-01

    The aim of this work was to study whether fear of movement, and pain catastrophizing predict pain related-disability and depression in sub-acute whiplash patients. Moreover, we wanted to test if fear of movement is a mediator in the relation between catastrophizing and pain-related disability/depression as has been suggested by the fear-avoidance model [Vlaeyen JWS, Kole-Snijders AMJ, Boeren RGB, van Eek H. Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain 1995;62:363-72]. The convenience sample used was of 147 sub-acute whiplash patients (pain duration less than 3 months). Two stepwise regression analyses were performed using fear of movement and catastrophizing as the independent variables, and disability and depression as the dependent variables. After controlling for descriptive variables and pain characteristics, catastrophizing and fear of movement were found to be predictors of disability and depression. Pain intensity was a predictor of disability but not of depression. The mediation effect of fear of movement in the relationships between catastrophizing and disability, and between catastrophizing and depression was also supported. The results of this study are in accordance with the fear-avoidance model, and support a biopsychosocial perspective for whiplash disorders.

  19. A controlled trial of ambroxol in chronic bronchitis.

    Science.gov (United States)

    Guyatt, G H; Townsend, M; Kazim, F; Newhouse, M T

    1987-10-01

    Ambroxol is a mucolytic agent which is widely used in chronic bronchitis in Europe. We conducted a double-blind randomized controlled trial of ambroxol vs matched placebo in 90 patients with chronic bronchitis and difficulty clearing secretions. It was concluded that there was no advantage to taking ambroxol.

  20. Can kinesiophobia predict the duration of neck symptoms in acute whiplash?

    NARCIS (Netherlands)

    Buitenhuis, J; Jaspers, JPC; Fidler, [No Value

    2006-01-01

    Objectives: In low back pain, clinical studies suggest that kinesiophobia (fear of movement/(re)injury) is important in the etiology of chronic symptoms. In this prospective cohort study, the predictive role of kinesiophobia in the development of late whiplash syndrome was examined. Methods: Victims

  1. Novel insights into the interplay between ventral neck muscles in individuals with whiplash-associated disorders.

    Science.gov (United States)

    Peterson, Gunnel; Nilsson, David; Trygg, Johan; Falla, Deborah; Dedering, Åsa; Wallman, Thorne; Peolsson, Anneli

    2015-10-16

    Chronic whiplash-associated disorder (WAD) is common after whiplash injury, with considerable personal, social, and economic burden. Despite decades of research, factors responsible for continuing pain and disability are largely unknown, and diagnostic tools are lacking. Here, we report a novel model of mechanical ventral neck muscle function recorded from non-invasive, real-time, ultrasound measurements. We calculated the deformation area and deformation rate in 23 individuals with persistent WAD and compared them to 23 sex- and age-matched controls. Multivariate statistics were used to analyse interactions between ventral neck muscles, revealing different interplay between muscles in individuals with WAD and healthy controls. Although the cause and effect relation cannot be established from this data, for the first time, we reveal a novel method capable of detecting different neck muscle interplay in people with WAD. This non-invasive method stands to make a major breakthrough in the assessment and diagnosis of people following a whiplash trauma.

  2. Interdisciplinary rehabilitation after whiplash injury

    Science.gov (United States)

    Haiduk, Philipp; Benz, Thomas; Lehmann, Susanne; Gysi-Klaus, Francoise; Aeschlimann, André; Michel, Beat A.; Angst, Felix

    2017-01-01

    Abstract Whiplash injury associated disorders (WAD) cause high costs for public health care. Neck pain is number 16 on the global prevalence lists for the 50 most common sequelae. It is of importance to obtain long-term data on disability and working capacity outcomes after rehabilitation. Long-term prospective data of the outcome course of whiplash are sparse. The aim of this study was to quantify improvements of pain, function/role performance, vitality, and working capacity 5 years after whiplash injury and to compare the state of health to normative values at 5 years after rehabilitation. In this naturalistic, observational, prospective cohort study, 115 patients were assessed 5 years (60 months) after a multidisciplinary rehabilitation program. The assessment set consisted of the Short Form 36 (SF-36), parts of the North American Spine Society's cervical spine assessment questionnaire (NASS) and the coping strategies questionnaire (CSQ). The effects were quantified by effect size (ES) and standardized response mean (SRM). Score differences over the course were tested by the Wilcoxon–Mann–Whitney U test for significance. Comparing data between entry and 60 months after rehabilitation 8 of 15 parameters improved with large ES/SRM. Outcome between 6 and 60 months showed small to moderate ES/SRM. Working capacity increased from 0 at entry to rehabilitation to 21 h/wk at 6 months and to 30 h/wk at 60 months follow-up. After large improvements in health and working capacity in the mid-term, further important improvements were observed in the long-term course. It can be hypothesized that part of those can be attributed to the interventions during inpatient rehabilitation, for example, due to better coping strategies. PMID:28248865

  3. Whiplash-potilaan osteopaattinen hoito : tapaustutkimus

    OpenAIRE

    Aalto, Jutta; Levä, Eero

    2011-01-01

    Opinnäytetyössämme perehdymme Whiplash-vammaan ja tutkimme osteopaattisen hoidon vaikuttavuutta whiplash-vamman kroonistuneisiin oireiisin tapaustutkimuksen keinoin. Työmme on suunnattu osteopaateille. Työmme sisältää tutkimustietoa lääketieteellisistä tietokannoista ja osteopaattisista lähteistä sekä tapaustutkimuksen. Työssä selvitimme whiplash-vamman traumamekanismeja ja onnettomuudesta kuntoutumista. Kävimme läpi kuntoutuksen periaatteita sekä konservatiivisesta että osteopaattisesta näkö...

  4. Some observations on whiplash injuries.

    Science.gov (United States)

    Evans, R W

    1992-11-01

    Motor vehicle accidents with a whiplash mechanism of injury are one of the most common causes of neck injuries, with an incidence of perhaps 1 million per year in the United States. Proper adjustment of head restraints can reduce the incidence of neck pain in rear-end collisions by 24%. Persistent neck pain is more common in women by a ratio of 70:30. Whiplash injuries usually result in neck pain owing to myofascial trauma, which has been documented in both animal and human studies. Headaches, reported in 82% of patients acutely, are usually of the muscle contraction type, often associated with greater occipital neuralgia and less often temporomandibular joint syndrome. Occasionally migraine headaches can be precipitated. Dizziness often occurs and can result from vestibular, central, and cervical injury. More than one third of patients acutely complain of paresthesias, which frequently are caused by trigger points and thoracic outlet syndrome and less commonly by cervical radiculopathy. Some studies have indicated that a postconcussion syndrome can develop from a whiplash injury. Interscapular and low back pain are other frequent complaints. Although most patients recover within 3 months after the accident, persistent neck pain and headaches after 2 years are reported by more than 30% and 10% of patients. Risk factors for a less favorable recovery include older age, the presence of interscapular or upper back pain, occipital headache, multiple symptoms or paresthesias at presentation, reduced range of movement of the cervical spine, the presence of an objective neurologic deficit, preexisting degenerative osteoarthritic changes; and the upper middle occupational category. There is only a minimal association of a poor prognosis with the speed or severity of the collision and the extent of vehicle damage. Whiplash injuries result in long-term disability with upward of 6% of patients not returning to work after 1 year. Although litigation is very common and always

  5. The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST)

    DEFF Research Database (Denmark)

    Winther, Kristian Hillert; Watt, Torquil; Bjørner, Jakob Bue;

    2014-01-01

    BACKGROUND: Patients with chronic autoimmune thyroiditis have impaired health-related quality of life. The thyroid gland has a high selenium concentration, and specific selenoprotein enzyme families are crucial to immune function, and catalyze thyroid hormone metabolism and redox processes...... in thyroid cells. Previous randomized controlled trials have found that selenium supplementation decreases thyroid-disease-specific antibody levels. We hypothesize that selenium might be beneficial in the treatment of chronic autoimmune thyroiditis. METHODS/DESIGN: The CATALYST trial is an investigator......-initiated randomized, blinded, multicentre clinical trial of selenium supplementation versus placebo in patients with chronic autoimmune thyroiditis. Inclusion criteria: age ≥18 years; serum thyroid peroxidase antibody level ≥100 IU/ml within the previous 12 months; treatment with levothyroxine and written informed...

  6. Diagnostic considerations on whiplash associated disorders

    OpenAIRE

    Tjell, Carsten

    1998-01-01

    Whiplash is caused by an acceleration-/deceleration transfer of energy to the neck. It commonly occurs in motor vehicle accidents. The force may result in lesions of the cervical spine and soft tissues, which may result in many clinical manifestations: whiplash associated disorders (WAD), according to the Quebec classification. However, the extent of coincident brainstem injury is still unknown. The symptoms of WAD vary, the commonest being: neck pain, concentration difficul...

  7. Use of botulinum toxin-A for musculoskeletal pain in patients with whiplash associated disorders [ISRCTN68653575

    Directory of Open Access Journals (Sweden)

    Juan Francisco J

    2004-02-01

    Full Text Available Abstract Background Whiplash associated disorder is commonly linked to motor vehicle accidents and sports injuries. Cervical injury is attributed to rapid extension followed by neck flexion. The exact pathophysiology of whiplash is uncertain but probably involves some degree of aberrant muscle spasms and may produce a wide range of symptoms. The most commonly prescribed pharmacological agents for initial treatment of whiplash-associated pain are oral muscle relaxants and nonsteroidal anti-inflammatory drugs. However, potential systemic adverse effects limit these agents. Physical interventions such as mobilization, manipulation, and exercises have proved beneficial for pain and dysfunction but only on a time-limited basis. Little evidence suggests that physical therapy specifically aimed at the musculature (e.g., transcutaneous electrical nerve stimulation, ultrasonography, heat, ice, and acupuncture improves prognosis in acute whiplash associated disorder. A new approach to treatment is the use of botulinum toxin, which acts to reduce muscle spasms. Methods/design This is a prospective, randomized, controlled clinical trial and botulinum toxin-A (Botox® injections will be compared with placebo injections. The primary objective is to determine the efficacy of Botox® in the management of musculoskeletal pain in whiplash associated disorders. Discussion Botulinum toxin type-A toxin has been studied in small trials on whiplash associated disorder patients and has generally been found to relieve pain and improve range of motion. Specifically, we seek to assess the efficacy of Botox® in reducing pain and to improve the cervical spine range of movement, during the 6-month trial period.

  8. Whiplash

    Science.gov (United States)

    ... the neck, usually because of sudden extension and flexion. The disorder commonly occurs as the result of an automobile accident and may include injury to intervertebral joints, discs, and ligaments, cervical muscles, and nerve roots. Symptoms such as neck ...

  9. Treatment Strategies for Chronic Cases

    Directory of Open Access Journals (Sweden)

    Susan M Lord

    2003-01-01

    Full Text Available The treatment of chronic somatic pain, including pain referred to the head, neck, shoulder girdle and upper limb from somatic structures, is addressed. Levels of evidence for the various treatments that have been prescribed for chronic whiplash associated disorders are considered. The challenge to find a treatment strategy for chronic pain after whiplash that completely relieves the condition and prevents its sequelae is reviewed.

  10. The return-to-work process of individuals sick-listed because of whiplash-associated disorder

    DEFF Research Database (Denmark)

    Biering-Sørensen, Sarah; Møller, Anne; Stoltenberg, C.;

    2014-01-01

    BACKGROUND: The chronic course of whiplash-associated disorder (WAD) has implications for both the individual and society. It has been shown that up to 50% of patients have not yet returned to work six months after a whiplash injury. We wanted to study the return-to-work (RTW) process......% returned to work in the WAD group as compared to 58% in the MSD group. CONCLUSION: Sick-listed individuals with whiplash-associated disorder are less likely to return to work than individuals who are sick-listed because of other musculoskeletal disorders. In both groups, RTW stabilised after two years...... from an existing database. Data on public transfer income were collected and the RTW process was followed on a weekly basis. Multivariate logistic regression analysis of RTW was done four times during the first three years after the start of sick-listing. RESULTS: One hundred and four individuals were...

  11. Use of cervical collar after whiplash injuries.

    Science.gov (United States)

    Józefiak-Wójtowicz, Anna; Stolarczyk, Artur; Deszczyński, Jarosław Michał; Materek, Magdalena; Pietras, Marta; Bażant, Katarzyna

    2014-08-08

    Whiplash injuries, also known as neck sprains and strains, are currently some of the most common injuries of the cervical spine. Mechanism of injury is still controversial and current treatment methods do not provide satisfactory results. In this article we present QTF classification of related disorders, epidemiological data and treatment methods. We described basic principles of using a soft collar, goals and effects of collar use and potential complications ensuing from immobilization. Authors reviewed publications comparing the effects of collar use with other methods of treatment and physiotherapy following whiplash injury.

  12. Post-traumatic stress, depression, and community integration a long time after whiplash injury

    Directory of Open Access Journals (Sweden)

    Britt-Marie Stålnacke

    2010-01-01

    Full Text Available Psychological factors such as post-traumatic stress and depression may play an important role in the recovery after whiplash injuries. Difficulties in psychosocial functioning with limitations in everyday life may dominate for some time after the injury. Our study therefore investigates the relationships between pain, post-traumatic stress, depression, and community integration. A set of questionnaires was answered by 191 persons (88 men, 103 women five years after a whiplash injury to assess pain intensity (visual analogue scale, VAS, whiplash-related symptoms, post-traumatic stress (impact of event scale, IES, depression (Beck depression inventory, BDI-II, community integration (community integration questionnaire, CIQ, life satisfaction (LiSat-11. One or more depressive symptoms were reported by 74% of persons; 22% reported scores that were classified as mild to severe depression. The presence of at least one post-traumatic symptom was reported by 70% of persons, and 38% reported mild to severe stress. Total scores of community integration for women were statistically significantly higher than for men. The total VAS score was correl-ated positively to the IES (r=0.456, P less than 0.456, the BDI (r=0.646, P less than 0.001, and negatively to the CIQ (r=-0.300, P less than 0.001. These results highlight the view that a significant proportion of people experience both pain and psycho- logical difficulties for a long time after a whiplash injury. These findings should be taken into consideration in the management of subjects with chronic whiplash symptoms and may support a multi-professional rehabilitation model that integrates physical, psychological, and psychosocial factors.

  13. Brain Connectivity Predicts Placebo Response across Chronic Pain Clinical Trials

    Science.gov (United States)

    Tétreault, Pascal; Mansour, Ali; Vachon-Presseau, Etienne; Schnitzer, Thomas J.; Apkarian, A. Vania

    2016-01-01

    Placebo response in the clinical trial setting is poorly understood and alleged to be driven by statistical confounds, and its biological underpinnings are questioned. Here we identified and validated that clinical placebo response is predictable from resting-state functional magnetic-resonance-imaging (fMRI) brain connectivity. This also led to discovering a brain region predicting active drug response and demonstrating the adverse effect of active drug interfering with placebo analgesia. Chronic knee osteoarthritis (OA) pain patients (n = 56) underwent pretreatment brain scans in two clinical trials. Study 1 (n = 17) was a 2-wk single-blinded placebo pill trial. Study 2 (n = 39) was a 3-mo double-blinded randomized trial comparing placebo pill to duloxetine. Study 3, which was conducted in additional knee OA pain patients (n = 42), was observational. fMRI-derived brain connectivity maps in study 1 were contrasted between placebo responders and nonresponders and compared to healthy controls (n = 20). Study 2 validated the primary biomarker and identified a brain region predicting drug response. In both studies, approximately half of the participants exhibited analgesia with placebo treatment. In study 1, right midfrontal gyrus connectivity best identified placebo responders. In study 2, the same measure identified placebo responders (95% correct) and predicted the magnitude of placebo’s effectiveness. By subtracting away linearly modeled placebo analgesia from duloxetine response, we uncovered in 6/19 participants a tendency of duloxetine enhancing predicted placebo response, while in another 6/19, we uncovered a tendency for duloxetine to diminish it. Moreover, the approach led to discovering that right parahippocampus gyrus connectivity predicts drug analgesia after correcting for modeled placebo-related analgesia. Our evidence is consistent with clinical placebo response having biological underpinnings and shows that the method can also reveal that active

  14. Clinical trials in CIDP and chronic autoimmune demyelinating polyneuropathies.

    Science.gov (United States)

    Dalakas, Marinos C

    2012-05-01

    The main chronic autoimmune neuropathies include chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy (MMN), and anti-myelin-associated glycoprotein (MAG) demyelinating neuropathy. On the basis of randomized controlled studies, corticosteroids, intravenous immunoglobulin (IVIg), and plasmapheresis provide short-term benefits in CIDP. MMN responds only to IVIg. Because in MMN and CIDP, IVIg infusions are required every 3-6 weeks to sustain benefits or long-term remissions, there is a need for "IVIg-sparing" agents. In CIDP, immunosuppressive drugs, such as azathioprine, cyclosporine, methotrexate, mycophenolate, and cyclophosphamide, are used, but controlled trials have not shown that they are effective. Controlled trials have also not shown benefit to any agents in anti-MAG neuropathy. However, clinicians use many immunosuppressive drugs in both settings, but all have potentially serious side effects and are only effective in some patients. Thus, there is a need for new therapies in the inflammatory and paraproteinemic neuropathies. New agents targeting T cells, B cells, and transmigration and transduction molecules are discussed as potential treatment options for new trials. The need for biomarkers that predict therapeutic responses or identify patients with active disease is emphasized, and the search for better scoring tools that capture meaningful changes after response to therapies is highlighted.

  15. ISCHEMIA in chronic kidney disease: improving the representation of patients with chronic kidney disease in cardiovascular trials.

    Science.gov (United States)

    Wyatt, Christina M; Shineski, Matthew; Chertow, Glenn M; Bangalore, Sripal

    2016-06-01

    Despite the high cardiovascular risk associated with chronic kidney disease, a recent systematic review confirmed that patients with kidney disease remain underrepresented in cardiovascular trials. Two ongoing trials are assessing the risk:benefit of aggressive evaluation and intervention for ischemic heart disease in patients with advanced chronic kidney disease.

  16. Whiplash and post-traumatic stress disorder

    NARCIS (Netherlands)

    Jaspers, JPC

    1998-01-01

    Purpose : This study examined the comorbidity of whiplash and post-traumatic stress disorder (PTSD) following motor vehicle accidents. A treatment strategy in cases with both disorders is proposed. Method: A review of the literature on psychological consequences of motor vehicle accidents and on ris

  17. Whiplash injuries and the potential for mechanical instability

    OpenAIRE

    1998-01-01

    Whiplash injury to the cervical spine is poorly understood. Symptoms often do not correlate to the clinical findings. It has been hypothesized that the long-term clinical symptoms associated with whiplash have their basis in mechanical derangement of the cervical spine caused at the time of trauma. Before such a hypothesis can be proven, one needs to document and quantify the soft tissue injuries of the cervical spine in whiplash. The purpose of the study was to quantify the mechanical change...

  18. Naturopathic care for chronic low back pain: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Orest Szczurko

    Full Text Available OBJECTIVE: Chronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain. METHODS: This study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39 or standardized physiotherapy (n = 36 over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes. RESULTS: Sixty-nine participants (92% completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (-6.89, 95% CI. -9.23 to -3.54, p = <0.0001 as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001 and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045. All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001, weight-loss (p = 0.0052 and Body Mass Index (-0.52, 95% CI, -0.96 to -0.08, p = 0.01. CONCLUSIONS: Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain. TRIAL REGISTRATION: Controlled-Trials

  19. Acute stress response and recovery after whiplash injuries. A one-year prospective study.

    Science.gov (United States)

    Kongsted, Alice; Bendix, Tom; Qerama, Erisela; Kasch, Helge; Bach, Flemming W; Korsholm, Lars; Jensen, Troels S

    2008-05-01

    Chronic whiplash-associated disorder (WAD) represents a major medical and psycho-social problem. The typical symptomatology presented in WAD is to some extent similar to symptoms of post traumatic stress disorder. In this study we examined if the acute stress reaction following a whiplash injury predicted long-term sequelae. Participants with acute whiplash-associated symptoms after a motor vehicle accident were recruited from emergency units and general practitioners. The predictor variable was the sum score of the impact of event scale (IES) completed within 10 days after the accident. The main outcome-measures were neck pain and headache, neck disability, general health, and working ability one year after the accident. A total of 737 participants were included and completed the IES, and 668 (91%) participated in the 1-year follow-up. A baseline IES-score denoting a moderate to severe stress response was obtained by 13% of the participants. This was associated with increased risk of considerable persistent pain (OR=3.3; 1.8-5.9), neck disability (OR=3.2; 1.7-6.0), reduced working ability (OR=2.8; 1.6-4.9), and lowered self-reported general health one year after the accident. These associations were modified by baseline neck pain intensity. It was not possible to distinguish between participants who recovered and those who did not by means of the IES (AUC=0.6). In conclusion, the association between the acute stress reaction and persistent WAD suggests that post traumatic stress reaction may be important to consider in the early management of whiplash injury. However, the emotional response did not predict chronicity in individuals.

  20. Functional health status in subjects after a motor vehicle accident, with emphasis on whiplash associated disorders: design of a descriptive, prospective inception cohort study

    Directory of Open Access Journals (Sweden)

    Helders Paul JM

    2008-12-01

    Full Text Available Abstract Background The clinical consequences of whiplash injuries resulting from a motor vehicle accident (MVA are poorly understood. Thereby, there is general lack of research on the development of disability in patients with acute and chronic Whiplash Associated Disorders. Methods/Design The objective is to describe the design of an inception cohort study with a 1-year follow-up to determine risk factors for the development of symptoms after a low-impact motor vehicle accident, the prognosis of chronic disability, and costs. Victims of a low-impact motor vehicle accident will be eligible for participation. Participants with a Neck Disability Index (NDI score of 7 or more will be classified as experiencing post-traumatic neck pain and will enter the experimental group. Participants without complaints (a NDI score less than 7 will enter the reference group. The cohort will be followed up by means of postal questionnaires and physical examinations at baseline, 3 months, 6 months, and 12 months. Recovery from whiplash-associated disorders will be measured in terms of perceived functional health, and employment status (return to work. Life tables will be generated to determine the 1-year prognosis of whiplash-associated disorders, and risk factors and prognostic factors will be assessed using multiple logistic regression analysis. Discussion Little is known about the development of symptoms and chronic disability after a whiplash injury. In the clinical setting, it is important to identify those people who are at risk of developing chronic symptoms. This inception prospective cohort study will provide insight in the influence of risk factors, of the development of functional health problems, and costs in people with whiplash-associated disorders.

  1. Long-term Labour Market Performance of Whiplash Claimants

    DEFF Research Database (Denmark)

    Leth-Petersen, Søren; Rotger, Gabriel Pons

    A whiplash is a sudden acceleration-deceleration of the neck and head, typically associated with a rear-end car collision that may produce injuries in the soft tissue. Often there are no objective signs or symptoms of injury, and diagnosing lasting whiplash associated disorders (WAD) is difficult...

  2. Long term labour market performance of whiplash claimants

    DEFF Research Database (Denmark)

    Leth-Petersen, Søren; Rotger, Gabriel Pons

    2009-01-01

    A whiplash is a sudden acceleration-deceleration of the neck and head, typically associated with a rear-end car collision that may produce injuries in the soft tissue. Often there are no objective signs or symptoms of injury, and diagnosing lasting whiplash-associated disorders (WAD) is difficult...

  3. [The relationship between whiplash injury and temporomandibular joint dysfunction].

    Science.gov (United States)

    Barak, Shlomo

    2013-10-01

    This article aims to discuss the possible relationship between rapid extension-flexion of the neck-whiplash injury and temporomandibular disorders (TMD). Clinical experience and studies revealed that whiplash injury may cause TMD. The pathophysiology of TMD is described as well as clinical and imaging diagnostic criteria. The treatment modalities for TMD are: physiotherapy, nonsteroidal anti-inflammatory drugs and occlusal splints.

  4. Resolution of whiplash-associated allodynia following cervicothoracic thrust and non-thrust manipulation.

    Science.gov (United States)

    Lowry, Carina D; O'Hearn, Michael A; Courtney, Carol A

    2011-08-01

    Whiplash injuries of the cervical spine comprise 30% of injuries reported following motor vehicle accident (MVA) and often progress to chronic painful conditions. The purpose of this case report is to describe the management of a 37-year-old female referred to physical therapy with neck and shoulder pain after whiplash injury. The patient demonstrated limited cervical and shoulder active range of motion as well as quantitative sensory testing (QST) results consistent with central nervous system sensitization. She was treated for 11 visits over a 6-week period with manual therapy and specific exercise directed to the cervicothoracic spine. Her pain decreased from 9/10 to 2/10 by the end of treatment and remained improved at 1/10 at the 6-month follow-up. Her Copenhagen Neck Functional Disability Scale decreased from 23/30 to 4/30 by the 11th visit. In addition, she demonstrated clinically significant increases in cervical active range of motion and normal somatosensation. Manual therapy of the cervicothoracic spine may be a beneficial adjunct to the standard care of patients with signs and symptoms of central sensitization after whiplash-associated disorder and primary report of neck and shoulder pain.

  5. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol

    OpenAIRE

    Cox, Helen; Tilbrook, Helen; Aplin, John; Chuang, Ling-Hsiang; Hewitt, Catherine; Jayakody, Shalmini; Semlyen, Anna; Soares, Marta O; Torgerson, David; Trewhela, Alison; Watt, Ian; Worthy, Gill

    2010-01-01

    A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is...

  6. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A

    2015-07-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

  7. The chronic care for wet age related macular degeneration (CHARMED) study: a randomized controlled trial

    OpenAIRE

    Markun, Stefan; Dishy, Avraham; Neuner-Jehle, Stefan; Rosemann, Thomas; Frei, Anja

    2015-01-01

    BACKGROUND: In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM). METHODS: Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, ...

  8. The Chronic Care for Wet Age Related Macular Degeneration (CHARMED) Study: A Randomized Controlled Trial

    OpenAIRE

    Stefan Markun; Avraham Dishy; Stefan Neuner-Jehle; Thomas Rosemann; Anja Frei

    2015-01-01

    Background In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM). Methods Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using...

  9. A Research Synthesis of Therapeutic Interventions for Whiplash-Associated Disorder: Part 1 – Overview and Summary

    Directory of Open Access Journals (Sweden)

    Robert W Teasell

    2010-01-01

    Full Text Available Whiplash-associated disorder (WAD represents a significant public health problem, resulting in a substantial socioeconomic burden throughout the industrialized world, wherever costs are documented. While many treatments have been advocated for patients with WAD, scientific evidence of their effectiveness is often lacking. A systematic review was conducted to evaluate the strength of evidence supporting various WAD therapies. Multiple databases (including Web of Science, EMBASE and PubMed were searched to identify all studies published from January 1980 through March 2009 that evaluated the effectiveness of any clearly defined treatment for acute (less than two weeks, subacute (two to 12 weeks or chronic (longer than 12 weeks WAD. The present article, the first in a five-part series, provides an overview of the review methodology as well as a summary and discussion of the review’s main findings. Eighty-three studies met the inclusion criteria, 40 of which were randomized controlled trials. The majority of studies (n=47 evaluated treatments initiated in the chronic stage of the disorder, while 23 evaluated treatments for acute WAD and 13 assessed therapies for subacute WAD. Exercise and mobilization programs for acute and chronic WAD had the strongest supporting evidence, although many questions remain regarding the relative effectiveness of various protocols. At present, there is insufficient evidence to support any treatment for subacute WAD. For patients with chronic WAD who do not respond to conventional treatments, it appears that radiofrequency neurotomy may be the most effective treatment option. The present review found a relatively weak but growing research base on which one could make recommendations for patients at any stage of the WAD continuum. Further research is needed to determine which treatments are most effective at reducing the disabling symptoms associated with WAD.

  10. Do subjects with whiplash-associated disorders respond differently in the short-term to manual therapy and exercise than those with mechanical neck pain?

    DEFF Research Database (Denmark)

    Castaldo, Matteo; Catena, Antonella; Chiarotto, Alessandro

    2017-01-01

    with whiplash-associated disorders participated. Clinical and physical outcomes including neck pain intensity, neck-related disability, and pain area, as well as cervical range of motion and pressure pain thresholds over the upper trapezius and tibialis anterior muscles, were obtained at baseline and after...... outcomes and cervical range of motion with both groups experiencing similar improvements (all P  0.222). CONCLUSIONS : The current clinical trial found that subjects with mechanical neck pain and whiplash......OBJECTIVE : To compare the short-term effects of manual therapy and exercise on pain, related disability, range of motion, and pressure pain thresholds between subjects with mechanical neck pain and whiplash-associated disorders. METHODS : Twenty-two subjects with mechanical neck pain and 28...

  11. A Research Synthesis of Therapeutic Interventions for Whiplash-Associated Disorder (WAD: Part 3 – Interventions for Subacute WAD

    Directory of Open Access Journals (Sweden)

    Robert W Teasell

    2010-01-01

    Full Text Available Whiplash-associated disorder (WAD represents a significant public health problem, resulting in substantial social and economic costs throughout the industrialized world. While many treatments have been advocated for patients with WAD, scientific evidence supporting their effectiveness is often lacking. A systematic review was conducted to evaluate the strength of evidence associated with various WAD therapies. Multiple databases (including Web of Science, EMBASE and PubMed were searched to identify all studies published from January 1980 through March 2009 that evaluated the effectiveness of any clearly defined treatment for acute (less than two weeks, subacute (two to 12 weeks or chronic (longer than 12 weeks WAD. The present article, the third in a five-part series, evaluates the evidence for interventions initiated during the subacute phase of WAD. Thirteen studies that met the inclusion criteria were identified, six of which were randomized controlled trials with ‘good’ overall methodology (median Physiotherapy Evidence Database score of 6. Although some evidence was identified to support the use of interdisciplinary interventions and chiropractic manipulation, the evidence was not strong for any of the evaluated treatments. There is a clear need for further research to evaluate interventions aimed at treating patients with subacute WAD because there are currently no interventions satisfactorily supported by the research literature.

  12. Are altered smooth pursuit eye movements related to chronic pain and disability following whiplash injuries? A prospective trial with one-year follow-up

    DEFF Research Database (Denmark)

    Kongsted, Alice; Jørgensen, Lars Vincents; Leboeuf-Yde, Charlotte

    2008-01-01

    collision were determined. RESULTS: Results of early eye movement tests were not associated with the prognosis. Reduced smooth pursuit performance when tested in static cervical rotation at the one-year follow-up was significantly associated with higher neck pain intensity at that time (regression...

  13. Grade II whiplash injuries to the neck: what is the benefit for patients treated by different physical therapy modalities?

    Directory of Open Access Journals (Sweden)

    Krischak Gert

    2009-01-01

    Full Text Available Abstract Background In a majority of cases, whiplash injuries are a domain of conservative therapy. Nevertheless it remains unclear whether physical therapy is of medical or economic benefit in patients with whiplash injuries. Methods Seventy patients with acute Quebec Task Force (QTF grade II whiplash injuries were randomized to two therapy groups and received either active (APT or passive (PPT physical therapy. Patients were compared with regard to pain and range of motion with data obtained in an earlier study from a group with grade II whiplash injuries in which the therapy recommendation had been "act as usual" (AAU; n = 20. The above-mentioned parameters were assessed at 24 hours and two months after the injury. Furthermore patients' period of disability was documented after two months. Results After two months, patients in both the APT and PPT groups showed significant improvement in the median period of disability (active: 14 days; passive: 14 days compared to the AAU group (49 days. No group difference was observed with regard to median improvement in range of motion (active: 120°; passive: 108°; activity as usual: 70°. The median pain reduction was significantly greater in the APT group (50.5 than in the PPT (39.2 or AAU group (28.8. Conclusion Our data show that active physical therapy results in enhanced pain reduction and shortening of post-injury disability. Therefore, active physical therapy should be considered the treatment of choice in patients with QTF grade II whiplash injuries. Trial registration The study complied with applicable German law and with the principles of the Helsinki Declaration and was approved by the institutional ethics commission.

  14. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Dworkin, Robert H; Turk, Dennis C; Peirce-Sandner, Sarah; Baron, Ralf; Bellamy, Nicholas; Burke, Laurie B; Chappell, Amy; Chartier, Kevin; Cleeland, Charles S; Costello, Ann; Cowan, Penney; Dimitrova, Rozalina; Ellenberg, Susan; Farrar, John T; French, Jacqueline A; Gilron, Ian; Hertz, Sharon; Jadad, Alejandro R; Jay, Gary W; Kalliomäki, Jarkko; Katz, Nathaniel P; Kerns, Robert D; Manning, Donald C; McDermott, Michael P; McGrath, Patrick J; Narayana, Arvind; Porter, Linda; Quessy, Steve; Rappaport, Bob A; Rauschkolb, Christine; Reeve, Bryce B; Rhodes, Thomas; Sampaio, Cristina; Simpson, David M; Stauffer, Joseph W; Stucki, Gerold; Tobias, Jeffrey; White, Richard E; Witter, James

    2010-05-01

    There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain.

  15. Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults

    DEFF Research Database (Denmark)

    Silberstein, S.; Tfelt-Hansen, P.; Dodick, D.W.

    2008-01-01

    In 1991 the Clinical Trials Subcommittee of the International Headache Society (IHS) developed and published its first edition of the Guidelines on controlled trials of drugs in episodic migraine because only quality trials can form the basis for international collaboration on drug therapy...... to assist in the design of well-controlled clinical trials of chronic migraine in adults, and do not apply to studies in children or adolescents Udgivelsesdato: 2008/5...

  16. MRI of car occupants with whiplash injury

    Energy Technology Data Exchange (ETDEWEB)

    Voyvodic, F. [Dept. of Radiology, Flinders Medical Centre, Bedford Park, SA (Australia); Dolinis, J. [National Injury Surveillance Unit, Bedford Park, SA (Australia)]|[National Health and Medical Research Council Road Accident Research Unit, Univ. of Adelaide, SA (Australia); Moore, V.M. [National Health and Medical Research Council Road Accident Research Unit, Univ. of Adelaide, SA (Australia); Ryan, G.A. [National Health and Medical Research Council Road Accident Research Unit, Univ. of Adelaide, SA (Australia); Slavotinek, J.P. [Dept. of Radiology, Flinders Medical Centre, Bedford Park, SA (Australia); Whyte, A.M. [Ashford Hospital Specialist Centre, SA (Australia); Hoile, R.D. [Ashford Hospital Specialist Centre, SA (Australia); Taylor, G.W. [National Health and Medical Research Council Road Accident Research Unit, Univ. of Adelaide, SA (Australia)

    1997-01-01

    Our purpose was to document and investigate the prognostic significance of features seen on MRI of patients with whiplash injury following relatively minor road traffic crashes. MRI was obtained shortly and at 6 months after the crash using a 0.5 T imager. The images were assessed independently by two radiologists for evidence of fracture or other injury; loss of lordosis and spondylosis were also recorded. Clinical examinations were used to assess the status of patients initially and at 6 months. The results of the independent MRI and clinical investigations were then examined for association using statistical tests. Initial MRI was performed on 29 patients, of whom 19 had repeat studies at 6 months; 48 examinations were thus examined. Apart from spondylosis and loss of lordosis, only one abnormality was detected: an intramedullary lesion consistent with a small cyst or syrinx. There were no statistically significant associations between the outcome of injury and spondylosis or loss of lordosis. No significant changes were found when comparing the initial and follow-up MRI. It appears that MRI of patients with relatively less severe whiplash symptoms reveals a low frequency of abnormalities, apart from spondylosis and loss of lordosis, which have little short-term prognostic value. Routine investigation of such patients with MRI is not justified in view of the infrequency of abnormalities detected, the lack of prognostic value and the high cost of the procedure. (orig.). With 1 fig., 1 tab.

  17. MRI in acute phase of whiplash injury

    Energy Technology Data Exchange (ETDEWEB)

    Fagerlund, M. [Dept. of Diagnostic Radiology, Univ. Hospital of Northern Sweden, Umeaa (Sweden); Bjoernebrink, J. [Dept. of Diagnostic Radiology, Univ. Hospital of Northern Sweden, Umeaa (Sweden); Pettersson, K. [Dept. of Orthopaedic Surgery, Univ. Hospital of Northern Sweden, Umeaa (Sweden); Hildingsson, C. [Dept. of Orthopaedic Surgery, Univ. Hospital of Northern Sweden, Umeaa (Sweden)

    1995-11-01

    A prospective MRI study of 39 whiplash patients was performed and the results were compared with the clinical findings within 15 days after trauma. The MRI parameters included disc bulging either with impingement on the anterior epidural space or with medullary compression, foraminal stenosis, dorsal ligament thickening, osteophyte extension and intramedullary or paravertebral soft tissue injury. All changes were graded visually on a four-point scale (no, some, moderate or extensive changes). After the MRI evaluation was made the clinical findings were analysed by two orthopaedic surgeons using a specially designed protocol. With MRI 29 patients (74 %) showed no or only slight changes, and were thus regarded as normal variations. Of these, 10 of 29 patients (34 %) had as the only symptom pain in the head or in the neck, 19 of 29 patients (66 %) showed neurological changes, either paresthesias, sensory deficits or weakness of upper extremities. In 10 (26 %) patients with moderate or extensive MRI changes, 3 of 10 (33 %) had only head or neck pain, or both, and 7 of 10 (66 %) had neurological changes. Use of MRI in whiplash injury is helpful, but it is not the first-choice radiological examination method. Despite neurological changes, the frequency of true traumatic lesions is low. There is no clear correlation between the patients` subjective symptoms or clinical signs and the findings with MRI. However, MRI can be used to find patients with disk herniation that can be treated surgically. (orig.)

  18. Delayed onset of fatal basilar thrombotic embolus after whiplash injury

    DEFF Research Database (Denmark)

    Viktrup, L; Knudsen, G M; Hansen, S H

    1995-01-01

    BACKGROUND: Whiplash injuries are generally seen after rear-end rather than frontal car collisions. Previous reports have documented death up to 8 days after serious whiplash injury. We report a case of lethal basilar thrombotic embolus that occurred 2 months after the patient's injury...... in a collision. CASE DESCRIPTION: After whiplash trauma in a car accident, a 50-year-old taxi driver suffered from headache and episodic visual disturbances. Two months after the accident he suddenly lost consciousness and was admitted to the hospital. A CT scan performed at that time was indicative of basilar...... thrombosis. The patient died 3 days later. The autopsy revealed a thrombosis in the right vertebral artery and a thrombotic embolus in the basilar artery. Microscopically, a lesion of the right vertebral artery was found at the level of the atlantoaxial joint. CONCLUSIONS: We conclude that the whiplash...

  19. Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details

    Science.gov (United States)

    Buffel du Vaure, Céline; Dechartres, Agnès; Battin, Constance; Ravaud, Philippe; Boutron, Isabelle

    2016-01-01

    Objectives To systematically assess registration details of ongoing randomised controlled trials (RCTs) targeting 10 common chronic conditions and registered at ClinicalTrials.gov and to determine the prevalence of (1) trial records excluding patients with concomitant chronic condition(s) and (2) those specifically targeting patients with concomitant chronic conditions. Design Systematic review of trial registration records. Data sources ClinicalTrials.gov register. Study selection All ongoing RCTs registered from 1 January 2014 to 31 January 2015 that assessed an intervention targeting adults with coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease, painful condition, depression and dementia with a target sample size ≥100. Data extraction From the trial registration records, 2 researchers independently recorded the trial characteristics and the number of exclusion criteria and determined whether patients with concomitant chronic conditions were excluded or specifically targeted. Results Among 319 ongoing RCTs, despite the high prevalence of the concomitant chronic conditions, patients with these conditions were excluded in 251 trials (79%). For example, although 91% of patients with CHD had a concomitant chronic condition, 69% of trials targeting such patients excluded patients with concomitant chronic condition(s). When considering the co-occurrence of 2 chronic conditions, 31% of patients with chronic pain also had depression, but 58% of the trials targeting patients with chronic pain excluded patients with depression. Only 37 trials (12%) assessed interventions specifically targeting patients with concomitant chronic conditions; 31 (84%) excluded patients with concomitant chronic condition(s). Conclusions Despite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions

  20. Research design considerations for chronic pain prevention clinical trials

    DEFF Research Database (Denmark)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C

    2015-01-01

    , outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues...

  1. Persistent post-traumatic headache, postconcussion syndrome, and whiplash injuries: the evidence for a non-traumatic basis with an historical review.

    Science.gov (United States)

    Evans, Randolph W

    2010-04-01

    There has been intense controversy about postconcussion syndrome since Erichsen's publication in 1866 on railway brain and railway spine. The fascinating history of this debate will be reviewed and then the non-organic explanations for postconcussion syndrome, headaches after head injury, and chronic whiplash injuries and headaches will be explored including the following: psychogenic, psychosocial, sociocultural, base rate misattribution, chronic pain, compensation and litigation, and malingering.

  2. [Medical and legal considerations in whiplash injury].

    Science.gov (United States)

    Castillo-Chávez, Miguel Angel

    2013-01-01

    Whiplash injury usually occurs in people who suffered an automobile accident, but also occurs as a result of physical assault and other mechanisms. Diagnosis and initial management of the patient by the emergency physician or orthopedist, and prescribing indications, are taken into account by two forensic intervention specialists. One of these is the medical officer, who, through analysis of the injury mechanism, establishes a cause-effect relationship and concludes whether the accident suffered by a worker it is related to work or not, determines how long the worker will remain disabled and if the injury caused permanent disability under Federal Labor Law. The medical examiner by injury classification assists the Public Ministry so that it can frame the crime of injury to the Criminal Code of Federal District. For these reasons a review of medical information about the mechanism of injury, diagnosis, treatment and healing time was performed to help both specialists to standardize their approach in their daily activities.

  3. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial

    Science.gov (United States)

    Clark, William F; Sontrop, Jessica M; Huang, Shih-Han; Gallo, Kerri; Moist, Louise; House, Andrew A; Weir, Matthew A; Garg, Amit X

    2013-01-01

    Background and objectives Increased water intake may benefit kidney function. Prior to initiating a larger randomised controlled trial (RCT), we examined the safety and feasibility of asking adults with chronic kidney disease (CKD) to increase their water intake. Design, setting, participants and measurements Beginning in October 2012, we randomly assigned 29 adults with stage 3 CKD (estimated glomerular filtration rate (eGFR) 30–60 mL/min/1.73 m2 and albuminuria) to one of the two groups of water intake: hydration (n=18) or standard (n=11). We asked the hydration group to increase their water intake by 1.0–1.5 L/day (in addition to usual intake, depending on sex and weight) for 6 weeks, while the control group carried on with their usual intake. Participants collected a 24 h urine sample at baseline and at 2 and 6 weeks after randomisation. Our primary outcome was the between-group difference in change in 24 h urine volume from baseline to 6 weeks. Results (63%)of participants were men, 81% were Caucasians and the average age was 61 years (SD 14 years). The average baseline eGFR was 40 mL/min/1.73 m2 (SD 11 mL/min/1.73 m2); the median albumin to creatinine ratio was 19 mg/mmol (IQR 6–74 mg/mmol). Between baseline and 6-week follow-up, the hydration group's average 24 h urine volume increased by 0.7 L/day (from 2.3 to 3.0 L/day) and the control group's 24 h urine decreased by 0.3 L/day (from 2.0 to 1.7 L/day; between-group difference in change: 0.9 L/day (95% CI 0.4 to 1.5; p=0.002)). We found no significant changes in urine, serum osmolality or electrolyte concentrations, or eGFR. No serious adverse events or changes in quality of life were reported. Conclusions A pilot RCT indicates adults with stage 3 CKD can successfully and safely increase water intake by up to 0.7 L/day in addition to usual fluid intake. Trial registration Registered with Clinical Trials—government identifier NCT01753466. PMID:24362012

  4. Chronic edema of the lower extremities: international consensus recommendations for compression therapy clinical research trials.

    Science.gov (United States)

    Stout, N; Partsch, H; Szolnoky, G; Forner-Cordero, I; Mosti, G; Mortimer, P; Flour, M; Damstra, R; Piller, N; Geyer, M J; Benigni, J-P; Moffat, C; Cornu-Thenard, A; Schingale, F; Clark, M; Chauveau, M

    2012-08-01

    Chronic edema is a multifactorial condition affecting patients with various diseases. Although the pathophysiology of edema varies, compression therapy is a basic tenant of treatment, vital to reducing swelling. Clinical trials are disparate or lacking regarding specific protocols and application recommendations for compression materials and methodology to enable optimal efficacy. Compression therapy is a basic treatment modality for chronic leg edema; however, the evidence base for the optimal application, duration and intensity of compression therapy is lacking. The aim of this document was to present the proceedings of a day-long international expert consensus group meeting that examined the current state of the science for the use of compression therapy in chronic edema. An expert consensus group met in Brighton, UK, in March 2010 to examine the current state of the science for compression therapy in chronic edema of the lower extremities. Panel discussions and open space discussions examined the current literature, clinical practice patterns, common materials and emerging technologies for the management of chronic edema. This document outlines a proposed clinical research agenda focusing on compression therapy in chronic edema. Future trials comparing different compression devices, materials, pressures and parameters for application are needed to enhance the evidence base for optimal chronic oedema management. Important outcomes measures and methods of pressure and oedema quantification are outlined. Future trials are encouraged to optimize compression therapy in chronic edema of the lower extremities.

  5. Prevalence of whiplash trauma in TMD patients: a systematic review.

    Science.gov (United States)

    Häggman-Henrikson, B; Rezvani, M; List, T

    2014-01-01

    The purpose of this systematic review was to describe the prevalence of whiplash trauma in patients with temporomandibular disorders (TMDs) and to describe clinical signs and symptoms in comorbid TMD/whiplash compared with TMD localised to the facial region. A systematic literature search of the PubMed, Cochrane Library and Bandolier databases was carried out for articles published from 1 January 1966 to 31 December 2012. The systematic search identified 129 articles. After the initial screening of abstracts, 32 articles were reviewed in full text applying inclusion and exclusion criteria. Six studies on the prevalence of neck trauma in patients with TMD met the inclusion criteria and were included in the review. Two of the authors evaluated the methodological quality of the included studies. The reported prevalence of whiplash trauma ranged from 8·4% to 70% (median 35%) in TMD populations, compared with 1·7-13% in the non-TMD control groups. Compared with patients with TMD localised to the facial region, TMD patients with a history of whiplash trauma reported more TMD symptoms, such as limited jaw opening and more TMD pain, and also more headaches and stress symptoms. In conclusion, the prevalence of whiplash trauma is higher in patients with TMD compared with non-TMD controls. Furthermore, patients with comorbid TMD/whiplash present with more jaw pain and more severe jaw dysfunction compared with TMD patients without a history of head-neck trauma. These results suggest that whiplash trauma might be an initiating and/or aggravating factor as well as a comorbid condition for TMD.

  6. A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

    DEFF Research Database (Denmark)

    Kasch, Helge; Kongsted, Alice; Qerama, Erisela;

    2013-01-01

    (pafter whiplash. Neck......OBJECTIVES: An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. DESIGN: The design was an observational prospective study of risk factors embedded in a randomised controlled study. SETTING: Acute whiplash...... patients from units, general practitioners in four Danish counties were referred to two research centres. PARTICIPANTS: During a 2-year inclusion period, acute consecutive whiplash-injured (age 18-70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I-III, symptoms...

  7. Kinematics of a Head-Neck Model Simulating Whiplash

    Science.gov (United States)

    Colicchia, Giuseppe; Zollman, Dean; Wiesner, Hartmut; Sen, Ahmet Ilhan

    2008-02-01

    A whiplash event is a relative motion between the head and torso that occurs in rear-end automobile collisions. In particular, the large inertia of the head results in a horizontal translation relative to the thorax. This paper describes a simulation of the motion of the head and neck during a rear-end (whiplash) collision. A head-neck model that qualitatively undergoes the same forces acting in whiplash and shows the same behavior is used to analyze the kinematics of both the head and the cervical spine and the resulting neck loads. The rapid acceleration during a whiplash event causes the extension and flexion of the cervical spine, which in turn can cause dislocated vertebrae, torn ligaments, intervertebral disc herniation, and other trauma that appear to be the likely causes of subsequent painful headache or neck pain symptoms. Thus, whiplash provides a connection between the dynamics of the human body and physics. Its treatment can enliven the usual teaching in kinematics, and both theoretical and experimental approaches provide an interesting biological context to teach introductory principles of mechanics.

  8. Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials

    OpenAIRE

    Mary E Lynch; Campbell, Fiona

    2011-01-01

    Effective therapeutic options for patients living with chronic pain are limited. The pain relieving effect of cannabinoids remains unclear. A systematic review of randomized controlled trials (RCTs) examining cannabinoids in the treatment of chronic non-cancer pain was conducted according to the PRISMA statement update on the QUORUM guidelines for reporting systematic reviews that evaluate health care interventions. Cannabinoids studied included smoked cannabis, oromucosal extracts of cannabi...

  9. Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial

    OpenAIRE

    Daniel Pach; Xiaoli Yang-Strobel; Rainer Lüdtke; Stephanie Roll; Katja Icke; Benno Brinkhaus; Witt, Claudia M.

    2013-01-01

    We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture). Patients received ei...

  10. Acute stress response and recovery after whiplash injuries. A one-year prospective study

    DEFF Research Database (Denmark)

    Kongsted, Alice; Bendix, Tom; Montvilas, Erisela Qerama

    2008-01-01

    outcome-measures were neck pain and headache, neck disability, general health, and working ability one year after the accident. A total of 737 participants were included and completed the IES, and 668 (91%) participated in the 1-year follow-up. A baseline IES-score denoting a moderate to severe stress...... response was obtained by 13% of the participants. This was associated with increased risk of considerable persistent pain (OR=3.3; 1.8-5.9), neck disability (OR=3.2; 1.7-6.0), reduced working ability (OR=2.8; 1.6-4.9), and lowered self-reported general health one year after the accident. These associations......Chronic whiplash-associated disorder (WAD) represents a major medical and psycho-social problem. The typical symptomatology presented in WAD is to some extent similar to symptoms of post traumatic stress disorder. In this study we examined if the acute stress reaction following a whiplash injury...

  11. Acute stress response and recovery after whiplash injuries. A one-year prospective study

    DEFF Research Database (Denmark)

    Kongsted, Alice; Bendix, Tom; Qerama, Erisela

    2007-01-01

    outcome-measures were neck pain and headache, neck disability, general health, and working ability one year after the accident. A total of 737 participants were included and completed the IES, and 668 (91%) participated in the 1-year follow-up. A baseline IES-score denoting a moderate to severe stress...... response was obtained by 13% of the participants. This was associated with increased risk of considerable persistent pain (OR=3.3; 1.8-5.9), neck disability (OR=3.2; 1.7-6.0), reduced working ability (OR=2.8; 1.6-4.9), and lowered self-reported general health one year after the accident. These associations......Chronic whiplash-associated disorder (WAD) represents a major medical and psycho-social problem. The typical symptomatology presented in WAD is to some extent similar to symptoms of post traumatic stress disorder. In this study we examined if the acute stress reaction following a whiplash injury...

  12. Are cervical multifidus muscles active during whiplash and startle? An initial experimental study

    Directory of Open Access Journals (Sweden)

    Carpenter Mark G

    2008-06-01

    Full Text Available Abstract Background The cervical multifidus muscles insert onto the lower cervical facet capsular ligaments and the cervical facet joints are the source of pain in some chronic whiplash patients. Reflex activation of the multifidus muscle during a whiplash exposure could potentially contribute to injuring the facet capsular ligament. Our goal was to determine the onset latency and activation amplitude of the cervical multifidus muscles to a simulated rear-end collision and a loud acoustic stimuli. Methods Wire electromyographic (EMG electrodes were inserted unilaterally into the cervical multifidus muscles of 9 subjects (6M, 3F at the C4 and C6 levels. Seated subjects were then exposed to a forward acceleration (peak acceleration 1.55 g, speed change 1.8 km/h and a loud acoustic tone (124 dB, 40 ms, 1 kHz. Results Aside from one female, all subjects exhibited multifidus activity after both stimuli (8 subjects at C4, 6 subjects at C6. Neither onset latencies nor EMG amplitude varied with stimulus type or spine level (p > 0.13. Onset latencies and amplitudes varied widely, with EMG activity appearing within 160 ms of stimulus onset (for at least one of the two stimuli in 7 subjects. Conclusion These data indicate that the multifidus muscles of some individuals are active early enough to potentially increase the collision-induced loading of the facet capsular ligaments.

  13. A Research Synthesis of Therapeutic Interventions for Whiplash-Associated Disorder (WAD: Part 2 – Interventions for Acute WAD

    Directory of Open Access Journals (Sweden)

    Robert W Teasell

    2010-01-01

    Full Text Available Whiplash-associated disorder (WAD represents a significant public health problem, resulting in substantial social and economic costs throughout the industrialized world. While many treatments have been advocated for patients with WAD, scientific evidence supporting their effectiveness is often lacking. A systematic review was conducted to evaluate the strength of evidence associated with various WAD therapies. Multiple databases (including Web of Science, EMBASE and PubMed were searched to identify all studies published from January 1980 through March 2009 that evaluated the effectiveness of any clearly defined treatment for acute (less than two weeks, subacute (two to 12 weeks or chronic (more than 12 weeks WAD. The present article, the second in a five-part series, evaluates the evidence for interventions initiated during the acute phase of WAD. Twenty-three studies that met the inclusion criteria were identified, 16 of which were randomized controlled trials with ‘fair’ overall methodological quality (median Physiotherapy Evidence Database score of 5.5. For the treatment of acute WAD, there was strong evidence to suggest that not only is immobilization with a soft collar ineffective, but it may actually impede recovery. Conversely, although exercise programs, active mobilization and advice to act as usual all appeared to improve recovery, it is not clear which of these interventions was the most effective. While there was also evidence supporting the use of pulsed electromagnetic field therapy and methylprednisolone infusion, the evidence was insufficient to establish the effectiveness of either of these treatments. Based on current evidence, activation-based therapy is recommended for the treatment of acute WAD; however, additional research is required to determine the relative effectiveness of various exercise/mobilization programs.

  14. The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST)

    DEFF Research Database (Denmark)

    Winther, Kristian Hillert; Watt, Torquil; Bjørner, Jakob Bue;

    2014-01-01

    . Exclusion criteria: previous diagnosis of toxic nodular goitre, Graves' hyperthyroidism, postpartum thyroiditis, Graves' orbitopathy; previous antithyroid drug treatment, radioiodine therapy or thyroid surgery; immune-modulatory or other medication affecting thyroid function; pregnancy, planned pregnancy...... or breastfeeding; allergy towards any intervention or placebo component; intake of selenium supplementation >55 mug/day; inability to read or understand Danish or lack of informed consent. The trial will include 2 x 236 participants. The experimental intervention and control groups will receive 200 mug selenium...

  15. Whiplash: are you at risk for ongoing pain or disability?

    Science.gov (United States)

    2015-04-01

    Have you recently sustained an injury and been diagnosed with whiplash or a whiplash-associated disorder? If so, you may be wondering what your recovery will be like. If health care providers could identify, soon after the initial injury, which patients would probably improve naturally over time and which ones would not, they could better manage the patient's treatment in the early stages of recovery. A study published in the April 2015 issue of JOSPT provides new insights into this challenge, which may help improve decision making for providers and outcomes for patients.

  16. Hyperextension strain of ``whiplash`` injuries to the cervical spine

    Energy Technology Data Exchange (ETDEWEB)

    Griffiths, H.J. [Dept. of Radiology, Univ. of Minnesota Hospital and Clinic, Minneapolis, MN (United States); Olson, P.N. [Dept. of Radiology, Univ. of Minnesota Hospital and Clinic, Minneapolis, MN (United States); Everson, L.I. [Dept. of Radiology, Univ. of Minnesota Hospital and Clinic, Minneapolis, MN (United States); Winemiller, M. [Dept. of Radiology, Univ. of Minnesota Hospital and Clinic, Minneapolis, MN (United States)

    1995-05-01

    A full cervical spine radiographic series (including flexion and extension views) was reviewed in 40 patients with clinically proven ``whiplash`` injuries and compared to the radiographs in 105 normal controls. The level and degree of kinking or kyphosis, subluxation, and the difference in the amount of fanning between spinous processes on flexion and extension films were measured in each patient. Localized kinking greater than 10 and over 12 mm of fanning, often occurring at the level below the kinking or kyphosis, occurred mainly in the group of whiplash patients (sensitivity 81%, specificity 76%, accuracy 80%). (orig./VHE)

  17. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Dworkin, Robert H; Turk, Dennis C; Peirce-Sandner, Sarah; Burke, Laurie B; Farrar, John T; Gilron, Ian; Jensen, Mark P; Katz, Nathaniel P; Raja, Srinivasa N; Rappaport, Bob A; Rowbotham, Michael C; Backonja, Misha-Miroslav; Baron, Ralf; Bellamy, Nicholas; Bhagwagar, Zubin; Costello, Ann; Cowan, Penney; Fang, Weikai Christopher; Hertz, Sharon; Jay, Gary W; Junor, Roderick; Kerns, Robert D; Kerwin, Rosemary; Kopecky, Ernest A; Lissin, Dmitri; Malamut, Richard; Markman, John D; McDermott, Michael P; Munera, Catherine; Porter, Linda; Rauschkolb, Christine; Rice, Andrew S C; Sampaio, Cristina; Skljarevski, Vladimir; Sommerville, Kenneth; Stacey, Brett R; Steigerwald, Ilona; Tobias, Jeffrey; Trentacosti, Ann Marie; Wasan, Ajay D; Wells, George A; Williams, Jim; Witter, James; Ziegler, Dan

    2012-06-01

    A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated. Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ("assay sensitivity"). Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development. Therefore, an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was reviewed and discussed. On the basis of this meeting and subsequent discussions, the authors recommend consideration of a number of patient, study design, study site, and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments. Increased attention to and research on methodological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence-based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety.

  18. The RESOLVE Trial for people with chronic low back pain: protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Matthew K Bagg

    2017-01-01

    Full Text Available Introduction: Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials

  19. Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial.

    Science.gov (United States)

    Pach, Daniel; Yang-Strobel, Xiaoli; Lüdtke, Rainer; Roll, Stephanie; Icke, Katja; Brinkhaus, Benno; Witt, Claudia M

    2013-01-01

    We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture). Patients received either standardized acupuncture or individualized acupuncture. Treatment encompassed between 10 and 15 treatments based on individual symptoms with two treatments per week. The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale (0 mm = no pain, 100 mm = worst imaginable pain). No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7 (95% CI, 1460.4; 2077.1); standardized acupuncture 1482.9 (1177.2; 1788.7); group difference, 285.8 (-33.9; 605.5) P = 0.080). In this single-center trial, individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain. As a next step, a multicenter noninferiority study should be performed to investigate whether standardised acupuncture treatment for chronic low back pain might be applicable in a broader usual care setting. This trial is registered with ClinicalTrials.gov NCT00758017.

  20. Controlled trial of inhaled budesonide in patients with cystic fibrosis and chronic bronchopulmonary Psuedomonas aeruginosa infection

    DEFF Research Database (Denmark)

    Bisgaard, H; Pedersen, S S; Nielsen, K G;

    1997-01-01

    The efficacy and safety of anti-inflammatory treatment with inhaled glucocorticosteroids in patients with cystic fibrosis (CF) and complicating chronic Pseudomonas aeruginosa (P.a.) lung infection was studied in a placebo-controlled, parallel, double-blind single center trial. Active treatment...

  1. Randomized clinical trial evaluating elective laparoscopic appendicectomy for chronic right lower-quadrant pain.

    NARCIS (Netherlands)

    Roumen, R.M.; Groenendijk, R.P.R.; Sloots, C.E.J.; Duthoi, K.E.; Scheltinga, M.R.; Bruijninckx, C.M.

    2008-01-01

    BACKGROUND: It is questionable whether elective appendicectomy can effectively reduce persistent or recurrent right lower-quadrant abdominal pain due to chronic or recurrent appendicitis. METHODS: This single-centre double-blind randomized clinical trial studied the effects of elective laparoscopic

  2. Yoga for Chronic Low Back Pain: A Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Susan Holtzman

    2013-01-01

    Full Text Available OBJECTIVES: To evaluate the efficacy of yoga as an intervention for chronic low back pain (CLBP using a meta-analytical approach. Randomized controlled trials (RCTs that examined pain and/or functional disability as treatment outcomes were included. Post-treatment and follow-up outcomes were assessed.

  3. Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Daniel Pach

    2013-01-01

    Full Text Available We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture. Patients received either standardized acupuncture or individualized acupuncture. Treatment encompassed between 10 and 15 treatments based on individual symptoms with two treatments per week. The main outcome measure was the area under the curve (AUC summarizing eight weeks of daily rated pain severity measured with a visual analogue scale (0 mm = no pain, 100 mm = worst imaginable pain. No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7 (95% CI, 1460.4; 2077.1; standardized acupuncture 1482.9 (1177.2; 1788.7; group difference, 285.8 (−33.9; 605.5 P=0.080. In this single-center trial, individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain. As a next step, a multicenter noninferiority study should be performed to investigate whether standardised acupuncture treatment for chronic low back pain might be applicable in a broader usual care setting. This trial is registered with ClinicalTrials.gov NCT00758017.

  4. Examination of the diagnostic validity of 'headache attributed to whiplash injury': a controlled, prospective study.

    Science.gov (United States)

    Schrader, H; Stovner, L J; Obelieniene, D; Surkiene, D; Mickeviciene, D; Bovim, G; Sand, T

    2006-11-01

    Acute and chronic headache attributed to whiplash injury are new diagnostic entities in the International Classification of Headache Disorders, second edition. A main objective of the present study was to assess the validity of these nosologic entities by studying the headache pattern in an inception cohort of 210 rear-end car collision victims and in 210 matched controls. Consecutive drivers involved in rear-end collisions were identified from the daily records of the Traffic Police Department of Kaunas, Lithuania. A standard self-report questionnaire was sent to the drivers between 2 and 7 days after the collision, and their passengers were recruited as well. Headache and neck pain were evaluated within 7 days of the collision, at 2 months and 1 year after the collision. A control group of non-traumatized subjects received questionnaires at the time of the selection and 1 year later. Of the 75 collision victims who developed headache within the first 7 days of the collision, 37 had a clinical picture in accordance with the criteria for acute whiplash headache (i.e., concomitant neck pain) and 38 did not. For acute headache after collision, concomitant neck pain was of no relevance to the headache type or its course. In both these subgroups, migraine and tension-type headache could be diagnosed in similar proportions and the prognosis after 2 months and 1 year was also similar. Preexisting headache was a strong prognostic factor in both groups for both acute and chronic pain. Compared with the non-traumatized control group, the 1-year incidence of new or worsened headache, or of headache improvement, was the same. A likely interpretation of the data is that acute headaches after rear-end car collisions mainly represent episodes of a primary headache precipitated by the stress of the situation. We conclude that the nosologic validity of both acute and chronic whiplash headache is poor as the headaches, in accordance with the criteria lack distinguishing clinical

  5. Proliferative Chronic Myelomonocytic Leukemia (CMML) | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available dad de ruxolitinib (INCB018424) en pacientes con leucemia mielomonocítica crónica (LMMC) de tipo mieloprolif...a Ensayo clínico para evaluar la eficacia y la seguridad de ruxolitinib en pacientes con leucemia...investigated Proliferative Chronic Myelomonocytic Leukemia (CMML) leucemia mielom...Chronic Myelomonocytic Leukemia leucemia mielomonocítica crónica E.1.1.2Therapeutic area Diseases [C] - Bloo

  6. Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials.

    Science.gov (United States)

    Lynch, Mary E; Campbell, Fiona

    2011-11-01

    Effective therapeutic options for patients living with chronic pain are limited. The pain relieving effect of cannabinoids remains unclear. A systematic review of randomized controlled trials (RCTs) examining cannabinoids in the treatment of chronic non-cancer pain was conducted according to the PRISMA statement update on the QUORUM guidelines for reporting systematic reviews that evaluate health care interventions. Cannabinoids studied included smoked cannabis, oromucosal extracts of cannabis based medicine, nabilone, dronabinol and a novel THC analogue. Chronic non-cancer pain conditions included neuropathic pain, fibromyalgia, rheumatoid arthritis, and mixed chronic pain. Overall the quality of trials was excellent. Fifteen of the eighteen trials that met the inclusion criteria demonstrated a significant analgesic effect of cannabinoid as compared with placebo and several reported significant improvements in sleep. There were no serious adverse effects. Adverse effects most commonly reported were generally well tolerated, mild to moderate in severity and led to withdrawal from the studies in only a few cases. Overall there is evidence that cannabinoids are safe and modestly effective in neuropathic pain with preliminary evidence of efficacy in fibromyalgia and rheumatoid arthritis. The context of the need for additional treatments for chronic pain is reviewed. Further large studies of longer duration examining specific cannabinoids in homogeneous populations are required.

  7. A Test-Retest Reliability Study of the Whiplash Disability Questionnaire in Patients With Acute Whiplash-Associated Disorders

    DEFF Research Database (Denmark)

    Stupar, Maja; Côté, Pierre; Beaton, Dorcas E;

    2015-01-01

    OBJECTIVE: The purpose of this study was to determine the test-retest reliability and the Minimal Detectable Change (MDC) of the Whiplash Disability Questionnaire (WDQ) in individuals with acute whiplash-associated disorders (WADs). METHODS: We performed a test-retest reliability study. We included...... insurance claimants from Ontario who were at least 18years of age, within 21days of their motor vehicle collision and diagnosed as having acute WAD grades I to III. The WDQ, a 13-item questionnaire scored from 0 (no disability) to 130 (complete disability), was administered to all participants at baseline...

  8. Endoscopic vs. Surgical Interventions for Painful Chronic Pancreatitis: What is Needed for Future Clinical Trials

    Science.gov (United States)

    Windsor, John A; Reddy, Nageshwar D

    2017-01-01

    The treatment of painful chronic pancreatitis remains controversial. The available evidence from two randomized controlled trials favor surgical intervention, whereas an endotherapy-first approach is widely practiced. Chronic pancreatitis is complex disease with different genetic and environmental factors, different pain mechanisms and different treatment modalities including medical, endoscopic, and surgical. The widely practiced step-up approach remains unproven. In designing future clinical trials there are some important pre-requisites including a more comprehensive pain assessment tool, the optimization of conservative medical treatment and interventional techniques. Consideration should be given to the need of a control arm and the optimal timing of intervention. Pending better designed studies, the practical way forward is to identify subgroups of patients who clearly warrant endotherapy or surgery first, and to design the future clinical trials for the remainder. PMID:28079861

  9. The Chronic CARe for diAbeTes study (CARAT: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Birnbaum Beatrice

    2010-06-01

    Full Text Available Abstract Background Diabetes is a major challenge for the health care system and especially for the primary care provider. The Chronic Care Model represents an evidence-based framework for the care for chronically ill. An increasing number of studies showed that implementing elements of the Chronic Care Model improves patient relevant outcomes and process parameters. However, most of these findings have been performed in settings different from the Swiss health care system which is dominated by single handed practices. Methods/Design CARAT is a cluster randomized controlled trial with general practitioners as the unit of randomization (trial registration: ISRCTN05947538. The study challenges the hypothesis that implementing several elements of the Chronic Care Model via a specially trained practice nurse improves the HbA1c level of diabetes type II patients significantly after one year (primary outcome. Furthermore, we assume that the intervention increases the proportion of patients who achieve the recommended targets regarding blood pressure ( Discussion This study challenges the hypothesis that the Chronic Care Model can be easily implemented by a practice nurse focused approach. If our results will confirm this hypothesis the suggestion arises whether this approach should be implemented in other chronic diseases and multimorbid patients and how to redesign care in Switzerland.

  10. Whiplash, Real or Not Real? : A Review and New Concept

    NARCIS (Netherlands)

    Vállez Garcia, David; Dierckx, Rudi; Otte, Andreas; Holstege, Gert; Dierckx, Rudi AJO; Otte, Andreas; de Vries, Erik FJ; van Waarde, Aren; Leenders, Klaus L

    2014-01-01

    Whiplash-associated disorder (WAD) describes a heterogeneous group of symptoms, which develops frequently after an unexpected rear-end car collision. In some of these patients, the symptoms persist for years. There is an ongoing scientific debate about the existence of tissue injury to support this

  11. Prognosis of patients with whiplash-associated disorders consulting physiotherapy

    DEFF Research Database (Denmark)

    Bohman, Tony; Côté, Pierre; Boyle, Eleanor

    2012-01-01

    BACKGROUND: Patients with whiplash-associated disorders (WAD) have a generally favourable prognosis, yet some develop longstanding pain and disability. Predicting who will recover from WAD shortly after a traffic collision is very challenging for health care providers such as physical therapists....

  12. Neck ligament strength is decreased following whiplash trauma

    Directory of Open Access Journals (Sweden)

    Rubin Wolfgang

    2006-12-01

    Full Text Available Abstract Background Previous clinical studies have documented successful neck pain relief in whiplash patients using nerve block and radiofrequency ablation of facet joint afferents, including capsular ligament nerves. No previous study has documented injuries to the neck ligaments as determined by altered dynamic mechanical properties due to whiplash. The goal of the present study was to determine the dynamic mechanical properties of whiplash-exposed human cervical spine ligaments. Additionally, the present data were compared to previously reported control data. The ligaments included the anterior and posterior longitudinal, capsular, and interspinous and supraspinous ligaments, middle-third disc, and ligamentum flavum. Methods A total of 98 bone-ligament-bone specimens (C2–C3 to C7-T1 were prepared from six cervical spines following 3.5, 5, 6.5, and 8 g rear impacts and pre- and post-impact flexibility testing. The specimens were elongated to failure at a peak rate of 725 (SD 95 mm/s. Failure force, elongation, and energy absorbed, as well as stiffness were determined. The mechanical properties were statistically compared among ligaments, and to the control data (significance level: P Results For all whiplash-exposed ligaments, the average failure elongation exceeded the average physiological elongation. The highest average failure force of 204.6 N was observed in the ligamentum flavum, significantly greater than in middle-third disc and interspinous and supraspinous ligaments. The highest average failure elongation of 4.9 mm was observed in the interspinous and supraspinous ligaments, significantly greater than in the anterior longitudinal ligament, middle-third disc, and ligamentum flavum. The average energy absorbed ranged from 0.04 J by the middle-third disc to 0.44 J by the capsular ligament. The ligamentum flavum was the stiffest ligament, while the interspinous and supraspinous ligaments were most flexible. The whiplash

  13. Ph+ chronic myeloid leukemia (CML) | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available e suspender el medicamento nilotinib (Tasigna) en la leucemia mieloide crónica (LMC) de los pacientes que ti...ic form of leukemia, called chronic myeloid leukemia Forma específica de leucemia, llamada leucemia mieloide

  14. Whiplash(-like) injury diagnoses and co-morbidities--both before and after the injury

    DEFF Research Database (Denmark)

    Bendix, Tom; Kjellberg, Jakob; Ibsen, Rikke;

    2016-01-01

    BACKGROUND: Previous studies suggest that a greater proportion of neck injury patients, whose injuries were sustained through whiplash accidents, become chronic due to a component of sickness-focusing. However, it is also possible that some of those with neck injuries were already more frail prior...... to the injury, resulting in more consequences from a certain intensity of injury. The objective of this study was to compare co-morbidity and mortality in people with a registered neck injury diagnosis, evaluated prior to and after the neck injury, to people without a registered neck injury evaluated...... at year 1, who thus had no prior data, and for those at year 12 who did not have post data, were not included. The same applied to their individually matched controls. Health data for up to 3 years prior to and up to 3 years after the year of injury were recorded. RESULTS: We identified 94,224 cases...

  15. Physical and psychological factors predict outcome following whiplash injury.

    Science.gov (United States)

    Sterling, Michele; Jull, Gwendolen; Vicenzino, Bill; Kenardy, Justin; Darnell, Ross

    2005-03-01

    Predictors of outcome following whiplash injury are limited to socio-demographic and symptomatic factors, which are not readily amenable to secondary and tertiary intervention. This prospective study investigated the predictive capacity of early measures of physical and psychological impairment on pain and disability 6 months following whiplash injury. Motor function (ROM; kinaesthetic sense; activity of the superficial neck flexors (EMG) during cranio-cervical flexion), quantitative sensory testing (pressure, thermal pain thresholds, brachial plexus provocation test), sympathetic vasoconstrictor responses and psychological distress (GHQ-28, TSK, IES) were measured in 76 acute whiplash participants. The outcome measure was Neck Disability Index scores at 6 months. Stepwise regression analysis was used to predict the final NDI score. Logistic regression analyses predicted membership to one of the three groups based on final NDI scores (pain and disability, >30 moderate/severe pain and disability). Higher initial NDI score (1.007-1.12), older age (1.03-1.23), cold hyperalgesia (1.05-1.58), and acute post-traumatic stress (1.03-1.2) predicted membership to the moderate/severe group. Additional variables associated with higher NDI scores at 6 months on stepwise regression analysis were: ROM loss and diminished sympathetic reactivity. Higher initial NDI score (1.03-1.28), greater psychological distress (GHQ-28) (1.04-1.28) and decreased ROM (1.03-1.25) predicted subjects with persistent milder symptoms from those who fully recovered. These results demonstrate that both physical and psychological factors play a role in recovery or non-recovery from whiplash injury. This may assist in the development of more relevant treatment methods for acute whiplash.

  16. Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial

    Directory of Open Access Journals (Sweden)

    Shin Im

    2010-06-01

    Full Text Available Abstract Background Use of acupuncture has widely increased in patients with chronic low back pain. However, the evidence supporting its efficacy remains unclear. In this article, we report the design and the protocol of a multi-center randomized sham-controlled trial to treat chronic low back pain. Our goal is to verify the effect of acupuncture on chronic low back pain. Methods/Design This study is a multi-center randomized sham-controlled trial with 2 parallel arms. Participants included in the study met the following criteria: 1 low back pain lasting for at least the last 3 months, 2 a documented ≥ 5 points on a 10 cm visual analog scale for bothersomeness of low back pain at the time of screening and 3 between 18 and 65 years of age. Participants were blinded to the real and sham acupuncture treatments. The real acupuncture treatment group received real acupuncture 2 times a week, during a total of 12 sessions over 6 weeks. The control group received sham acupuncture during the same period. In order to assess the primary and secondary outcome measures, the participants were asked to fill out a questionnaire at the baseline and 6, 8, 12 and 24 weeks after starting the treatments. The primary outcome was measured using the visual analog scale for bothersomeness of low back pain at 8 weeks after the initiation of treatments. Discussion The result of this trial (which will be available in 2010 will demonstrate the efficacy of using acupuncture to treat chronic low back pain. Trial registration This study is registered with the U.S. National Institutes of Health Clinical Trials registry: NCT00815529

  17. PTSD Symptoms Mediate the Effect of Attachment on Pain and Somatisation after Whiplash Injury

    OpenAIRE

    2013-01-01

    Introduction: The development of persistent pain post-whiplash injury is still an unresolved mystery despite the fact that approximately 50% of individuals reporting whiplash develop persistent pain. There is agreement that high initial pain and PTSD symptoms are indicators of a poor prognosis after whiplash injury. Recently attachment insecurity has been proposed as a vulnerability factor for both pain and PTSD. In order to guide treatment it is important to examine possible mechanisms which...

  18. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

    DEFF Research Database (Denmark)

    Dworkin, R.H.; Turk, D.C.; Wyrwich, K.W.;

    2008-01-01

    . Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. PERSPECTIVE: Systematically collecting and reporting the recommended information needed to evaluate the clinical importance......A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group...... of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT...

  19. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia : 2-year follow-up from a randomized phase 3 trial (DASISION)

    NARCIS (Netherlands)

    Kantarjian, Hagop M.; Shah, Neil P.; Cortes, Jorge E.; Baccarani, Michele; Agarwal, Mohan B.; Soledad Undurraga, Maria; Wang, Jianxiang; Kassack Ipina, Juan Julio; Kim, Dong-Wook; Ogura, Michinori; Pavlovsky, Carolina; Junghanss, Christian; Milone, Jorge H.; Nicolini, Franck E.; Robak, Tadeusz; Van Droogenbroeck, Jan; Vellenga, Edo; Bradley-Garelik, M. Brigid; Zhu, Chao; Hochhaus, Andreas

    2012-01-01

    Dasatinib is a highly potent BCR-ABL inhibitor with established efficacy and safety in imatinib-resistant/-intolerant patients with chronic myeloid leukemia (CML). In the phase 3 DASISION trial, patients with newly diagnosed chronic-phase (CP) CML were randomized to receive dasatinib 100 mg (n = 259

  20. Risk Factors of Poor Prognosis after Whiplash Injury

    Directory of Open Access Journals (Sweden)

    Samy Suissa

    2003-01-01

    Full Text Available Whiplash, a common injury following motor vehicle crashes, is associated with high costs and a prognosis that is variable and difficult to predict. In this paper, we review findings from the Quebec cohort epidemiological study on predictive factors of recovery from whiplash injury after a motor vehicle crash. We formed a population-based incident cohort of all 4,759 individuals who sustained a whiplash injury resulting from a motor vehicle crash in the province of Québec, Canada, in 1987, and followed these patients for up to seven years. The data were obtained from the universal automobile insurance plan (SAAQ that covers all seven million residents of the Province for all vehicular-related injuries. From this cohort, we formed the cohort of 3,014 for whom a police report was completed. For this cohort, we obtained data on crash-related factors directly from the police report. We also formed the cohort of 2,627 subjects who had strictly a whiplash injury, without associated injuries. For this cohort, the data on signs and symptoms were obtained from the medical charts kept by the SAAQ. For both cohorts, data on the outcome, the recovery time from whiplash, was obtained from the SAAQ databases. The crash-related cohort study found that socio-demographic factors associated with a longer recovery from whiplash include older age, female sex, having dependents and not being employed full time and that each decreases the rate of recovery by 14 to 16 per cent. Factors related to the crash conditions indicate that being in a truck or bus, with a decrease of 52% in the rate of recovery, being a passenger in the vehicle (15%, colliding with a moving vehicle (16%, and a side or frontal collision (15% all decrease the rate of recovery. We introduce a combined risk score that predicts longer recovery. In the cohort of subjects with signs and symptoms, the median recovery time was 32 days and 12% of subjects had still not recovered after 6 months. The signs

  1. Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Seitsalo Seppo

    2007-12-01

    Full Text Available Abstract Background Arthroscopy is often used to treat patients with chronic patellofemoral pain syndrome (PFPS. As there is a lack of evidence, we conducted a randomized controlled trial to study the efficacy of arthroscopy in patients with chronic PFPS. Methods A total of 56 patients with chronic PFPS were randomized into two treatment groups: an arthroscopy group (N = 28, treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28, treated with the 8-week home exercise program only. The arthroscopy included finding-specific surgical procedures according to current recommendations. The primary outcome was the Kujala score on patellofemoral pain and function at 9 months following randomization. Secondary outcomes were visual analog scales (VASs to assess activity-related symptoms. We also estimated the direct healthcare costs. Results Both groups showed marked improvement during the follow-up. The mean improvement in the Kujala score was 12.9 (95% confidence interval (CI 8.2–17.6 in the arthroscopy group and 11.4 (95% CI 6.9–15.8 in the control group. However, there was no difference between the groups in mean improvement in the Kujala score (group difference 1.1 (95% CI -7.4 - 5.2 or in any of the VAS scores. Total direct healthcare costs in the arthroscopy group were estimated to exceed on average those of the control group by €901 per patient (p Conclusion In this controlled trial involving patients with chronic PFPS, the outcome when arthroscopy was used in addition to a home exercise program was no better than when the home exercise program was used alone. Trial registration Current Controlled Trials ISRCTN 41800323

  2. Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial.

    Science.gov (United States)

    Herbert, Matthew Scott; Afari, Niloofar; Liu, Lin; Heppner, Pia; Rutledge, Thomas; Williams, Kathryn; Eraly, Satish; VanBuskirk, Katie; Nguyen, Cathy; Bondi, Mark; Atkinson, J Hampton; Golshan, Shahrokh; Wetherell, Julie Loebach

    2017-02-01

    The purpose of this randomized noninferiority trial was to compare video teleconferencing (VTC) versus in-person (IP) delivery of an 8-week acceptance and commitment therapy (ACT) intervention among veterans with chronic pain (N = 128) at post-treatment and at 6-month follow-up. The primary outcome was the pain interference subscale of the Brief Pain Inventory. Secondary outcomes included measures of pain severity, mental and physical health-related quality of life, pain acceptance, activity level, depression, pain-related anxiety, and sleep quality. In intent to treat analyses using mixed linear effects modeling, both groups exhibited significant improvements on primary and secondary outcomes, with the exception of sleep quality. Further, improvements in activity level at 6-month follow-up were significantly greater in the IP group. The noninferiority hypothesis was supported for the primary outcome and several secondary outcomes. Treatment satisfaction was similar between groups; however, significantly more participants withdrew during treatment in the VTC group compared with the IP group, which was moderated by activity level at baseline. These findings generally suggest that ACT delivered via VTC can be as effective and acceptable as IP delivery for chronic pain. Future studies should examine the optimal delivery of ACT for patients with chronic pain who report low levels of activity. This trial was registered at ClinicalTrials.gov (NCT01055639).

  3. Controlled trials of antibiotic treatment in patients with post-treatment chronic Lyme disease.

    Science.gov (United States)

    Klempner, Mark S

    2002-01-01

    Some patients have persistence of profound fatigue, myalgias, arthralgias without arthritis, dysesthesia/paresthesia, and mood and memory disturbances after standard courses of antibiotic treatment for Lyme disease. This constellation of symptoms has been variously referred to as "chronic Lyme disease," "post-Lyme disease syndrome," and "post-treatment chronic Lyme disease." Persistent symptoms have been reported in patients who are seropositive for IgG antibodies against Borrelia burgdorferi as well as in patients who are seronegative. The cause or causes of persistent symptoms in these patients have not been clearly defined and are controversial. Because of the temporal association of these symptoms with infection with B. burgdorferi, some patients have been treated with prolonged courses of antibiotics. Case reports and uncontrolled trials have reported the efficacy of prolonged antibiotic therapy, often with relapse of the symptoms after discontinuation of therapy. To date, only one randomized, placebo-controlled, double-blind trial of antibiotic therapy for these patients has been published. An abstract of a second placebo-controlled trial of antibiotic therapy in a smaller cohort has also been presented. This paper will describe this patient population in detail and will review the clinical, microbiological, and selected biochemical and immunologic parameters and their responses to antibiotic treatment in the setting of a controlled trial.

  4. Spirulina did not ameliorate idiopathic chronic fatigue in four N-of-1 randomized controlled trials.

    Science.gov (United States)

    Baicus, Cristian; Baicus, Anda

    2007-06-01

    Idiopathic chronic fatigue is an exclusion diagnosis established when no chronic disease is found. Spirulina platensis is an alga with a rich content of proteins, vitamins, minerals and amino acids and is considered as a bioactive additive with multiple effects, among them being effects against fatigue. However, despite the worldwide utilization of Spirulina, there are only a few quality studies with it and none concerning fatigue. The N-of-1 randomized trials are made on one patient, and by this kind of study the efficacy of a treatment on that particular patient can be assessed. A series of four N-of-1 double-blind, randomized trials were performed on four physicians who complained of chronic fatigue. Each patient was his own control and received three pairs of treatments comprising 4 weeks of spirulina and 4 weeks of placebo. Spirulina platensis was administered in a dose of 3 g/day. For each pair, the order of treatments was randomized. Outcome measures were severity of fatigue measured on a 10-point scale. The scores of fatigue were not significantly different between spirulina and placebo. Spirulina administered in a dose of 3 g/day did not ameliorate fatigue more than the placebo in any of the four subjects, and possibly it has no effect on chronic fatigue.

  5. Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial.

    LENUS (Irish Health Repository)

    Hurley, Deirdre A

    2010-01-01

    Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population.

  6. [Expert evidence in whiplash injury: interdisciplinary orthopaedic and biomechanical approach].

    Science.gov (United States)

    Magin, M N; Auer, C

    2014-03-01

    Considering the controversially discussed issue of whiplash injury a pragmatic approach based on our own experience in the area of forensic expert opinion is presented. Findings of accident analysis and biomechanics are correlated with the individual situation after the accident (initial clinical appearance), the course of the ailment and the indispensable physical examination. The latter leads to determination of the individual vulnerability (not increased/increased) which is important for the evaluation of the physical condition and estimation of the physical stress limit. These limits vary widely between individuals and must be considered carefully when relating dose and effect of accident severity to a possible physical injury. Determination of the accident severity is especially important when there are no objective signs of injury and the existence of a minor whiplash injury (Quebec Task Force degree 1 or 2) is in question.

  7. Does cervical kyphosis relate to symptoms following whiplash injury?

    DEFF Research Database (Denmark)

    Johansson, Mats Peter; Baann Liane, Martin Skogheim; Bendix, Tom

    2011-01-01

    The mechanisms for developing long-lasting neck pain after whiplash injuries are still largely unrevealed. In the present study it was investigated whether a kyphotic deformity of the cervical spine, as opposed to a straight or a lordotic spine, was associated with the symptoms at baseline......, and with the prognosis one year following a whiplash injury. MRI was performed in 171 subjects about 10 d after the accident, and 104 participated in the pain recording at 1-year follow-up. It was demonstrated that postures as seen on MRI can be reliably categorized and that a straight spine is the most frequent...... appearance of the cervical spine in supine MRI. In relation to symptoms it was seen that a kyphotic deformity was associated with reporting the highest intensities of headache at baseline, but not with an increased risk of long-lasting neck pain or headache. In conclusion, a kyphotic deformity...

  8. The effect of continuous ultrasound on chronic low back pain: protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Naghdi Soofia

    2011-03-01

    Full Text Available Abstract Background Chronic non-specific low-back pain (LBP is one of the most common and expensive musculoskeletal disorders in industrialized countries. Similar to other countries in the world, LBP is a common health and socioeconomic problem in Iran. One of the most widely used modalities in the field of physiotherapy for treating LBP is therapeutic ultrasound. Despite its common use, there is still inconclusive evidence to support its effectiveness in this group of patients. This randomised trial will evaluate the effectiveness of continuous ultrasound in addition to exercise therapy in patients with chronic LBP. Methods and design A total of 46 patients, between the ages 18 and 65 years old who have had LBP for more than three months will be recruited from university hospitals. Participants will be randomized to receive continuous ultrasound plus exercise therapy or placebo ultrasound plus exercise therapy. These groups will be treated for 10 sessions during a period of 4 weeks. Primary outcome measures will be functional disability and pain intensity. Lumbar flexion and extension range of motion, as well as changes in electromyography muscle fatigue indices, will be measured as secondary outcomes. All outcome measures will be measured at baseline, after completion of the treatment sessions, and after one month. Discussion The results of this trial will help to provide some evidence regarding the use of continuous ultrasound in chronic LBP patients. This should lead to a more evidence-based approach to clinical decision making regarding the use of ultrasound for LBP. Trial registration Netherlands Trial Register (NTR: NTR2251

  9. The Chronic Care for Wet Age Related Macular Degeneration (CHARMED Study: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Stefan Markun

    Full Text Available In real life, outcomes in wet age related macular degeneration (W-AMD continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM.Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using reminder systems, performing structured follow-up, empowering patients in self-monitoring and giving decision-support. In the control usual care was continued. Main outcome measures were changes in ETDRS visual acuity, optical coherence tomography (OCT macular retinal thickness and quality of life (NEI VFQ-25 questionnaire.169 consecutive patients in Swiss ophthalmology centers were included. Mean ETDRS baseline visual acuity of eyes with W-AMD was 57.8 (± 18.7. After 12 months, the between-group difference in mean change of ETDRS visual acuity was -4.8 (95%CI: -10.8 to +1.2, p = 0.15; difference in mean change of OCT was +14.0 (95% CI -39.6 to 67.6, p = 0.60; difference in mean change of NEI VFQ-25 composite score mean change was +2.1(95%CI: -1.3 to +5.5, p = 0.19.The intervention aiming at improving chronic care was not associated with favorable outcomes within 12 months. Other approaches need to be tested to close the evidence-performance gap in W-AMD.Controlled-Trials.com ISRCTN32507927.

  10. Relatie tussen de trekhaak en whiplash : notitie ten behoeve van het Verbond van Verzekeraars.

    NARCIS (Netherlands)

    Schoon, C.C. & Broertjes, P.

    1995-01-01

    Whiplash injury occurs mainly as a result of rear-end collisions. The assumption is that the less easily flexible rear-end a car has, the greater the chance of whiplash. A fitted towing hook increases the stiffness of the rear-end of cars. This report explores the relationship between towing hooks a

  11. Clinical Holistic Medicine: Whiplash, Fibromyalgia, and Chronic Fatigue

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2005-01-01

    Full Text Available Holistic treatment of the highly complex, “new diseases” are often possible with the tools of consciousness-based medicine. The treatment is more complicated and the cure usually takes longer than for less-complex diseases. The problem with these patients is that they have less easily accessible resources than most patients, as they suffer from a combined socio-psycho-physical problem with depression, poor social standing, low confidence, and low self-esteem. Often, they have also already tried most of the specialist and alternative treatments on the market. To cure them, the most important thing is to coach them to improve their social life by changing their behavior to be of more value to others. Holding and processing must be especially careful and the contract with the patients must be extremely explicit in order to work on their personal development for 6—12 months. The new diseases can be cured with consciousness-based medicine if the patients are motivated and keep their appointments and agreements. Low responsibility, low personal energy, little joy of life, and limited insight into self and existence are some of the features of the new diseases that make them difficult to cure. The important thing is to keep a pace the patient can follow and give the patient a row of small successes and as few failures as possible. The new diseases are a challenge, a unique chance to improve communication, holding, and processing skills.

  12. A Phase I Trial of Epstein-Barr Virus Gp350 Vaccine for Children With Chronic Kidney Disease Awaiting Transplantation

    NARCIS (Netherlands)

    Rees, L.; Tizard, E.J.; Morgan, A.J.; Cubitt, W.D.; Finerty, S.; Oyewole-Eletu, T.A.; Owen, K.; Royed, C.; Stevens, S.J.C.; Shroff, R.C.; Tanday, M.K.; Wilson, A.; Middeldorp, J.M.; Amlot, P.L.; Steven, N.M.

    2009-01-01

    Background. Vaccination against Epstein-Barr virus (EBV), inducing an antibody response to the envelope glycoprotein gp350, might protect EBV-negative children with chronic kidney disease from lymphoproliferative disease after transplantation. Methods. A phase I trial recruited children with chronic

  13. Chronic hand eczema - self-management and prognosis: a study protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Mollerup Annette

    2012-06-01

    Full Text Available Abstract Background Hand eczema has a one-year prevalence of approximately 10 % in the general Danish population. Often the disease becomes chronic with numerous implications for the individual’s daily life, occupation and quality of life. However, no guidelines of self-management recommendations beyond the acute stage are given. Self-management of the disease is pivotal and involves self-monitoring of the condition, medication adherence, and preventive behaviour. Interventions best to support the individual in this ongoing process need to be developed. Methods/design This paper describes the design of a randomised clinical trial to test a newly developed intervention of individual counselling versus conventional information. 300 patients consecutively referred to dermatologic treatment at two different settings are individually randomised to either the intervention programme, named ‘The Healthy Skin Clinic’ or to the control group. Block-wise randomisation according to setting and gender is carried out. The intervention offers a tool for self-monitoring; basic and specific individual counselling; the possibility of asynchronous communication with the intervention team; and an electronic patient dialogue forum. Primary outcome variable is objective assessment of the hand eczema severity performed at baseline prior to randomisation, and repeated at six months follow-up. Secondary outcome variables are dermatology related life quality and perceived global burden of disease. Discussion The trial aims at evaluating a newly developed guidance programme which is expected to support self-management of patients referred to dermatology treatment due to chronic hand eczema. The design of the protocol is pragmatic with blinding of neither participants nor the investigator. Thus, in the interpretation of the results, the investigator takes into account effects that may be attributed to actors of the interventions rather than the intervention per se as

  14. Tai Chi for Chronic Pain Conditions: A Systematic Review and Meta-analysis of Randomized Controlled Trials

    OpenAIRE

    Ling Jun Kong; Romy Lauche; Petra Klose; Jiang Hui Bu; Xiao Cun Yang; Chao Qing Guo; Gustav Dobos; Ying Wu Cheng

    2016-01-01

    Several studies reported that Tai Chi showed potential effects for chronic pain, but its role remains controversial. This review assessed the evidence regarding the effects of Tai Chi for chronic pain conditions. 18 randomized controlled trials were included in our review. The aggregated results have indicated that Tai Chi showed positive evidence on immediate relief of chronic pain from osteoarthritis (standardized mean difference [SMD], −0.54; 95% confidence intervals [CI], −0.77 to −0.30; ...

  15. A mHealth Application for Chronic Wound Care: Findings of a User Trial

    Directory of Open Access Journals (Sweden)

    Marcia R. Friesen

    2013-11-01

    Full Text Available This paper reports on the findings of a user trial of a mHealth application for pressure ulcer (bedsore documentation. Pressure ulcers are a leading iatrogenic cause of death in developed countries and significantly impact quality of life for those affected. Pressure ulcers will be an increasing public health concern as the population ages. Electronic information systems are being explored to improve consistency and accuracy of documentation, improve patient and caregiver experience and ultimately improve patient outcomes. A software application was developed for Android Smartphones and tablets and was trialed in a personal care home in Western Canada. The software application provides an electronic medical record for chronic wounds, replacing nurses’ paper-based charting and is positioned for integration with facility’s larger eHealth framework. The mHealth application offers three intended benefits over paper-based charting of chronic wounds, including: (1 the capacity for remote consultation (telehealth between facilities, practitioners, and/or remote communities, (2 data organization and analysis, including built-in alerts, automatically-generated text-based and graph-based wound histories including wound images, and (3 tutorial support for non-specialized caregivers. The user trial yielded insights regarding the software application’s design and functionality in the clinical setting, and highlighted the key role of wound photographs in enhancing patient and caregiver experiences, enhancing communication between multiple healthcare professionals, and leveraging the software’s telehealth capacities.

  16. Effect of allopurinol in chronic nonbacterial prostatitis: a double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Amir M. Ziaee

    2006-04-01

    Full Text Available INTRODUCTION: The exact mechanism of chronic nonbacterial prostatitis has not been yet elucidated and the outcome with the current management is dismal. In this trial, we studied the effect of allopurinol in the treatment of this disease. MATERIALS AND METHODS: In this randomized double blind controlled trial, a calculated sample size of 56 were grouped into "intervention group" who received allopurinol (100 mg tds for 3 months with ofloxacin (200 mg tds for 3 weeks (n = 29 and "control group" who received placebo tablets with ofloxacin (n = 27. Patients’ scores based on the National Institute of Health Chronic Prostatitis Symptom Score were recorded before therapy and then every month during the study. A four-glass study was performed before intervention and after 3 months. RESULTS: The 2 groups were similar regarding outcome variables. In the first month of study, a significant but similar improvement in symptom scores was observed in both groups. Microscopic examination of prostate massage and post-massage samples were also similar in both groups. No side effects due to allopurinol were observed in patients. CONCLUSION: We did not find any advantage for allopurinol in the management of chronic prostatitis versus placebo in patients receiving routine antibacterial treatment.

  17. Randomized Multicenter Feasibility Trial of Myofascial Physical Therapy for Treatment of Urologic Chronic Pelvic Pain Syndrome

    Science.gov (United States)

    FitzGerald, Mary P; Anderson, Rodney U; Potts, Jeannette; Payne, Christopher K; Peters, Kenneth M; Clemens, J Quentin; Kotarinos, Rhonda; Fraser, Laura; Cosby, Annamarie; Fortman, Carole; Neville, Cynthia; Badillo, Suzanne; Odabachian, Lisa; Sanfield, Anna; O’Dougherty, Betsy; Halle-Podell, Rick; Cen, Liyi; Chuai, Shannon; Landis, J Richard; Kusek, John W; Nyberg, Leroy M

    2010-01-01

    Objectives To determine the feasibility of conducting a randomized clinical trial designed to compare two methods of manual therapy (myofascial physical therapy (MPT) and global therapeutic massage (GTM)) among patients with urologic chronic pelvic pain syndromes. Materials and Methods Our goal was to recruit 48 subjects with chronic prostatitis/chronic pelvic pain syndrome or interstitial cystitis/painful bladder syndrome at six clinical centers. Eligible patients were randomized to either MPT or GTM and were scheduled to receive up to 10 weekly treatments, each 1 hour in duration. Criteria to assess feasibility included adherence of therapists to prescribed therapeutic protocol as determined by records of treatment, adverse events which occurred during study treatment, and rate of response to therapy as assessed by the Patient Global Response Assessment (GRA). Primary outcome analysis compared response rates between treatment arms using Mantel-Haenszel methods. Results Twenty-three (49%) men and 24 (51%) women were randomized over a six month period. Twenty-four (51%) patients were randomized to GTM, 23 (49%) to MPT; 44 (94%) patients completed the study. Therapist adherence to the treatment protocols was excellent. The GRA response rate of 57% in the MPT group was significantly higher than the rate of 21% in the GTM treatment group (p=0.03). Conclusions The goals to judge feasibility of conducting a full-scale trial of physical therapy methods were met. The preliminary findings of a beneficial effect of MPT warrants further study. PMID:19535099

  18. Influence of sympathetic nervous system on sensorimotor function: whiplash associated disorders (WAD) as a model.

    Science.gov (United States)

    Passatore, Magda; Roatta, Silvestro

    2006-11-01

    There is increasing interest about the possible involvement of the sympathetic nervous system (SNS) in initiation and maintenance of chronic muscle pain syndromes of different aetiology. Epidemiological data show that stresses of different nature, e.g. work-related, psychosocial, etc., typically characterised by SNS activation, may be a co-factor in the development of the pain syndrome and/or negatively affect its time course. In spite of their clear traumatic origin, whiplash associated disorders (WAD) appear to share many common features with other chronic pain syndromes affecting the musculo-skeletal system. These features do not only include symptoms, like type of pain or sensory and motor dysfunctions, but possibly also some of the pathophysiological mechanisms that may concur to establish the chronic pain syndrome. This review focuses on WAD, particular emphasis being devoted to sensorimotor symptoms, and on the actions exerted by the sympathetic system at muscle level. Besides its well-known action on muscle blood flow, the SNS is able to affect the contractility of muscle fibres, to modulate the proprioceptive information arising from the muscle spindle receptors and, under certain conditions, to modulate nociceptive information. Furthermore, the activity of the SNS itself is in turn affected by muscle conditions, such as its current state of activity, fatigue and pain signals originating in the muscle. The possible involvement of the SNS in the development of WAD is discussed in light of the several positive feedback loops in which it is implicated.

  19. Effectiveness of Telephone-Based Health Coaching for Patients with Chronic Conditions: A Randomised Controlled Trial

    Science.gov (United States)

    Dwinger, Sarah; Kriston, Levente; Herbarth, Lutz; Siegmund-Schultze, Elisabeth; Bermejo, Isaac; Matschinger, Herbert; Heider, Dirk; König, Hans-Helmut

    2016-01-01

    Background Chronic diseases, like diabetes mellitus, heart disease and cancer are leading causes of death and disability. These conditions are at least partially preventable or modifiable, e.g. by enhancing patients’ self-management. We aimed to examine the effectiveness of telephone-based health coaching (TBHC) in chronically ill patients. Methods and Findings This prospective, pragmatic randomized controlled trial compares an intervention group (IG) of participants in TBHC to a control group (CG) without TBHC. Endpoints were assessed two years after enrolment. Three different groups of insurees with 1) multiple conditions (chronic campaign), 2) heart failure (heart failure campaign), or 3) chronic mental illness conditions (mental health campaign) were targeted. The telephone coaching included evidence-based information and was based on the concepts of motivational interviewing, shared decision-making, and collaborative goal setting. Patients received an average of 12.9 calls. Primary outcome was time from enrolment until hospital readmission within a two-year follow-up period. Secondary outcomes comprised the probability of hospital readmission, number of daily defined medication doses (DDD), frequency and duration of inability to work, and mortality within two years. All outcomes were collected from routine data provided by the statutory health insurance. As informed consent was obtained after randomization, propensity score matching (PSM) was used to minimize selection bias introduced by decliners. For the analysis of hospital readmission and mortality, we calculated Kaplan-Meier curves and estimated hazard ratios (HR). Probability of hospital readmission and probability of death were analysed by calculating odds ratios (OR). Quantity of health service use and inability to work were analysed by linear random effects regression models. PSM resulted in patient samples of 5,309 (IG: 2,713; CG: 2,596) in the chronic campaign, of 660 (IG: 338; CG: 322) in the

  20. Magnesium for acute exacerbation of chronic obstructive pulmonary disease: A systematic review of randomised trials

    Directory of Open Access Journals (Sweden)

    Mitrakrishnan Chrishan Shivanthan

    2014-01-01

    Full Text Available The efficacy of magnesium sulphate in chronic obstructive pulmonary disease (COPD was assessed by conducting a systematic review of published randomized clinical trials through extensive searches in MEDLINE and SCOPUS with no date limits, as well as manual review of journals. Outcome measures varied depending on route(s of administration of magnesium sulphate and medications co-administered. Risk of bias was evaluated and quality of evidence was graded. Four (4 randomized trials were included. All trials had a moderate risk of bias and were of average methodological quality. Magnesium sulphate given intravenously did not seem to have an immediate bronchodilatory effect; however it appears to potentiate the bronchodilatory effect of inhaled beta-2 agonists. Increase in peak expiratory flow rate (PEFR at 30 and 45 min was greater in those who received magnesium sulphate compared to placebo (P = 0.03, although the mean percentage change in PEFR was just 24%, without significant differences in dyspnoea scores, hospital admission rates, or emergency department readmission rates compared to placebo. Nebulized magnesium sulphate with salbutamol versus nebulized salbutamol with saline placebo showed no significant differences is forced expiratory volume in 1 s (FEV 1 measured at 90 min after adjustment for baseline FEV 1 (P = 0.34 or differences in the need for hospital admission. Combined inhalational and intravenous magnesium sulphate versus intravenous saline placebo and nebulized ipratropium bromide were comparable in terms of hospital admission, intubation and death, but the ipratropium bromide group showed better bronchodilator effect and improvement in arterial blood gas parameters. Overall, trial evidence for trial evidence for magnesium sulphate in acute exacerbation of COPD is poor, and further well-designed trials are needed.

  1. Improving the external validity of clinical trials: the case of multiple chronic conditions

    Directory of Open Access Journals (Sweden)

    Martin Fortin

    2013-12-01

    Full Text Available The U.S. Department of Health and Human Services vision and strategic framework on multiple chronic conditions (MCCs incorporates recommendations designed to facilitate research that will improve our knowledge about interventions and systems that will benefit individuals with MCCs (or multimorbidity. The evidence base supporting the management of patients with MCCs will be built both through intervention trials specifically designed to address multimorbidity and identification of MCCs in participants across the clinical trial range. This article specifically focuses on issues relating to external validity with specific reference to trials involving patients with MCCs. The exclusion of such patients from clinical trials has been well documented. Randomized control trials (RCTs are considered the “gold standard” of evidence, but may have drawbacks in relation to external validity, particularly in relation to multimorbidity. It may, therefore, be necessary to consider a broader range of research methods that can provide converging evidence on intervention effects to address MCCs. Approaches can also be taken to increase the usefulness of RCTs in general for providing evidence to inform multimorbidity management. Additional improvements to RCTs would include better reporting of inclusion and exclusion criteria and participant characteristics in relation to MCCs. New trials should be considered in terms of how they will add to the existing evidence base and should inform how interventions may work in different settings and patient groups. Research on treatments and interventions for patients with MCCs is badly needed. It is important that this research includes patient-centered measures and that generalizability issues be explicitly addressed.

  2. Adipose-derived mesenchymal stromal cells for chronic myocardial ischemia (MyStromalCell Trial)

    DEFF Research Database (Denmark)

    Qayyum, Abbas Ali; Haack-Sørensen, Mandana; Mathiasen, Anders Bruun;

    2012-01-01

    for regenerative therapy to replace injured tissue by creating new blood vessels and cardiomyocytes in patients with chronic ischemic heart disease. The aim of this special report is to review the present preclinical data leading to clinical stem cell therapy using ADSCs in patients with ischemic heart disease......Adipose tissue represents an abundant, accessible source of multipotent adipose-derived stromal cells (ADSCs). Animal studies have suggested that ADSCs have the potential to differentiate in vivo into endothelial cells and cardiomyocytes. This makes ADSCs a promising new cell source....... In addition, we give an introduction to the first-in-man clinical trial, MyStromalCell Trial, which is a prospective, randomized, double-blind, placebo-controlled study using culture-expanded ADSCs obtained from adipose-derived cells from abdominal adipose tissue and stimulated with VEGF-A(165) the week...

  3. Intensive dynamic training for females with chronic neck/shoulder pain. A randomized controlled trial

    DEFF Research Database (Denmark)

    Randløv, A; Østergaard, Mikkel; Manniche, C;

    1998-01-01

    OBJECTIVES: To compare the clinical effectiveness of an intensive three-month training programme with a less intensive programme on females suffering from chronic neck/shoulder pain. STUDY DESIGN: A prospective observer-blinded clinical trial including 12-month pretreatment follow-up. SETTING......: Patients were referred to the Departments of Rheumatology and Physical Medicine at Hvidovre Hospital by their general practitioners. Training was undertaken at a satellite clinic for physiotherapy of Hvidovre Hospital. SUBJECTS: Female patients aged 18-65 years suffering from chronic neck/shoulder pain...... for a minimum of six months. INTERVENTION: Patients were examined by a physician in order to exclude serious diseases. They were then randomized to either an intensive neck/shoulder training programme or a programme of lesser intensity but of similar duration. MAIN OUTCOME MEASURES: Scales measuring pain...

  4. Randomized clinical trial for treatment of chronic nightmares in trauma-exposed adults.

    Science.gov (United States)

    Davis, Joanne L; Wright, David C

    2007-04-01

    Nightmares and sleep disturbance are fundamental concerns for victims of trauma. This study examined the efficacy of a manualized cognitive-behavioral treatment (CBT) for chronic nightmares in trauma-exposed individuals via a randomized clinical trial. Participants were randomly assigned to a treatment group or wait-list control group, with 27 participants completing the treatment. At the 6-month follow-up assessment, 84% of treated participants reported an absence of nightmares in the previous week. Significant decreases were also reported in symptoms of depression and posttraumatic stress, fear of sleep, and number of sleep problems, while sleep quality and quantity improved. The present study adds to the growing literature indicating this brief CBT as a first-line treatment for trauma-exposed individuals with chronic nightmares.

  5. Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Brian E Lacy

    Full Text Available Abdominal bloating is a common and bothersome symptom of chronic idiopathic constipation. The objective of this trial was to evaluate the efficacy and safety of linaclotide in patients with chronic idiopathic constipation and concomitant moderate-to-severe abdominal bloating.This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale during the 14-day baseline period. Patients reported abdominal symptoms (including bloating and bowel symptoms daily; adverse events were monitored. The primary responder endpoint required patients to have ≥3 complete spontaneous bowel movements/week with an increase of ≥1 from baseline, for ≥9 of 12 weeks. The primary endpoint compared linaclotide 145 μg vs. placebo.The intent-to-treat population included 483 patients (mean age=47.3 years, female=91.5%, white=67.7%. The primary endpoint was met by 15.7% of linaclotide 145 μg patients vs. 7.6% of placebo patients (P<0.05. Both linaclotide doses significantly improved abdominal bloating vs. placebo (P<0.05 for all secondary endpoints, controlling for multiplicity. Approximately one-third of linaclotide patients (each group had ≥50% mean decrease from baseline in abdominal bloating vs. 18% of placebo patients (P<0.01. Diarrhea was reported in 6% and 17% of linaclotide 145 and 290 μg patients, respectively, and 2% of placebo patients. AEs resulted in premature discontinuation of 5% and 9% of linaclotide 145 μg and 290 μg patients, respectively, and 6% of placebo patients.Once-daily linaclotide (145 and 290 μg significantly improved bowel and abdominal symptoms in chronic idiopathic constipation patients with moderate-to-severe baseline abdominal bloating; in particular

  6. Acupuncture for chronic neck pain: a pilot for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bland Martin J

    2006-12-01

    Full Text Available Abstract Background Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. Methods Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ at 3 months. The primary analysis was to determine the sample size for the full scale study. Results Of the 227 patients with neck pain identified from the GP database, 28 (12.3% consenting patients were eligible to participate in the pilot and 24 (10.5% were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients. Conclusion This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence

  7. Melodic Intonation Therapy in chronic aphasia: evidence from a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ineke Van Der Meulen

    2016-11-01

    Full Text Available AbstractMelodic Intonation Therapy (MIT is a language production therapy for severely non-fluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT examining the efficacy of MIT are rare. In an earlier publication, we presented the results of an RCT on MIT in subacute aphasia and found that MIT was effective on trained and untrained items. Further, we observed a clear trend in improved functional language use after MIT. Subacute aphasic patients receiving MIT improved considerably on language tasks measuring connected speech and daily life verbal communication. Here, we present the results of a pilot RCT on MIT in chronic aphasia and compare these to the results observed in subacute aphasia. We used a multicenter waiting-list randomized controlled trial design. Patients with chronic (>1 year post-stroke aphasia were randomly allocated to the experimental group (6 weeks MIT or to the control group (6 weeks no intervention followed by 6 weeks MIT. Assessments were done at baseline (T1, after 6 weeks (T2, and 6 weeks later (T3. Efficacy was evaluated at T2 using univariable linear regression analyses. Outcome measures were chosen to examine several levels of therapy success: improvement on trained items, generalization to untrained items, and generalization to verbal communication. Of 17 included patients, 10 were allocated to the experimental condition and 7 to the control condition. MIT significantly improved repetition of trained items (β=13.32, p=.02. This effect did not remain stable at follow-up assessment. In contrast to earlier studies, we found only a limited and temporary effect of MIT, without generalization to untrained material or to functional communication. The results further suggest that the effect of MIT in chronic aphasia is more restricted than its effect in earlier stages post stroke. This

  8. Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Barlow William E

    2008-02-01

    Full Text Available Abstract Background Chronic back pain is a major public health problem and the primary reason patients seek acupuncture treatment. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients with this common condition. This study addresses methodological shortcomings that have plagued previous studies evaluating acupuncture for chronic low back pain. Methods and Design A total of 640 participants (160 in each of four arms between the ages of 18 and 70 years of age who have low back pain lasting at least 3 months will be recruited from integrated health care delivery systems in Seattle and Oakland. They will be randomized to one of two forms of Traditional Chinese Medical (TCM acupuncture needling (individualized or standardized, a "control" group (simulated acupuncture, or to continued usual medical care. Ten treatments will be provided over 7 weeks. Study participants and the "Diagnostician" acupuncturists who evaluate participants and propose individualized treatments will be masked to the acupuncture treatment actually assigned each participant. The "Therapist" acupuncturists providing the treatments will not be masked but will have limited verbal interaction with participants. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, and use and costs of healthcare services for back pain will also be measured. The primary analysis comparing outcomes by randomized treatment assignment will be analysis of covariance adjusted for baseline value. For both primary outcome measures, this trial will have 99% power to detect the presence of a minimal clinically significant difference among all four treatment groups and over 80% power for

  9. The relation between initial symptoms and signs and the prognosis of whiplash.

    Science.gov (United States)

    Suissa, S; Harder, S; Veilleux, M

    2001-02-01

    Whiplash, a common injury following motor vehicle crashes, is associated with high costs and a prognosis that is variable and difficult to predict. We studied the profile of recovery from whiplash and assessed whether presenting signs and symptoms directly after the crash were predictive of whiplash prognosis. We formed a population-based incident cohort of all 2627 individuals who sustained a whiplash injury resulting from a motor vehicle crash in the province of Québec, Canada, in 1987, and followed these patients for up to 7 years. The data on signs and symptoms were obtained from the medical charts kept by the universal automobile insurance plan (Société de l'assurance automobile du Québec), which covers all 7 million residents of the province, while data on the outcome--the recovery time from whiplash--was obtained from their databases. The median recovery time was 32 days, and 12% of subjects had still not recovered after 6 months. The signs and symptoms that were found to be independently associated with a slower recovery from whiplash, besides female gender and older age, are neck pain on palpation, muscle pain, pain or numbness radiating from the neck to arms, hands or shoulders, and headache. Together, these factors in older females (age 60) predicted a median recovery time of 262 days, compared with 17 days for younger males (age 20) who do not have this profile. In contrast, using a classification of injury severity previously proposed by the Québec Whiplash Associated Disorders Task Force, the median recovery time varied from 17 to only 123 days. We conclude that whiplash patients presenting with several specific musculoskeletal and neurological signs and symptoms will have a longer recovery period. These patients can easily be identified and closely monitored and targeted for the evaluation of early intervention programmes aimed at managing whiplash patients with a poor prognosis.

  10. A controlled trial of paroxetine for chronic PTSD, dissociation, and interpersonal problems in mostly minority adults.

    Science.gov (United States)

    Marshall, Randall D; Lewis-Fernandez, Roberto; Blanco, Carlos; Simpson, H Blair; Lin, Shu-Hsing; Vermes, Donna; Garcia, Wendy; Schneier, Franklin; Neria, Yuval; Sanchez-Lacay, Arturo; Liebowitz, Michael R

    2007-01-01

    This study evaluated the efficacy of paroxetine for symptoms and associated features of chronic posttraumatic stress disorder (PTSD), interpersonal problems, and dissociative symptoms in an urban population of mostly minority adults. Adult outpatients with a primary DSM-IV diagnosis of chronic PTSD received 1 week of single-blind placebo (N = 70). Those not rated as significantly improved were then randomly assigned to placebo (N = 27) or paroxetine (N = 25) for 10 weeks, with a flexible dosage design (maximum 60 mg by week 7). Significantly more patients treated with paroxetine were rated as responders (14/21, 66.7%) on the Clinical Global Impression-Improvement Scale (CGI-I) compared to patients treated with placebo (6/22, 27.3%). Mixed effects models showed greater reductions on the Clinician-Administered PTSD Scale (CAPS) total score (primary plus associated features of PTSD) in the paroxetine versus placebo groups. Paroxetine was also superior to placebo on reduction of dissociative symptoms [Dissociative Experiences Scale (DES) score] and reduction in self-reported interpersonal problems [Inventory of Interpersonal Problems (IIP) score]. In a 12-week maintenance phase, paroxetine response continued to improve, but placebo response did not. Paroxetine was well tolerated and superior to placebo in ameliorating the symptoms of chronic PTSD, associated features of PTSD, dissociative symptoms, and interpersonal problems in the first trial conducted primarily in minority adults.

  11. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

    Science.gov (United States)

    Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

    2016-09-01

    Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain.

  12. A prospective study of the 1-year incidence of fibromyalgia after acute whiplash injury

    OpenAIRE

    Ferrari, Robert

    2015-01-01

    Objective To measure the 1-year incidence of fibromyalgia in a cohort of acute whiplash-injured participants. Methods Consecutive acute patients with whiplash were assessed via the 2010 Modified American College of Rheumatology (ACR) criteria for fibromyalgia at 3 months, 6 months and 1 year postinjury. At each of these follow-up points, participants were also examined for recovery from whiplash injury. Results Of an initial 268 participants, data on recovery was available for 264 participant...

  13. Retropharyngeal hematoma secondary to whiplash injury in childhood: a case report.

    Science.gov (United States)

    Nurata, Hakan; Yilmaz, Muhammet Bahadır; Borcek, Alp Ozgun; Oner, Ali Yusuf; Baykaner, M Kemali

    2012-01-01

    Whiplash Associated Disorders (WAD) has been reported as an adult phenomenon. Whiplash injury has classically been described as a cervical soft tissue hyperextension- flexion injury after a trauma such as a rear end impact car crash, contact sport injuries, blows to the head from a falling object or a punch and shaken baby syndrome and is mostly seen in adults . It is important as it may cause severe disability due to spinal cord injury, decrease work productivity and even retropharyngeal hematoma resulting airway obstruction and mortality due to bleeding amongst deep cervical fascias. We describe a case of retropharyngeal hematoma after whiplash injury in a childhood.

  14. A prospective study of 39 patients with whiplash injury

    DEFF Research Database (Denmark)

    Karlsborg, M; Smed, A; Jespersen, H

    1997-01-01

    of whiplash injury were examined clinically three times; within 14 days, after 1 month and finally 7 months postinjury. In addition, MRI of the brain and the cervical spine, neuropsychological tests and motor evoked potentials (MEP) were done one month postinjury and repeated after 6 months, if abnormalities...... were found. RESULTS: The total recovery rate (asymptomatic patients) was 29% after 7 months. MRI was repeated in 6 patients. The correlation between MRI and the clinical findings was poor. Cognitive dysfunction as a symptom of brain injury was not found. Stress at the same time predicted more symptoms...

  15. Whiplash Injuries Can be Visible by Functional Magnetic Resonance Imaging

    Directory of Open Access Journals (Sweden)

    Bengt H Johansson

    2006-01-01

    Full Text Available Whiplash trauma can result in injuries that are difficult to diagnose. Diagnosis is particularly difficult in injuries to the upper segments of the cervical spine (craniocervical joint [CCJ] complex. Studies indicate that injuries in that region may be responsible for the cervicoencephalic syndrome, as evidenced by headache, balance problems, vertigo, dizziness, eye problems, tinnitus, poor concentration, sensitivity to light and pronounced fatigue. Consequently, diagnosis of lesions in the CCJ region is important. Functional magnetic resonance imaging is a radiological technique that can visualize injuries of the ligaments and the joint capsules, and accompanying pathological movement patterns.

  16. Trial-based cost-effectiveness analysis comparing surgical and endoscopic drainage in patients with obstructive chronic pancreatitis

    Science.gov (United States)

    Laramée, Philippe; Wonderling, David; Cahen, Djuna L; Dijkgraaf, Marcel G; Gouma, Dirk J; Bruno, Marco J; Pereira, Stephen P

    2013-01-01

    Objective Published evidence indicates that surgical drainage of the pancreatic duct was more effective than endoscopic drainage for patients with chronic pancreatitis. This analysis assessed the cost-effectiveness of surgical versus endoscopic drainage in obstructive chronic pancreatitis. Design This trial-based cost-utility analysis (ISRCTN04572410) was conducted from a UK National Health Service (NHS) perspective and during a 79-month time horizon. During the trial the details of the diagnostic and therapeutic procedures, and pancreatic insufficiency were collected. The resource use was varied in the sensitivity analysis based on a review of the literature. The health outcome was the Quality-Adjusted Life Year (QALY), generated using EQ-5D data collected during the trial. There were no pancreas-related deaths in the trial. All-cause mortality from the trial was incorporated into the QALY estimates in the sensitivity analysis. Setting Hospital. Participants Patients with obstructive chronic pancreatitis. Primary and secondary outcome measures Costs, QALYs and cost-effectiveness. Results The result of the base-case analysis was that surgical drainage dominated endoscopic drainage, being both more effective and less costly. The sensitivity analysis varied mortality and resource use and showed that the surgical option remained dominant in all scenarios. The probability of cost-effectiveness for surgical drainage was 100% for the base case and 82% in the assessed most conservative case scenario. Conclusions In obstructive chronic pancreatitis, surgical drainage is highly cost-effective compared with endoscopic drainage from a UK NHS perspective. PMID:24065699

  17. Alternate-day fasting and chronic disease prevention: a review of human and animal trials.

    Science.gov (United States)

    Varady, Krista A; Hellerstein, Marc K

    2007-07-01

    Calorie restriction (CR) and alternate-day fasting (ADF) represent 2 different forms of dietary restriction. Although the effects of CR on chronic disease prevention were reviewed previously, the effects of ADF on chronic disease risk have yet to be summarized. Accordingly, we review here animal and human evidence concerning ADF and the risk of certain chronic diseases, such as type 2 diabetes, cardiovascular disease, and cancer. We also compare the magnitude of risk reduction resulting from ADF with that resulting from CR. In terms of diabetes risk, animal studies of ADF find lower diabetes incidence and lower fasting glucose and insulin concentrations, effects that are comparable to those of CR. Human trials to date have reported greater insulin-mediated glucose uptake but no effect on fasting glucose or insulin concentrations. In terms of cardiovascular disease risk, animal ADF data show lower total cholesterol and triacylglycerol concentrations, a lower heart rate, improved cardiac response to myocardial infarction, and lower blood pressure. The limited human evidence suggests higher HDL-cholesterol concentrations and lower triacylglycerol concentrations but no effect on blood pressure. In terms of cancer risk, there is no human evidence to date, yet animal studies found decreases in lymphoma incidence, longer survival after tumor inoculation, and lower rates of proliferation of several cell types. The findings in animals suggest that ADF may effectively modulate several risk factors, thereby preventing chronic disease, and that ADF may modulate disease risk to an extent similar to that of CR. More research is required to establish definitively the consequences of ADF.

  18. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain

    OpenAIRE

    Little, Paul; Lewith, George; Webley, Fran; Evans, Maggie; Beattie, Angela; Middleton, Karen; Barnett, Jane; Ballard, Kathleen; Oxford, Frances; Smith, Peter; Yardley, Lucy; Hollinghurst, Sandra; Sharp, Debbie

    2008-01-01

    Objective To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. Design Factorial randomised trial. Setting 64 general practices in England. Participants 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons...

  19. The Effects of Exercise with TENS on Spasticity, Balance, and Gait in Patients with Chronic Stroke: A Randomized Controlled Trial

    OpenAIRE

    Park, Junhyuck; Seo, DongKwon; Choi, WonJae; Lee, Seungwon

    2014-01-01

    Background Transcutaneous electrical nerve stimulation (TENS) is a useful modality for pain control. TENS has recently been applied to decrease spasticity. The purpose of this study is to determine whether the addition of TENS to an exercise program reduces spasticity and improves balance and gait in chronic stroke patients. Material/Methods This was a single-blinded, multicenter, randomized controlled trial. Thirty-four ambulatory individuals with chronic stroke participated and were randoml...

  20. A Randomized, Controlled Trial of Cognitive Behavioral Social Skills Training for Middle-Aged and Older Outpatients With Chronic Schizophrenia

    OpenAIRE

    2005-01-01

    The number of older patients with chronic schizophrenia is increasing. There is a need for empirically validated psychotherapy interventions for these older patients. A randomized controlled trial compared treatment as usual (TAU) with TAU plus cognitive-behavioral social skills training (TAU+CBSST) in 76 middle-aged and older patients with chronic schizophrenia. CBSST teaches cognitive-behavioral coping techniques, social functioning skills, problem solving and compensatory aids for neurocog...

  1. The tongue after whiplash: case report and osteopathic treatment

    Science.gov (United States)

    Bordoni, Bruno; Marelli, Fabiola; Morabito, Bruno

    2016-01-01

    The tongue plays a fundamental role in several bodily functions; in the case of a dysfunction, an exhaustive knowledge of manual techniques to treat the tongue is useful in order to help patients on their path toward recovery. A 30-year-old male patient with a recent history of whiplash, with increasing cervical pain during swallowing and reduced ability to open the mouth, was treated with osteopathic techniques addressed to the tongue. The osteopathic techniques led to a disappearance of pain and the complete recovery of the normal functions of the tongue, such as swallowing and mouth opening. The manual osteopathic approach consists of applying a low load, in order to produce a long-lasting stretching of the myofascial complex, with the aim of restoring the optimal length of this continuum, decreasing pain, and improving functionality. According to the authors’ knowledge, this is the first article reporting a case of resolution of a post whiplash disorder through osteopathic treatment of the tongue. PMID:27462180

  2. Determination of fibromyalgia syndrome after whiplash injuries: methodologic issues.

    Science.gov (United States)

    Robinson, James P; Theodore, Brian R; Wilson, Hilary D; Waldo, Peter G; Turk, Dennis C

    2011-06-01

    Problems in diagnosing fibromyalgia syndrome (FM) among motor vehicle collision (MVC) patients with whiplash (WL) include the following: the predominance of tender points (TPs) in the neck/shoulder girdle region; the 3-month duration of widespread pain criterion; and, the stability of diagnosis. The present study examined the prevalence of FM in a cohort (N = 326) patients with persistent neck pain 3 months after WL injury who were enrolled in a treatment program. Physical examinations were performed at baseline and at the end of treatment. Results indicated that WL patients had a greater proportion of neck/shoulder girdle TPs, relative to distal TPs. Compared with a matched cohort of treatment-seeking FM patients, WL patients indicated less distal TPs (mean = 7.3 TPs vs. mean = 5.6 TPs, P after an MVC). In conclusion, present criteria used in determining FM may result in spuriously inflated rates of diagnosis among WL patients because of persistent localized tenderness after an MVC. Furthermore, the transient nature of FM "symptoms" among WL patients should be taken into account before making a final diagnosis. The present criteria used in determining fibromyalgia may result in spuriously inflated rates of diagnosis among whiplash patients because of persistent localized tenderness after motor vehicle collisions.

  3. The tongue after whiplash: case report and osteopathic treatment

    Directory of Open Access Journals (Sweden)

    Bordoni BB

    2016-07-01

    Full Text Available Bruno Bordoni,1-3 Fabiola Marelli,2,3 Bruno Morabito2-4 1Department of Cardiology, Santa Maria Nascente IRCCS, Don Carlo Gnocchi Foundation, Institute of Hospitalization and Care with Scientific Address, Milan, 2CRESO, School of Osteopathic Centre for Research and Studies, Castellanza,3CRESO, School of Osteopathic Centre for Research and Studies, Falconara Marittima, Ancona, 4Foundation Polyclinic University A, Gemelli University Cattolica del Sacro Cuore, Rome, Italy Abstract: The tongue plays a fundamental role in several bodily functions; in the case of a dysfunction, an exhaustive knowledge of manual techniques to treat the tongue is useful in order to help patients on their path toward recovery. A 30-year-old male patient with a recent history of whiplash, with increasing cervical pain during swallowing and reduced ability to open the mouth, was treated with osteopathic techniques addressed to the tongue. The osteopathic techniques led to a disappearance of pain and the complete recovery of the normal functions of the tongue, such as swallowing and mouth opening. The manual osteopathic approach consists of applying a low load, in order to produce a long-lasting stretching of the myofascial complex, with the aim of restoring the optimal length of this continuum, decreasing pain, and improving functionality. According to the authors’ knowledge, this is the first article reporting a case of resolution of a post whiplash disorder through osteopathic treatment of the tongue. Keywords: tongue, indirect osteopathic techniques, fascia, fascial release

  4. A randomized controlled trial of solcoseryl and duoderm in chronic sickle-cell ulcers.

    Science.gov (United States)

    La Grenade, L; Thomas, P W; Serjeant, G R

    1993-09-01

    A randomized controlled trial of Solcoseryl, DuoDerm and conventional conservative therapy with Eusol has been performed in 32 patients with homozygous sickle-cell (SS) disease. After 12 weeks' baseline observation, patients were randomized to one of three therapies and monitored for a further 12 weeks. Of 44 ulcerated legs, 20 received control treatment, 12 Solcoseryl and 12 DuoDerm. DuoDerm was generally unacceptable, and two-thirds of the patients defaulted from this treatment. Solcoseryl increased ulcer healing compared to the controls but the difference was not significant. Solcoseryl was well tolerated and may have a role in the treatment of chronic leg ulcers of sickle-cell disease.

  5. A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

    DEFF Research Database (Denmark)

    Kasch, Helge; Kongsted, Alice; Qerama, Erisela;

    2013-01-01

    OBJECTIVES: An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. DESIGN: The design was an observational prospective study of risk factors embedded in a randomised controlled study. SETTING: Acute whiplash...... patients from units, general practitioners in four Danish counties were referred to two research centres. PARTICIPANTS: During a 2-year inclusion period, acute consecutive whiplash-injured (age 18-70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I-III, symptoms...... and examined by a study nurse after 5 days; 605 were completed after 1 year. A risk score which included items of initial neck pain/headache intensity, a number of non-painful complaints and active neck mobility was applied. The primary outcome parameter was 1-year work disability. RESULTS: The risk score...

  6. Peritoneal dialysis for chronic cardiorenal syndrome:Lessons learned from ultrafiltration trials

    Institute of Scientific and Technical Information of China (English)

    Amir; Kazory

    2015-01-01

    The current models of cardiorenal syndrome(CRS) are mainly based on a cardiocentric approach; they assume that worsening renal function is an adverse consequence of the decline in cardiac function rather than a separate and independent pathologic phenomenon. If this assumption were true,then mechanical extraction of fluid(i.e.,ultrafiltration therapy) would be expected to portend positive impact on renal hemodynamics and function through improvement in cardio-circulatory physiology and reduction in neurohormonal activation. However,currently available ultrafiltration trials,whether in acute heart failure(AHF) or in CRS,have so far failed to show any improvement in renal function; they have reported no impact or even observed adverse renal outcomes in this setting. Moreover,the presence or absence of renal dysfunction seems to affect the overall safety and efficacy of ultrafiltration therapy in AHF. This manuscript briefly reviews cardiorenal physiology in AHF and concludes that therapeutic options for CRS should not only target cardio-circulatory status of the patients,but they need to also have the ability of addressing the adverse homeostatic consequences of the associated decline in renal function. Peritoneal dialysis(PD) can be such an option for the chronic cases of CRS as it has been shown to provide efficient intracorporeal ultrafiltration and sodium extraction in volume overloaded patients while concurrently correcting the metabolic consequences of diminished renal function. Currently available trials on PD in heart failure have shown the safety and efficacy of this therapeutic modality for patients with chronic CRS and suggest that it could represent a pathophysiologically and conceptually relevant option in this setting.

  7. Hypnosis as a treatment of chronic widespread pain in general practice: A randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Grøndahl Jan

    2008-09-01

    Full Text Available Abstract Background Hypnosis treatment in general practice is a rather new concept. This pilot study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP. Methods The study was designed as a randomized control group-controlled study. Sixteen patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering. Data were analyzed by means of T-tests. Results The treatment group improved from their symptoms, (change from 62.5 to 55.4, while the control group deteriorated, (change from 37.2 to 45.1, (p = 0,045. The 12 patients who completed the treatment showed a mean improvement from 51.5 to 41.6. (p = 0,046. One year later the corresponding result was 41.3, indicating a persisting improvement. Conclusion The study indicates that hypnosis treatment may have a positive effect on pain and quality of life for patients with chronic muscular pain. Considering the limited number of patients, more studies should be conducted to confirm the results. Trial Registration The study was registered in ClinicalTrials.gov and released 27.08.07 Reg nr NCT00521807 Approval Number: 05032001.

  8. Differential Predictors of Pain and Disability in Patients with Whiplash Injuries

    OpenAIRE

    2002-01-01

    The psychological predictors of pain and disability were examined in a sample of people who sustained whiplash injuries during rear-end motor vehicle accidents. Sixty-five patients referred to a specialty pain clinic with a diagnosis of whiplash injury completed measures of depression, anxiety, catastrophizing, pain and perceived disability. Regression analysis revealed that psychological variables accounted for 18% of the variance in pain ratings. The magnification subscale of the Pain Catas...

  9. Systematic review of enriched enrolment, randomised withdrawal trial designs in chronic pain: a new framework for design and reporting.

    Science.gov (United States)

    Moore, R Andrew; Wiffen, Philip J; Eccleston, Christopher; Derry, Sheena; Baron, Ralf; Bell, Rae F; Furlan, Andrea D; Gilron, Ian; Haroutounian, Simon; Katz, Nathaniel P; Lipman, Arthur G; Morley, Stephen; Peloso, Paul M; Quessy, Steve N; Seers, Kate; Strassels, Scott A; Straube, Sebastian

    2015-08-01

    Enriched enrolment, randomised withdrawal (EERW) pain trials select, before randomisation, patients who respond by demonstrating a predetermined degree of pain relief and acceptance of adverse events. There is uncertainty over the value of this design. We report a systematic review of EERW trials in chronic noncancer pain together with a critical appraisal of methods and potential biases in the methods used and recommendations for the design and reporting of future EERW trials. Electronic and other searches found 25 EERW trials published between 1995 and June 2014, involving 5669 patients in a randomised withdrawal phase comparing drug with placebo; 13 (median, 107 patients) had a randomised withdrawal phase of 6 weeks or less, and 12 (median, 334) lasted 12 to 26 weeks. Risks of bias included short duration, inadequate outcome definition, incomplete outcome data reporting, small size, and inadequate dose tapering on randomisation to placebo. Active treatment was usually better than placebo (22/25 trials). This review reduces the uncertainty around the value of EERW trials in pain. If properly designed, conducted, and reported, they are feasible and useful for making decisions about pain therapies. Shorter, small studies can be explanatory; longer, larger studies can inform practice. Current evidence is inadequate for valid comparisons in outcome between EERW and classical trials, although no gross differences were found. This systematic review provides a framework for assessing potential biases and the value of the EERW trials, and for the design of future studies by making recommendations for the conduct and reporting of EERW trials.

  10. Singing classes for chronic obstructive pulmonary disease: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lord Victoria M

    2012-11-01

    Full Text Available Abstract Background There is some evidence that singing lessons may be of benefit to patients with chronic obstructive pulmonary disease (COPD. It is not clear how much of this benefit is specific to singing and how much relates to the classes being a group activity that addresses social isolation. Methods Patients were randomised to either singing classes or a film club for eight weeks. Response was assessed quantitatively through health status questionnaires, measures of breathing control, exercise capacity and physical activity and qualitatively, through structured interviews with a clinical psychologist. Results The singing group (n=13 mean(SD FEV1 44.4(14.4% predicted and film group (n=11 FEV1 63.5(25.5%predicted did not differ significantly at baseline. There was a significant difference between the response of the physical component score of the SF-36, favouring the singing group +12.9(19.0 vs -0.25(11.9 (p=0.02, but no difference in response of the mental component score of the SF-36, breathing control measures, exercise capacity or daily physical activity. In the qualitative element, positive effects on physical well-being were reported in the singing group but not the film group. Conclusion Singing classes have an impact on health status distinct from that achieved simply by taking part in a group activity. Trials registration Registration Current Controlled Trials - ISRCTN17544114

  11. Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain.

    Science.gov (United States)

    Witt, Claudia M; Jena, Susanne; Selim, Dagmar; Brinkhaus, Benno; Reinhold, Thomas; Wruck, Katja; Liecker, Bodo; Linde, Klaus; Wegscheider, Karl; Willich, Stefan N

    2006-09-01

    In a randomized controlled trial plus a nonrandomized cohort, the authors investigated the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic low back pain and assessed whether the effects of acupuncture differed in randomized and nonrandomized patients. In 2001, German patients with chronic low back pain were allocated to an acupuncture group or a no-acupuncture control group. Persons who did not consent to randomization were included in a nonrandomized acupuncture group. All patients were allowed to receive routine medical care in addition to study treatment. Back function (Hannover Functional Ability Questionnaire), pain, and quality of life were assessed at baseline and after 3 and 6 months, and cost-effectiveness was analyzed. Of 11,630 patients (mean age=52.9 years (standard deviation, 13.7); 59% female), 1,549 were randomized to the acupuncture group and 1,544 to the control group; 8,537 were included in the nonrandomized acupuncture group. At 3 months, back function improved by 12.1 (standard error (SE), 0.4) to 74.5 (SE, 0.4) points in the acupuncture group and by 2.7 (SE, 0.4) to 65.1 (SE, 0.4) points among controls (difference=9.4 points (95% confidence interval 8.3, 10.5); pAcupuncture plus routine care was associated with marked clinical improvements in these patients and was relatively cost-effective.

  12. Efficacy of acupunture in patients with chronic neck pain--a randomised, sham controlled trial.

    Science.gov (United States)

    Sahin, Nilay; Ozcan, Emel; Sezen, Kasim; Karatas, Omer; Issever, Halim

    2010-01-01

    The aim of this study was to compare the efficacy of electroacupuncture and sham acupuncture in the treatment of patients with chronic neck pain. 31 patients with chronic neck pain were included in a randomised, controlled trial. Electric stimulation was given for 30 minutes at low frequency (1-4Hz), pulse width of 200 micros, interrupted wave form. Of the 29 patients who completed the therapy, 13 were assigned to conventional acupuncture and 16 to sham acupuncture groups, receiving 3 sessions a week for a total of 10 sessions, each lasting for 30 minutes. Patients were evaluated before and after therapy and 3 months later by Visual Analogue Scale (VAS) and the bodily pain subscale of the Short Form Health Survey-36 scale. The treating physician was different from the evaluating physician who, like the patient, was blinded. VAS scores in both groups significantly reduced after therapy and at 3 months post-therapy, but the difference between groups was not significant. In respect of bodily pain, there was a significant improvement in the acupuncture group after therapy (P<0.01). Stimulation of conventional acupuncture points was not generally superior to needling ofnonspecific points on the neck, and both treatments were associated with improvement of symptoms. Needles inserted into the neck are likely to be an inappropriate sham control for acupuncture.

  13. The effectiveness of Long's manipulation on patients with chronic mechanical neck pain: a randomized controlled trial.

    Science.gov (United States)

    Lin, Jian Hua; Shen, Tong; Chung, Raymond Chi Keung; Chiu, Thomas Tai Wing

    2013-08-01

    Long's manipulation (LM) is a representative Chinese manipulation approach incorporating both spinal manipulation and traditional Chinese massage (TCM) techniques. This randomized controlled trial (RCT) aimed to compare the immediate and short-term relative effectiveness of LM to TCM on patients with chronic neck pain. Patients were randomly assigned to either LM group or TCM group. LM group was treated with Long's manipulation, while the TCM group received TCM therapy. Patients attended 8 sessions of treatment (one session every three days). Outcome measures included neck disability (Northwick Park Neck Pain Questionnaire; NPQ), pain intensity (Numeric Pain Rating Scale; NPRS), patient perceived satisfaction of care (PPS) (11-point scale), craniovertebral angle (CV angle) and cervical range of motion (ROM). A blinded assessor performed assessment at baseline, immediate after treatment and 3 months post treatment. LM group achieved significantly greater improvement than TCM group in pain intensity (p angle and most of cervical ROM between groups (p = 0.169 ∼ 0.888) with an exception of flexion at 3-month follow-up (p = 0.005). This study shows that LM could produce better effects than TCM in relieving pain and improving disability in the management of patients with chronic mechanical neck pain.

  14. Singing teaching as a therapy for chronic respiratory disease - a randomised controlled trial and qualitative evaluation

    Directory of Open Access Journals (Sweden)

    Kelly Julia L

    2010-08-01

    Full Text Available Abstract Background Despite optimal pharmacological therapy and pulmonary rehabilitation, patients with COPD continue to be breathless. There is a need to develop additional strategies to alleviate symptoms. Learning to sing requires control of breathing and posture and might have benefits that translate into daily life. Methods To test this hypothesis we performed a randomised controlled trial, comparing a six week course of twice weekly singing classes to usual care, in 28 COPD patients. The experience of singing was assessed in a qualitative fashion, through interviews with a psychologist. In addition, we surveyed patients with chronic respiratory conditions who participated in a series of open singing workshops. Results In the RCT, the physical component score of the SF36 improved in the singers (n = 15 compared to the controls (n = 13; +7.5(14.6 vs. -3.8(8.4 p = 0.02. Singers also had a significant fall in HAD anxiety score; -1.1(2.7 vs. +0.8(1.7 p = 0.03. Singing did not improve single breath counting, breath hold time or shuttle walk distance. In the qualitative element, 8 patients from the singing group were interviewed. Positive effects on physical sensation, general well-being, community/social support and achievement/efficacy emerged as common themes. 150 participants in open workshops completed a questionnaire. 96% rated the workshops as "very enjoyable" and 98% thought the workshop had taught them something about breathing in a different way. 81% of attendees felt a "marked physical difference" after the workshop. Conclusion Singing classes can improve quality of life measures and anxiety and are viewed as a very positive experience by patients with respiratory disease; no adverse consequences of participation were observed. Trial Registration Current Controlled Trials - ISRCTN17544114.

  15. Topical glyceryl trinitrate treatment of chronic patellar tendinopathy : a randomised, double-blind, placebo-controlled clinical trial

    NARCIS (Netherlands)

    Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

    2013-01-01

    Objectives To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN

  16. Acceleration-caused injury of the cervical spine. Whiplash injury; Beschleunigungsverletzung der Halswirbelsaeule. HWS-Schleudertrauma

    Energy Technology Data Exchange (ETDEWEB)

    Wedig, Hans-Dieter (eds.) [Kanzlei Dr. W.G. Schmidt, Sonthofen (Germany); Graf, Michael; Grill, Christian

    2009-07-01

    Acceleration injuries of the cervical spine are mostly caused by car accidents. Due to the high traffic density and the increasing number of car accidents with personal injuries the number of concerned persons is also increasing. A large percentage of injured persons suffer ongoing troubles following ineffective therapy trials up to occupational disability. Therefore the whiplash injury is a significant medical and legal problem. The book includes contributions of international experts on the latest state of research and the actual knowledge on the controversial discussed field. An interdisciplinary forum discusses medical, injury-mechanical, consultant-related and legal questions and therapeutic approaches that might be successful. [German] Beschleunigungsverletzungen der Halswirbelsaeule treten ueberwiegend nach Autounfaellen auf. Aufgrund der hohen Verkehrsdichte und der steigenden Anzahl an Verkehrsunfaellen mit Personenschaeden steigt auch die Zahl der Betroffenen stetig an. Einer grossen Zahl von Unfallgeschaedigten, die nach kurzer Zeit beschwerdefrei leben koennen, steht leider eine wachsende Zahl von Betroffenen mit anhaltenden Beschwerden, erfolglosen Therapieversuchen bis hin zur Berufsunfaehigkeit gegenueber. Das 'HWS-Schleudertrauma' stellt nach wie vor ein erhebliches medizinisches und rechtliches Problem dar. In diesem Buch beschreiben international ausgewiesene Experten den neuesten Forschungsstand, das aktuelle Wissen und die Lehrmeinungen auf diesem kontrovers diskutierten und komplexen Gebiet. In einem interdisziplinaeren Ansatz werden medizinische, verletzungsmechanische, gutachterliche und gerichtliche Fragestellungen diskutiert und Erfolg versprechende Therapieansaetze eroertert. Aerzte, Juristen, Versicherungen und Betroffene werden in einen gemeinsamen Dialog gebracht, mit dem Ziel, konstruktive Loesungen zu erarbeiten. Eine praktische Arbeitshilfe - das Buch fuer alle, die mit dieser Problematik befasst sind. (orig.)

  17. Statistical analysis of 4 types of neck whiplash injuries based on classical meridian theory.

    Science.gov (United States)

    Chen, Yemeng; Zhao, Yan; Xue, Xiaolin; Li, Hui; Wu, Xiuyan; Zhang, Qunce; Zheng, Xin; Wang, Tianfang

    2015-01-01

    As one component of the Chinese medicine meridian system, the meridian sinew (Jingjin, (see text), tendino-musculo) is specially described as being for acupuncture treatment of the musculoskeletal system because of its dynamic attributes and tender point correlations. In recent decades, the therapeutic importance of the sinew meridian has become revalued in clinical application. Based on this theory, the authors have established therapeutic strategies of acupuncture treatment in Whiplash-Associated Disorders (WAD) by categorizing four types of neck symptom presentations. The advantage of this new system is to make it much easier for the clinician to find effective acupuncture points. This study attempts to prove the significance of the proposed therapeutic strategies by analyzing data collected from a clinical survey of various WAD using non-supervised statistical methods, such as correlation analysis, factor analysis, and cluster analysis. The clinical survey data have successfully verified discrete characteristics of four neck syndromes, based upon the range of motion (ROM) and tender point location findings. A summary of the relationships among the symptoms of the four neck syndromes has shown the correlation coefficient as having a statistical significance (P syndrome factors are more related to the Liver, as originally described in classical theory. The hypothesis of meridian sinew syndromes in WAD is clearly supported by the statistical analysis of the clinical trials. This new discovery should be beneficial in improving therapeutic outcomes.

  18. Reporting of cross-over clinical trials of analgesic treatments for chronic pain: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review and recommendations.

    Science.gov (United States)

    Gewandter, Jennifer S; McDermott, Michael P; McKeown, Andrew; Hoang, Kim; Iwan, Katarzyna; Kralovic, Sarah; Rothstein, Daniel; Gilron, Ian; Katz, Nathaniel P; Raja, Srinivasa N; Senn, Stephen; Smith, Shannon M; Turk, Dennis C; Dworkin, Robert H

    2016-11-01

    Cross-over trials are typically more efficient than parallel group trials in that the sample size required to yield a desired power is substantially smaller. It is important, however, to consider some issues specific to cross-over trials when designing and reporting them, and when evaluating the published results of such trials. This systematic review evaluated the quality of reporting and its evolution over time in articles of cross-over clinical trials of pharmacologic treatments for chronic pain published between 1993 and 2013. Seventy-six (61%) articles reported a within-subject primary analysis, or if no primary analysis was identified, reported at least 1 within-subject analysis, which is required to achieve the gain in power associated with the cross-over design. For 39 (31%) articles, it was unclear whether analyses conducted were within-subject or between-group. Only 36 (29%) articles reported a method to accommodate missing data (eg, last observation carried forward, n = 29), and of those, just 14 included subjects in the analysis who provided data from only 1 period. Of the articles that identified a within-subject primary analysis, 21 (51%) provided sufficient information for the results to be included in a meta-analysis (ie, estimates of the within-subject treatment effect and variability). These results and others presented in this article demonstrate deficiencies in reporting of cross-over trials for analgesic treatments. Clearer reporting in future trials could improve readers' ability to critically evaluate the results, use these data in meta-analyses, and plan future trials. Recommendations for proper reporting of cross-over trials that apply to any condition are provided.

  19. Randomized pilot trial of a synbiotic dietary supplement in chronic HIV-1 infection

    Directory of Open Access Journals (Sweden)

    Schunter Marco

    2012-06-01

    Synbiotic treatment for 4 weeks can successfully augment the levels of probiotic species in the gut during chronic HIV-1 infection. Associated changes in microbial translocation appear to be absent, and markers of systemic immune activation appear largely unchanged. These findings may help inform future studies aimed at testing pre- and probiotic approaches to improve gut function and mucosal immunity in chronic HIV-1 infection. Trial registration Clinical Trials.gov: NCT00688311

  20. Psychosocial effects of workplace physical exercise among workers with chronic pain: Randomized controlled trial.

    Science.gov (United States)

    Andersen, Lars L; Persson, Roger; Jakobsen, Markus D; Sundstrup, Emil

    2017-01-01

    While workplace physical exercise can help manage musculoskeletal disorders, less is known about psychosocial effects of such interventions. This aim of this study was to investigate the effect of workplace physical exercise on psychosocial factors among workers with chronic musculoskeletal pain.The trial design was a 2-armed parallel-group randomized controlled trial with allocation concealment. A total of 66 slaughterhouse workers (51 men and 15 women, mean age 45 years [standard deviation (SD) 10]) with upper limb chronic musculoskeletal pain were randomly allocated to group-based strength training (physical exercise group) or individual ergonomic training and education (reference group) for 10 weeks. Social climate was assessed with the General Nordic Questionnaire for Psychological and Social Factors at Work, and vitality and mental health were assessed with the 36-item Short Form Health Survey. All scales were converted to 0 to 100 (higher scores are better). Between-group differences from baseline to follow-up were determined using linear mixed models adjusted for workplace, age, gender, and baseline values of the outcome.Mean baseline scores of social climate, mental health, and vitality were 52.2 (SD 14.9), 79.5 (SD 13.7), and 53.9 (SD 19.7), respectively. Complete baseline and follow-up data were obtained from 30 and 31 from the physical exercise and reference groups, respectively. The between-group differences from baseline to follow-up between physical exercise and reference were 7.6 (95% CI 0.3 to 14.9), -2.3 (95% CI -10.3 to 5.8), and 10.1 (95% CI 0.6 to 19.5) for social climate, mental health, and vitality, respectively. For social climate and vitality, this corresponded to moderate effect sizes (Cohen d = 0.51 for both) in favor of physical exercise. There were no reported adverse events.In conclusion, workplace physical exercise performed together with colleagues improves social climate and vitality among workers with chronic musculoskeletal

  1. Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial

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    Deyo Richard A

    2009-10-01

    Full Text Available Abstract Background Chronic back pain is a major public health problem and the primary reason patients seek massage treatment. Despite the growing use of massage for chronic low back pain, there have been few studies of its effectiveness. This trial will be the first evaluation of the effectiveness of relaxation massage for chronic back pain and the first large trial of a focused structural form of massage for this condition. Methods and Design A total of 399 participants (133 in each of three arms between the ages of 20 and 65 years of age who have low back pain lasting at least 3 months will be recruited from an integrated health care delivery system. They will be randomized to one of two types of massage ("focused structural massage" or "relaxation massage", or continued usual medical care. Ten massage treatments will be provided over 10 weeks. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline and after 10, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, perceived stress, and use and costs of healthcare services for back pain will also be measured. Outcomes across assigned treatment groups will be compared using generalized estimating equations, accounting for participant correlation and adjusted for baseline value, age, and sex. For both primary outcome measures, this trial will have at least 85% power to detect the presence of a minimal clinically significant difference among the three treatment groups and 91% power for pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount. Conclusion Results of this trial will help clarify the value of two types of massage therapy for chronic low back pain. Trial registration Clinical Trials.gov NCT 00371384.

  2. Cinacalcet in patients with chronic kidney disease: a cumulative meta-analysis of randomized controlled trials.

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    Suetonia C Palmer

    Full Text Available BACKGROUND: Calcimimetic agents lower serum parathyroid hormone levels in people with chronic kidney disease (CKD, but treatment effects on patient-relevant outcomes are uncertain. We conducted a systematic review and meta-analysis to summarize the benefits and harms of calcimimetic therapy in adults with CKD and used cumulative meta-analysis to identify how evidence for calcimimetic treatment has developed in this clinical setting. METHODS AND FINDINGS: Cochrane and Embase databases (through February 7, 2013 were electronically searched to identify randomized trials evaluating effects of calcimimetic therapy on mortality and adverse events in adults with CKD. Two independent reviewers identified trials, extracted data, and assessed risk of bias. Eighteen trials comprising 7,446 participants compared cinacalcet plus conventional therapy with placebo or no treatment plus conventional therapy in adults with CKD. In moderate- to high-quality evidence (based on Grading of Recommendations Assessment, Development, and Evaluation criteria in adults with CKD stage 5D (dialysis, cinacalcet had little or no effect on all-cause mortality (relative risk, 0.97 [95% confidence interval, 0.89-1.05], had imprecise effect on cardiovascular mortality (0.67 [0.16-2.87], and prevented parathyroidectomy (0.49 [0.40-0.59] and hypercalcemia (0.23 [0.05-0.97], but increased hypocalcemia (6.98 [5.10-9.53], nausea (2.02 [1.45-2.81], and vomiting (1.97 [1.73-2.24]. Data for clinical outcomes were sparse in adults with CKD stages 3-5. On average, treating 1,000 people with CKD stage 5D for 1 y had no effect on survival and prevented about three patients from experiencing parathyroidectomy, whilst 60 experienced hypocalcemia and 150 experienced nausea. Analyses were limited by insufficient data in CKD stages 3-5 and kidney transplant recipients. CONCLUSIONS: Cinacalcet reduces the need for parathyroidectomy in patients with CKD stage 5D, but does not appear to improve all

  3. Cinacalcet in Patients with Chronic Kidney Disease: A Cumulative Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Palmer, Suetonia C.; Nistor, Ionut; Craig, Jonathan C.; Pellegrini, Fabio; Messa, Piergiorgio; Tonelli, Marcello; Covic, Adrian; Strippoli, Giovanni F. M.

    2013-01-01

    Background Calcimimetic agents lower serum parathyroid hormone levels in people with chronic kidney disease (CKD), but treatment effects on patient-relevant outcomes are uncertain. We conducted a systematic review and meta-analysis to summarize the benefits and harms of calcimimetic therapy in adults with CKD and used cumulative meta-analysis to identify how evidence for calcimimetic treatment has developed in this clinical setting. Methods and Findings Cochrane and Embase databases (through February 7, 2013) were electronically searched to identify randomized trials evaluating effects of calcimimetic therapy on mortality and adverse events in adults with CKD. Two independent reviewers identified trials, extracted data, and assessed risk of bias. Eighteen trials comprising 7,446 participants compared cinacalcet plus conventional therapy with placebo or no treatment plus conventional therapy in adults with CKD. In moderate- to high-quality evidence (based on Grading of Recommendations Assessment, Development, and Evaluation criteria) in adults with CKD stage 5D (dialysis), cinacalcet had little or no effect on all-cause mortality (relative risk, 0.97 [95% confidence interval, 0.89–1.05]), had imprecise effect on cardiovascular mortality (0.67 [0.16–2.87]), and prevented parathyroidectomy (0.49 [0.40–0.59]) and hypercalcemia (0.23 [0.05–0.97]), but increased hypocalcemia (6.98 [5.10–9.53]), nausea (2.02 [1.45–2.81]), and vomiting (1.97 [1.73–2.24]). Data for clinical outcomes were sparse in adults with CKD stages 3–5. On average, treating 1,000 people with CKD stage 5D for 1 y had no effect on survival and prevented about three patients from experiencing parathyroidectomy, whilst 60 experienced hypocalcemia and 150 experienced nausea. Analyses were limited by insufficient data in CKD stages 3–5 and kidney transplant recipients. Conclusions Cinacalcet reduces the need for parathyroidectomy in patients with CKD stage 5D, but does not appear to improve

  4. Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rubinstein Ethan

    2010-01-01

    Full Text Available Abstract Background Acute exacerbations contribute to the morbidity and mortality associated with chronic obstructive pulmonary disease (COPD. This proof-of-concept study evaluates whether intermittent pulsed moxifloxacin treatment could reduce the frequency of these exacerbations. Methods Stable patients with COPD were randomized in a double-blind, placebo-controlled trial to receive moxifloxacin 400 mg PO once daily (N = 573 or placebo (N = 584 once a day for 5 days. Treatment was repeated every 8 weeks for a total of six courses. Patients were repeatedly assessed clinically and microbiologically during the 48-week treatment period, and for a further 24 weeks' follow-up. Results At 48 weeks the odds ratio (OR for suffering an exacerbation favoured moxifloxacin: per-protocol (PP population (N = 738, OR 0.75, 95% confidence interval (CI 0.565-0.994, p = 0.046, intent-to-treat (ITT population (N = 1149, OR 0.81, 95% CI 0.645-1.008, p = 0.059, and a post-hoc analysis of per-protocol (PP patients with purulent/mucopurulent sputum production at baseline (N = 323, OR 0.55, 95% CI 0.36-0.84, p = 0.006. There were no significant differences between moxifloxacin and placebo in any pre-specified efficacy subgroup analyses or in hospitalization rates, mortality rates, lung function or changes in St George's Respiratory Questionnaire (SGRQ total scores. There was, however, a significant difference in favour of moxifloxacin in the SGRQ symptom domain (ITT: -8.2 vs -3.8, p = 0.009; PP: -8.8 vs -4.4, p = 0.006. Moxifloxacin treatment was not associated with consistent changes in moxifloxacin susceptibility. There were more treatment-emergent, drug related adverse events with moxifloxacin vs placebo (p Conclusions Intermittent pulsed therapy with moxifloxacin reduced the odds of exacerbation by 20% in the ITT population, by 25% among the PP population and by 45% in PP patients with purulent/mucopurulent sputum at baseline. There were no unexpected adverse

  5. Effect of electroacupuncture on opioid consumption in patients with chronic musculoskeletal pain: protocol of a randomised controlled trial

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    Xue Charlie CL

    2012-09-01

    Full Text Available Abstract Background Chronic musculoskeletal pain is common and has been increasingly managed by opioid medications, of which the long-term efficacy is unknown. Furthermore, there is evidence that long-term use of opioids is associated with reduced pain control, declining physical function and quality of life, and could hinder the goals of integrated pain management. Electroacupuncture (EA has been shown to be effective in reducing postoperative opioid consumption. Limited evidence suggests that acupuncture could assist patients with chronic pain to reduce their requirements for opioids. The proposed research aims to assess if EA is an effective adjunct therapy to standard pain and medication management in reducing opioids use by patients with chronic musculoskeletal pain. Methods In this multicentre, randomised, sham-acupuncture controlled, three-arm clinical trial, 316 patients regularly taking opioids for pain control and meeting the defined selection criteria will be recruited from pain management centres and clinics of primary care providers in Victoria, Australia. After a four-week run-in period, the participants are randomly assigned to one of three treatment groups to receive EA, sham EA or no-EA with a ratio of 2:1:1. All participants receive routine pain medication management delivered and supervised by the trial medical doctors. Twelve sessions of semi-structured EA or sham EA treatment are delivered over 10 weeks. Upon completion of the acupuncture treatment period, there is a 12-week follow-up. In total, participants are involved in the trial for 26 weeks. Outcome measures of opioid and non-opioid medication consumption, pain scores and opioid-related adverse events are documented throughout the study. Quality of life, depression, function, and attitude to pain medications are also assessed. Discussion This randomised controlled trial will determine whether EA is of significant clinical value in assisting the management of

  6. Alar ligaments: radiological aspects in the diagnosis of patients with whiplash injuries; Stellenwert bildgebender Verfahren in der Diagnostik der Ligg. alaria nach Beschleunigungsverletzung der Halswirbelsaeule

    Energy Technology Data Exchange (ETDEWEB)

    Muhle, C. [Klinik fuer Nuklearmedizin, Christian-Albrechts-Univ. zu Kiel (Germany); Brossmann, J.; Biederer, J.; Jahnke, Th.; Grimm, J.; Heller, M. [Klinik fuer Diagnostische Radiologie, Christian-Albrechts-Univ. zu Kiel (Germany)

    2002-04-01

    Post-traumatic changes of the alar ligaments have been proposed to be the cause of chronic pain in patients after whiplash injury of the cervical spine. In addition to an asymmetric dens position, widening of the atlantodental distance to more than 12 mm can be an indirect sign of an alar ligament rupture. CT is recommended for detection of a avulsion fracture of the occipital condyle. Isolated ruptures of the alar ligaments are best visualized on MRI. In patients with chronic impairments after whiplash injuries changes of the alar ligaments on MRI must be differentiated from normal variants in healthy individuals. (orig.) [German] Posttraumatische Veraenderungen der Ligg. alaria werden als ursaechlich fuer chronische Beschwerden bei Patienten mit Beschleunigungsverletzungen der Halswirbelsaeule angesehen. Eine asymmetrische Densposition sowie eine Erweiterung der anterioren atlantoaxialen Distanz auf ueber 12 mm koennen auf konventionellen Roentgenaufnahmen ein indirektes Zeichen fuer das Vorliegen einer Fluegelbandverletzung sein. Die Computertomographie ist die Methode der Wahl zum Nachweis einer kondylaeren Ausrissfraktur des Lig. alare. Isolierte akute Bandverletzungen der Ligg. alaria sind hingegen in der MRT direkt nachweisbar. Bei Patienten mit chronischen Beschwerden nach Beschleunigungsverletzungen der Halswirbelsaeule muessen allerdings morphologische Auffaelligkeiten der Ligg. alaria im MRT von Normvarianten abgegrenzt werden. (orig.)

  7. International Congress on Whiplash Associated Disorders - The Bern Symposium

    Directory of Open Access Journals (Sweden)

    Harold Merskey

    2003-01-01

    Full Text Available We take pleasure in this issue in presenting a series of plenary session lectures and some additional contributions from the Bern Symposium, a meeting held in Berne, Switzerland from March 8 to 10, 2001. The symposium was organized by Dr Bogdan Radanov and colleagues from that city where they had themselves undertaken an enormous amount of classical work in the investigation of cervical sprain syndrome. Radanov's work resolved a number of definitive issues in the investigation of whiplash, despite those who say otherwise for medicolegal reasons. He and his colleagues showed clearly that pain after cervical sprain injury was primarily correlated with the intensity of the initial pain, with the occurrence of premorbid injury and with age. Personality status before injury had no bearing on the outcome, and the intensity of pain at the beginning of injury was also correlated with depression or cognitive change later (1.

  8. Nordic Walking and chronic low back pain: design of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hartvigsen Jan

    2006-10-01

    activity level. Results No results available at this point. Discussion This study will investigate the effect of Nordic Walking on pain and function in a population of people with chronic LBP. Trial Registration http://www.ClinicalTrials.gov registration # NCT00209820

  9. Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548

    Science.gov (United States)

    Ersek, Mary; Turner, Judith A; Cain, Kevin C; Kemp, Carol A

    2004-01-01

    Background Chronic pain is a common and frequently disabling problem in older adults. Clinical guidelines emphasize the need to use multimodal therapies to manage persistent pain in this population. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples. This training includes education about pain as well as instruction and practice in several management techniques, including relaxation, physical exercise, modification of negative thoughts, and goal setting. Few studies have examined the effectiveness of this therapy in older adult samples. Methods/Design This is a randomized, controlled trial to assess the effectiveness of a pain self-management training group intervention, as compared with an education-only control condition. Participants are recruited from retirement communities in the Pacific Northwest of the United States and must be 65 years or older and experience persistent, noncancer pain that limits their activities. The primary outcome is physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes are depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurs by facility to minimize cross-contamination between groups. The target sample size is 273 enrolled, which assuming a 20% attrition rate at 12 months, will provide us with 84% power to detect a moderate effect size of .50 for the primary outcome. Discussion Few studies have investigated the effects of multimodal pain self-management training among older adults. This randomized controlled trial is designed to assess the efficacy of a pain self-management program that incorporates physical and psychosocial pain coping skills among adults in the mid-old to old-old range. PMID:15285783

  10. BIOBEHAVIORAL PROGNOSTIC FACTORS IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE: Results from the INSPIRE-II Trial

    Science.gov (United States)

    Blumenthal, James A.; Smith, Patrick J.; Durheim, Michael; Mabe, Stephanie; Emery, Charles F.; Martinu, Tereza; Diaz, Philip T.; Babyak, Michael; Welty-Wolf, Karen; Palmer, Scott

    2015-01-01

    Objective To examine the prognostic value of select biobehavioral factors in patients with chronic obstructive pulmonary disease (COPD) in a secondary analysis of participants from the INSPIRE-II trial. Methods Three hundred twenty six outpatients with COPD underwent assessments of pulmonary function, physical activity, body mass index, inflammation, pulmonary symptoms, depression, and pulmonary quality of life, and were followed for up to 5.4 years for subsequent clinical events. The prognostic value of each biobehavioral factor, considered individually and combined, also was examined in the context of existing Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 risk stratification. Results Sixty-nine individuals experienced a hospitalization or died over a mean follow-up time period of 2.4 (interquartile range = 1.6) years. GOLD classification was associated with an increased risk of clinical events (HR = 2.72 [95% CI 1.63, 4.54], per stage); Six Minute Walk (HR = 0.50 [0.34, 0.73] per 500 feet), total steps (HR = 0.82 [0.71, 0.94] per 1,000 steps), hsC-reactive protein (HR = 1.44 [1.01, 2.06] per 4.5 mg/L), depression (HR = 1.12 [1.01, 1.25] per 4 points), and pulmonary quality of life (HR = 1.73 [1.14, 2.63] per 25 points) were each predictive over and above the GOLD assessment. However, only GOLD group and Six Minute Walk were predictive of all-cause mortality and COPD hospitalization when all biobehavioral variables were included together in a multivariable model. Conclusion Biobehavioral factors provide added prognostic information over and above measures of COPD severity in predicting adverse events in patients with COPD. PMID:26780299

  11. Reproducibility and responsiveness of the Whiplash Disability Questionnaire.

    Science.gov (United States)

    Willis, Cameron; Niere, Kenneth Robert; Hoving, Jan Lucas; Green, Sally; O'Leary, Elizabeth F; Buchbinder, Rachelle

    2004-08-01

    This study continued the validation of a Whiplash Specific Disability Questionnaire (WDQ) that was developed from the Neck Disability Index (NDI) using self-reported disabilities in a group of participants experiencing whiplash-associated disorders [J Manipulative Physiol Ther 14 (1991) 409]. Previous research has established the content, construct and face validity and internal consistency of the WDQ. The aim of this study was to establish the short-term and medium-term test-retest reliability and responsiveness of the WDQ. Participants (n = 63) receiving physiotherapy treatment for WAD were recruited from 30 private physiotherapy practices in Melbourne, Australia. Each participant completed three WDQ questionnaires over a 1-month period, the first two separated by 24 h. The third questionnaire contained an additional item that asked respondents to rate their perceived change in condition over the month. Reproducibility was determined using an intra-class correlation co-efficient. Responsiveness was assessed via correlation with participant perceived change, the effect size, standardised response mean (SRM) and the responsiveness statistic. Results demonstrated excellent short-term test-retest reliability (ICC 0.96). Reproducibility over 1 month was excellent (ICC 0.93). Correlation between change in WDQ score over 1 month and participant perceived change was r(s) = 0.64, the effect size was 0.03, the SRM was 0.08 and the responsiveness statistics were 0.90 (participants who improved) and -1.60 (participants who deteriorated). The minimal detectable change of the WDQ was established at 15 points. These results demonstrate that the WDQ has excellent short- and medium-term reproducibility and responsiveness in a population seeking treatment for WAD.

  12. Fatty infiltrate in the cervical extensor muscles is not a feature of chronic, insidious-onset neck pain

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    Elliott, J. [Division of Physiotherapy, School of Health and Rehabilitation Sciences, University of Queensland, Brisbane (Australia); Department of Physical Therapy, Rueckert-Hartman School for Health Professions, Regis University, Denver, Colorado (United States); Centre for Magnetic Resonance, University of Queensland, Brisbane (Australia)], E-mail: jelltt@regis.edu; Sterling, M. [Division of Physiotherapy, School of Health and Rehabilitation Sciences, University of Queensland, Brisbane (Australia); Noteboom, J.T. [Department of Physical Therapy, Rueckert-Hartman School for Health Professions, Regis University, Denver, Colorado (United States); Darnell, R. [Division of Physiotherapy, School of Health and Rehabilitation Sciences, University of Queensland, Brisbane (Australia); Galloway, G. [Centre for Magnetic Resonance, University of Queensland, Brisbane (Australia); Jull, G. [Division of Physiotherapy, School of Health and Rehabilitation Sciences, University of Queensland, Brisbane (Australia)

    2008-06-15

    Aim: To investigate the presence of fatty infiltrate in the cervical extensor musculature in patients with insidious-onset neck pain to better understand the possible pathophysiology underlying such changes in chronic whiplash-associated disorders (WAD). Materials and methods: A sample of convenience of 23 women with persistent insidious-onset neck pain (mean age 29.2 {+-} 6.9 years) was recruited for the study. Magnetic resonance imaging (MRI) was used to quantify fatty infiltration in the cervical extensor musculature. Quantitative Sensory Testing (QST; pressure and thermal pain thresholds) was performed as sensory features are present in chronic whiplash. Self-reported pain and disability, as well as psychological distress, were measured using the Neck Disability Index (NDI) and the General Health Questionnaire-28 (GHQ-28), respectively. Results: Measures were compared with those of a previous dataset of chronic whiplash patients (n = 79, mean age 29.7 {+-} 7.8 years). Using a classification tree, insidious-onset neck pain was clearly identified from whiplash (p < 0.001), based on the presence of MRI fatty infiltrate in the cervical extensor musculature (0/102 individuals) and altered temperature thresholds (cold; 3/102 individuals). Conclusion: Fatty infiltrates in the cervical extensor musculature and widespread hyperalgesia were not features of the insidious-onset neck pain group in this study; whereas these features have been identified in patients with chronic WAD. This novel finding may enable a better understanding of the underlying pathophysiological processes in patients with chronic whiplash.

  13. Results of a non-specific immunomodulation therapy on chronic heart failure (ACCLAIM trial): a placebo-controlled randomised trial

    DEFF Research Database (Denmark)

    Torre-Amione, G.; Anker, S.D.; Bourge, R.C.;

    2008-01-01

    Background Evidence suggests that inflammatory mediators contribute to development and progression of chronic heart failure. We therefore tested the hypothesis that immunomodulation might counteract this pathophysiological mechanism in patients. Methods We did a double-blind, placebo-controlled s...

  14. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Dworkin, Robert H; Turk, Dennis C; McDermott, Michael P; Peirce-Sandner, Sarah; Burke, Laurie B; Cowan, Penney; Farrar, John T; Hertz, Sharon; Raja, Srinivasa N; Rappaport, Bob A; Rauschkolb, Christine; Sampaio, Cristina

    2009-12-01

    An essential component of the interpretation of results of randomized clinical trials of treatments for chronic pain involves the determination of their clinical importance or meaningfulness. This involves two distinct processes--interpreting the clinical importance of individual patient improvements and the clinical importance of group differences--which are frequently misunderstood. In this article, we first describe the essential differences between the interpretation of the clinical importance of patient improvements and of group differences. We then discuss the factors to consider when evaluating the clinical importance of group differences, which include the results of responder analyses of the primary outcome measure, the treatment effect size compared to available therapies, analyses of secondary efficacy endpoints, the safety and tolerability of treatment, the rapidity of onset and durability of the treatment benefit, convenience, cost, limitations of existing treatments, and other factors. The clinical importance of individual patient improvements can be determined by assessing what patients themselves consider meaningful improvement using well-described methods. In contrast, the clinical meaningfulness of group differences must be determined by a multi-factorial evaluation of the benefits and risks of the treatment and of other available treatments for the condition in light of the primary goals of therapy. Such determinations must be conducted on a case-by-case basis, and are ideally informed by patients and their significant others, clinicians, researchers, statisticians, and representatives of society at large.

  15. Improving Preclinic Preparation for Patients with Chronic Conditions in Quito, Ecuador: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    K. Rodriguez

    2015-01-01

    Full Text Available Objectives. As in many settings, patients in community health centers in Ecuador do not complete previsit forms or receive assistance to identify questions and concerns they would like to address in brief clinic visits with physicians. We examined the comparative effectiveness of providing (1 a previsit form to complete; (2 a previsit form along with assistance in completing the form; and (3 usual care. Methods. Parallel, three-arm randomized controlled trial in two health centers serving indigent to low-income communities in Quito, Ecuador, among 199 adult patients who took medications for at least one chronic condition. Outcome measures were self-reported satisfaction with the visit, confidence in asking questions, and extent to which patients’ objectives were met. Results. Patients who received assistance in completing a previsit form were more than twice as likely as participants in usual care to report achieving everything they wanted during their visit (AOR 2.2, P=0.039. There were no differences in any outcomes between the groups who received the previsit form with no assistance and usual care. Conclusions. For high-quality patient-centered primary care, it is important to develop and test innovative and scalable interventions for patients and physicians to make the best use of limited clinic time.

  16. A Randomized Clinical Trial of Auricular Point Acupressure for Chronic Low Back Pain: A Feasibility Study

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    Chao Hsing Yeh

    2013-01-01

    Full Text Available Objectives. This prospective, randomized clinical trial (RCT was designed to investigate the feasibility and effects of a 4-week auricular point acupressure (APA for chronic low back pain (CLBP. Methods. Participants were randomized to either true APA (true acupoints with taped seeds on the designated ear points for CLBP or sham APA (sham acupoints with taped seeds but on different locations than those designated for CLBP. The duration of treatment was four weeks. Participants were assessed before treatment, weekly during treatment, and 1 month following treatment. Results. Participants in the true APA group who completed the 4-week APA treatment had a 70% reduction in worst pain intensity, a 75% reduction in overall pain intensity, and a 42% improvement in disability due to back pain from baseline assessment. The reductions of worst pain and overall pain intensity in the true APA group were statistically greater than participants in the sham group (P<0.01 at the completion of a 4-week APA and 1 month followup. Discussion. The preliminary findings of this feasibility study showed a reduction in pain intensity and improvement in physical function suggesting that APA may be a promising treatment for patients with CLBP.

  17. The chronic care for age-related macular degeneration study (CHARMED: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Held Ulrike

    2011-10-01

    Full Text Available Abstract Background Neovascular age-related macular degeneration is the leading cause of irreversible blindness in people 50 years of age or older in the developed world. As in other chronic diseases, several effective treatments are available, but in clinical daily practice there is an evidence performance gap. The Chronic Care Model represents an evidence-based framework for the care of chronically ill patients and aims at closing that gap. However, no data are available regarding patients with neovascular age-related macular degeneration. Methods/Design CHARMED is a multicenter randomized controlled trial. The study challenges the hypothesis that the implementation of core elements of the Chronic Care Model (patient empowerment, delivering evidence based information, clinical information system, reminder system with structured follow up and frequent monitoring via a specially trained Chronic Care Coach in Swiss centres for neovascular age-related macular degeneration results in better visual acuity (primary outcome and an increased disease specific quality of life (secondary outcome in patients with neovascular age-related macular degeneration. According to the power calculation, a total sample size of 352 patients is needed (drop out rate of 25%. 14 specialised medical doctors from leading ophtalmologic centres in Switzerland will include 25 patients. In each centre, a Chronic Care Coach will provide disease specific care according to the Chronic Care Model for intervention group. Patients from the control group will be treated as usual. Baseline measurements will be taken in month III - XII, starting in March 2011. Follow-up data will be collected after 6 months and 1 year. Discussion Multiple studies have shown that implementing Chronic Care Model elements improve clinical outcomes as well as process parameters in different chronic diseases as osteoarthritis, depression or e.g. the cardiovascular risk profile of diabetes patients. This

  18. Neuro Emotional Technique for the treatment of trigger point sensitivity in chronic neck pain sufferers: A controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Pollard Henry

    2008-05-01

    improved when compared to a control group which received a sham protocol of NET. Chronic neck pain sufferers may benefit from NET treatment in the relief of trigger point sensitivity. Further research including long-term randomised controlled trials for the effect of NET on chronic neck pain, and other chronic pain syndromes are recommended. Trial Registration This trial has been registered and allocated the Australian Clinical Trials Registry (ACTR number ACTRN012607000358448. The ACTR has met the requirements of the ICMJE's trials registration policy and is an ICMJE acceptable registry.

  19. Association between body mass index and recovery from whiplash injuries: a cohort study.

    Science.gov (United States)

    Yang, Xiaoqing; Côté, Pierre; Cassidy, J David; Carroll, Linda

    2007-05-01

    It is hypothesized that excess weight is a risk factor for delayed recovery from neck pain, such as from whiplash injuries. However, the association between obesity and recovery from whiplash injury has not been studied. The authors examined the association between body mass index and time to recovery from whiplash injuries in a population-based cohort study of traffic injuries in Saskatchewan, Canada. The cohort included 4,395 individuals who made an insurance claim to Saskatchewan Government Insurance and were treated for whiplash injury between July 1, 1994, and December 31, 1995. Of those, 87.7% had recovered by November 1, 1997. No association was found between baseline body mass index and time to recovery. Compared with individuals with normal weight, those who were underweight (hazard rate ratio = 0.88, 95% confidence interval: 0.73, 1.06), overweight (hazard rate ratio = 1.01, 95% confidence interval: 0.94, 1.09), and obese (hazard rate ratio = 0.99, 95% confidence interval: 0.90, 1.08) had similar rates of recovery, even after adjustment for other factors. The results do not support the hypothesis that individuals who are overweight or obese have a worse prognosis for whiplash.

  20. Road safety engineering: an effective tool in the fight against whiplash injuries.

    Science.gov (United States)

    Navin, F; Zein, S; Felipe, E

    2000-03-01

    Road safety engineering can play an integral part in the prevention of whiplash injuries. While improvements to vehicle design can reduce the severity of whiplash injuries when a crash occurs, improvements to road safety can prevent whiplash-inducing crashes from occurring in the first place. Whiplash injuries are most commonly associated with rear end crashes. Unfortunately, rear end crashes are also the most common type of crash at urban signalized intersections, where the majority of crashes occur in British Columbia, Canada. The Insurance Corporation of British Columbia (ICBC), through the road improvement program, has been funding road improvements in order to reduce the frequency of collisions at high crash locations in British Columbia. Several road safety engineering countermeasures specifically targeted at rear end collisions have been researched and deployed. These countermeasures include simple and affordable solutions such as signal visibility enhancements, as well as complex and expensive solutions such as intersection geometric upgrades. When appropriately used, these countermeasures have proven to be extremely cost-effective in reducing the frequency of rear end collisions. Widespread application of signal visibility enhancements is now being pursued to further decrease the risk of rear end collisions and whiplash injuries. Costs are the direct cost of the ICBC portion of the investment and benefits are only those associated with reduced insurance claims over a 2-year period.

  1. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial

    OpenAIRE

    Lewis Stephanie; Badlani Sameer; Dalapathi Vijay; Harris Vanessa; Ridge Alana; Bilderback Andrew; Hatipoğlu Umur; Diette Gregory B; Mahajan Amit K; Charbeneau Jeff T; Naureckas Edward T; Krishnan Jerry A

    2011-01-01

    Abstract Background High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD). Methods Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients receiv...

  2. Behaviour change and social blinkers? The role of sociology in trials of self-management behaviour in chronic conditions.

    Science.gov (United States)

    Ong, Bie Nio; Rogers, Anne; Kennedy, Anne; Bower, Peter; Sanders, Tom; Morden, Andrew; Cheraghi-Sohi, Sudeh; Richardson, Jane C; Stevenson, Fiona

    2014-02-01

    Individual-focused self-management interventions are one response to both an ageing society and the purported increase in chronic conditions. They tend to draw on psychological theories in self-management interventions, but over-reliance on these theories can reinforce a narrow focus on specified attitudinal and behavioural processes, omitting aspects of living with a chronic condition. While advances have been made in health behaviour change theory and practice, scant attention has been paid to the social, with the question of social context remaining under-theorised and under-explored empirically. This is particularly noticeable in trials of behaviour change interventions for self-management. The common sociological critique is that these ignore context and thus no explanation can be given as to why, for whom and under what circumstances a treatment works. Conversely, sociologists are criticised for offering no positive suggestions as to how context can be taken into account and for over-emphasising context with the risk of inhibiting innovation. This article provides an overview of these issues and provides examples of how context can be incorporated into the rigid method of trials of self-management for chronic conditions. We discuss modifications to both trial interventions and design that make constructive use of the concept of context.

  3. Efficacy of pulmonary rehabilitation in patients with moderate chronic obstructive pulmonary disease: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Román Miguel

    2013-02-01

    Full Text Available Abstract Background Pulmonary Rehabilitation for moderate Chronic Obstructive Pulmonary Disease in primary care could improve patients’ quality of life. Methods This study aimed to assess the efficacy of a 3-month Pulmonary Rehabilitation (PR program with a further 9 months of maintenance (RHBM group compared with both PR for 3 months without further maintenance (RHB group and usual care in improving the quality of life of patients with moderate COPD. We conducted a parallel-group, randomized clinical trial in Majorca primary health care in which 97 patients with moderate COPD were assigned to the 3 groups. Health outcomes were quality of life, exercise capacity, pulmonary function and exacerbations. Results We found statistically and clinically significant differences in the three groups at 3 months in the emotion dimension (0.53; 95%CI0.06-1.01 in the usual care group, (0.72; 95%CI0.26-1.18 the RHB group (0.87; 95%CI 0.44-1.30 and the RHBM group as well as in fatigue (0.47; 95%CI 0.17-0.78 in the RHBM group. After 1 year, these differences favored the long-term rehabilitation group in the domains of fatigue (0.56; 95%CI 0.22-0.91, mastery (0.79; 95%CI 0.03-1.55 and emotion (0.75; 95%CI 0.17-1.33. Between-group analysis only showed statistically and clinically significant differences between the RHB group and control group in the dyspnea dimension (0.79 95%CI 0.05-1.52. No differences were found for exacerbations, pulmonary function or exercise capacity. Conclusions We found that patients with moderate COPD and low level of impairment did not show meaningful changes in QoL, exercise tolerance, pulmonary function or exacerbation after a one-year, community based rehabilitation program. However, long-term improvements in the emotional, fatigue and mastery dimensions (within intervention groups were identified. Trial registration ISRCTN94514482

  4. Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

    Science.gov (United States)

    2014-10-01

    Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease PRINCIPAL INVESTIGATOR: Shirin Shafazand...PAP) will improve cognitive impairment, sleep quality, quality of life, and cardiovascular disease (CVD) surrogate measures in persons with chronic

  5. Addition of posttraumatic stress and sensory hypersensitivity more accurately estimates disability and pain than fear avoidance measures alone after whiplash injury.

    Science.gov (United States)

    Pedler, Ashley; Kamper, Steven J; Sterling, Michele

    2016-08-01

    The fear avoidance model (FAM) has been proposed to explain the development of chronic disability in a variety of conditions including whiplash-associated disorders (WADs). The FAM does not account for symptoms of posttraumatic stress and sensory hypersensitivity, which are associated with poor recovery from whiplash injury. The aim of this study was to explore a model for the maintenance of pain and related disability in people with WAD including symptoms of PTSD, sensory hypersensitivity, and FAM components. The relationship between individual components in the model and disability and how these relationships changed over the first 12 weeks after injury were investigated. We performed a longitudinal study of 103 (74 female) patients with WAD. Measures of pain intensity, cold and mechanical pain thresholds, symptoms of posttraumatic stress, pain catastrophising, kinesiophobia, and fear of cervical spine movement were collected within 6 weeks of injury and at 12 weeks after injury. Mixed-model analysis using Neck Disability Index (NDI) scores and average 24-hour pain intensity as the dependent variables revealed that overall model fit was greatest when measures of fear of movement, posttraumatic stress, and sensory hypersensitivity were included. The interactive effects of time with catastrophising and time with fear of activity of the cervical spine were also included in the best model for disability. These results provide preliminary support for the addition of neurobiological and stress system components to the FAM to explain poor outcome in patients with WAD.

  6. Inspiratory muscle training during pulmonary rehabilitation in chronic obstructive pulmonary disease: A randomized trial.

    Science.gov (United States)

    Beaumont, M; Mialon, P; Le Ber-Moy, C; Lochon, C; Péran, L; Pichon, R; Gut-Gobert, C; Leroyer, C; Morelot-Panzini, C; Couturaud, F

    2015-11-01

    Although recommended by international guidelines, the benefit of inspiratory muscle training (IMT) in addition to rehabilitation remains uncertain. The objective was to demonstrate the effectiveness of IMT on dyspnea using Borg scale and multidimensional dyspnea profile questionnaire at the end of a 6-minute walk test (6MWT) in patients with chronic obstructive pulmonary disease (COPD) with preserved average maximum inspiratory pressure (PImax) of 85 cm H2O (95% of predicted (pred.) value) and admitted for a rehabilitation program in a dedicated center. In a randomized trial, comparing IMT versus no IMT in 32 COPD patients without inspiratory muscle weakness (PImax >60 cm H2O) who were admitted for pulmonary rehabilitation (PR) for 3 weeks, we evaluated the effect of IMT on dyspnea, using both Borg scale and multidimensional dyspnea profile (MDP) at the end of the 6MWT, and on functional parameters included inspiratory muscle function (PImax) and 6MWT. All testings were performed at the start and the end of PR. In unadjusted analysis, IMT was not found to be associated with an improvement of either dyspnea or PImax. After adjustment on confounders (initial Borg score) and variables of interaction (forced expiratory volume in 1 second (FEV1)), we found a trend toward an improvement of "dyspnea sensory intensity", items from MDP and a significant improvement on the variation in the 2 items of MDP ("tight or constricted" and "breathing a lot"). In the subgroup of patients with FEV1 50% pred. IMT did not significantly improve dyspnea or functional parameter in COPD patients with PImax > 60 cm H2O. However, in the subgroup of patients with FEV1 < 50% pred., MDP was significantly improved.

  7. Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial.

    Science.gov (United States)

    Groessl, Erik J; Schmalzl, Laura; Maiya, Meghan; Liu, Lin; Goodman, Debora; Chang, Douglas G; Wetherell, Julie L; Bormann, Jill E; Atkinson, J Hamp; Baxi, Sunita

    2016-05-01

    Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2× weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans.

  8. Osteopathic manipulative treatment for facial numbness and pain after whiplash injury.

    Science.gov (United States)

    Genese, Josephine Sun

    2013-07-01

    Whiplash injury is often caused by rear-end motor vehicle collisions. Symptoms such as neck pain and stiffness or arm pain or numbness are common with whiplash injury. The author reports a case of right facial numbness and right cheek pain after a whiplash injury. Osteopathic manipulative treatment techniques applied at the level of the cervical spine, suboccipital region, and cranial region alleviated the patient's facial symptoms by treating the right-sided strain of the trigeminal nerve. The strain on the trigeminal nerve likely occurred at the upper cervical spine, at the nerve's cauda, and at the brainstem, the nerve's point of origin. The temporal portion of the cranium played a major role in the strain on the maxillary.

  9. Participant Preferences for Pharmacologic Chronic Pain Treatment Trial Characteristics: An ACTTION Adaptive Choice-Based Conjoint Study.

    Science.gov (United States)

    Smith, Shannon M; Gewandter, Jennifer S; Kitt, Rachel A; Markman, John D; Vaughan, Janet A; Cowan, Penney; Kopecky, Ernest A; Malamut, Richard; Sadosky, Alesia; Tive, Leslie; Turk, Dennis C; Dworkin, Robert H

    2016-11-01

    Barriers to clinical trial recruitment can delay study completion, potentially resulting in increased costs and an unrepresentative sample. In the current study of 150 participants with chronic pain, we used a computerized adaptive choice-based conjoint survey that included 8 characteristics that may affect enrollment in pharmacologic pain treatment trials (ie, treatment allocation, frequency of pain ratings, treatment administration method, current medications, number of study visits, availability of evening and weekend visits, invasiveness of laboratory procedures, payment). These data were analyzed using Sawtooth Software ver. 8.4.8 (Sawtooth Software, Inc, Orem, UT), which identifies the characteristics that dominate participants' decisions across multiple sets of potential trials. Three characteristics had the largest relative importance in participants' trial preferences: 1) invasiveness of required laboratory procedures (ie, 22%), with no procedures or blood tests preferred over ice-water sensory testing or skin biopsy; 2) ability to continue current pain medications (21%); and 3) payment for study participation (21%), with higher payment preferred. The fourth most important characteristic was number of study visits (13%), with participants preferring fewer in-person visits and more phone contacts. Understanding the preferences of potential participants is an important step toward enhancing enrollment in pain treatment trials.

  10. Randomized clinical trial of a phytotherapic compound containing Pimpinella anisum, Foeniculum vulgare, Sambucus nigra, and Cassia augustifolia for chronic constipation

    Directory of Open Access Journals (Sweden)

    Amaral Karine M

    2010-04-01

    Full Text Available Abstract Background A phytotherapic compound containing Pimpinella anisum L., Foeniculum vulgare Miller, Sambucus nigra L., and Cassia augustifolia is largely used in Brazil for the treatment of constipation. However, the laxative efficacy of the compound has never been tested in a randomized clinical trial. The aim of this study was to evaluate the efficacy and safety of the product. Methods This randomized, crossover, placebo-controlled, single-blinded trial included 20 patients presenting with chronic constipation according to the criteria of the American Association of Gastroenterology. The order of treatments was counterbalanced across subjects: half of the subjects received the phytotherapic compound for a 5-day period, whereas the other half received placebo for the same period. Both treatment periods were separated by a 9-day washout period followed by the reverse treatment for another 5-day period. The primary endpoint was colonic transit time (CTT, measured radiologically. Secondary endpoints included number of evacuations per day, perception of bowel function, adverse effects, and quality of life. Results Mean CTT assessed by X ray was 15.7 hours (95%CI 11.1-20.2 in the active treatment period and 42.3 hours (95%CI 33.5-51.1 during the placebo treatment (p Conclusions The findings of this randomized controlled trial allow to conclude that the phytotherapic compound assessed has laxative efficacy and is a safe alternative option for the treatment of constipation. Trial registration ClinicalTrial.gov NCT00872430

  11. Are Prevalent Self-reported Cardiovascular Disorders Associated with Delayed Recovery From Whiplash-associated Disorders

    DEFF Research Database (Denmark)

    Palmlöf, Lina; Côté, Pierre; Holm, Lena W;

    2015-01-01

    OBJECTIVES:: The aim of this cohort study was to investigate the association between self-reported cardiovascular disorders (CVD) and recovery from whiplash associated disorder (WAD) after a traffic collision. METHODS:: This study was based on the Saskatchewan Government Insurance cohort, including...... individuals over 18 years of age, who made a traffic- injury claim or received health care after a traffic injury, between 1997 and 1999. Participants completed a baseline questionnaire and were followed up by telephone interviews at 6 weeks, 3 months, 6 months, 9 months, and 12 months post injury. Our sample...... on the recovery of individuals with whiplash-associated disorders....

  12. Are there gender differences in coping with neck pain following acute whiplash trauma?

    DEFF Research Database (Denmark)

    Carstensen, T B W; Frostholm, Lisbeth; Oernboel, E

    2012-01-01

    BACKGROUND: Little is known about gender differences in coping after whiplash, and to date possible interaction of gender and coping on recovery has not been investigated. AIMS: To examine if gender differences in coping are associated with long-lasting neck pain after acute whiplash. METHODS......: Seven hundred and forty participants referred from emergency departments or general practitioners after car accidents in Denmark. Within a median of five days, post-collision participants completed questionnaires on collision characteristics, psychological distress, and socio-demographics. After 3months...

  13. Tai Chi for Chronic Pain Conditions: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Kong, Ling Jun; Lauche, Romy; Klose, Petra; Bu, Jiang Hui; Yang, Xiao Cun; Guo, Chao Qing; Dobos, Gustav; Cheng, Ying Wu

    2016-04-29

    Several studies reported that Tai Chi showed potential effects for chronic pain, but its role remains controversial. This review assessed the evidence regarding the effects of Tai Chi for chronic pain conditions. 18 randomized controlled trials were included in our review. The aggregated results have indicated that Tai Chi showed positive evidence on immediate relief of chronic pain from osteoarthritis (standardized mean difference [SMD], -0.54; 95% confidence intervals [CI], -0.77 to -0.30; P Tai Chi practice for osteoarthritis may be more than 5 weeks. And there were some beneficial evidences regarding the effects of Tai Chi on immediate relief of chronic pain from low back pain (SMD, -0.81; 95% CI, -1.11 to -0.52; P osteoporosis (SMD, -0.83; 95% CI, -1.37 to -0.28; P = 0.003). Therefore, clinicians may consider Tai Chi as a viable complementary and alternative medicine for chronic pain conditions.

  14. Radial extracorporeal shock-wave therapy in patients with chronic rotator cuff tendinitis: a prospective randomised double-blind placebo-controlled multicentre trial

    NARCIS (Netherlands)

    Kolk, A. van der; Yang, K.G.; Tamminga, R.; Hoeven, H. van der

    2013-01-01

    The aim of this study was to determine the effect of radial extracorporeal shock-wave therapy (rESWT) on patients with chronic tendinitis of the rotator cuff. This was a randomised controlled trial in which 82 patients (mean age 47 years (24 to 67)) with chronic tendinitis diagnosed clinically were

  15. Kansas Primary Care Weighs In: A Pilot Randomized Trial of a Chronic Care Model Program for Obesity in 3 Rural Kansas Primary Care Practices

    Science.gov (United States)

    Ely, Andrea C.; Banitt, Angela; Befort, Christie; Hou, Qing; Rhode, Paula C.; Grund, Chrysanne; Greiner, Allen; Jeffries, Shawn; Ellerbeck, Edward

    2008-01-01

    Context: Obesity is a chronic disease of epidemic proportions in the United States. Primary care providers are critical to timely diagnosis and treatment of obesity, and need better tools to deliver effective obesity care. Purpose: To conduct a pilot randomized trial of a chronic care model (CCM) program for obesity care in rural Kansas primary…

  16. Risk Factors for Prolonged Treatment of Whiplash-Associated Disorders.

    Directory of Open Access Journals (Sweden)

    Hiroyuki Oka

    Full Text Available Whiplash-associated disorders (WAD are the most common injuries that are associated with car collisions in Japan and many Western countries. However, there is no clear evidence regarding the potential risk factors for poor recovery from WAD. Therefore, we used an online survey of the Japanese population to examine the association between potential risk factors and the persistence of symptoms in individuals with WAD.An online survey was completed by 127,956 participants, including 4,164 participants who had been involved in a traffic collision. A random sample of the collision participants (n = 1,698 were provided with a secondary questionnaire. From among the 974 (57.4% respondents to the secondary questionnaire, we selected 183 cases (intractable neck pain that was treated over a period of 6 months and 333 controls (minor neck pain that was treated within 3 months. Multivariable logistic regression analysis was used to evaluate the potential risk factors for prolonged treatment of WAD.Female sex, the severity of the collision, poor expectations of recovery, victim mentality, dizziness, numbness or pain in the arms, and lower back pain were associated with a poor recovery from WAD.In the present study, the baseline symptoms (dizziness, numbness or pain in the arms, and lower back pain had the strongest associations with prolonged treatment for WAD, although the psychological and behavioral factors were also important. These risk factors should be considered when evaluating patients who may have the potential for poor outcomes.

  17. The therapeutic effects of acupuncture on patients with chronic neck myofascial pain syndrome: a single-blind randomized controlled trial.

    Science.gov (United States)

    Sun, Mei-Yuan; Hsieh, Ching-Liang; Cheng, Yung-Yen; Hung, Hung-Chang; Li, Tsai-Chung; Yen, Sch-May; Huang, I-Shin

    2010-01-01

    Chronic neck myofascial pain syndrome (MPS) is a common disorder seen in clinics. There is no gold standard method to treat myofascial pain. We investigated the effects of acupuncture on patients with chronic neck MPS by a single-blind randomized controlled trial. A total of 35 patients were randomly allocated to an acupuncture group (AG) or a sham acupuncture group (SG). Each subject received acupuncture treatment twice per week for three consecutive weeks. The primary outcome measure was quality of life as assessed with Short Form-36, and secondary outcome measures were neck range of motion (ROM), motion-related pain, and Short-Form McGill Pain Questionnaire (SF-MPQ), as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as four weeks (F1) and 12 weeks (F2) after the end of the treatment. A total of 34 patients completed the trial. The results indicated that there is no significant difference in the ROM, motion-related pain, and SF-MPQ scores between AG and SG at AT, F1 and F2 (all p > 0.05). However, AG has greater improvement in physical functioning and role emotional of Short Form-36 quality of life at F2. The results indicate that acupuncture may be used to improve the quality of life in patients with chronic neck MPS.

  18. The influence of psychosocial factors on recovery following acute whiplash trauma.

    Science.gov (United States)

    Carstensen, Tina Birgitte Wisbech

    2012-12-01

    Persistent pain and disability after whiplash trauma has become an increasingly significant problem in many industrialized countries entailing comprehensive individual as well as social costs. The dissertation includes two areas of research within whiplash trauma. The first part contains two empirical articles focusing on risk factors for poor recovery. The second part contains a systematic review and an empirical article and concerns the influence of coping strategies on recovery with a special emphasis on possible gender differences. All empirical articles in the dissertation are based on self-reported questionnaire data on a patient cohort of whiplash-exposed. Patients are consecutively included in the study within the first ten days of collision recruited from emergency departments and general practitioners in four counties in Denmark from April 2001 to June 2003. One of the empirical articles in the dissertation is supplemented with data from a social register of transfer benefits on the patient cohort as well as on a matched register control cohort in the general population. In this dissertation we wish to answer the following questions: 1) Do self-reported pre-collision health-related and socio-demographic factors affect self-reported work capability and neck pain one year after acute whiplash trauma? 2) Do transfer benefits before the accident predict negative change in future health-related provisional situation and future neck pain? 3) Do persons with acute whiplash trauma experience more negative change in future health-related provisional situation compared to a matched register control group? 4) Does research in the use of coping strategies after whiplash trauma show that these predict poor restitution and is there any research on gender differences in the use of coping strategies in whiplash-exposed? 5) Do gender and coping strategies interact in the prediction of future neck pain following acute whiplash trauma? Self-reported unspecified pain, female

  19. Effect of soy protein supplementation in patients with chronic hepatitis C: A randomized clinical trial

    Institute of Scientific and Technical Information of China (English)

    Lucivalda PM Oliveira; Rosangela P de Jesus; Ramona SSB Boulhosa; Carlos Mauricio C Mendes; Maria Cecilia Gnoatto; Denise C Lemaire; Maria Betania P Toralles

    2012-01-01

    AIM:To evaluate the effects of soy supplementation on insulin resistance,fatty liver and alanine aminotransferase (ALT) levels in non-diabetic patients with chronic hepatitis C (CHC).METHODS:In a prospective,randomized and singleblinded clinical trial,we compared patients with CHC who had casein as a supplement (n =80) (control group),with patients who consumed a soy supplement diet (n =80) [intervention group (IG)].Both groups received 32 g/d of protein for 12 wk.RESULTS:Patients' baseline features showed that 48.1% were overweight,43.7% had abdominal fat accumulation,34.7% had hepatic steatosis and 36.3% had an homeostasis model assessment index of insulin resistance (HOMA-IR) ≥ 3.0.Descriptive analysis showed that protein supplementation diet reduced hepatic steatosis in both groups; however,significant reductions in ALT levels occurred in the soy group.Multiple regression modeling indicated that in the presence of severe fibrosis (F3/F4),y glutamyl transferase elevation and high density lipoprotein (HDL) reduction,the intervention group had 75% less chance of developing hepatic steatosis (OR=0.25; 95% CI:0.06-0.82) and 55% less chance of presenting with an ALT level ≥ 1.5× the upper limit of normal (ULN) (OR =0.45,95%CI:0.22-0.89).Soy treatment did not have any effect on insulin resistance (OR =1.92; 95% CI:0.80-4.83),which might be attributed to the fact that the HOMAIR values at baseline in most of our patients were in the normal range.Advanced hepatic fibrosis,an ALT level > 1.5 × ULN and visceral fat were predictors of an HOMA-IR ≥ 3.The IG group had a reduced risk of an ALT level > 1.5 × ULN.An HOMA-IR ≥ 3.0 and HDL <35 mg/dL were also risk factors for increased ALT.CONCLUSION:Soy supplementation decreased ALT levels and thus may improve liver inflammation in hepatitis C virus (HCV) patients; it also reduced hepatic steatosis in a subgroup of patients but did not change insulin resistance.It should be considered in the

  20. A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA in the treatment of chronic pelvic pain: The trial protocol [ISRCTN41196151

    Directory of Open Access Journals (Sweden)

    2003-12-01

    Full Text Available Abstract Background Chronic pelvic pain is a common condition with a major impact on health-related quality of life, work productivity and health care utilisation. The cause of the pain is not always obvious as no pathology is seen in 40–60% of the cases. In the absence of pathology there is no established treatment. The Lee-Frankenhauser sensory nerve plexuses and parasympathetic ganglia in the uterosacral ligaments carry pain from the uterus, cervix and other pelvic structures. Interruption of these nerve trunks by laparoscopic uterosacral nerve ablation (LUNA may alleviate pain. However, the balance of benefits and risks of this intervention have not been reliably assessed. LUNA has, nevertheless, been introduced into practice, although there remains controversy regarding indications for LUNA. Hence, there is an urgent need for a randomised controlled trial to confirm, or refute, any worthwhile effectiveness. The principal hypothesis is that, in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score ≤ 5 LUNA alleviates pain and improves life quality at 12 months. Methods/Design The principal objective is to test the hypothesis that in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score ≤ 5 LUNA alleviates pain and improves life quality at 12 months. A multi-centre, prospective, randomised-controlled-trial will be carried out with blind assessment of outcomes in eligible consenting patients randomised at diagnostic laparoscopy to LUNA (experimental group or to no pelvic denervation (control group. Postal questionnaires including visual analogue scale for pain (primary outcome, an index of sexual satisfaction and the EuroQoL 5D-EQ instrument (secondary outcomes will be administered at 3, 6 and 12 months. The primary assessment of the effectiveness of LUNA will be from comparison of outcomes at the one

  1. Disc pathology after whiplash injury. A prospective magnetic resonance imaging and clinical investigation; Pathologie vertebrale apres le coup du lapin. Une investigation clinique et d` imagerie prospective par resonance magnetique

    Energy Technology Data Exchange (ETDEWEB)

    Pettersson, K.; Hildingsson, C.; Toolanen, G.; Fagerlund, M.; Bjornebrink, J. [University Hospital of Northem (Sweden)

    1997-09-01

    Although disc pathology seems to be one contributing factor in the development of chronic symptoms after whiplash injury, it may be unnecessary to examine these patients in the acute phase with magnetic resonance imaging ; correlating initial symptoms and signs to magnetic resonance imaging findings is difficult because of the relatively high proportion of false-positive results. Magnetic resonance imaging is indicated later in the course of treatment in patients with persistent arm pain, neurologic deficits, or clinical signs of nerve root compression to diagnose disc herniations requiring surgery. (authors).

  2. Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1: A Pilot Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Steff C Lewis

    Full Text Available Chronic pelvic pain (CPP affects 2.1-24% of women. Frequently, no underlying pathology is identified, and the pain is difficult to manage. Gabapentin is prescribed for CPP despite no robust evidence of efficacy. We performed a pilot trial in two UK centres to inform the planning of a future multicentre RCT to evaluate gabapentin in CPP management. Our primary objective was to determine levels of participant recruitment and retention. Secondary objectives included estimating potential effectiveness, acceptability to participants of trial methodology, and cost-effectiveness of gabapentin. Women with CPP and no obvious pelvic pathology were assigned to an increasing regimen of gabapentin (300-2700mg daily or placebo. We calculated the proportion of eligible women randomised, and of randomised participants who were followed up to six months. The analyses by treatment group were by intention-to-treat. Interviews were conducted to evaluate women's experiences of the trial. A probabilistic decision analytical model was used to estimate cost-effectiveness. Between September 2012-2013, 47 women (34% of those eligible were randomised (22 to gabapentin, 25 to placebo, and 25 (53% completed six-month follow-up. Participants on gabapentin had less pain (BPI difference 1.72 points, 95% CI:0.07-3.36, and an improvement in mood (HADS difference 4.35 points, 95% CI:1.97-6.73 at six months than those allocated placebo. The majority of participants described their trial experience favorably. At the UK threshold for willingness-to-pay, the probabilities of gabapentin or no treatment being cost-effective are similar. A pilot trial assessing gabapentin for CPP was feasible, but uncertainty remains, highlighting the need for a large definitive trial.

  3. Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A Pilot Randomised Controlled Trial.

    Science.gov (United States)

    Lewis, Steff C; Bhattacharya, Siladitya; Wu, Olivia; Vincent, Katy; Jack, Stuart A; Critchley, Hilary O D; Porter, Maureen A; Cranley, Denise; Wilson, John A; Horne, Andrew W

    2016-01-01

    Chronic pelvic pain (CPP) affects 2.1-24% of women. Frequently, no underlying pathology is identified, and the pain is difficult to manage. Gabapentin is prescribed for CPP despite no robust evidence of efficacy. We performed a pilot trial in two UK centres to inform the planning of a future multicentre RCT to evaluate gabapentin in CPP management. Our primary objective was to determine levels of participant recruitment and retention. Secondary objectives included estimating potential effectiveness, acceptability to participants of trial methodology, and cost-effectiveness of gabapentin. Women with CPP and no obvious pelvic pathology were assigned to an increasing regimen of gabapentin (300-2700 mg daily) or placebo. We calculated the proportion of eligible women randomised, and of randomised participants who were followed up to six months. The analyses by treatment group were by intention-to-treat. Interviews were conducted to evaluate women's experiences of the trial. A probabilistic decision analytical model was used to estimate cost-effectiveness. Between September 2012-2013, 47 women (34% of those eligible) were randomised (22 to gabapentin, 25 to placebo), and 25 (53%) completed six-month follow-up. Participants on gabapentin had less pain (BPI difference 1.72 points, 95% CI:0.07-3.36), and an improvement in mood (HADS difference 4.35 points, 95% CI:1.97-6.73) at six months than those allocated placebo. The majority of participants described their trial experience favorably. At the UK threshold for willingness-to-pay, the probabilities of gabapentin or no treatment being cost-effective are similar. A pilot trial assessing gabapentin for CPP was feasible, but uncertainty remains, highlighting the need for a large definitive trial.

  4. Managing cardiovascular risk in people with chronic kidney disease: a review of the evidence from randomized controlled trials.

    Science.gov (United States)

    Jun, Min; Lv, Jicheng; Perkovic, Vlado; Jardine, Meg J

    2011-07-01

    Cardiovascular disease is the leading cause of death and morbidity in people with chronic kidney disease (CKD) making measures to modify cardiovascular risk a clinical priority. The relationship between risk factors and cardiovascular outcomes is often substantially different in people with CKD compared with the general population, leading to uncertainty around pathophysiological mechanisms and the validity of generalizations from the general population. Furthermore, published reports of subgroup analyses from clinical trials have suggested that a range of interventions may have different effects in people with kidney disease compared with those with normal kidney function. There is a relative scarcity of randomized controlled trials (RCTs) conducted in CKD populations, and most such trials are small and underpowered. As a result, evidence to support cardiovascular risk modification measures for people with CKD is largely derived from small trials and post hoc analyses of RCTs conducted in the general population. In this review, we examine the available RCT evidence on interventions aimed at preventing cardiovascular events in people with kidney disease to identify beneficial treatments as well as current gaps in knowledge that should be a priority for future research.

  5. Reduction of chronic non-specific low back pain: A randomised controlled clinical trial on acupuncture and baclofen

    Directory of Open Access Journals (Sweden)

    Rastqar Ali

    2010-04-01

    Full Text Available Abstract Background Chronic non-specific low back pain (LBP is a prevalent (80% and multi-dimensional illness. This study aims to test whether acupuncture, baclofen, or combined treatment with acupuncture and baclofen alleviates symptoms of non-specific chronic LBP in men. Methods Eight-four (84 men aged 50-60 years with non-specific chronic LBP were randomly assigned to four groups: the baclofen group received only baclofen (30 mg/day; the acupuncture group received only acupuncture at selected acupoints; the acupuncture + baclofen group received combined treatment with acupuncture and baclofen treatments; and the control group received no pain reduction treatment. After five weeks of treatment, visual analogue scale (VAS and self-reported pain disability with the Roland-Morris Disability Questionnaire (RDQ were conducted for outcome measures. Results After treatment, the baclofen, acupuncture and acupuncture + baclofen groups all had lower VAS and RDQ scores. Significantly higher reduction and improvement in VAS and RDQ scores were found in the acupuncture and acupuncture + baclofen groups compared to the baclofen group. Conclusion The present study indicates that the combined treatment of acupuncture and baclofen is more effective than baclofen treatment alone to reduce pain in patients with non-specific chronic LBP. Trial registration number ACTRN12609000698279

  6. Smertetilstand og psykologisk distress før uheldet praedikterer gener efter whiplash-traume--sekundaerpublikation

    DEFF Research Database (Denmark)

    Carstensen, Tina Birgitte Wisbech; Frostholm, Lisbeth; Ørnbøl, Eva

    2009-01-01

    Patients with acute whiplash trauma were followed to examine if pre-collision pain and psychological distress were associated with reduced work capability and neck pain at 12 month follow-up. Pre-collision unspecified pain was associated with reduced work capability, and neck pain and pre...

  7. What Happens When Compensation for Whiplash Claims Is Made More Generous?

    DEFF Research Database (Denmark)

    Cassidy, J. David; Leth-Petersen, Søren; Pons Rotger, Gabriel

    2016-01-01

    We examine the effect of a Danish reform in 2002 that increased compensation for permanent loss of earnings capacity and extended the period when whiplash claimants could get compensation for temporary loss of earnings. The first is subject to extensive state verification by the government while ...

  8. Five years post whiplash injury: Symptoms and psychological factors in recovered versus non-recovered

    Directory of Open Access Journals (Sweden)

    Stålnacke Britt-Marie

    2010-07-01

    Full Text Available Abstract Background Few studies have focused on the differences between persons who are recovered after whiplash injury and those who suffer from persistent disability. The primary aim of this study was therefore to examine differences in symptoms, psychological factors and life satisfaction between subjects classified as recovered and those with persistent disability five years after whiplash injury based on the Neck Disability Index (NDI. Methods A set of questionnaires was answered by 158 persons (75 men, 83 women to assess disability (NDI, pain intensity (VAS, whiplash-related symptoms (Rivermead Post-Concussion Symptoms Questionnaire, RPQ, post-traumatic stress (Impact of Event Scale, IES, depression (Beck's depression inventory, BDI and life satisfaction (LiSat-11. The participants were divided into three groups based on the results of the NDI: recovered (34.8%, mild disability (37.3% and moderate/severe disability (27.3%. Results The moderate/severe group reported significantly higher VAS, BDI and IES scores and lower level of physical health and psychological health compared to the mild and the recovered groups. Less significant differences were reported between the mild and the recovered groups. Conclusions The group with the highest disability score reported most health problems with pain, symptoms, depression, post-traumatic stress and decreased life satisfaction. These findings indicate that classifying these subjects into subgroups based on disability levels makes it possible to optimize the management and treatment after whiplash injury.

  9. A rare and lethal case of right common carotid pseudoaneurysm following whiplash trauma.

    Science.gov (United States)

    Pomara, Cristoforo; Bello, Stefania; Serinelli, Serenella; Fineschi, Vittorio

    2015-03-01

    Whiplash trauma from a car crash is one of the most common causes of neck injury, resulting in pain and dysfunction. We report on an unusual case of post-whiplash pseudoaneurysm of the right common carotid artery, which led to acute massive hemorrhage and death days after the initial trauma. A post-mortem computed tomography angiography showed rupture of the pseudoaneurysm of the right common carotid artery with the contrast agent leaking out into the mouth. The subsequent autopsy confirmed a large hemorrhagic clot extending to the right side of the neck and mediastinum. A rupture of the right wall of the oropharynx was identified with massive bronchial hemoaspiration. The case demonstrates a rare but lethal clinical entity, and is important in providing a better understanding of the potentially fatal consequences of minor trauma, such as whiplash injury, and its physiopathological mechanisms. Thus, changing symptoms after a whiplash injury should be carefully evaluated since they can be related to the underlying severe consequences of a rapid hyperextension-hyperflexion of the neck, as in the reported case.

  10. Noise-intolerance and state-dependent factors in patients with whiplash associated disorder

    NARCIS (Netherlands)

    Blokhorst, M.G.B.G.; Meeldijk, S.J.; Luijtelaar, E.L.J.M. van; Toor, T. van; Lousberg, R.; Ganzevles, P.

    2005-01-01

    An experiment was carried out in which the level of noise-intolerance in patients with a Whiplash Associated Disorder (WAD) was compared to healthy matched control subjects. In addition, the relationship between state-dependent factors (as headache, neck pain, fatigue and tension) and noise-intolera

  11. Potential processes involved in the initiation and maintenance of whiplash-associated disorders : discussion paper 3

    NARCIS (Netherlands)

    Sterling, Michele; McLean, Samuel A.; Sullivan, Michael J. L.; Elliott, James M.; Buitenhuis, Jan; Kamper, Steven J.

    2011-01-01

    Study Design. Nonsystematic review and discussion of the etiological processes involved in whiplash-associated disorders (WAD). Objective. To summarize the research and identify priorities for future research. Summary of Background Data. Although there is convergent evidence of a peripheral lesion i

  12. Construct Validity of Functional Capacity Evaluation in Patients with Whiplash-Associated Disorders

    NARCIS (Netherlands)

    Trippolini, M. A.; Dijkstra, P. U.; Geertzen, J. H. B.; Reneman, M. F.

    2015-01-01

    Purpose The construct validity of functional capacity evaluations (FCE) in whiplash-associated disorders (WAD) is unknown. The aim of this study was to analyse the validity of FCE in patients with WAD with cultural differences within a workers' compensation setting. Methods 314 participants (42 % fe

  13. Reliability and Safety of Functional Capacity Evaluation in Patients with Whiplash Associated Disorders

    NARCIS (Netherlands)

    Trippolini, M. A.; Reneman, M. F.; Jansen, B.; Dijkstra, P. U.; Geertzen, J. H. B.

    2013-01-01

    Introduction Whiplash-associated disorders (WAD) are a burden for both individuals and society. It is recommended to evaluate patients with WAD at risk of chronification to enhance rehabilitation and promote an early return to work. In patients with low back pain (LBP), functional capacity evaluatio

  14. Treatment of Whiplash-Associated Disorders - Part II: Medical and Surgical Interventions

    Directory of Open Access Journals (Sweden)

    Anne Conlin

    2005-01-01

    Full Text Available BACKGROUND: Whiplash-associated disorder (WAD is a term used to describe injury due to an acceleration-deceleration mechanism at the neck. In 1995, the Quebec Task Force published a report that contained evidence-based recommendations regarding the treatment of WAD based on studies completed before 1993 and consensus-based recommendations.

  15. Can Functional Capacity Tests Predict Future Work Capacity in Patients With Whiplash-Associated Disorders?

    NARCIS (Netherlands)

    Trippolini, Maurizio A.; Dijkstra, Pieter U.; Cote, Pierre; Scholz-Odermatt, Stefan M.; Geertzen, J.H.B.; Reneman, Michiel F.

    2014-01-01

    Objective: To determine whether functional capacity evaluation (FCE) tests predict future work capacity (WC) of patients with whiplash-associated disorders (WADs) grades I and II who did not regain full WC 6 to 12 weeks after injury. Design: Prospective cohort study. Setting: Rehabilitation center.

  16. PET Imaging of Mild Traumatic Brain Injury and Whiplash Associated Disorder

    NARCIS (Netherlands)

    Vállez García, David

    2015-01-01

    Traumatic brain injury is the leading cause of brain injury in our society with 235 per 100,000 inhabitants per year in the European Union and about 500 per 100,000 inhabitants per year in the United States. About 80% of all these events are accounted for as mild cases. At the same time, whiplash-as

  17. Applying the Quebec Task Force criteria as a frame of reference for studies of whiplash injuries

    NARCIS (Netherlands)

    Versteegen, GJ; van Es, FD; Kingma, J; Meijler, WJ; ten Duis, HJ

    2001-01-01

    Research prior to 1995 showed a diversity of either inclusion or exclusion criteria (or both) for diagnosing whiplash injury. As a consequence, the Quebec Task Force (QTF) developed expert-based criteria, which may be considered as a the 'new' gold standard. Here, we examined the inclusion criteria

  18. Subacromial impingement in patients with whiplash injury to the cervical spine

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    Giddins Grey E

    2008-06-01

    Full Text Available Abstract Background Impingement syndrome and shoulder pain have been reported to occur in a proportion of patients following whiplash injuries to the neck. In this study we aim to examine these findings to establish the association between subacromial impingement and whiplash injuries to the cervical spine. Methods and results We examined 220 patients who had presented to the senior author for a medico-legal report following a whiplash injury to the neck. All patients were assessed for clinical evidence of subacromial impingement. 56/220 patients (26% had developed shoulder pain following the injury; of these, 11/220 (5% had clinical evidence of impingement syndrome. Only 3/11 patients (27% had the diagnosis made prior to evaluation for their medico-legal report. In the majority, other clinicians had overlooked the diagnosis. The seatbelt shoulder was involved in 83% of cases (p Conclusion After a neck injury a significant proportion of patients present with shoulder pain, some of whom have treatable shoulder pathology such as impingement syndrome. The diagnosis is, however, frequently overlooked and shoulder pain is attributed to pain radiating from the neck resulting in long delays before treatment. It is important that this is appreciated and patients are specifically examined for signs of subacromial impingement after whiplash injuries to the neck. Direct seatbelt trauma to the shoulder is one possible explanation for its aetiology.

  19. HYPERTRANSLATION OF THE HEAD BACKWARDS - PART OF THE MECHANISM OF CERVICAL WHIPLASH INJURY

    NARCIS (Netherlands)

    PENNING, L

    1994-01-01

    Based upon a review of the literature, a theory is developed that in whiplash injury the primary mechanism of the trauma is not hyperretroflexion but hypertranslation of the head backwards. Thus a hyperanteflexion (not hyperretroflexion) of the upper cervical spine, probably especially of the atlant

  20. Study protocol for a randomised, double-blinded, placebo-controlled, clinical trial of S-ketamine for pain treatment in patients with chronic pancreatitis (RESET trial)

    DEFF Research Database (Denmark)

    Juel, Jacob; Olesen, Søren Schou; Olesen, Anne Estrup;

    2015-01-01

    INTRODUCTION: Chronic pancreatitis (CP) is an inflammatory disease that causes irreversible damage to pancreatic tissue. Pain is its most prominent symptom. In the absence of pathology suitable for endoscopic or surgical interventions, pain treatment usually includes opioids. However, opioids often...... of central sensitisation is abnormal activation of the N-methyl-D-aspartate receptor, which can be antagonised by S-ketamine. The RESET trial is investigating the analgaesic and antihyperalgesic effect of S-ketamine in patients with CP. METHODS AND ANALYSIS: 40 patients with CP will be enrolled. Patients...... include changes in patient-reported outcome measures, opioid consumption and rates of side effects. The end points are registered through the 4-week medication period and for an additional follow-up period of 8 weeks to investigate long-term effects. In addition, experimental pain measures also serves...

  1. Research designs for proof-of-concept chronic pain clinical trials

    DEFF Research Database (Denmark)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C

    2014-01-01

    -pharmacodynamic relationships, and minimization of missing data. Efficiency of single-dose studies for treatments with rapid onset is discussed. The trade-off between parallel-group and crossover designs with respect to overall sample sizes, trial duration, and applicability is summarized. The advantages and disadvantages...... indication and thus whether it is worth investing the financial resources and participant exposure necessary for a confirmatory trial of that intervention. A challenge in designing POC trials is obtaining sufficient information to make this important go/no-go decision in a cost-effective manner. An IMMPACT...... consensus meeting was convened to discuss design considerations for POC trials in analgesia, with a focus on maximizing power with limited resources and participants. We present general design aspects to consider including patient population, active comparators and placebos, study power, pharmacokinetic...

  2. Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD. TECEPOC: study protocol for a partially randomized controlled trial (preference trial

    Directory of Open Access Journals (Sweden)

    Leiva-Fernández Francisca

    2012-05-01

    Full Text Available Abstract Background Drugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD. Methods This study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1 the patients´ preference group with two arms and 2 the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques. Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center. Discussion Our hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice. Trial registration Current Controlled Trials ISRTCTN15106246

  3. Randomised controlled trial comparing two different intravenous immunoglobulins in chronic inflammatory demyelinating polyradiculoneuropathy

    NARCIS (Netherlands)

    K. Kuitwaard; L.H. van den Berg; M. Vermeulen; E. Brusse; E.A. Cats; A.J. van der Kooi; N.C. Notermans; W.L. van der Pol; I.N. van Schaik; S.I. van Nes; W.C.J. Hop; P.A. van Doorn

    2010-01-01

    Background Different preparations of intravenous immunoglobulin (IVIg) are considered to have comparable clinical efficacy but this has never been formally investigated. Some patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) report that some IVIg brands are more effectiv

  4. Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: the SMILE study.

    Science.gov (United States)

    Weisbord, Steven D; Shields, Anne Marie; Mor, Maria K; Sevick, Mary Ann; Homer, Marcia; Peternel, Janet; Porter, Patricia; Rollman, Bruce L; Palevsky, Paul M; Arnold, Robert M; Fine, Michael J

    2010-09-01

    Despite the high prevalence of pain, sexual dysfunction, and depression in patients on chronic hemodialysis, these symptoms are often unrecognized and under-treated by renal providers. This report describes the rationale and methodology of the SMILE study (Symptom Management Involving End-Stage Renal Disease), a multi-center, randomized clinical trial comparing the effectiveness of two strategies for implementing treatment for these symptoms in patients receiving chronic hemodialysis. Approximately 250 patients from nine outpatient dialysis units will participate. Over a 2-12 month observational phase, participants complete monthly surveys characterizing their pain, sexual dysfunction, and depression. Following this observational period, subjects are randomized to one of two study arms to receive a 12-month intervention. In one study arm (feedback intervention), patients continue to complete the same three symptom surveys, and the presence and severity of the symptoms reported on these surveys is mailed to the patient's renal provider along with evidence-based algorithms outlining treatment options for these symptoms. Decisions on treatment are left at the discretion of the provider. Patients randomized to the other study arm (management intervention) also continue to complete the same monthly symptom surveys and are evaluated by a symptom management nurse trained in the management of these symptoms. This nurse then discusses the patient's symptoms with the renal provider, provides specific recommendations for treatment, and facilitates the implementation of treatment. The primary endpoints are changes in scores on pain, erectile dysfunction, and depression surveys. This report describes the rationale and methodology of this clinical trial.

  5. The pathology of whiplash maculopathy and retinopathy : Illustrated observations derived from a fatal roller-coaster accident.

    Science.gov (United States)

    Parsons, M A; Talbot, J F; Mudhar, H S; Rutty, Guy N

    2005-03-01

    We present a single case report of a 20-year-old female who died following a severe whiplash head and neck injury sustained during a roller-coaster incident. We present the pathology of her eyes, which we believe to be the first pathological illustration of whiplash maculopathy and retinopathy to be reported within the medical literature. This article presents the macroscopic and microscopic pathology identified in this case and discusses the possible causation of the findings.

  6. Validation of a new questionnaire to assess the impact of Whiplash Associated Disorders: The Whiplash Activity and participation List (WAL).

    Science.gov (United States)

    Stenneberg, Martijn S; Schmitt, Maarten A; van Trijffel, Emiel; Schröder, Carin D; Lindeboom, Robert

    2015-02-01

    Valid questionnaires for measuring functional limitations in patients with Whiplash Associated Disorders (WAD) are lacking, since existing measures are not suitable for addressing the specific limitations of these patients and because of cross contamination between theoretical constructs. The objective of this study was to evaluate dimensionality, test-retest reliability, measurement error, construct validity, and responsiveness of a new condition-specific questionnaire for WAD as well as to estimate the minimally important change score. Patients with WAD grade I or II were recruited from physical therapy practices and rehabilitation centers. Dimensionality was examined by internal consistency analysis (Cronbach's alpha) and factor analysis. Test-retest reliability was estimated by intraclass correlations and measurement error was calculated by the minimal detectable change (MDC) scores. Construct validity was investigated by testing predefined hypotheses on correlations of the WAL scores with generic health measures and by using the known group method. Responsiveness was expressed as the minimal clinically important change (MCIC) score. 73 patients (53 women) were included. Cronbach's alpha was high (0.95) and unidimensionality was plausible because factor analysis showed 40.3% variance explained by one dominant factor, which was more than 4.5 times larger than the second largest factor. Test-retest reliability was excellent (0.92, 95% CI 0.87-0.95). Construct validity was supported by 14 out of 15 confirmed hypotheses and the WAL showed statistically significant differences between known groups. MDC was 16 points while the MCIC was 18 points. In conclusion, the present study suggests that the WAL has adequate measurement properties, but additional research is needed.

  7. A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Schuengel Carlo

    2011-07-01

    Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

  8. Is “fear of passive movement” a distinctive component of the Fear-Avoidance Model in whiplash?

    Science.gov (United States)

    Vernon, Howard; Guerriero, Rocco; Kavanaugh, Shawn; Puhl, Aaron

    2015-01-01

    Objectives: Modify the Tampa Scale for Kinesiophobia (TSK) for ‘fear of passive motion’ beliefs. Methods: With permission, a 14-item modification, the TSK-PM (passive movement), was created. Test-retest reliability was tested first. Construct validity was tested in chronic whiplash patients by comparing the TSK-PM with the TSK, the Neck Disability Index (NDI) and cervical ranges of motion. Results: The TSK-PM showed high test-retest reliability (r = 0.83) and high correlation with the original TSK (r = 0.84). Low, non-significant correlations were found with other variables. NDI scores were strongly correlated with ranges of motion. Conclusions: While having high test-retest reliability and a single factor structure, the TSK-PM failed to demonstrate distinctive construct validity vs the original TSK. The original TSK is likely to be sufficient to assess fear of being moved in neck pain patients in a clinical setting. Modifications to the current version of the TSK-PM might improve its construct validity in future studies. PMID:26500363

  9. Building equity in chronic disease management in Thailand: a whole-system provincial trial of systematic, pro-active chronic illness care.

    Science.gov (United States)

    Wanitkun, N; Batterham, R; Vichathai, C; Leetongin, G; Osborne, R H

    2011-03-01

    Thailand has a history of implementing innovative and proactive policies to address the health needs of its population. Since 1962 Thailand has implemented initiatives that led to it having a health system characterized by a primary care focus, decentralization and mechanisms to maximize equity and universal access to basic care at the local level. Thai health structures initially evolved to meet challenges including infectious and developmental diseases and later HIV. Early in the 21st century chronic illness rapidly became the greatest cause of morbidity and mortality and the question has arisen how Thailand can adapt its strong health system to deal with the new epidemics. This article describes an effort to reorient provincial health services to meet the needs of the increasing number of people with diabetes and heart disease. It describes measures taken to build on the equity-promoting elements of the Thai health system. The project included; a situational analysis, development and implementation of a chronic disease self-management intervention implemented by nurses and alignment of provincial health services. The self-management intervention is currently being evaluated within a clustered randomized control trial. The evaluation has been developed to fit with the focus on equity in relation to both selection criteria and the outcomes that are being assessed.

  10. Evaluation of a system of structured, pro-active care for chronic depression in primary care: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Beecham Jennifer

    2010-08-01

    Full Text Available Abstract Background People with chronic depression are frequently lost from effective care, with resulting psychological, physical and social morbidity and considerable social and financial societal costs. This randomised controlled trial will evaluate whether regular structured practice nurse reviews lead to better mental health and social outcomes for these patients and will assess the cost-effectiveness of the structured reviews compared to usual care. The hypothesis is that structured, pro-active care of patients with chronic depression in primary care will lead to a cost-effective improvement in medical and social outcomes when compared with usual general practitioner (GP care. Methods/Design Participants were recruited from 42 general practices throughout the United Kingdom. Eligible participants had to have a history of chronic major depression, recurrent major depression or chronic dsythymia confirmed using the Composite International Diagnostic Interview (CIDI. They also needed to score 14 or above on the Beck Depression Inventory (BDI-II at recruitment. Once consented, participants were randomised to treatment as usual from their general practice (controls or the practice nurse led intervention. The intervention includes a specially prepared education booklet and a comprehensive baseline assessment of participants' mood and any associated physical and psycho-social factors, followed by regular 3 monthly reviews by the nurse over the 2 year study period. At these appointments intervention participants' mood will be reviewed, together with their current pharmacological and psychological treatments and any relevant social factors, with the nurse suggesting possible amendments according to evidence based guidelines. This is a chronic disease management model, similar to that used for other long-term conditions in primary care. The primary outcome is the BDI-II, measured at baseline and 6 monthly by self-complete postal questionnaire

  11. A single trial of transcutaneous electrical nerve stimulation (TENS) improves spasticity and balance in patients with chronic stroke.

    Science.gov (United States)

    Cho, Hwi-young; In, Tae Sung; Cho, Ki Hun; Song, Chang Ho

    2013-01-01

    Spasticity management is pivotal for achieving functional recovery of stroke patients. The purpose of this study was to investigate the effects of a single trial of transcutaneous electrical nerve stimulation (TENS) on spasticity and balance in chronic stroke patients. Forty-two chronic stroke patients were randomly allocated into the TENS (n = 22) or the placebo-TENS (n = 20) group. TENS stimulation was applied to the gastrocnemius for 60 min at 100 Hz, 200 µs with 2 to 3 times the sensory threshold (the minimal threshold in detecting electrical stimulation for subjects) after received physical therapy for 30 min. In the placebo-TENS group, electrodes were placed but no electrical stimulation was administered. For measuring spasticity, the resistance encountered during passive muscle stretching of ankle joint was assessed using the Modified Ashworth Scale, and the Hand held dynamometer was used to assess the resistive force caused by spasticity. Balance ability was measured using a force platform that measures postural sway generated by postural imbalance. The TENS group showed a significantly greater reduction in spasticity of the gastrocnemius, compared to the placebo-TENS group (p TENS resulted in greater balance ability improvements, especially during the eyes closed condition (p TENS provides an immediately effective means of reducing spasticity and of improving balance in chronic stroke patients. The present data may be useful to establish the standard parameters for TENS application in the clinical setting of stroke.

  12. Internet-delivered cognitive-behavioral treatment for adolescents with chronic pain and their parents: a randomized controlled multicenter trial.

    Science.gov (United States)

    Palermo, Tonya M; Law, Emily F; Fales, Jessica; Bromberg, Maggie H; Jessen-Fiddick, Tricia; Tai, Gabrielle

    2016-01-01

    Internet-delivered interventions are emerging as a strategy to address barriers to care for individuals with chronic pain. This is the first large multicenter randomized controlled trial of Internet-delivered cognitive-behavioral therapy (CBT) for pediatric chronic pain. Participants included were 273 adolescents (205 females and 68 males), aged 11 to 17 years with mixed chronic pain conditions and their parents, who were randomly assigned in a parallel-group design to Internet-delivered CBT (n = 138) or Internet-delivered Education (n = 135). Assessments were completed before treatment, immediately after treatment, and at 6-month follow-up. All data collection and procedures took place online. The primary analysis used linear growth models. Results demonstrated significantly greater reduction on the primary outcome of activity limitations from baseline to 6-month follow-up for Internet CBT compared with Internet education (b = -1.13, P = 0.03). On secondary outcomes, significant beneficial effects of Internet CBT were found on sleep quality (b = 0.14, P = 0.04), on reducing parent miscarried helping (b = -2.66, P = 0.007) and protective behaviors (b = -0.19, P = 0.001), and on treatment satisfaction (P values pain, and improvement in parent behavioral responses to pain). In conclusion, our Internet-delivered CBT intervention produced a number of beneficial effects on adolescent and parent outcomes, and could ultimately lead to wide dissemination of evidence-based psychological pain treatment for youth and their families.

  13. Combination of taping with Back School in patients with chronic low back pain: a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Andres Tana

    2016-11-01

    Full Text Available Introduction: 70-85% of the general population suffers from back pain. Back School programs have being effective in the treatment of chronic low back pain. Taping may be useful in reducing pain and normalizing muscle function. The objective of this study was to evaluate the effectiveness of the combination of taping with Back School at short- and long-term. Methods: Randomized controlled clinical trial. The experimental group used tape and made Back Scholl and the control group only made Back School. At the beginning and the end of treatment, pain was evaluated with a visual analogue scale, the flexibility determined with the Modified Finger Tip-to-Floor Test and functionality was calculated with the Roland Morris Disability Questionnaire. Depression was recorded with the Depression Beck Inventory just at the beginning. Results: 220 patients were enrolled, only 42 in the experimental group and 33 in the control group completed the treatment. The variation of pain between the first and the fifth session showed no differences between groups regardless of time (p = 0.329. There were no differences between groups in functionality (p = 0.75, flexibility (p = 0.20 and depression. Conclusion: The combination of taping and Back School compared with only Back School was not more effective in reducing pain, increasing functionality and flexibility in patients with chronic low back pain. Key words: Taping; chronic low back pain; spine school; therapy exercises; flexibility; depression.

  14. Expectations for recovery important in the prognosis of whiplash injuries.

    Directory of Open Access Journals (Sweden)

    Lena W Holm

    2008-05-01

    Full Text Available BACKGROUND: Individuals' expectations on returning to work after an injury have been shown to predict the duration of time that a person with work-related low back pain will remain on benefits; individuals with lower recovery expectations received benefits for a longer time than those with higher expectations. The role of expectations in recovery from traumatic neck pain, in particular whiplash-associated disorders (WAD, has not been assessed to date to our knowledge. The aim of this study was to investigate if expectations for recovery are a prognostic factor after experiencing a WAD. METHODS AND FINDINGS: We used a prospective cohort study composed of insurance claimants in Sweden. The participants were car occupants who filed a neck injury claim (i.e., for WAD to one of two insurance companies between 15 January 2004 and 12 January 2005 (n = 1,032. Postal questionnaires were completed shortly (average 23 d after the collision and then again 6 mo later. Expectations for recovery were measured with a numerical rating scale (NRS at baseline, where 0 corresponds to "unlikely to make a full recovery" and 10 to "very likely to make a full recovery." The scale was reverse coded and trichotomised into NRS 0, 1-4, and 5-10. The main outcome measure was self-perceived disability at 6 mo postinjury, measured with the Pain Disability Index, and categorised into no/low, moderate, and high disability. Multivariable polytomous logistic regression was used for the analysis. There was a dose response relationship between recovery expectations and disability. After controlling for severity of physical and mental symptoms, individuals who stated that they were less likely to make a full recovery (NRS 5-10, were more likely to have a high disability compared to individuals who stated that they were very likely to make a full recovery (odds ratio [OR] 4.2 [95% confidence interval (CI 2.1 to 8.5]. For the intermediate category (NRS 1-4, the OR was 2.1 (95% CI 1

  15. Randomized Controlled Non-Inferiority Trial of a Telehealth Treatment for Chronic Stuttering: The Camperdown Program

    Science.gov (United States)

    Carey, Brenda; O'Brian, Sue; Onslow, Mark; Block, Susan; Jones, Mark; Packman, Ann

    2010-01-01

    Background: Although there are treatments that can alleviate stuttering in adults for clinically significant periods, in Australia there are barriers to the accessibility and availability of best-practice treatment. Aims: This parallel group, non-inferiority randomized controlled trial with multiple blinded outcome assessments investigated whether…

  16. Effectiveness of behavioural graded activity compared with physiotherapy treatment in chronic neck pain: design of a randomised clinical trial [ISRCTN88733332

    OpenAIRE

    2004-01-01

    Abstract Background Chronic neck pain is a common complaint in the Netherlands with a point prevalence of 14.3%. Patients with chronic neck pain are often referred to a physiotherapist and, although many treatments are available, it remains unclear which type of treatment is to be preferred. The objective of this article is to present the design of a randomised clinical trial, Ephysion, which examines the clinical and cost effectiveness of behavioural graded activity compared with a physiothe...

  17. Kinesio Taping to generate skin convolutions is not better than sham taping for people with chronic non-specific low back pain: a randomised trial

    OpenAIRE

    Patrícia do Carmo Silva Parreira; Lucíola da Cunha Menezes Costa; Ricardo Takahashi; Luiz Carlos Hespanhol Junior; Maurício Antônio da Luz Junior; Tatiane Mota da Silva; Leonardo Oliveira Pena Costa

    2014-01-01

    Question: For people with chronic low back pain, does Kinesio Taping, applied according to the treatment manual to create skin convolutions, reduce pain and disability more than a simple application without convolutions? Design: Randomised trial with concealed allocation, intention-to-treat analysis and blinded assessment of some outcomes. Participants: 148 participants with chronic non-specific low back pain. Intervention: Experimental group participants received eight sessions (over four we...

  18. Epidural injection with or without steroid in managing chronic low back and lower extremity pain: ameta-analysis of ten randomized controlled trials

    OpenAIRE

    Zhai, Jinshuai; Zhang, Long; Li, Mengya; Tian, Yiren; Zheng, Wang; Chen, Jia; Huang, Teng; Li, Xicheng; Tian, Zhi

    2015-01-01

    Background: Chronic low back and lower extremity pain is mainly caused by lumbar disc herniation (LDH) and radiculitis. Various surgery and nonsurgical modalities, including epidural injections, have been used to treat LDH or radiculitis. Therefore, we conducted this meta-analysis to assess the effects of the two interventions in managing various chronic low and lower extremity pain. Methods: A systematic literature search was conducted to identify randomized controlled trials (RCTs) which co...

  19. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial

    Science.gov (United States)

    2012-01-01

    results could suggest a therapeutically feasible potential for Spirulina platensis in chronic HCV patients, worthy to conduct a larger sized and longer study to confirm these safety and efficacy encouraging results. Trial Registration WHO Clinical Trial Registration ID: ACTRN12610000958088 http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000958088 PMID:22497849

  20. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial

    Directory of Open Access Journals (Sweden)

    Yakoot Mostafa

    2012-04-01

    . Conclusions Our results could suggest a therapeutically feasible potential for Spirulina platensis in chronic HCV patients, worthy to conduct a larger sized and longer study to confirm these safety and efficacy encouraging results. Trial Registration WHO Clinical Trial Registration ID: ACTRN12610000958088 http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000958088

  1. Sick Leave within 5 Years of Whiplash Trauma Predicts Recovery: A Prospective Cohort and Register-Based Study.

    Directory of Open Access Journals (Sweden)

    Tina Birgitte Wisbech Carstensen

    Full Text Available 10-22% of individuals sustaining whiplash trauma develop persistent symptoms resulting in reduced working ability and decreased quality of life, but it is poorly understood why some people do not recover. Various collision and post-collision risk factors have been studied, but little is known about pre-collision risk factors. In particular, the impact of sickness and socioeconomic factors before the collision on recovery is sparsely explored. The aim of this study was to examine if welfare payments received within five years pre-collision predict neck pain and negative change in provisional situation one year post-collision.719 individuals with acute whiplash trauma consecutively recruited from emergency departments or primary care after car accidents in Denmark completed questionnaires on socio-demographic and health factors immediately after the collision. After 12 months, a visual analogue scale on neck pain intensity was completed. 3595 matched controls in the general population were sampled, and national public register data on social benefits and any other welfare payments were obtained for participants with acute whiplash trauma and controls from five years pre-collision to 15 months after. Participants with acute whiplash trauma who had received sickness benefit for more than 12 weeks pre-collision had increased odds for negative change in future provisional situation (Odds Ratio (OR (95% Confidence Interval (CI = 3.8 (2.1;7.1 and future neck pain (OR (95%CI = 3.3 (1.8;6.3, controlling for other known risk factors. Participants with acute whiplash trauma had weaker attachment to labour market (more weeks of sick leave (χ2(2 = 36.7, p < 0.001 and unemployment (χ2(2 = 12.5, p = 0.002 pre-collision compared with controls. Experiencing a whiplash trauma raised the odds for future negative change in provisional situation (OR (95%CI = 3.1 (2.3;4.4 compared with controls.Sick leave before the collision strongly predicted prolonged recovery

  2. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder : A randomized clinical trial

    NARCIS (Netherlands)

    Feder, Adriana; Parides, Michael K.; Murrough, James W.; Perez, Andrew M.; Morgan, Julia E.; Saxena, Shireen; Kirkwood, Katherine; Aan Het Rot, Marije; Lapidus, Kyle A.B.; Wan, Le-Ben; Iosifescu, Dan; Charney, Dennis S.

    2014-01-01

    IMPORTANCE Few pharmacotherapies have demonstrated sufficient efficacy in the treatment of posttraumatic stress disorder (PTSD), a chronic and disabling condition. OBJECTIVE To test the efficacy and safety of a single intravenous subanesthetic dose of ketamine for the treatment of PTSD and associate

  3. Melatonin for Chronic Insomnia in Angelman Syndrome: A Randomized Placebo-Controlled Trial

    NARCIS (Netherlands)

    Braam, W.J.; Didden, H.C.M.; Smits, M.G.; Curfs, L.M.G

    2008-01-01

    Previous studies suggested that melatonin improves sleep in insomniac patients with Angelman syndrome. To assess the efficacy of melatonin, a randomized placebo-controlled study was conducted in 8 children with Angelman syndrome with idiopathic chronic insomnia. After a 1-week baseline period, patie

  4. Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomised trial

    NARCIS (Netherlands)

    S.W. Schalm (Solko); J. Heathcote; J. Cianciara; G. Farrell; M.E. Sherman (Mark); B. Willems; A. Dhillon; A. Moorat; J. Barber; D.F. Gray

    2000-01-01

    textabstractBACKGROUND, AIM, AND METHODS: Alpha interferon is the generally approved therapy for HBe antigen positive patients with chronic hepatitis B, but its efficacy is limited. Lamivudine is a new oral nucleoside analogue which potently inhibits hepatitis B virus (HBV) DNA rep

  5. A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease

    NARCIS (Netherlands)

    Pfeffer, Marc A.; Burdmann, Emmanuel A.; Chen, Chao-Yin; Cooper, Mark E.; de Zeeuw, Dick; Eckardt, Kai-Uwe; Feyzi, Jan M.; Ivanovich, Peter; Kewalramani, Reshma; Levey, Andrew S.; Lewis, Eldrin F.; McGill, Janet B.; McMurray, John J. V.; Parfrey, Patrick; Parving, Hans-Henrik; Remuzzi, Giuseppe; Singh, Ajay K.; Solomon, Scott D.; Toto, Robert

    2009-01-01

    BACKGROUND Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately te

  6. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease

    DEFF Research Database (Denmark)

    Pfeffer, Marc A; Burdmann, Emmanuel A; Chen, Chao-Yin

    2009-01-01

    BACKGROUND: Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequatel...

  7. Cytokine inhibition in chronic fatigue syndrome patients: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Roerink, M.E.; Knoop, H.; Bredie, S.J.H.; Heijnen, M.; Joosten, L.A.B.; Netea, M.G.; Dinarello, C.A.; Meer, J.W.M. van der

    2015-01-01

    BACKGROUND: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine network has been suspected to play a role in the pathophysiology of CFS. The disturbances of the cytokine network de

  8. The effect of acclydine in chronic fatigue syndrome: a randomized controlled trial.

    NARCIS (Netherlands)

    The, G.K.H.; Bleijenberg, G.; Meer, J.W.M. van der

    2007-01-01

    OBJECTIVES: It is unclear whether insulin-like growth factor (IGF) function is involved in the pathophysiology of chronic fatigue syndrome (CFS). Unpublished data and reports in patient organization newsletters suggest that Acclydine, a food supplement, could be effective in the treatment of CFS by

  9. Barriers for recruitment of patients with chronic obstructive pulmonary disease to a controlled telemedicine trial

    DEFF Research Database (Denmark)

    Broendum, Eva; Ulrik, Charlotte Suppli; Gregersen, Thorbjorn;

    2016-01-01

    not want to participate in clinical research. Compared to consenting patients, subjects declining participation were significantly older, more often female, had higher lung function (%predicted), lower body mass index, higher admission-rate for chronic obstructive pulmonary disease in the previous year...

  10. Renal effects of chronic exposure to organic solvents. A clinical controlled trial

    DEFF Research Database (Denmark)

    Krusell, Lars Romer; Nielsen, H K; Bælum, Jesper;

    1985-01-01

    Chronic effects of organic solvents on renal function were measured by creatinine clearances and urinary excretion rates of beta 2-microglobulin and albumin. Forty-three male printing trade workers occupationally exposed to different organic solvents for 9-25 years were compared with 43 age-match...

  11. Treatment of myofascial trigger points in patients with chronic shoulder pain : a randomized, controlled trial

    NARCIS (Netherlands)

    Bron, Carel; de Gast, Arthur; Dommerholt, Jan; Stegenga, Boudewijn; Wensing, Michel; Oostendorp, Rob A. B.

    2011-01-01

    Background: Shoulder pain is a common musculoskeletal problem that is often chronic or recurrent. Myofascial trigger points (MTrPs) cause shoulder pain and are prevalent in patients with shoulder pain. However, few studies have focused on MTrP therapy. The aim of this study was to assess the effecti

  12. Effects of pregabalin on central sensitization in patients with chronic pancreatitis in a randomized, controlled trial

    NARCIS (Netherlands)

    S.A.W. Bouwense (Stefan); S.S. Olesen (Søren); A.M. Drewes (Asbjørn); J.-W. Poley (Jan-Werner); H. van Goor (Harry); O.H.G. Wilder-Smith (Oliver)

    2012-01-01

    textabstractBackground: Intense abdominal pain is the dominant feature of chronic pancreatitis. During the disease changes in central pain processing, e.g. central sensitization manifest as spreading hyperalgesia, can result from ongoing nociceptive input. The aim of the present study is to evaluate

  13. Effects of pregabalin on central sensitization in patients with chronic pancreatitis in a randomized, controlled trial.

    NARCIS (Netherlands)

    Bouwense, S.A.W.; Olesen, S.S.; Drewes, A.M.; Poley, J.W.; Goor, H. van; Wilder-Smith, O.H.G.

    2012-01-01

    BACKGROUND: Intense abdominal pain is the dominant feature of chronic pancreatitis. During the disease changes in central pain processing, e.g. central sensitization manifest as spreading hyperalgesia, can result from ongoing nociceptive input. The aim of the present study is to evaluate the effect

  14. Empowering employees with chronic diseases; development of an intervention aimed at job retention and design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Heutink Annelies

    2008-11-01

    , 12 and 24 months. Primary outcome measures are job retention, self efficacy, fatigue and work pleasure. Secondary outcome measures are work-related problems, sick leave, quality of life, acquired work accommodations, burnout, and several quality of work measures. A process evaluation will be conducted and satisfaction with the training, its components and the training methods will be assessed. Discussion Many employees with a chronic condition experience problems in performing tasks and in managing social relations at work. We developed an innovative intervention that addresses practical as well as psychosocial problems. The results of the study will be relevant for employees, employers, occupational health professionals and human resource professionals (HRM. Trial registration ISRCTN77240155

  15. Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial

    Directory of Open Access Journals (Sweden)

    Sherman Karen J

    2012-09-01

    Full Text Available Abstract Background Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low “doses” of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1 the optimal combination of number of treatments per week and length of individual treatment session, and 2 the optimal number of weeks of treatment. Methods/design In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week. At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. Discussion A broad dosing schedule

  16. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  17. Simulated Pain and Cervical Motion in Patients with Chronic Disorders of the Cervical Spine

    Directory of Open Access Journals (Sweden)

    Zeevi Dvir

    2004-01-01

    Full Text Available The primary objective of the present study was to determine how simulated severe cervical pain affects cervical motion in patients suffering from two distinct chronic cervical disorders: whiplash (n=25 and degenerative changes (n=25. The second objective was to derive an index that would allow the differentiation of maximal from submaximal performances of cervical range of motion. Patients first performed maximal movement of the head (maximal effort in each of the six primary directions and then repeated the test as if they were suffering from a much more intense level of pain (submaximal effort. All measurements were repeated within four to seven days. In both groups, there was significant compression of cervical motion during the submaximal effort. This compression was also highly stable on a test-retest basis. In both groups, a significantly higher average coefficient of variation was associated with the imagined pain and it was significantly different between the two clinical groups. In the whiplash group, a logistic regression model allowed the derivation of coefficient of variation-based cutoff scores that might, at selected levels of probability and an individual level, identify chronic whiplash patients who intentionally magnify their motion restriction using pain as a cue. However, the relatively small and very stable compression of cervical motion under pain simulation supports the view that the likelihood that chronic whiplash patients are magnifying their restriction of cervical range of motion using pain as a cue is very low.

  18. [Trial of the combined use of trental and solcoseryl in treating patients with chronic pancreatitis].

    Science.gov (United States)

    Vakhrushev, Ia M; Trusov, V V; Solov'eva, N E

    1988-01-01

    The effect of combined use of pentoxifylline and solcoseryl was studied in 35 patients with chronic pancreatitis. General clinical findings were studied in parallel with the time course of pancreatic exocrine (trypsin) and endocrine (insulin, C-peptide) function. The blood level of gastrin and changes in intestinal function using 131I-lipids were also studied. The incorporation of both drugs in multimodality therapy made a positive therapeutic effect, resulting in a decrease in the pain syndrome and dyspeptic symptoms. At the same time some favorable shifts in pancreatic and GI tract function were noted. Possible mechanisms of a positive therapeutic effect were discussed. A conclusion was made that the incorporation of pentoxifylline and solcoseryl in multimodality therapy of chronic pancreatitis was clinically justified and determined pathogenetically.

  19. Kinesio Taping® is not better than placebo in reducing pain and disability in patients with chronic non-specific low back pain: a randomized controlled trial

    OpenAIRE

    Luz Júnior,Maurício A.; Manoel V. Sousa; Neves, Luciana A. F. S.; Aline A. C. Cezar; Costa, Leonardo O. P.

    2015-01-01

    Background: Kinesio Taping® has been widely used in clinical practice. However, it is unknown whether this type of tape is more effective than placebo taping in patients with chronic lower back pain. Objective: To compare the effectiveness of Kinesio Taping® in patients with chronic non-specific low back pain against a placebo tape and a control group. Method: This is a 3-arm, randomized controlled trial with a blinded assessor. Sixty patients with chronic non-specific low back pain were r...

  20. Problem-solving skills training for parents of children with chronic pain: a pilot randomized controlled trial.

    Science.gov (United States)

    Palermo, Tonya M; Law, Emily F; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C

    2016-06-01

    This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem-solving skills training (PSST) compared with treatment as usual on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional, and physical functioning) were also examined. Participants included 61 parents of children aged 10 to 17 years with chronic pain randomized to PSST (n = 31) or treatment as usual (n = 30) groups. Parents receiving PSST participated in 4 to 6 individual sessions of training in problem-solving skills. Outcomes were assessed at pretreatment, immediately after treatment, and at a 3-month follow-up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with posttreatment improvements in parental depression (d = -0.68), general mental health (d = 0.64), and pain catastrophizing (d = -0.48), as well as in child depression (d = -0.49), child general anxiety (d = -0.56), and child pain-specific anxiety (d = -0.82). Several effects were maintained at the 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youths with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results.

  1. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  2. Virtual Reality Reflection Therapy Improves Balance and Gait in Patients with Chronic Stroke: Randomized Controlled Trials.

    Science.gov (United States)

    In, Taesung; Lee, Kyeongjin; Song, Changho

    2016-10-28

    BACKGROUND Virtual reality reflection therapy (VRRT) is a technically enhanced version of the mirror therapy concept. The aim of this study was to investigate whether VRRT could improve the postural balance and gait ability of patients with chronic stroke. MATERIAL AND METHODS Twenty-five patients with chronic stroke were randomly allocated into the VRRT group (n=13) and the control group (n=12). The participants in both groups performed a conventional rehabilitation program for 30 minutes. The VRRT group also performed a VRRT program for 30 minutes, five times a week for 4 weeks. The control group performed conventional rehabilitation program and a placebo VRRT program. Outcome measures included Berg Balance Scale (BBS), the Functional Reaching Test (FRT), and the Timed Up and Go (TUG) test (for dynamic balance ability), postural sway (for static balance ability), and 10 meter walking velocity (10 mWV) for gait ability. RESULTS There were statistically significant improvements in the VRRT group compared with the control group for BBS, FRT, TUG, postural sway (mediolateral sway distance with eyes open and eyes closed, anteroposterior and total sway distance with eyes open but not with eyes closed), and 10 mWV (ptreatment) along with a conventional rehabilitation program for patients with chronic stroke might be even more beneficial than conventional rehabilitation program alone in improving affected lower limb function. Future studies should investigate the effectiveness of VRRT with optimal patient selection, and duration and intensity of training.

  3. Vitamin E treatment for children with chronic hepatitis B: A randomized placebo controlled trial

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    AIM: To evaluate the safety and efficacy of vitamin E in children with chronic hepatitis B. METHODS: We randomly assigned patients with chronic hepatitis B, positive for hepatitis B e antigen (HBeAg), to receive either vitamin E or placebo once daily for 6 mo in a 3:1 ratio and double-blind manner. The primary end point was HBeAg seroconversion, defined as the loss of HBeAg, undetectable levels of serum hepatitis B virus DNA, and the appearance of antibodies against HBeAg 12 rno after therapy. RESULTS: At baseline visit, 49 patients had normal and 43 had increased serum aminotransferase levels. Twenty-nine patients did not respond to previous treatment with interferon-α or lamivudine. Seventy-six children completed the study; 16 were non-compliant (n = 7), lost to follow-up (n = 7), or started another antiviral treatment (n = 3). Intention-to-treat analysis showed HBeAg seroconversion in 16 children (23.2%) treated with vitamin E and two (8.7%) in the placebo group (P = 0.13). Vitamin E was well tolerated. CONCLUSION: There is only a tendency that vitamin E may promote HBeAg seroconversion. Erefore larger studies are needed to clarify the role of antioxidants in the therapy of chronic hepatitis B.

  4. Treatment of Whiplash-Associated Disorders - Part I: Non-Invasive Interventions

    Directory of Open Access Journals (Sweden)

    Anne Conlin

    2005-01-01

    Full Text Available BACKGROUND: A whiplash-associated disorder (WAD is an injury due to an acceleration-deceleration mechanism at the neck. WAD represents a very common and costly condition, both economically and socially. In 1995, the Quebec Task Force published a report that contained evidence-based recommendations regarding the treatment of WAD based on studies completed before 1993 and consensus-based recommendations.

  5. Is one better than another?: A randomized clinical trial of manual therapy for patients with chronic neck pain.

    Science.gov (United States)

    Izquierdo Pérez, Honorio; Alonso Perez, Jose Luis; Gil Martinez, Alfonso; La Touche, Roy; Lerma-Lara, Sergio; Commeaux Gonzalez, Noelia; Arribas Perez, Hector; Bishop, Mark D; Fernández-Carnero, Josue

    2014-06-01

    Our purpose was to compare the effectiveness of three manual therapy techniques: high velocity, low amplitude (HVLA), mobilization (Mob) and sustained natural apophyseal glide (SNAG) in patients with chronic neck pain (CNP). The randomized controlled trial included patients with mechanically reproducible CNP, who were randomized to the treatment group. Outcome measures were the Visual Analogue scale (VAS), Neck Disability Index (NDI), Global Rating of Change (GROC) and Cervical Range of Motion (CROM). Two-way repeated measures analysis of variance compared outcomes at baseline, at the end of treatment and 1, 2 and 3 months after treatment. A total of 51 subjects completed the trial. No significant differences were found between HVLA, Mob and SNAG at the end of treatment and during the follow-up in any of the analysed outcomes. There were no differences in satisfaction for all techniques. The results lead to the conclusion that there is no long-term difference between the application of HVLA, Mob and SNAG in pain, disability and cervical range of motion for patients with CNP.

  6. Effectiveness of inulin intake on indicators of chronic constipation; a meta-analysis of controlled randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Luis Collado Yurrita

    2014-08-01

    Full Text Available Background: Constipation is an intestinal dysfunction. Prebiotics, such as inulin, can improve bowel function by positively influencing intestinal biota. Aim: To analyze the scientific evidence for the role of inulin in improving bowel function in patients with chronic constipation. Methods: A meta-analysis of randomized controlled clinical trials was conducted, grounded on a literature search for the period 1995-2013 (descriptors: inulin & constipation on PubMed, ScieLo and Central Trials Register Cochrane databases. A total of 24 articles were found, 5 of them were selected for this meta-analysis, involving 252 subjects (experimental group: n = 144, control group: n = 108. The quality of the studies was assessed using the Jadad scale. Results: We found a significant overall effect of inulin on stool frequency (DEM = 0.69, 95%CI: 0.04, 1.34, stool consistency (Bristol scale (DEM = 1.07, 95% CI: 0.70, 1.45, transit time (DEM = -0.57, 95% CI: -0.99, -0.15 and hardness of stool (RR = 0.42, 95% CI: 0.26, 0.70. Pain and bloating do not improve with inulin intake. Conclusions: inulin intake has a positive effect on bowel function.

  7. Randomized controlled trial of consensus interferon with or without zinc for chronic hepatitis C patients with genotype 2

    Institute of Scientific and Technical Information of China (English)

    Hideyuki Suzuki; Masatomo Mori; Ken Sato; Hitoshi Takagi; Daisuke Kanda; Naondo Sohara; Satoru Kakizaki; Hiroaki Nakajima; Toshiyuki Otsuka; Takeaki Nagamine

    2006-01-01

    AIM: The beneficial effect of zinc supplementation on the efficacy of interferon as a treatment for chronic hepatitis C had been demonstrated in hepatitis virus genotype 1b of high viral load. This study focused on patients with genotype 2, which is more sensitive to interferon than genotype 1b, and used consensus interferon (CIFN) with or without zinc.METHODS: We randomized 83 patients with chronic hepatitis C to CIFN at 18 MIU six times/wk for 4 wk,followed by CIFN at 18 MIU six times/wk for another 20wk, in combination with polaprezinc 300 mg (regimen A,n=41) or as monotherapy (regimen B, n=42). Thirtyone patients in regimen A and 33 patients in regimen B completed the clinical trial; the remaining patients withdrew because of side effects or a transfer to another hospital.RESULTS: Sustained biochemical response, defined as a normal aminotransferase level at the end of the 6-mo post-treatment observation, was 68% and 69%, and sustained virological response, defined as undetectable HCV-RNA at the end of the 6-mo post-treatment observation, was 54% and 67% for regimens A and B,respectively.CONCLUSION: CIFN treatment combined with zinc did not enhance the effect of CIFN as shown by biochemical,virological criteria. No side effects related to polaprezinc were noted.

  8. A trial of Scrambler therapy in the treatment of cancer pain syndromes and chronic chemotherapy-induced peripheral neuropathy.

    Science.gov (United States)

    Coyne, Patrick J; Wan, Wen; Dodson, Patricia; Swainey, Craig; Smith, Thomas J

    2013-12-01

    Neuropathic pain is common among cancer patients and often difficult to treat. This study used Scrambler therapy, a patient-specific electrocutaneous nerve stimulation device, to treat cancer patients with pain. Patients received Scrambler therapy for 10 sessions (one daily) over a two-week period. The primary outcome was changed in pain numerical rating scale (NRS) at one month; secondary outcomes were changes in the Brief Pain Inventory and European Organization for Treatment and Cancer QLC-CIPN-20(EORTC CIPN-20), over time. Thirty-nine patients, mean age 56.5 yr, 16 men and 23 women, were treated over an 18-month period for an average of 9.3 days each. The "now" pain scores reduced from 6.6 before treatment to 4.5 at 14 days, 4.6, 4.8, and 4.6 at 1, 2, and 3 months, respectively (p pain; BPI interference with life scores, and motor and sensory scales on the EORTC CIPN-20. No adverse effects were observed. In this single arm trial, Scrambler therapy appeared to relieve cancer-associated chronic neuropathic pain both acutely and chronically, and provided sustained improvements in many indicators of quality of life.

  9. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Lewis Stephanie

    2011-09-01

    Full Text Available Abstract Background High frequency chest wall oscillation (HFCWO is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD. Methods Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change, spontaneously expectorated sputum volume, and forced expired volume in 1 second. Results Fifty-two participants were randomized to active (n = 25 or sham (n = 27 treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70. Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04. There were no significant differences in other secondary outcomes. Conclusions HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population. Trial Registration ClinicalTrials.gov: NCT00181285

  10. Outcome of transcutaneous electrical nerve stimulation in chronic pain: short-term results of a double-blind, randomised, placebo-controlled trial.

    NARCIS (Netherlands)

    Oosterhof, J.; Boo, T.M. de; Oostendorp, R.A.B.; Wilder-Smith, O.H.G.; Crul, B.J.P.

    2006-01-01

    The aim of this study was to test the efficacy of shortterm transcutaneous electrical nerve stimulation (TENS) treatment in chronic pain with respect to pain intensity and patients' satisfaction with treatment results. We therefore performed a randomised controlled trial comparing TENS and sham TENS

  11. One-year follow-up of a randomised controlled trial on added splinting to eccentric exercises in chronic midportion Achilles tendinopathy

    NARCIS (Netherlands)

    S. de Jonge (Suzan); R.J. de Vos (Robert-Jan); J.T.M. van Schie (Hans); J.A.N. Verhaar (Jan); A. Weir (Adam); J.L. Tol (Johannes)

    2010-01-01

    textabstractOBJECTIVE: The study examined whether the addition of a night splint to eccentric exercises is beneficial for functional outcome in chronic mid-portion Achilles tendinopathy. DESIGN: One-year follow-up of a randomised controlled single blinded clinical trial. SETTING: Sports medicine dep

  12. [An open randomized comparative trial of efficacy and safety of selective alpha-adrenoblocker setegis (terazosin) in therapy of patients with chronic bacterial prostatitis].

    Science.gov (United States)

    Trapeznikova, M F; Morozov, A P; Dutov, V V; Urenkov, S B; Pozdniakov, K V; Bychkova, N V

    2007-01-01

    An open randomized comparative trial of setegis (terazosine) has shown good subjective and objective results in patients with chronic bacterial prostatitis. The drug is well tolerated and produces insignificant side effects. It is also demonstrated that combined therapy with alpha-adrenoblockers is more effective that monotherapy with antibacterial drugs in patients with bacterial prostatitis.

  13. MRI of cerebrum and cervical columna within two days after whiplash neck sprain injury.

    Science.gov (United States)

    Borchgrevink, G; Smevik, O; Haave, I; Haraldseth, O; Nordby, A; Lereim, I

    1997-01-01

    The present study was undertaken to evaluate if MRI within 2 days of a motor vehicle accident could reveal pathology of importance for understanding long-term disability after whiplash neck-sprain injuries. As part of a prospective study cervical and cerebral MRI was performed on 40 neck sprain patients with whiplash injury after car accidents. The imaging was done within 2 days of the injury to make sure that any neck muscle bleeding, oedema or other soft tissue injuries could be detected. The MRI findings from the patients were both correlated to reported symptoms 6 months after the accident and compared to a control group of 20 volunteers. The MRI of both brain and neck revealed no significant differences between the patients and the control group. When the patients were grouped according to the main MRI findings at intake and compared according to the development of subjective symptoms reported by the patients, the only significant difference was more headaches at 6 months in the groups with disk pathology or spondylosis when compared to the group with no pathology. In conclusion, MRI within 2 days of the whiplash neck-sprain injury could not detect pathology connected to the injury nor predict symptom development and outcome.

  14. Therapy recommendation "act as usual" in patients with whiplash injuries QTF I°.

    Science.gov (United States)

    Dehner, Christoph; Kraus, Michael; Schöll, Hendrik; Schneider, Florian; Richter, Peter; Kramer, Michael

    2012-08-20

    Up to now no therapy study has used the classification system of the Quebec Task Force (QTF) to differentiate between patients with (QTF II°) and without functional disorders (QTF I°). This differentiation seems meaningful, as this difference may be relevant for the correct treatment planning. In this context the effect of the therapy recommendation "act as usual" has been evaluated in a homogeneous patient collective with whiplash injuries QTF I°. 470 patients with acute whiplash injuries had been catched in this study and classified according to the QTF. 359 patients (76.4%) with QTF I° injuries could be identified. Out of that 162 patients were enrolled to the study and received the therapy recommendation "act as usual" and the adapted pain treatment with non-steroidal anti-inflammatory drugs (NSAID). After six months the outcome was evaluated by phone. After injury the median pain score assessed by a visual analogue scale (VAS) was 5.4 (min = 3.3; max = 8.5). After six months 5 of the 162 patients complained intermittent pain symptoms (VAS values After injury, the median pain disability index (PDI) was 3.9 (min = 1.9; max = 7.7). After six months 3 of the 162 patients stated persisting disability during sporting and physical activities (VAS values whiplash injuries QTF I° do not need physical therapy. An escalation of therapy measures should be reserved to patients with complicated healing processes.

  15. Analysis of Whiplash Effect of Structures%结构的鞭梢效应分析

    Institute of Scientific and Technical Information of China (English)

    曲淑英; 王心健; 曲乃泗; 王建新

    2001-01-01

    It is explained why the whiplash effect occurs to building having prominent part on its top by analysis of building of multiple degrees of freedom on earthquake effect. It is shown that whiplash effect can occur when the fundamental frequency of prominent part equals to the natural frequency of the monolithic structure containing main part and prominent part, or this frequency nearly equals to the earthquake frequency. This is proved to be right by example. Decreasing the influence of whiplash effect, people shouldn't only increase the stiffness of prominent parts while adjusting structure's stiffness and mass distribution by dynamic computation in order to make frequency difference of prominent part and the monolithic structure bigger. Thus, more reliable data could be supplied for design of structures.%系统地探讨了结构产生鞭梢效应的原因,发现当突出物的基本频率与整体结构的固有频率相同或近似,并与地面扰频相接近时,最易发生鞭梢效应,通过适当调整结构的刚度或质量分布使突出物的频率与整体结构的频率的差值增大,可减少鞭梢效应的影响,从而为结构设计提供更可靠的依据.

  16. Oxymatrine therapy for chronic hepatitis B: A randomized double-blind and placebo- controlled multi- center trial

    Institute of Scientific and Technical Information of China (English)

    Lun-Gen Lu; Wei-Min She; Xiong Cai; Jun Ye; Xia-Qiu Zhou; Hui Wang; Sham-Ming Wu; Mei-Fang Tang; Jin-Shui Zhu; Wei-Xiong Chen; Hui-Quan Zhang; Min-De Zeng; Yi-Min Mao; Ji-Qiang Li; Mo-Bin Wan; Cheng-Zhong Li; Cheng-Wei Chen; Qing-Chun Fu; Ji-Yao Wang

    2003-01-01

    AIM: To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B.METHODS: A randomised double-blind and placebocontrolled multicenter trial was conducted. Injection of oxymatrine was used as positive-control drug. A total of 216 patients with chronic hepatitis B entered the study for 24 weeks, of them 108 received capsule oxymatrine, 36 received injection of oxymatrine, and 72 received placebo.After and before the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reaction were observed.RESULTS: Among the 216 patients, six were dropped off,and 11 inconsistent with the standard were excluded.Therefore, the efficacy and safety of oxymatrine in patients were analysed. In the capsule treated patients, 76.47 % became normal in ALT level, 38.61% and 31.91% became negative both in HBV DNA and in HBeAg. In the injection treated patients, 83.33 % became normal in ALT level,43.33 % and 39.29 % became negative both in HBV DNA and in HBeAg. In the placebo treated patients, 40.00 % became normal in ALT level, 7.46 % and 6.45 % became negative both in HBV DNA and in HBeAg. The rates of complete response and partial response were 24.51% and 57.84 % in the capsule treated patients, and 33.33 % and 50.00 % in the injection treated patients, and 2.99 % and 41.79 % in the placebo treated patients, respectively.There was no significance between the two groups of patients, but both were significantly higher than the placebo. The adverse drug reaction rates of the capsule,injection and placebo were 7.77 %, 6.67 % and 8.82 %,respectively. There was no statistically significant difference among them.CONCLUSION: Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.

  17. Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES trial

    Directory of Open Access Journals (Sweden)

    Hawkes Rene J

    2010-03-01

    Full Text Available Abstract Background Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM therapies. Yoga is an increasingly popular "mind-body" CAM therapy often used for relieving back pain and several small studies have found yoga effective for this condition. This study will assess whether yoga is effective for treating chronic low back pain compared with self care and exercise and will explore the mechanisms responsible for any observed benefits. Methods/Design A total of 210 participants with low back pain lasting at least 3 months will be recruited from primary care clinics of a large healthcare system based in Seattle. They will be randomized in a 2:2:1 ratio to receive 12 weekly yoga classes, 12 weekly conventional therapeutic exercise classes of comparable physical exertion, or a self-care book. Interviewers masked to participants' treatment group will assess outcomes at baseline and 6, 12 and 26 weeks after randomization. Primary outcomes will be back-related dysfunction and symptom bothersomeness. In addition, data will be collected on physical measurements (e.g., flexion at baseline and 12 weeks and saliva samples will be obtained at baseline, 6 and 12 weeks. Information will be collected on specific physical, psychological, and physiological factors to allow exploration of possible mechanisms of action through which yoga could relieve back pain and dysfunction. The effectiveness of yoga will be assessed using analysis of covariance (using general estimating equations - GEE within an intention-to-treat context. If yoga is found effective, further analyses will explore whether yoga's benefits are attributable to physical, psychological and/or physiological factors. Conclusions This study will provide the clearest evidence to date about the value of yoga as a therapeutic option for treating chronic back pain, and if the results are positive, will help

  18. Limitations of clinical trials in chronic diseases: is the efficacy of methotrexate (MTX) underestimated in polyarticular psoriatic arthritis on the basis of limitations of clinical trials more than on limitations of MTX, as was seen in rheumatoid arthritis?

    Science.gov (United States)

    Pincus, Theodore; Bergman, Martin J; Yazici, Yusuf

    2015-01-01

    Clinical trials are the optimal method to establish efficacy of a drug versus placebo or another drug. Nonetheless, important limitations are seen, particularly in chronic diseases over long periods, although most are ignored. Pragmatic limitations of clinical trials include a relatively short observation period, suboptimal dosage schedules, suboptimal surrogate markers for long-term outcomes, statistically significant results which may not be clinically unimportant and vice versa. Even ideal clinical trials have intrinsic limitations, including the influence of design on results, data reported in groups which ignore individual variation, non-standard observer-dependent interpretation of a balance of efficacy and toxicity, and distortion of a "placebo effect." Limitations are seen in many clinical trials of methotrexate (MTX) in rheumatoid arthritis (RA) and psoriatic arthritis (PsA). The first MTX clinical trial in rheumatology documented excellent efficacy in PsA, but frequent adverse events in 1964, explained by intravenous doses up to 150 kg. MTX was abandoned until the 1980s for RA, while gold salts and penicillamine were termed "remission-inducing," on the basis limitations of clinical trials. In the most recent MTX in PsA (MIPA) trial, all outcomes favoured MTX, but only patient and physician global estimates met the pclinical trials than from limitations of MTX.

  19. [A control trial of home I.P.P.B. therapy in patients with chronic obstructive respiratory insufficiency. Protocol and state of the study (author's transl)].

    Science.gov (United States)

    Kompalitch, M; Brille, D; Diaz, M; Kauffmann, F; Hatzfeld, C; Decroix, G

    1979-01-01

    Because a previous retrospective study did not allow any conclusion as to the efficacy of home IPPB therapy in patients with chronic airflow obstruction, a control trial has been started. The protocol includes definition of patients, modalities of treatment, criteria for evaluation. Among criteria for a patient to enter the trial is a chronic hypercapnia (with PaCO2 greater than or equal to 48 mmHg) observed over a preliminary period of 4 months. At the end of this period patients are allocated at random into two groups with and without IPPB at home (at least 1 to 2 hours daily through a mouthpiece); medical prescriptions are same in the 2 groups so as surveillance which is planned for 2 years. Evaluation should be based upon 5 predetermined criteria. This trial is in progress.

  20. Herbal medicine Ninjinyoeito ameliorates ribavirin-induced anemia in chronic hepatitis C: A randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    Yoshiharu Motoo; Hisatsugu Mouri; Koushiro Ohtsubo; Yasushi Yamaguchi; Hiroyuki Watanabe; Norio Sawabu

    2005-01-01

    AIM: Ribavirin (RBV) shows a strong antiviral effect on hepatitis C virus when used in combination with interferon.However, RBV-induced anemia is a major problem in this therapy. It would be of great clinical importance to ameliorate the anemia without reducing the RBV dose.We report here that, Ninjinyoeito (NYT), a herbal medicine can reduce the RBV-induced anemia.METHODS: Twenty-three patients with chronic hepatitis C were treated with interferon alpha 2b plus RBV with (NYT group) or without (control group) NYT by a randomized selection. Eighteen patients completed the treatment schedule, and hemato-biochemical and virological effects were evaluated.RESULTS: There was no significant difference in biochemical and virological responses between the two groups. However, anemia was significantly reduced in the NYT group compared with the control group. The maximal decrease of Hb in the NYT group (2.59±1.10 g/dL)was significantly (P= 0.026) smaller than that in the control group (3.71±0.97 g/dL). There was no significant difference in serum glutathione peroxidase activity, serum RBV concentration, and Th1/Th2 balance between the two groups. There was no specific adverse effect in NYT administration.CONCLUSION: These results suggest that NYT could be used as a supportive remedy to reduce the RBV-induced anemia in the treatment of chronic hepatitis C.

  1. Effect of enalapril on the progression of chronic renal failure. A randomized controlled trial

    DEFF Research Database (Denmark)

    Kamper, A L; Strandgaard, S; Leyssac, P P

    1992-01-01

    In order to study the influence of angiotensin converting enzyme (ACE) inhibition on the progression of chronic nephropathy, 70 patients with a median glomerular filtration rate (GFR) of 15 (range, 6 to 54) mL/min/1.73 m2 were randomized in an open study to basic treatment with enalapril or conve......In order to study the influence of angiotensin converting enzyme (ACE) inhibition on the progression of chronic nephropathy, 70 patients with a median glomerular filtration rate (GFR) of 15 (range, 6 to 54) mL/min/1.73 m2 were randomized in an open study to basic treatment with enalapril....... The therapeutic goal was a BP of 120 to 140/80 to 90 mm Hg. The GFR, estimated by the plasma clearance of 51Cr-EDTA, was measured every third month, and the individual rate of progression was calculated as the slope of the GFR v time plot. In the enalapril group, the median decline in GFR was -0.20 (range, +0...

  2. Randomized trial of trigger point acupuncture treatment for chronic shoulder pain: a preliminary study.

    Science.gov (United States)

    Itoh, Kazunori; Saito, Shingo; Sahara, Shunsaku; Naitoh, Yuki; Imai, Kenji; Kitakoji, Hiroshi

    2014-04-01

    There is evidence for the efficacy of acupuncture treatment for chronic shoulder pain, but it remains unclear which acupuncture modes are most effective. We compared the effect of trigger point acupuncture (TrP), with that of sham (SH) acupuncture treatments, on pain and shoulder function in patients with chronic shoulder pain. The participants were 18 patients (15 women, 3 men; aged 42-65 years) with nonradiating shoulder pain for at least 6 months and normal neurological findings. The participants were randomized into two groups, each receiving five treatment sessions. The TrP group received treatment at trigger points for the muscle, while the other group received SH acupuncture treatment on the same muscle. Outcome measures were pain intensity (visual analogue scale, VAS) and shoulder function (Constant-Murley Score: CMS). After treatment, pain intensity between pretreatment and 5 weeks after TrP decreased significantly (pShoulder function also increased significantly between pretreatment and 5 weeks after TrP (pshoulder pain.

  3. The effectiveness of thoracic manipulation on patients with chronic mechanical neck pain - a randomized controlled trial.

    Science.gov (United States)

    Lau, Herman Mun Cheung; Wing Chiu, Thomas Tai; Lam, Tai-Hing

    2011-04-01

    The aim of our study was to assess the effectiveness of thoracic manipulation (TM) on patients with chronic neck pain. 120 patients aged between 18 and 55 were randomly allocated into two groups: an experimental group which received TM and a control group without the manipulative procedure. Both groups received infrared radiation therapy (IRR) and a standard set of educational material. TM and IRR were given twice weekly for 8 sessions. Outcome measures included craniovertebral angle (CV angle), neck pain (Numeric Pain Rating Scale; NPRS), neck disability (Northwick Park Neck Disability Questionnaire; NPQ), health-related quality of life status (SF36 Questionnaire) and neck mobility. These outcome measures were assessed immediately after 8 sessions of treatment, 3-months and at a 6-month follow-up. Patients that received TM showed significantly greater improvement in pain intensity (p = 0.043), CV angle (p = 0.049), NPQ (p = 0.018), neck flexion (p = 0.005), and the Physical Component Score (PCS) of the SF36 Questionnaire (p = 0.002) than the control group immediately post-intervention. All these improvements were maintained at the 6-month follow-ups. This study shows that TM was effective in reducing neck pain, improving dysfunction and neck posture and neck range of motion (ROM) for patients with chronic mechanical neck pain up to a half-year post-treatment.

  4. Impact of cyclosporine reduction with MMF: a randomized trial in chronic allograft dysfunction. The 'reference' study.

    Science.gov (United States)

    Frimat, L; Cassuto-Viguier, E; Charpentier, B; Noël, C; Provôt, F; Rostaing, L; Glotz, D; Sraer, J D; Bourbigot, B; Moulin, B; Lang, P; Ducloux, D; Pouteil-Noble, C; Girardot-Seguin, S; Kessler, M

    2006-11-01

    Long-term use of calcineurine inhibitors (CNIs) may contribute to the development of chronic allograft dysfunction (CAD). We investigate the impact of the introduction of MMF combined with cyclosporine (CsA) 50% dose reduction. An open, randomized, controlled, multicenter, prospective study was conducted in 103 patients, receiving a CsA-based therapy with a serum creatinine between 1.7-3.4 mg/dL, more than 1 year after transplantation. They were randomized to receive MMF with half dose of CsA (MMF group) or to continue their maintenance CsA dose (control group). A total of 96 weeks after randomization, the evolution of renal function assessed by regression line analysis of 1/SeCr improved in the MMF group (positive slope) vs. the control group (negative slope), 4.2 x 10(-4) vs. -3.0 x 10(-4), respectively (p MMF group. No episode of biopsy-proven acute rejection occurred. One patient in each group lost his graft because of biopsy-proven chronic allograft nephropathy. There was a significant decrease of triglycerides level in the MMF group. Anemia and diarrhea were statistically more frequent in the MMF group. In CAD, the reduction of CsA in the presence of MMF results in significant improvement in renal function during a 2-year follow-up.

  5. A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions: study rationale and protocol

    Directory of Open Access Journals (Sweden)

    Malcolm W. Battersby

    2010-03-01

    Full Text Available BackgroundSupporting self management is seen as an important healthservice strategy in dealing with the large and increasing healthburden of chronic conditions. Several types of selfmanagementprograms are available. Evidence to datesuggests that disease-specific and lay-led self managementprograms provide only part of the support needed forimproved outcomes. The Flinders Program is promising as ageneric self management intervention, which can becombined with targeted disease-specific and lay-ledinterventions, but it has yet to be evaluated for a range ofchronic conditions using a rigorous controlled trial design. Thispaper gives the rationale for a randomised controlled trial andprocess evaluation of the Flinders Program of chroniccondition self-management in community practice, and detailsand justifies the design of such a study.MethodThe design for a randomised trial and associated processevaluation, suited to evaluation of a complex and behaviouralintervention as it is applied in actual practice, is presented andjustified.ConclusionA randomised trial of the Flinders Program is required and afunctional design is presented. Results from this trial,currently underway, will test the effectiveness of the FlindersProgram in improving patient competencies in selfmanagementof chronic conditions in practice conditions.A process evaluation alongside the trial will exploresystem, provider and patient factors associated withgreater and lesser Program effectiveness.

  6. A randomized controlled trial of telemonitoring in older adults with multiple chronic conditions: the Tele-ERA study

    Directory of Open Access Journals (Sweden)

    Takahashi Paul Y

    2010-09-01

    Full Text Available Abstract Background Older adults with multiple chronic illnesses are at risk for worsening functional and medical status and hospitalization. Home telemonitoring may help slow this decline. This protocol of a randomized controlled trial was designed to help determine the impact of home telemonitoring on hospitalization. The specific aim of the study reads as follows: to determine the effectiveness of home telemonitoring compared with usual care in reducing the combined outcomes of hospitalization and emergency department visits in an at-risk population 60 years of age or older. Methods/Design Two-hundred patients with the highest 10% Mayo Clinic Elder Risk Assessment scores will be randomly assigned to one of two interventions. Home telemonitoring involves the use of a computer device, the Intel Health Guide, which records biometric and symptom data from patients in their homes. This information is monitored by midlevel providers associated with a primary care medical practice. Under the usual care scenario, patients make appointments with their providers as problems arise and use ongoing support such as a 24-hour nurse line. Patients will have initial evaluations of gait and quality of life using instruments such as the SF-12 Health Survey, the Kokmen Short Test of Mental Status, and the PHQ-9 health questionnaire. Patients will be followed for 1 year for primary outcomes of hospitalizations and emergency department visits. Secondary analysis will include quality of life, compliance with the device, and attitudes about telemonitoring. Sample size is based on an 80% power to detect a 36% difference between the two groups. The primary analysis will involve Cox proportional time-to-event analysis. Secondary analysis will use t-test comparisons for continuous variables and the chi square test for proportional analysis. Discussion Patients randomized to home telemonitoring will have daily assessments of their health status using the device

  7. Melatonin for chronic insomnia in Angelman syndrome: a randomized placebo-controlled trial.

    Science.gov (United States)

    Braam, Wiebe; Didden, Robert; Smits, Marcel G; Curfs, Leopold M G

    2008-06-01

    Previous studies suggested that melatonin improves sleep in insomniac patients with Angelman syndrome. To assess the efficacy of melatonin, a randomized placebo-controlled study was conducted in 8 children with Angelman syndrome with idiopathic chronic insomnia. After a 1-week baseline period, patients received, depending on age, either melatonin 5 or 2.5 mg, or placebo, followed by 4 weeks of open treatment. Parents recorded lights off time, sleep onset time, wake-up time, and epileptic seizures in a diary. Salivary melatonin levels were measured at baseline and the last evening of the fourth treatment week. Melatonin significantly advanced sleep onset by 28 minutes, decreased sleep latency by 32 minutes, increased total sleep time by 56 minutes, reduced the number of nights with wakes from 3.1 to 1.6 nights a week, and increased endogenous salivary melatonin levels. Parents were satisfied with these results. Indications that melatonin dose in Angelman syndrome patients should be low, are discussed.

  8. Photodynamic therapy in non-surgical treatment of chronic periodontitis: short term randomized clinical trial study

    Science.gov (United States)

    Russo, C.; Palaia, G.; Loskutova, E.; Libotte, F.; Kornblit, R.; Gaimari, G.; Tenore, G.; Romeo, U.

    2016-03-01

    Introduction: Periodontitis is a chronic inflammatory disease due to exposition to plaque and tartar. Conventional treatments consist of scaling and root planing (SRP) and antibiotics administration. Among them encouraging results have been obtained using alternative protocols, like the antimicrobial photodynamic therapy (PDT). Aim of the Study: Evaluation of PDT effects added to conventional methods. Materials and Methods: 11 patients (4M/7F, 37-67 years aged, non-smoking) affected by untreated chronic periodontal disease, with >3mm pockets in at least 4 teeth were divided in two groups, test and control group. Each patient had to made full-intraoral before and after the treatment. The test group received SRP+PDT, while the control group was subjected to SRP. The PDT was performed through the HELBO®TheraLite (Bredent Medical), diode laser battery powered 670nm with an output of 75mW/cm2. The Helbo Blue photosensitizer, containing methylene blue, was used. The exposure time to the laser effect was of 10'' for each site, for a total of 60'' at 3J/cm2. Results: Both groups had a significant improvement in the reduction of pocket depth (PD), above all in the test group. Statistical analysis was performed through the T-test, evaluating PD between the two groups p=0.96 (p> 0.05), resulting not statistically significant. Conclusion: PDT is a promising support to SRP, achieving a significant reduction in the pocket depth, but more cases are needed to confirm the validity of the used protocol.

  9. Vestibular and stabilometric findings in whiplash injury and minor head trauma.

    Science.gov (United States)

    Nacci, A; Ferrazzi, M; Berrettini, S; Panicucci, E; Matteucci, J; Bruschini, L; Ursino, F; Fattori, B

    2011-12-01

    Vertigo and postural instability following whiplash and/or minor head injuries is very frequent. According to some authors, post-whiplash vertigo cannot be caused by real injury to vestibular structures; other authors maintain that vestibular damage is possible even in the case of isolated whiplash, with vascular or post-traumatic involvement. Furthermore, many of the balance disorders reported after trauma can be justified by post-traumatic modification to the cervical proprioceptive input, with consequent damage to the vestibular spinal reflex. The aim of this study was to evaluate the vestibular condition and postural status in a group of patients (Group A, n = 90) affected with balance disorders following whiplash, and in a second group (Group B, n = 20) with balance disorders after minor head injury associated with whiplash. Both groups were submitted to videonystagmography (VNG) and stabilometric investigation (open eyes - O E, closed eyes - CE, closed eyes with head retroflexed - CER) within 15 days of their injuries and repeated within 10 days after conclusion of cervical physiotherapy treatment. The VNG tests revealed vestibulopathy in 19% of cases in Group A (11% peripheral, 5% central, 3% in an undefined site) and in 60% of subjects in Group B (50% peripheral, 10% central). At the follow-up examination, all cases of non-compensated labyrinth deficit showed signs of compensation, while there were two cases (2%) in Group A and one case (5%) in Group B of PPV. As far as the altered posturographic recordings are concerned, while there was no specific pattern in the two groups, they were clearly pathologic, especially during CER. Both in OE and in CE there was an increase in the surface values and in those pertaining to shifting of the gravity centre on the sagittal plane, which was even more evident during CER. In Group A, the pre-post-physiotherapy comparison of CER results showed that there was a statistically significant improvement in the majority of the

  10. Epidemiología y problemática médico forense del síndrome de latigazo cervical en España Epidemiology and forensic problems of the whiplash syndrome in Spain

    Directory of Open Access Journals (Sweden)

    P.M. Garamendi

    2003-04-01

    Full Text Available Presentamos una revisión bibliográfica actualizada y centrada en los aspectos epidemiológicos del síndrome de latigazo cervical. En la revisión, se destaca la variedad y diversidad de conclusiones en los estudios publicados en relación tanto con el esguince cervical en su fase aguda (menos de 6 meses de evolución clínica como en su fase crónica (persistencia sintomática más allá de 6 meses de evolución. Finalmente, se apuntan algunos de los problemas que el trastorno produce en la actividad médico forense en España.We present a review of the current literature on the whiplash syndrome focusing on its epidemiological profiles. The review points out the variety and diversity of conclusions in the studies published on the acute whiplash syndrome (less than 6 months of clinical evolution and the chronic syndrome (symptomatic persistence after 6 months. Finally, we enumerate some of the problems the syndrome generates in forensic practise in Spain.

  11. Mucolytic Effectiveness of Tyloxapol in Chronic Obstructive Pulmonary Disease - A Double-Blind, Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Martin Koppitz

    Full Text Available Mucoactive drugs should increase the ability to expectorate sputum and, ideally, have anti-inflammatory properties. The aim of the study was to evaluate the mucolytic activity of Tyloxapol compared to saline (0.9% in COPD.A randomized, placebo-controlled, double-blinded crossover, clinical trial was carried out. Patients were randomly assigned to either inhale 5 ml Tyloxapol 1% or saline 0.9% solution three times daily for 3 weeks and vice versa for another 3 weeks. 28 patients (18 male, 10 female, 47 to 73 years old, median age 63.50 were screened, 21 were treated and 19 patients completed the study per protocol.A comparison of the two treatment phases showed that the primary endpoint sputum weight was statistically significant higher when patients inhaled Tyloxapol (mean 4.03 g, 95% CI: 2.34-5.73 g at week 3 compared to saline (mean 2.63 g, 95% CI: 1.73-3.53 g at week 3. The p-value at three weeks of treatment was 0.041 between treatment arms. Sputum cells decreased during the Tyloxapol treatment after 3 weeks, indicating that Tyloxapol might have some anti-neutrophilic properties. Lung function parameters (FVC, FEV1, RV, and RV/TLC remained stable during the study, and no treatment effect was shown. Interestingly, there was a mean increase in all inflammatory cytokines (IL-1β, IL-6, and IL-8 during the saline treatment from day 1 to week 3, whereas during the Tyloxapol treatment, all cytokines decreased. Due to the small sample size and the large individual variation in sputum cytokines, these differences were not significant. However, analyses confirmed that Tyloxapol has significant anti-inflammatory properties in vitro. Despite the high number of inhalations (more than 1000, only 27 adverse events (20 during the Tyloxapol and seven during saline were recorded. Eleven patients experienced AEs under Tyloxapol and six under saline treatment, which indicates that inhalation of saline or Tyloxapol is a very safe procedure.Our study

  12. Home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized clinical trial

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    Dias FD

    2013-11-01

    Full Text Available Fernanda Dultra Dias,1 Luciana Maria Malosá Sampaio,1 Graziela Alves da Silva,1 Évelim LF Dantas Gomes,1 Eloisa Sanches Pereira do Nascimento,1 Vera Lucia Santos Alves,2 Roberto Stirbulov,2 Dirceu Costa11Post Graduate Program in Rehabilitation Sciences, Nove de Julho University – UNINOVE, São Paulo, Brazil; 2Pneumology Clinic at Santa Casa de Misericórdia de São Paulo (AME, São Paulo, BrazilIntroduction: Pulmonary rehabilitation (PR is a multidisciplinary program of care for patients with chronic obstructive pulmonary disease (COPD with the goal of improving the functional capacity and quality of life, as well as maintaining the clinical stability of COPD sufferers. However, not all patients are available for such a program despite discomfort with their condition. The aim of this study was to evaluate the effects of a home-based PR (HBPR program on functional ability, quality of life, and respiratory muscle strength and endurance.Patients and methods: Patients with COPD according to the Global Initiative of Chronic Obstructive Lung Disease were randomized (double-blind into two groups. One group performed a protocol at home with aerobic and muscle strength exercises and was called the intervention group; the other group received only instructions to perform breathing and stretching exercises, characterizing it as the control group (CG. We assessed the following variables at baseline and 2 months: exercise tolerance (incremental shuttle walk test and upper limb test, respiratory muscle (strength and endurance test, and health-related quality of life (Airways Questionnaire 20.Results: There were no significant changes after the intervention in either of the two groups in exercise tolerance and quality of life. However, the intervention group had improved respiratory endurance compared with the CG, while the CG presented a decrease in the load sustained by the respiratory muscles after the HBPR.Conclusion: A program of HBPR with biweekly

  13. Randomized, controlled trial of therapy interruption in chronic HIV-1 infection.

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    Emmanouil Papasavvas

    2004-12-01

    Full Text Available BACKGROUND: Approaches to limiting exposure to antiretroviral therapy (ART drugs are an active area of HIV therapy research. Here we present longitudinal follow-up of a randomized, open-label, single-center study of the immune, viral, and safety outcomes of structured therapy interruptions (TIs in patients with chronically suppressed HIV-1 infection as compared to equal follow-up of patients on continuous therapy and including a final therapy interruption in both arms. METHODS AND FINDINGS: Forty-two chronically HIV-infected patients on suppressive ART with CD4 counts higher than 400 were randomized 1:1 to either (1 three successive fixed TIs of 2, 4, and 6 wk, with intervening resumption of therapy with resuppression for 4 wk before subsequent interruption, or (2 40 wk of continuous therapy, with a final open-ended TI in both treatment groups. Main outcome was analysis of the time to viral rebound (>5,000 copies/ml during the open-ended TI. Secondary outcomes included study-defined safety criteria, viral resistance, therapy failure, and retention of immune reconstitution. There was no difference between the groups in time to viral rebound during the open-ended TI (continuous therapy/single TI, median [interquartile range] = 4 [1-8] wk, n = 21; repeated TI, median [interquartile range] = 5 [4-8] wk, n = 21; p = 0.36. No differences in study-related adverse events, viral set point at 12 or 20 wk of open-ended interruption, viral resistance or therapy failure, retention of CD4 T cell numbers on ART, or retention of lymphoproliferative recall antigen responses were noted between groups. Importantly, resistance detected shortly after initial viremia following the open-ended TI did not result in a lack of resuppression to less than 50 copies/ml after reinitiation of the same drug regimen. CONCLUSION: Cycles of 2- to 6-wk time-fixed TIs in patients with suppressed HIV infection failed to confer a clinically significant benefit with regard to viral

  14. Origanum vulgar inhaler in the treatment of chronic rhinosinositis, a double blind placebo controlled randomized clinical trial

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    K. Rabie

    2007-01-01

    Full Text Available AbstractBackground and purpose: Symptoms of chronic rhinisinositis (CRS are cumbersome and refractory to most systemic medications and even after surgical intervention, the recurrence of symptoms are frequent. In order to study the beneficial effects of Origanum vulgar inhaler in relaxing the symptoms, this study was conducted in Boo Ali Sina Hospital, Sari, Iran.Materials and Methods: The study was a randomized double blind placebo controlled clinical trial carried out from April to December 2005. The diagnosis of CRS was made by an ENT specialist upon clinical and CT scan findings and or signs during functional endoscopy sinuses surgery (FESS. Patients younger than 15 years old, with a history of allergic eye disease and symptoms of infections were excluded. Patients were randomized in case and control groups (32 in each according to age, sex and disease chronicity. After verbal explanation of the trial, an informed consent form was signed by each patient. The study was approved by the medical ethics committee of the Mazandaran University of Medical Sciences, Iran. Origanum vulgar was gathered from local mountains (Kojor area, Nour, Mazandaran, Iran, and identified by an experienced botanist. The airial organs of the herb were dried, macerated followed by 75% hydroalcoholic extraction and standardized by Emerson method. The active ingredient and placebo in the same bottles were administered to the patients and they were asked to add 5 ml of the liquid to boiling water and inhale it for 15 minutes, three times a day for two weeks. A telephone contact was made to the patients, to increase the compliance to treatment. A questionnaire was filled in for each patient before and after the intervention by a doctor blind to groups. Chi square test was used for comparing the differences in symptoms and P< 0.05 was considered statistically significant.Results: Sixty four patients were recruited and allocated equally in case and control groups matched for

  15. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients—A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Zickler, Daniel; Schindler, Ralf; Willy, Kevin; Martus, Peter; Pawlak, Michael; Storr, Markus; Hulko, Michael; Boehler, Torsten; Glomb, Marcus A.; Liehr, Kristin; Henning, Christian; Templin, Markus; Trojanowicz, Bogusz; Ulrich, Christof; Werner, Kristin; Fiedler, Roman; Girndt, Matthias

    2017-01-01

    Background To increase the removal of middle-sized uremic toxins a new membrane with enhanced permeability and selectivity, called Medium Cut-Off membrane (MCO-Ci) has been developed that at the same time ensures the retention of albumin. Because many middle-sized substances may contribute to micro-inflammation we hypothesized that the use of MCO-Ci influences the inflammatory state in hemodialysis patients. Methods The randomized crossover trial in 48 patients compared MCO-Ci dialysis to High-flux dialysis of 4 weeks duration each plus 8 weeks extension phase. Primary endpoint was the gene expression of TNF-α and IL-6 in peripheral blood mononuclear cells (PBMCs), secondary endpoints were plasma levels of specified inflammatory mediators and cytokines. Results After four weeks of MCO-Ci the expression of TNF-α mRNA (Relative quantification (RQ) from 0.92 ± 0.34 to 0.75 ± 0.31, -18.5%, pkappa and lambda free light chains, urea and an increase for Lp-PLA2 (PLA2G7) compared to High-flux. Albumin levels dropped significantly after 4 weeks of MCO dialysis but increased after additional 8 weeks of MCO dialysis. Twelve weeks treatment with MCO-Ci was well tolerated regarding the number of (S)AEs. In the extension period levels of CRP, TNF-α-mRNA and IL-6 mRNA remained stable in High-flux as well as in MCO-Ci. Conclusions MCO-Ci dialyzers modulate inflammation in chronic HD patients to a greater extent compared to High-flux dialyzers. Transcription of pro-inflammatory cytokines in peripheral leukocytes is markedly reduced and removal of soluble mediators is enhanced with MCO dialysis. Serum albumin concentrations stabilize after an initial drop. These results encourage further trials with longer treatment periods and clinical endpoints. PMID:28085888

  16. Randomized controlled trials in relapsed/refractory chronic lymphocytic leukemia: a systematic review and meta-analysis.

    Science.gov (United States)

    Police, Rachel L; Trask, Peter C; Wang, Jianmin; Olivares, Robert; Khan, Shahnaz; Abbe, Adeline; Colosia, Ann; Njue, Annete; Sherrill, Beth; Ruiz-Soto, Rodrigo; Kaye, James A; Hamadani, Mehdi

    2015-04-01

    This systematic literature review with meta-analysis was conducted on the clinical efficacy and safety of interventions used in the treatment of chronic lymphocytic leukemia (CLL). We systematically searched databases (PubMed, Cochrane Library, and Embase; 1997 to August 2, 2012), conference abstracts, bibliographic reference lists, recent reviews, and Clinicaltrials.gov. Primary efficacy outcomes were objective response rate, progression-free survival, and overall survival. Safety end points were Grade 3/4 toxicities, serious adverse events, withdrawals because of toxicity, and deaths due to toxicity. Studies were selected if they were randomized controlled trials (RCTs) reporting on the efficacy or safety of relapsed or refractory CLL and if outcomes for CLL were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 6 RCTs of pharmacologic treatment for relapsed/refractory CLL. The most common drugs investigated (alone or in combination) were fludarabine and cyclophosphamide. When reported, median overall survival ranged from 27.3 to 52.9 months, and overall response rate from 58% to 82%. Although meta-analysis of efficacy results was considered, details are not presented because only 3 studies qualified and the common comparator treatment was not clinically relevant. The relatively small number of RCTs, few overlapping treatment arms, and variability in end points studied make it difficult to formally compare therapies for relapsed/refractory CLL. Significant variability in RCT features presents a further challenge to meaningful comparisons. Additional well-designed RCTs are needed to fully understand the relative efficacy and safety of older and more recently developed therapies.

  17. Physiological Predictors of Response to Exposure, Relaxation, and Rescripting Therapy for Chronic Nightmares in a Randomized Clinical Trial

    Science.gov (United States)

    Davis, Joanne L.; Rhudy, Jamie L.; Pruiksma, Kristi E.; Byrd, Patricia; Williams, Amy E.; McCabe, Klanci M.; Bartley, Emily J.

    2011-01-01

    Study Objectives: Evidence supports the use of cognitive behavioral therapies for nightmares in trauma-exposed individuals. This randomized clinical trial replicated a study of exposure, relaxation, and rescripting therapy(ERRT) and extended prior research by including broad measures of mental health difficulties, self-reported physical health problems, and quality of life. Additionally, physiological correlates of treatment-related change assessed from a script-driven imagery paradigm were examined. Methods: Forty-seven individuals were randomized to treatment or waitlist control. Results: The treatment group demonstrated improvements relative to the control group at the one-week post-treatment assessment. At the 6-month follow-up assessment, significant improvements were found for frequency and severity of nightmares, posttraumatic stress disorder symptoms, depression, sleep quality and quantity, physical health symptoms, anger, dissociation, and tension reduction behaviors. Participants also reported improved quality of life. Treatment-related decreases in heart rate to nightmare imagery were correlated with improvements in sleep quality and quantity; treatment-related decreases in skin conductance to nightmare imagery were correlated with improvements in nightmare severity, posttraumatic stress disorder symptom severity, sleep quality, and fear of sleep; and treatment-related decreases in corrugator activity to nightmare imagery were correlated with improved physical health. Conclusions: Findings provide additional support for the use of ERRT in treating nightmares and related difficulties and improving sleep. Citation: Davis JL; Rhudy JL; Pruiksma KE; Byrd P; Williams AE; McCabe KM; Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med 2011;7(6):622-631. PMID:22171201

  18. Botulinum toxin type A for cephalic cutaneous allodynia in chronic migraine: a randomized, double-blinded, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Luciano Hollanda

    2014-12-01

    Full Text Available Cephalic allodynia (CA can be observed in 50-70% of patients with chronic migraine (CM. The aim of this trial was to assess the efficacy of botulinum toxin type A (Botx-A in the treatment of CA associated with CM. In this placebo-controlled trial, patients were randomized either into Botx-A or 0.9% saline injections and efficacy measures were assessed every 4 weeks for 3 months. Efficacy endpoints were number of migraine episodes associated with CA, changes from baseline in visual analogical scale scores for pain (VAS and frequency of common analgesics use for migraine. A total of 38 subjects were randomized to saline (n=18 or Botx-A (n=20. There were no significant differences in baseline between active intervention or placebo groups regarding mean age, number of headache episodes [mean 12.1 (9.22 and 17.00 (9.69 respectively; P=0.12], pain severity as measured by the VAS or frequency of analgesic use for headache episodes. Efficacy analysis showed that Botx-A injections led to an important decrease from baseline in the mean migraine episodes associated with CA after 12 weeks (5.20 versus 11.17; P=0.01. Also, VAS scores and frequency of analgesics use for headache were significantly reduced in the Botx-A group. This study suggests that Botx-A injections are superior to saline in the treatment of CA associated with CM, with mild self limited side effects.

  19. Meta-analysis of randomized controlled trials comparing isolated left ventricular and biventricular pacing in patients with chronic heart failure.

    Science.gov (United States)

    Liang, Yixiu; Pan, Wenzhi; Su, Yangang; Ge, Junbo

    2011-10-15

    Cardiac resynchronization therapy (CRT) has been mostly achieved by biventricular pacing (BVP) in patients with chronic heart failure (CHF), although it can also be provided by left ventricular pacing (LVP). The superiority of BVP over LVP remains uncertain. The present meta-analysis of randomized controlled trials was performed to compare the effects of LVP to BVP in patients with CHF. Outcomes analyzed included clinical status (6-minute walk distance, peak oxygen consumption, quality of life, New York Heart Association class), LV function (LV ejection fraction), and LV remodeling (LV end-systolic volume). Five trials fulfilled criteria for inclusion in analysis, which included 574 patients with CHF indicated for CRT. After a midterm follow-up, pooled analysis demonstrated that LVP resulted in similar improvements in 6-minute walk distance (weighted mean difference [WMD] 11.25, 95% confidence interval [CI] -12.39 to 34.90, p = 0.35), quality of life (WMD 0.34, 95% CI -3.72 to 4.39, p = 0.87), peak oxygen consumption (WMD 1.00, 95% CI -0.84 to 2.85, p = 0.29), and New York Heart Association class (WMD -0.19, 95% CI -0.79 to 0.42, p = 0.54). There was a trend toward a superiority of BVP over LVP for LV ejection fraction (WMD 1.28, 95% CI -0.11 to 2.68, p = 0.07) and LV end-systolic volume (WMD -5.73, 95% CI -11.86 to 0.39, p = 0.07). In conclusion, LVP achieves similar improvement in clinical status as BVP in patients with CHF, whereas there was a trend toward superiority of BVP over LVP for LV reverse modeling and systolic function.

  20. Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial

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    Steeds Richard P

    2011-02-01

    Full Text Available Abstract Background Serum phosphate is an independent predictor of cardiovascular morbidity and mortality in patients with chronic kidney disease and the general population. There is accumulating evidence that phosphate promotes arterial stiffening through structural vascular alterations such as medial calcification, which are already apparent in the early stages of chronic kidney disease. Aim To determine the effects of phosphate binding with sevelamer carbonate on left ventricular mass and function together with arterial stiffness in patients with stage 3 chronic kidney disease. Methods/Design A single-centre, prospective, randomised, double-blind, placebo-controlled trial of 120 subjects with stage 3 chronic kidney disease recruited from University Hospitals Birmingham NHS Foundation Trust. Baseline investigations include transthoracic echocardiography and cardiac magnetic resonance imaging to assess ventricular mass, volumes and function, applanation tonometry to determine pulse wave velocity and pulse wave analysis as surrogate measures of arterial stiffness and dual energy x-ray absorptiometry scanning to determine bone density. During an open-label run in phase, subjects will receive 1600 mg sevelamer carbonate with meals for four weeks. They will then be randomised to either continue sevelamer carbonate or receive an identical placebo (60 subjects per arm for the remaining 36 weeks. Four-weekly monitoring of serum electrolytes and bone biochemistry will be performed. All baseline investigations will be repeated at the end of the treatment period. The primary endpoint of the study is a reduction in left ventricular mass after 40 weeks of treatment. Secondary endpoints are: i change in aortic compliance; ii change in arterial stiffness; iii change in arterial elastance; iv change in left ventricular systolic and diastolic elastance; v change in left ventricular function; and vi change in bone density. Trial Registration This trial is

  1. Clinical Effects of Subgingivally Delivered Spirulina Gel in Chronic Periodontitis Cases: A Placebo Controlled Clinical Trial

    Science.gov (United States)

    Mahendra, Jaideep; Mahendra, Little; Muthu, Jananni; John, Libby; Romanos, Georgios E.

    2013-01-01

    Aims and Objectives: The aim of this study was to assess the clinical effects of Spirulina in-situ gel as an adjunct to Scaling And Root Planning (SRP) in the treatment of chronic periodontitis subjects. Material and Methods: 64 sites were selected with probing pocket depth of ≥5mm and they were divided into 2 groups; 33 sites were treated with SRP along with spirulina gel (Group A) and 31 sites were treated with SRP alone (Group B). Clinical parameters were recorded at baseline before SRP and at 120th day after the treatment therapy. The parameters included Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL). Results: Both the groups showed significant improvement in the parameters. However, Group A (SRP along with spirulina) showed statistically significant decrease in mean probing pocket depth and gain in the clinical attachment level after 120 days as compared to Group B SRP alone. Conclusion: Locally delivered spirulina gel, along with scaling and root planning, has been shown to cause a beneficial impact. The efficacy of the product as a local drug delivery system in the non-surgical treatment of periodontitis without any side effects has been proved. Spirulina appears to be promising. It exerts strong anti-inflammatory effects which are closely connected with its antioxidative activity. This study can have a significant impact on the treatment procedures of periodontitis, with the use of blue green algae in the future. PMID:24298522

  2. The Effectiveness of Cupping Therapy on Relieving Chronic Neck and Shoulder Pain: A Randomized Controlled Trial

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    Lee-Mei Chi

    2016-01-01

    Full Text Available The research aimed to investigate the effectiveness of cupping therapy (CT in changes on skin surface temperature (SST for relieving chronic neck and shoulder pain (NSP among community residents. A single-blind experimental design constituted of sixty subjects with self-perceived NSP. The subjects were randomly allocated to two groups. The cupping group received CT at SI 15, GB 21, and LI 15 acupuncture points, and the control group received no intervention. Pain was assessed using the SST, visual analog scale (VAS, and blood pressure (BP. The main results were SST of GB 21 acupuncture point raised from 30.6°C to 32.7°C and from 30.7°C to 30.6°C in the control group. Neck pain intensity (NPI severity scores were reduced from 9.7 to 3.6 in the cupping group and from 9.7 to 9.5 in the control group. The SST and NPI differences between the groups were statistically significant (P < 0.001. One treatment of CT is shown to increase SST. In conjunction with the physiological effect the subjective experience of NSP is reduced in intensity. Further studies are required to improve the understanding and potential long-term effects of CT.

  3. The Effectiveness of Cupping Therapy on Relieving Chronic Neck and Shoulder Pain: A Randomized Controlled Trial.

    Science.gov (United States)

    Chi, Lee-Mei; Lin, Li-Mei; Chen, Chien-Lin; Wang, Shu-Fang; Lai, Hui-Ling; Peng, Tai-Chu

    2016-01-01

    The research aimed to investigate the effectiveness of cupping therapy (CT) in changes on skin surface temperature (SST) for relieving chronic neck and shoulder pain (NSP) among community residents. A single-blind experimental design constituted of sixty subjects with self-perceived NSP. The subjects were randomly allocated to two groups. The cupping group received CT at SI 15, GB 21, and LI 15 acupuncture points, and the control group received no intervention. Pain was assessed using the SST, visual analog scale (VAS), and blood pressure (BP). The main results were SST of GB 21 acupuncture point raised from 30.6°C to 32.7°C and from 30.7°C to 30.6°C in the control group. Neck pain intensity (NPI) severity scores were reduced from 9.7 to 3.6 in the cupping group and from 9.7 to 9.5 in the control group. The SST and NPI differences between the groups were statistically significant (P < 0.001). One treatment of CT is shown to increase SST. In conjunction with the physiological effect the subjective experience of NSP is reduced in intensity. Further studies are required to improve the understanding and potential long-term effects of CT.

  4. Antioxidants and chronic pancreatitis: theory of oxidative stress and trials of antioxidant therapy.

    Science.gov (United States)

    Grigsby, Brianna; Rodriguez-Rilo, Horacio; Khan, Khalid

    2012-04-01

    Chronic pancreatitis (CP) is an inflammatory disease characterized by the progressive destruction of pancreatic tissue and resulting in pancreatic exocrine and endocrine insufficiency. Increased oxidative stress has been implicated as a potential mechanism in its etiology and pathology. A number of studies have demonstrated that CP patients have a compromised antioxidant status, which may be a contributing factor to the enhanced oxidative state associated with the disease. Nutrition is an essential consideration in the treatment of CP, especially since diet is a source of several antioxidants and cofactors required for the production of cellular antioxidant enzymes. Many CP patients have an inadequate intake of macro and micronutrients because of abdominal pain and discomfort, which often increase postprandially and discourage eating. Exocrine insufficiency leads to further complications by preventing adequate digestion and absorption of ingested food, thus causing even greater deficiencies and impairment of antioxidant status. The aims of this article are to review the oxidative stress model of CP and to examine the evidence for nutrition, and, particularly, antioxidants, in the treatment of CP.

  5. Open label trial of granulocyte apheresis suggests therapeutic efficacy in chronically active steroid refractory ulcerative colitis

    Institute of Scientific and Technical Information of China (English)

    Wolfgang Kruis; Robert L(o)fberg; Axel Dignass; Elisabeth Steinhagen-Thiessen; Julia Morgenstern; Joachim M(o)ssner; Stephan Schreiber; Maurizio Vecchi; Alberto Malesci; Max Reinshagen

    2005-01-01

    AIM:To study the efficacy, safety, and feasibility of a granulocyte adsorptive type apheresis system for the treatment of patients with chronically active ulcerative colitis despite standard therapy.METHODS: An open label multicenter study was carried out in 39 patients with active ulcerative colitis (CAI6-8) despite continuous use of steroids (a minimum total dose of 400 mg prednisone within the last 4 wk).Patients received a total of five aphereses using a granulocyte adsorptive technique (Adacolumn(R), Otsuka Pharmaceutical Europe, UK). Assessments at wk 6 and during follow-up until 4 mo comprised clinical (CAI) and endoscopic (EI) activity index, histology, quality of life(IBDQ), and laboratory tests.RESULTS: Thirty-five out of thirty-nine patients were qualified for intent-to-treat analysis. After the apheresis treatment at wk 6, 13/35 (37.1%) patients achieved clinical remission and 10/35 (28.6%) patients had endoscopic remission (CAI<4, EI<4). Quality of life (IBDQ) increased significantly (24 points, P<0.01)at wk 6. Apheresis could be performed in all but one patient. Aphereses were well tolerated, only one patient experienced anemia.CONCLUSION: In patients with steroid refractory ulcerative colitis, five aphereses with a granulocyte/monocyte depleting filter show potential short-term efficacy. Tolerability and technical feasibility of the procedure are excellent.

  6. Ghrelin treatment of cachectic patients with chronic obstructive pulmonary disease: a multicenter, randomized, double-blind, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Keisuke Miki

    Full Text Available BACKGROUND: Pulmonary cachexia is common in advanced chronic obstructive pulmonary disease (COPD, culminating in exercise intolerance and a poor prognosis. Ghrelin is a novel growth hormone (GH-releasing peptide with GH-independent effects. The efficacy and safety of adding ghrelin to pulmonary rehabilitation (PR in cachectic COPD patients were investigated. METHODOLOGY/PRINCIPAL FINDINGS: In a multicenter, randomized, double-blind, placebo-controlled trial, 33 cachectic COPD patients were randomly assigned PR with intravenous ghrelin (2 µg/kg or placebo twice daily for 3 weeks in hospital. The primary outcomes were changes in 6-min walk distance (6-MWD and the St. George Respiratory Questionnaire (SGRQ score. Secondary outcomes included changes in the Medical Research Council (MRC scale, and respiratory muscle strength. At pre-treatment, serum GH levels were increased from baseline levels by a single dose of ghrelin (mean change, +46.5 ng/ml; between-group p<0.0001, the effect of which continued during the 3-week treatment. In the ghrelin group, the mean change from pre-treatment in 6-MWD was improved at Week 3 (+40 m, within-group p = 0.033 and was maintained at Week 7 (+47 m, within-group p = 0.017, although the difference between ghrelin and placebo was not significant. At Week 7, the mean changes in SGRQ symptoms (between-group p = 0.026, in MRC (between-group p = 0.030, and in maximal expiratory pressure (MEP; between-group p = 0.015 were better in the ghrelin group than in the placebo group. Additionally, repeated-measures analysis of variance (ANOVA indicated significant time course effects of ghrelin versus placebo in SGRQ symptoms (p = 0.049 and MEP (p = 0.021. Ghrelin treatment was well tolerated. CONCLUSIONS/SIGNIFICANCE: In cachectic COPD patients, with the safety profile, ghrelin administration provided improvements in symptoms and respiratory strength, despite the lack of a significant between

  7. A cluster randomised controlled trial of nurse and GP partnership for care of Chronic Obstructive Pulmonary Disease

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    Middleton Sandy

    2008-06-01

    Full Text Available Abstract Background Chronic obstructive pulmonary disease (COPD is a significant health problem worldwide. This randomised controlled trial aims at testing a new approach that involves a registered nurse working in partnership with patients, general practitioners (GPs and other health professionals to provide care to patients according to the evidence-based clinical practice guidelines. The aim is to determine the impact of this partnership on the quality of care and patient outcomes. Methods A cluster randomised control trial design was chosen for this study. Randomisation occurred at practice level. GPs practising in South Western Sydney, Australia and their COPD patients were recruited for the study. The intervention was implemented by nurses specifically recruited and trained for this study. Nurses, working in partnership with GPs, developed care plans for patients based on the Australian COPDX guidelines. The aim was to optimise patient management, improve function, prevent deterioration and enhance patient knowledge and skills. Control group patients received 'usual' care from their GPs. Data collection includes patient demographic profiles and their co-morbidities. Spirometry is being performed to assess patients' COPD status and CO analyser to validate their smoking status. Patients' quality of life and overall health status are being measured by St George's Respiratory Questionnaire and SF-12 respectively. Other patient measures being recorded include health service use, immunisation status, and knowledge of COPD. Qualitative methods will be used to explore participants' satisfaction with the intervention and their opinion about the value of the partnership. Analysis Analysis will be by intention to treat. Intra-cluster (practice correlation coefficients will be determined and published for all primary outcome variables to assist future research. The effect of the intervention on outcomes measured on a continuous scale will be estimated

  8. Effects of Qianlie'an(前列安) Suppository in Patients with Chronic Prostatitis Syndrome: A Randomized Open-Labelled Prospective and Controlled Trial

    Institute of Scientific and Technical Information of China (English)

    邢俊平; 陈兴发; 杨志尚; 王明珠; 贺大林

    2003-01-01

    Objective: To evaluate the clinical efficacy of Qianlie'an(前列安,QLA) suppository via anal route administration in treating chronic prostatitis syndrome. Methods: A randomized open-labelled prospective controlled trial was carried out. The total of 120 patients with chronic prostatitis syndrome were randomly divided into 2 groups: 60 patients in the treated group who were treated with QLA suppository combined with ofloxacin, and the other 60 patients in the control group who were given ofloxacin alone. The efficacy was evaluated by WBC count in the expressed prostatic secretion (EPS) and the Chronic Prostatitis Symptom Index (CPSI) made by the National Institute of Health (NIH). The clinical effects were also observed in a 4-week follow-up. Results: All but six cases completed the trial and the follow-up.It showed that in the treated group recovery rate was 17. 2%, markedly effective rate 34. 5%, effective rate 32.8%, total markedly effective rate 51.7%, and total effective rate 84. 5%, all of which were superior to those in the control group (total markedly effective rate 32.1% and total effective rate 66.1%, respectively), P<0.01. Conclusion: Administration of QLA suppository via anal route combined with oral antibiotics is an effective therapy for chronic prostatitis syndrome. It can relieve the symptoms of chronic prostatitis syndrome markedly and rapidly. It is a new choice for treatment of the disease.

  9. Impact of Baseline Systolic Blood Pressure and Long-Term Outcomes in Patients with Advanced Chronic Systolic Heart Failure (Insights from the BEST Trial)

    OpenAIRE

    2010-01-01

    The impact of baseline systolic blood pressure (SBP) on outcomes in advanced chronic systolic heart failure (HF) patients has not been studied using propensity-matched design. Of the 2706 Beta-Blocker Evaluation of Survival Trial (BEST) participants with chronic HF, New York Heart Association class III–IV symptoms and left ventricular ejection fraction ≤35%, 1751 had SBP ≤120 (median, 108; range, 70–120) mm Hg and 955 had SBP >120 (median, 134; range 121–192) mm Hg. Propensity scores for SBP ...

  10. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial

    Science.gov (United States)

    Eftekharsadat, Bina; Babaei-Ghazani, Arash; Zeinolabedinzadeh, Vahideh

    2016-01-01

    Background: This study examined the effects of dry needling on chronic heel pain due to plantar fasciitis. Methods: During this single-blinded clinical trial, 20 eligible patients were randomized into two groups: A case group treated with dry needling and a control group. Patients’ plantar pain severity, (using modified visual analog scale [VAS] scoring system), range of motion of ankle joint in dorsiflexion [ROMDF] and plantar extension[ROMPE] and foot function index (using standard questionnaires of SEM5 and MDC7) were assessed at baseline, four weeks after intervention and four weeks after withdrawing treatment. Independent sample t-test, Mann-Whitney U test, paired t-test, Wilcoxon signed rank tests, and chi square test were used for data analysis. Results: The mean VAS scores in the case group was significantly lower than the control group after four weeks of intervention (pdry needling, by improving the severity of heel pain, can be used as a good alternative option before proceeding to more invasive therapies of plantar fasciitis. PMID:27683642

  11. Phase I clinical trial of CpG oligonucleotide 7909 (PF-03512676) in patients with previously treated chronic lymphocytic leukemia.

    Science.gov (United States)

    Zent, Clive S; Smith, Brian J; Ballas, Zuhair K; Wooldridge, James E; Link, Brian K; Call, Timothy G; Shanafelt, Tait D; Bowen, Deborah A; Kay, Neil E; Witzig, Thomas E; Weiner, George J

    2012-02-01

    CpG oligonucleotide 7909 (CpG 7909, PF-03512676), a synthetic 24mer single stranded agonist of TLR9 expressed by B cells and plasmacytoid dendritic cells, is immunomodulatory and can cause activation-induced death of chronic lymphocytic leukemia (CLL) cells. We report a phase I study of CpG 7909 in 41 patients with early relapsed CLL. A single intravenous dose of CpG 7909 was well tolerated with no clinical effects and no significant toxicity up to 1.05 mg/kg. Single dose subcutaneous CpG 7909 had a maximum tolerated dose (MTD) of 0.45 mg/kg with dose limiting toxicity of myalgia and constitutional effects. Multiple weekly subcutaneous doses at the MTD were well tolerated. CpG 7909 administration induced immunologic changes in CLL and non-malignant cells that were dose and route dependent. We conclude that multidose therapy with subcutaneous CpG 7909 (0.45 mg/kg) could be used in future phase II combination clinical trials for CLL.

  12. Progress in the treatment of elderly/unfit chronic lymphocytic leukemia patients: results of the German CLL-11 trial.

    Science.gov (United States)

    Molica, Stefano

    2015-01-01

    Chronic lymphocytic leukemia (CLL) is the most prevalent type of leukemia and affects mostly the elderly. Chemoimmunotherapy with fludarabine, cyclophosphamide and rituximab is generally considered a standard treatment for younger fit patients with CLL. In a recent randomized Phase III study of patients with newly diagnosed CLL and coexisting conditions, obinutuzumab, a humanized anti-CD20 glycoengineered type 2 antibody, used in combination with chlorambucil, demonstrated significant improvement in progression-free survival and several other outcome parameters, in comparison to rituximab plus chlorambucil. Grade 3-4 infusion-related reactions and neutropenia occurred more frequently in patients who received obinutuzumab compared with those who received rituximab; however, the rate of serious infections was similar. Results of this trial clearly established that obinutuzumab in combination with chlorambucil represent the new first-line standard of treatment in this setting. A broad range of novel agents with different mechanisms of action have already proven their efficacy in CLL. New drugs targeting specific molecular features, such as ibrutinib, idelalisib or ABT-199, are being tested at present, and their advent is very likely to change the future treatment paradigm of CLL that relies today on chemoimmunotherapy for both fit and elderly/unfit patients.

  13. Cervical kinematic training with and without interactive VR training for chronic neck pain - a randomized clinical trial.

    Science.gov (United States)

    Sarig Bahat, Hilla; Takasaki, Hiroshi; Chen, Xiaoqi; Bet-Or, Yaheli; Treleaven, Julia

    2015-02-01

    Impairments in cervical kinematics are common in patients with neck pain. A virtual reality (VR) device has potential to be effective in the management of these impairments. The objective of this study was to investigate the effect of kinematic training (KT) with and without the use of an interactive VR device. In this assessor-blinded, allocation-concealed pilot clinical trial, 32 participants with chronic neck pain were randomised into the KT or kinematic plus VR training (KTVR) group. Both groups completed four to six training sessions comprising of similar KT activities such as active and quick head movements and fine head movement control and stability over five weeks. Only the KTVR group used the VR device. The primary outcome measures were neck disability index (NDI), cervical range of motion (ROM), head movement velocity and accuracy. Kinematic measures were collected using the VR system that was also used for training. Secondary measures included pain intensity, TAMPA scale of kinesiophobia, static and dynamic balance, global perceived effect and participant satisfaction. The results demonstrated significant (p neck pain in a larger cohort.

  14. Clinical response and relapse in patients with chronic low back pain following osteopathic manual treatment: results from the OSTEOPATHIC Trial.

    Science.gov (United States)

    Licciardone, John C; Aryal, Subhash

    2014-12-01

    Clinical response and relapse following a regimen of osteopathic manual treatment (OMT) were assessed in patients with chronic low back pain (LBP) within the OSTEOPATHIC Trial, a randomized, double-blind, sham-controlled study. Initial clinical response and subsequent stability of response, including final response and relapse status at week 12, were determined in 186 patients with high baseline pain severity (≥50 mm on a 100-mm visual analogue scale). Substantial improvement in LBP, defined as 50% or greater pain reduction relative to baseline, was used to assess clinical response at weeks 1, 2, 4, 6, 8, and 12. Sixty-two (65%) patients in the OMT group attained an initial clinical response vs. 41 (45%) patients in the sham OMT group (risk ratio [RR], 1.45; 95% confidence interval [CI], 1.11-1.90). The median time to initial clinical response to OMT in these patients was 4 weeks. Among patients with an initial clinical response prior to week 12, 13 (24%) patients in the OMT group vs. 18 (51%) patients in the sham OMT group relapsed (RR, 0.47; 95% CI, 0.26-0.83). Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.

  15. Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial

    DEFF Research Database (Denmark)

    Andresen, Kristoffer; Burcharth, Jakob; Fonnes, Siv;

    2016-01-01

    PURPOSE: The open new simplified totally extraperitoneal (ONSTEP) technique for the repair of inguinal hernia was presented some years ago with promising initial results regarding chronic pain. We conducted a randomized clinical trial investigating the ONSTEP technique versus the Lichtenstein...... participants with primary unilateral hernias, having surgical repair of their hernia at one of five participating general surgical departments. At surgery, participants were allocated (1:1) to the ONSTEP or the Lichtenstein technique for inguinal hernia repair. Participants were followed up with questionnaires...... was not seen in the ONSTEP group. CONCLUSION: The ONSTEP technique was not superior to the Lichtenstein technique regarding chronic pain following repair of primary inguinal hernias in males. TRIAL REGISTRATION: https://clinicaltrials.gov NCT01753219....

  16. Effect of aerobic exercise training and cognitive behavioural therapy on reduction of chronic fatigue in patients with facioscapulohumeral dystrophy: protocol of the FACTS-2-FSHD trial

    Directory of Open Access Journals (Sweden)

    van Engelen Baziel GM

    2010-06-01

    Full Text Available Abstract Background In facioscapulohumeral dystrophy (FSHD muscle function is impaired and declines over time. Currently there is no effective treatment available to slow down this decline. We have previously reported that loss of muscle strength contributes to chronic fatigue through a decreased level of physical activity, while fatigue and physical inactivity both determine loss of societal participation. To decrease chronic fatigue, two distinctly different therapeutic approaches can be proposed: aerobic exercise training (AET to improve physical capacity and cognitive behavioural therapy (CBT to stimulate an active life-style yet avoiding excessive physical strain. The primary aim of the FACTS-2-FSHD (acronym for Fitness And Cognitive behavioural TherapieS/for Fatigue and ACTivitieS in FSHD trial is to study the effect of AET and CBT on the reduction of chronic fatigue as assessed with the Checklist Individual Strength subscale fatigue (CIS-fatigue in patients with FSHD. Additionally, possible working mechanisms and the effects on various secondary outcome measures at all levels of the International Classification of Functioning, Disability and Health (ICF are evaluated. Methods/Design A multi-centre, assessor-blinded, randomized controlled trial is conducted. A sample of 75 FSHD patients with severe chronic fatigue (CIS-fatigue ≥ 35 will be recruited and randomized to one of three groups: (1 AET + usual care, (2 CBT + usual care or (3 usual care alone, which consists of no therapy at all or occasional (conventional physical therapy. After an intervention period of 16 weeks and a follow-up of 3 months, the third (control group will as yet be randomized to either AET or CBT (approximately 7 months after inclusion. Outcomes will be assessed at baseline, immediately post intervention and at 3 and 6 months follow up. Discussion The FACTS-2-FSHD study is the first theory-based randomized clinical trial which evaluates the effect and the

  17. Correlation between expectations of recovery and injury severity perception in whiplash-associated disorders

    Institute of Scientific and Technical Information of China (English)

    Robert FERRARI; Deon LOUW

    2011-01-01

    Objective:To assess the correlation between expectations of recovery and whiplash patients' perceptions of injury sevedty using a simplified instrument.Expectations of recovery have been shown to predict rate of recovery from whiplash injury in population-based studies.The perception of having more severe pathology or more ominous diagnostic labels has also been associated with a worse prognosis.Methods:Consecutive patients with whiplashassociated disorder grade 1 or 2,presenting in the acute stage to a primary care centre,were asked "do you think that your injury will…" with response options "get better soon; get better slowly; never get better; don't know." Injury severity perception (ISP) was measured with a numerical rating scale which ranged from 0-10,on which subjects were asked to rate how severe (in terms of damage) they thought their injury was.The anchors were labeled "no damage" (0) and "severe,and maybe permanent damage" (10).The primary outcome measure was the correlation between the subject's ISP score and expectation of recovery.Results:A total of 94 subjects (34 males,60 females,and mean age (40.6+10.0) years,range 19-60 years) were included.The initial responses to expectation of recovery were:get better soon (29/94); get better slowly (22/94); never get better (11/94); don't know (32/94).The mean ISP score was 4.9+1.7(range 2-9 out of 10).There was a high correlation between expectations and ISP scores (Spearman's rank correlation coefficient 0.68).Those who expected to recover soon and those who expected to get better slowly had the lowest ISP scores.Conclusions:The more slowly whiplash patients expect to recover,or the less sure they are of recovery,the more severe their initial perceptions of injury.

  18. Dynamic Kine Magnetic Resonance Imaging in Whiplash Patients and in Age- and Sex-Matched Controls

    Directory of Open Access Journals (Sweden)

    Karl-August Lindgren

    2009-01-01

    Full Text Available The multitude of symptoms following a whiplash injury has given rise to much discussion because of the lack of objective radiological findings. The ligaments that stabilize the upper cervical spine can be injured. Dynamic kine magnetic resonance imaging (dMRI may reveal the pathological motion patterns caused by injury to these ligaments. To compare the findings and motion patterns in the upper cervical spine, 25 whiplash trauma patients with longstanding pain, limb symptoms and loss of balance indicating a problem at the level of C0–C2, as well as matched healthy controls were imaged using dMRI. Imaging was performed with an Intera 1.5 T (Philips Healthcare, USA magnet. A physiotherapist performed the bending and rotation of the upper cervical spine for the subjects to ensure that the movements were limited to the C0–C2 level. An oblique coronal T2- and proton density-weighted sequence and a balanced fast field echo axial sequence were used. The movements between C0–C2 and the signal from the alar ligaments were analyzed. Contact of the transverse ligament and the medulla in rotation was seen in two patients. The signal from the alar ligaments was abnormal in 92% of the patients and in 24% of the control subjects (P<0.0001. Abnormal movements at the level of C1–C2 were more common in patients than in controls (56% versus 20%, P=0.028. Whiplash patients with longstanding symptoms had both more abnormal signals from the alar ligaments and more abnormal movements on dMRI at the C0–C2 level than controls.

  19. Effectiveness of mat Pilates or equipment-based Pilates in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    da Luz Maurício Antônio

    2013-01-01

    Full Text Available Abstract Background Chronic low back pain is an expensive and difficult condition to treat. One of the interventions widely used by physiotherapists in the treatment of chronic non-specific low back pain is exercise therapy based upon the Pilates principles. Pilates exercises can be performed with or without specific equipment. These two types of Pilates exercises have never been compared on a high-quality randomised controlled trial. Methods/design This randomised controlled trial with a blinded assessor will evaluate eighty six patients of both genders with chronic low back pain, aged between 18 and 60 years, from one Brazilian private physiotherapy clinic. The patients will be randomly allocated into two groups: Mat Group will perform the exercises on the ground while the Equipment-based Group will perform the Pilates method exercises on the following equipment: Cadillac, Reformer, Ladder Barrel, and Step Chair. The general and specific disability of the patient, kinesiophobia, pain intensity and global perceived effect will be evaluated by a blinded assessor before randomisation and at six weeks and six months after randomisation. In addition, the expectation of the participants and their confidence with the treatment will be evaluated before randomisation and after the first treatment session, respectively. Discussion This will be the first study aiming to compare the effectiveness of Mat and Equipment-based Pilates exercises in patients with chronic non-specific low back pain. The results may help health-care professionals in clinical decision-making and could potentially reduce the treatment costs of this condition. Trial registration Brazilian Registry of Clinical Trials RBR-7tyg5j

  20. Feasibility of omega-3 fatty acid supplementation as an adjunct therapy for people with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

    OpenAIRE

    Fulton, Ashley S; Hill, Alison M.; Williams, Marie T; Howe, Peter RC; Frith, Peter A; Wood, Lisa G.; Garg, Manohar L.; Coates, Alison M.

    2013-01-01

    Background There is evidence to support the use of supplementation with long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) from oily fish or fish oil for the treatment of various inflammatory diseases such as rheumatoid arthritis. Chronic obstructive pulmonary disease (COPD) is a progressive, terminal disease characterized by persistent airflow limitation, lung and systemic inflammation. To date, one randomized controlled trial has been published that assessed the efficacy of LCn-3PUF...

  1. Effectiveness of anodal transcranial direct current stimulation in patients with chronic low back pain: Design, method and protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Luedtke Kerstin

    2011-12-01

    Full Text Available Abstract Background Electrical stimulation of central nervous system areas with surgically implanted stimulators has been shown to result in pain relief. To avoid the risks and side effects of surgery, transcranial direct current stimulation is an option to electrically stimulate the motor cortex through the skull. Previous research has shown that transcranial direct current stimulation relieves pain in patients with fibromyalgia, chronic neuropathic pain and chronic pelvic pain. Evidence indicates that the method is pain free, safe and inexpensive. Methods/Design A randomised controlled trial has been designed to evaluate the effect of transcranial direct current stimulation over the motor cortex for pain reduction in patients with chronic low back pain. It will also investigate whether transcranial direct current stimulation as a prior treatment enhances the symptom reduction achieved by a cognitive-behavioural group intervention. Participants will be randomised to receive a series of 5 days of transcranial direct current stimulation (2 mA, 20 mins or 20 mins of sham stimulation; followed by a cognitive-behavioural group programme. The primary outcome parameters will measure pain (Visual Analog Scale and disability (Oswestry Disability Index. Secondary outcome parameters will include the Fear Avoidance Beliefs Questionnaire, the Funktionsfragebogen Hannover (perceived function, Hospital Anxiety Depression Scale, bothersomeness and Health Related Quality of Life (SF 36, as well as Patient-Perceived Satisfactory Improvement. Assessments will take place immediately prior to the first application of transcranial direct current stimulation or sham, after 5 consecutive days of stimulation, immediately after the cognitive-behavioural group programme and at 4 weeks, 12 weeks and 24 weeks follow-up. Discussion This trial will help to determine, whether transcranial direct current stimulation is an effective treatment for patients with chronic low back

  2. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial

    OpenAIRE

    2013-01-01

    Background Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave® Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chro...

  3. Cost-effectiveness of minimal interventional procedures for chronic mechanical low back pain: design of four randomised controlled trials with an economic evaluation

    Directory of Open Access Journals (Sweden)

    Maas Esther T

    2012-12-01

    Full Text Available Abstract Background Minimal interventional procedures are frequently applied in patients with mechanical low back pain which is defined as pain presumably resulting from single sources: facet, disc, sacroiliac joint or a combination of these. Usually, these minimal interventional procedures are an integral part of a multidisciplinary pain programme. A recent systematic review issued by the Dutch Health Insurance Council showed that the effectiveness of these procedures for the total group of patients with chronic low back pain is yet unclear and cost-effectiveness unknown. The aim of the study is to evaluate whether a multidisciplinary pain programme with minimal interventional procedures is cost-effective compared to the multidisciplinary pain programme alone for patients with chronic mechanical low back pain who did not respond to conservative primary care and were referred to a pain clinic. Methods All patients with chronic low back pain who are referred to one of the 13 participating pain clinics will be asked to participate in an observational study. Patients with a suspected diagnosis of facet, disc or sacroiliac joint problems will receive a diagnostic block to confirm this diagnosis. If confirmed, they will be asked to participate in a Randomized Controlled Trial (RCT. For each single source a separate RCT will be conducted. Patients with a combination of facet, disc or sacroiliac joint problems will be invited for participation in a RCT as well. An economic evaluation from a societal perspective will be performed alongside these four RCTs. Patients will complete questionnaires at baseline, 3 and 6 weeks, 3, 6, 9 and 12 months after start of the treatment. Costs will be collected using self-completed cost questionnaires. Discussion No trials are yet available which have evaluated the cost-effectiveness of minimal interventional procedures in patients with chronic mechanical low back pain, which emphasizes the importance of this study

  4. Amount of health care and self-care following a randomized clinical trial comparing flexion-distraction with exercise program for chronic low back pain

    Directory of Open Access Journals (Sweden)

    Keenum Michael

    2006-08-01

    Full Text Available Abstract Background Previous clinical trials have assessed the percentage of participants who utilized further health care after a period of conservative care for low back pain, however no chiropractic clinical trial has determined the total amount of care during this time and any differences based on assigned treatment group. The objective of this clinical trial follow-up was to assess if there was a difference in the total number of office visits for low back pain over one year after a four week clinical trial of either a form of physical therapy (Exercise Program or a form of chiropractic care (Flexion Distraction for chronic low back pain. Methods In this randomized clinical trial follow up study, 195 participants were followed for one year after a four-week period of either a form of chiropractic care (FD or a form of physical therapy (EP. Weekly structured telephone interview questions regarded visitation of various health care practitioners and the practice of self-care for low back pain. Results Participants in the physical therapy group demonstrated on average significantly more visits to any health care provider and to a general practitioner during the year after trial care (p Conclusion During a one-year follow-up, participants previously randomized to physical therapy attended significantly more health care visits than those participants who received chiropractic care.

  5. Long-term Follow-up of Whiplash Injury of the Neck

    Directory of Open Access Journals (Sweden)

    Sameh El-Sallakh

    2013-12-01

    Conclusion: Whiplash injury patients have long-term residual symptoms; mainly pins and needles sensation in their limbs, headache, and dizziness. Increasing age and low back pain are bad prognostic factors. Claiming compensation prolongs the time for recovery. Sex, body mass index, type of treatment, smoking, and alcohol have no association with the incidence of persistent symptoms. However, smoking had a significant worsening effect on the severity of the symptoms in patients with high WDQS. WDQS, SF-36 and time to symptom relief are sensitive outcome measures of these injuries.

  6. The role of 25-hydroxyvitamin D deficiency in promoting insulin resistance and inflammation in patients with Chronic Kidney Disease: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Johnson David W

    2009-12-01

    Full Text Available Abstract Background Approximately 50% of patients with stage 3 Chronic Kidney Disease are 25-hydroxyvitamin D insufficient, and this prevalence increases with falling glomerular filtration rate. Vitamin D is now recognised as having pleiotropic roles beyond bone and mineral homeostasis, with the vitamin D receptor and metabolising machinery identified in multiple tissues. Worryingly, recent observational data has highlighted an association between hypovitaminosis D and increased cardiovascular mortality, possibly mediated via vitamin D effects on insulin resistance and inflammation. The main hypothesis of this study is that oral Vitamin D supplementation will ameliorate insulin resistance in patients with Chronic Kidney Disease stage 3 when compared to placebo. Secondary hypotheses will test whether this is associated with decreased inflammation and bone/adipocyte-endocrine dysregulation. Methods/Design This study is a single-centre, double-blinded, randomised, placebo-controlled trial. Inclusion criteria include; estimated glomerular filtration rate 30-59 ml/min/1.73 m2; aged ≥18 on entry to study; and serum 25-hydroxyvitamin D levels Discussion To date, no randomised controlled trial has been performed in pre-dialysis CKD patients to study the correlation between vitamin D status with supplementation, insulin resistance and markers of adverse cardiovascular risk. We remain hopeful that cholecalciferol may be a safe intervention, with health benefits beyond those related to bone-mineral homeostasis. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12609000246280.

  7. Executive Function, Survival, and Hospitalization in Chronic Obstructive Pulmonary Disease. A Longitudinal Analysis of the National Emphysema Treatment Trial (NETT)

    Science.gov (United States)

    Dodd, James W.; Novotny, Paul; Sciurba, Frank C.

    2015-01-01

    Rationale: Cognitive dysfunction has been demonstrated in chronic obstructive pulmonary disease (COPD), but studies are limited to cross-sectional analyses or incompletely characterized populations. Objectives: We examined longitudinal changes in sensitive measures of executive function in a well-characterized population of patients with severe COPD. Methods: This study was performed on patients enrolled in the National Emphysema Treatment Trial. To assess executive function, we analyzed trail making (TM) A and B times at enrollment in the trial (2,128 patients), and at 12 (731 patients) and 24 months (593 patients) after enrollment, adjusted for surgery, marriage status, age, education, income, depression, PaO2, PaCO2, and smoking. Associations with survival and hospitalizations were examined using Cox regression and linear regression models. Measurements and Main Results: The average age of the patients was 66.4 years, and the average FEV1 was 23.9% predicted. At the time of enrolment, 38% had executive dysfunction. Compared with those who did not, these patients were older, less educated, had higher oxygen use, higher PaCO2, worse quality of life as measured by the St. George’s Respiratory Quotient, reduced well-being, and lower social function. There was no significant change over 2 years in TM A or B times after adjustment for covariables. Changes in TM B times were modestly associated with survival, but changes in TM B − A times were not. Changes in TM scores were not associated with frequency of hospitalization. Lung function, PaO2, smoking, survival, and hospitalizations were not significantly different in those with executive dysfunction. Conclusions: In this large population of patients with severe emphysema and heavy cigarette smoking exposure, there was no significant decline over 2 years in cognitive executive function as measured by TM tests. There was no association between executive function impairment and frequency of hospitalization, and

  8. Effect of Behavior Modification on Outcome in Early- to Moderate-Stage Chronic Kidney Disease: A Cluster-Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Kunihiro Yamagata

    Full Text Available Owing to recent changes in our understanding of the underlying cause of chronic kidney disease (CKD, the importance of lifestyle modification for preventing the progression of kidney dysfunction and complications has become obvious. In addition, effective cooperation between general physicians (GPs and nephrologists is essential to ensure a better care system for CKD treatment. In this cluster-randomized study, we studied the effect of behavior modification on the outcome of early- to moderate-stage CKD.Stratified open cluster-randomized trial.A total of 489 GPs belonging to 49 local medical associations (clusters in Japan.A total of 2,379 patients (1,195 in group A (standard intervention and 1,184 in group B (advanced intervention aged between 40 and 74 years, who had CKD and were under consultation with GPs.All patients were managed in accordance with the current CKD guidelines. The group B clusters received three additional interventions: patients received both educational intervention for lifestyle modification and a CKD status letter, attempting to prevent their withdrawal from treatment, and the group B GPs received data sheets to facilitate reducing the gap between target and practice.The primary outcome measures were 1 the non-adherence rate of accepting continuous medical follow-up of the patients, 2 the collaboration rate between GPs and nephrologists, and 3 the progression of CKD.The rate of discontinuous clinical visits was significantly lower in group B (16.2% in group A vs. 11.5% in group B, p = 0.01. Significantly higher referral and co-treatment rates were observed in group B (p<0.01. The average eGFR deterioration rate tended to be lower in group B (group A: 2.6±5.8 ml/min/1.73 m2/year, group B: 2.4±5.1 ml/min/1.73 m2/year, p = 0.07. A significant difference in eGFR deterioration rate was observed in subjects with Stage 3 CKD (group A: 2.4±5.9 ml/min/1.73 m2/year, group B: 1.9±4.4 ml/min/1.73 m2/year, p = 0.03.Our care

  9. Impact of a chronic kidney disease registry and provider education on guideline adherence – a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Drawz Paul E

    2012-07-01

    Full Text Available Abstract Background Low adherence to chronic kidney disease (CKD guidelines may be due to unrecognized CKD and lack of guideline awareness on the part of providers. The goal of this study was to evaluate the impact of provider education and access to a CKD registry on guideline adherence. Methods We conducted a cluster randomized controlled trial at the Louis Stokes Cleveland VAMC. One of two primary care clinics was randomized to intervention. Providers from both clinics received a lecture on CKD guidelines at study initiation. Providers in the intervention clinic were given access to and shown how to use a CKD registry, which identifies patients with CKD and is automatically updated daily. Eligible patients had at least one primary care visit in the last year, had CKD based on eGFR, and had not received renal replacement therapy. The primary outcome was parathyroid hormone (PTH adherence, defined by at least one PTH measurement during the 12 month study. Secondary outcomes were measurement of phosphorus, hemoglobin, proteinuria, achievement of goal blood pressure, and treatment with a diuretic or renin-angiotensin system blocker. Results There were 418 and 363 eligible patients seen during the study in the control and intervention clinics, respectively. Compared to pre-intervention, measurement of PTH increased in both clinics (control clinic: 16% to 23%; intervention clinic: 13% to 28%. Patients in the intervention clinic were more likely to have a PTH measured during the study (adjusted odds ratio = 1.53; 95% CI (1.01, 2.30; P = 0.04. However, the intervention was not associated with a consistent improvement in secondary outcomes. Only 5 of the 37 providers in the intervention clinic accessed the registry. Conclusions An intervention that included education on CKD guidelines and access to a CKD patient registry marginally improved guideline adherence over education alone. Adherence to the primary process measure improved in both

  10. Panax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Story David

    2011-06-01

    Full Text Available Abstract Background Chronic obstructive pulmonary disease (COPD impairs quality of life and leads to premature mortality. COPD sufferers experience progressive deterioration of lung function and decreased ability to undertake day-to-day activities. Ginseng has been used for thousands of years in Chinese medicine for respiratory symptoms. Several controlled clinical trials using ginseng for COPD have shown promising clinical effect, however these studies were generally small and with some potential bias, prompting the need for rigorously designed studies. Aim The objective of this study is to evaluate the therapeutic value and safety profile of a standardised root extract of Panax ginseng C.A Meyer (ginseng for symptomatic relief, with a focus on quality of life (QoL improvements in individuals with moderate (Stage II COPD FEV1/FVC 1 50% - 80% predicted. Methods This paper describes the design of a randomised, multi-centre, double-blind, placebo controlled, two-armed parallel clinical trial. Two trial sites in Melbourne Australia will proportionately randomise a total of 168 participants to receive either ginseng capsule (100 mg or matching placebo twice daily for 24 weeks. The primary outcomes will be based on three validated QoL questionnaires, St Georges Respiratory Questionnaire (SGRQ, Short Form Health Survey (SF-36 and the COPD Assessment Test (CAT. Secondary outcomes are based on lung function testing, relief medication usage and exacerbation frequency and severity. Safety endpoints include blood tests and adverse event reporting. Intention-to-treat will be applied to all data analyses. Discussion Findings from this study may lead to new therapeutic development for chronic respiratory diseases, particularly COPD. This protocol may also guide other investigators to develop quality herbal medicine clinical trials in the future. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000768099

  11. Comorbidities of patients in tiotropium clinical trials: comparison with observational studies of patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Miravitlles M

    2015-03-01

    Full Text Available Marc Miravitlles,1 David Price,2 Klaus F Rabe,3,7 Hendrik Schmidt,4 Norbert Metzdorf,5 Bartolome Celli6 1Pneumology Department, Hospital Universitari Vall d’Hebron, Ciber de Enfermedades Respiratorias (CIBERES, Barcelona, Spain; 2Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 3Department of Medicine, Christian-Albrechts-Universität zu Kiel (CAU, Großhansdorf, Germany; 4Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 6Pulmonary Division, Brigham and Women’s Hospital, Boston, MA, USA; 7LungenClinic Grosshansdorf, Großhansdorf, Germany Background: There is an ongoing debate on whether patients with chronic obstructive pulmonary disease (COPD seen in real-life clinical settings are represented in randomized controlled trials (RCTs of COPD. It is thought that the stringent inclusion and exclusion criteria of RCTs may prevent the participation of patients with specific characteristics or risk factors.Methods: We surveyed a database of patients recruited into 35 placebo-controlled tiotropium RCTs and also conducted a systematic literature review of large-scale observational studies conducted in patients with a documented diagnosis of COPD between 1990 and 2013. Patient demographics and comorbidities with a high prevalence in patients with COPD were compared between the two patient populations at baseline. Using the Medical Dictionary for Regulatory Activities (MedDRA; v 14.0, patient comorbidities in the pooled tiotropium RCTs were classified according to system organ class, pharmacovigilance (PV endpoints, and Standardised MedDRA Queries to enable comparison with the observational studies.Results: We identified 24,555 patients in the pooled tiotropium RCTs and 61,361 patients among the 13 observational studies that met our

  12. The effect of lowering salt intake on ambulatory blood pressure to reduce cardiovascular risk in chronic kidney disease (LowSALT CKD study: protocol of a randomized trial

    Directory of Open Access Journals (Sweden)

    McMahon Emma J

    2012-10-01

    Full Text Available Abstract Background Despite evidence implicating dietary sodium in the pathogenesis of cardiovascular disease (CVD in chronic kidney disease (CKD, quality intervention trials in CKD patients are lacking. This study aims to investigate the effect of reducing sodium intake on blood pressure, risk factors for progression of CKD and other cardiovascular risk factors in CKD. Methods/design The LowSALT CKD study is a six week randomized-crossover trial assessing the effect of a moderate (180 mmol/day compared with a low (60 mmol/day sodium intake on cardiovascular risk factors and risk factors for kidney function decline in mild-moderate CKD (stage III-IV. The primary outcome of interest is 24-hour ambulatory blood pressure, with secondary outcomes including arterial stiffness (pulse wave velocity, proteinuria and fluid status. The randomized crossover trial (Phase 1 is supported by an ancillary trial (Phase 2 of longitudinal-observational design to assess the longer term effectiveness of sodium restriction. Phase 2 will continue measurement of outcomes as per Phase 1, with the addition of patient-centered outcomes, such as dietary adherence to sodium restriction (degree of adherence and barriers/enablers, quality of life and taste assessment. Discussion The LowSALT CKD study is an investigator-initiated study specifically designed to assess the proof-of-concept and efficacy of sodium restriction in patients with established CKD. Phase 2 will assess the longer term effectiveness of sodium restriction in the same participants, enhancing the translation of Phase 1 results into practice. This trial will provide much-needed insight into sodium restriction as a treatment option to reduce risk of CVD and CKD progression in CKD patients. Trial registration Universal Trial Number: U1111-1125-2149. Australian New Zealand Clinical Trials Registry Number: ACTRN12611001097932

  13. Complexities in understanding the role of compensation-related factors on recovery from whiplash-associated disorders : discussion paper 2

    NARCIS (Netherlands)

    Carroll, Linda J.; Connelly, Luke B.; Spearing, Natalie M.; Cote, Pierre; Buitenhuis, Jan; Kenardy, Justin

    2011-01-01

    Study Design. Focused discussion. Objective. To present some of the complexities in conducting research on the role of compensation and compensation-related factors in recovery from whiplash-associated disorders (WAD) and to suggest directions for future research. Summary of Background Data. There i

  14. Correlation of accident statistics to whiplash performance parameters using the RID 3D and BioRID dummy

    NARCIS (Netherlands)

    Cappon, H.J.; Hell, W.; Hoschopf, H.; Muser, M.; Song, E.; Wismans, J.S.H.M.

    2005-01-01

    Injury criteria are crucial in whiplash protection evaluations. Therefore, the real-life rear impact performance of eight car seats was compared with various injury criteria using linear correlation techniques. Two dummies, BioRID and RID 3D, and two types of pulses were used: generic and car specif

  15. Randomised, controlled trial of N-acetylcysteine for treatment of acute exacerbations of chronic obstructive pulmonary disease [ISRCTN21676344

    Directory of Open Access Journals (Sweden)

    Poole Phillippa J

    2004-12-01

    Full Text Available Abstract Background Prophylactic treatment with N-acetylcysteine (NAC for 3 months or more is associated with a reduction in the frequency of exacerbations of chronic obstructive pulmonary disease (COPD. This raises the question of whether treatment with NAC during an acute exacerbation will hasten recovery from the exacerbation. Methods We have examined this in a randomised, double-blind, placebo controlled trial. Subjects, admitted to hospital with an acute exacerbation of COPD, were randomised within 24 h of admission to treatment with NAC 600 mg b.d. (n = 25 or matching placebo (n = 25. Treatment continued for 7 days or until discharge (whichever occurred first. To be eligible subjects had to be ≥ 50 years, have an FEV1 ≤ 60% predicted, FEV1/VC ≤ 70% and ≥ 10 pack year smoking history. Subjects with asthma, heart failure, pneumonia and other respiratory diseases were excluded. All subjects received concurrent treatment with prednisone 40 mg/day, nebulised salbutamol 5 mg q.i.d and where appropriate antibiotics. FEV1, VC, SaO2 and breathlessness were measured 2 hours after a dose of nebulised salbutamol, at the same time each day. Breathlessness was measured on a seven point Likert scale. Results At baseline FEV1 (% predicted was 22% in the NAC group and 24% in the control group. There was no difference between the groups in the rate of change of FEV1, VC, SaO2 or breathlessness. Nor did the groups differ in the median length of stay in hospital (6 days for both groups. Conclusions Addition of NAC to treatment with corticosteroids and bronchodilators does not modify the outcome in acute exacerbations of COPD.

  16. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura : a double-blind randomised controlled trial

    NARCIS (Netherlands)

    Kuter, David J.; Bussel, James B.; Lyons, Roger M.; Pullarkat, Vinod; Gernsheimer, Terry B.; Senecal, Francis M.; Aledort, Louis M.; George, James N.; Kessler, Craig M.; Sanz, Miguel A.; Liebman, Howard A.; Slovick, Frank T.; de Wolf, J. Th M.; Bourgeois, Emmanuelle; Guthrie, Troy H.; Newland, Adrian; Wasser, Jeffrey S.; Hamburg, Solomon I.; Grande, Carlos; Lefrere, Francois; Lichtin, Alan Eli; Tarantino, Michael D.; Terebelo, Howard R.; Viallard, Jean-Francois; Cuevas, Francis J.; Go, Ronald S.; Henry, David H.; Redner, Robert L.; Rice, Lawrence; Schipperus, Martin R.; Guo, D. Matthew; Nichol, Janet L.

    2008-01-01

    Background Chronic immune thrombocytopenic purpura (ITP) is characterised by accelerated platelet destruction and decreased platelet production. Short-term administration of the thrombopoiesis-stimulating protein, romiplostim, has been shown to increase platelet counts in most patients with chronic

  17. A clinical trial comparing parenteral oxytetracyline and enrofloxacin on time to recovery in sheep lame with acute or chronic footrot in Kashmir, India

    Directory of Open Access Journals (Sweden)

    Kaler J

    2012-01-01

    Full Text Available Abstract Background No clinical trials have been conducted in India on the efficacy of parenteral antibacterials to treat footrot in sheep. In addition, there are no studies worldwide on the efficacy of parenteral antibacterials to treat chronic footrot. Sixty two sheep with acute footrot and 30 sheep with chronic footrot from 7 villages in Kashmir, India were recruited into two separate trials. Sheep with acute footrot were allocated to one of three treatments using stratified random sampling: long acting parenteral oxytetracycline, long acting parenteral enrofloxacin and topical application of potassium permanganate solution (a traditional treatment used by sheep farmers in India. In a quasi pre-post intervention design, sheep with chronic footrot that had not responded to treatment with potassium permanaganate were randomly allocated to treatment with one of the two parenteral antibacterials mentioned above. Sheep with acute footrot were treated on day 0 and those with chronic footrot on days 0, 3, 6 and 9. Sheep were monitored for up to 28 days after treatment. Time to recovery from lameness and initial healing of lesions was assessed using Kaplan-Meier survival curves, nonparametric log-rank and Wilcoxon sign-rank tests. Results There was significant correlation in recovery from lameness and presence of healing lesions in sheep with acute (r = 0.94 or chronic (r = 0.98 footrot. Sheep with acute footrot which were treated with parenteral antibacterials had a significantly more rapid recovery from lameness and had healing lesions (median = 7 days compared with those treated with topical potassium permanganate solution (less than 50% recovered in 28 days. The median time to recovery in sheep with chronic footrot treated with either antibacterial was 17 days; this was significantly lower than the median of 75 days lame before treatment with antibacterials. The median time to recovery for both acute and chronic footrot increased as the severity

  18. Analysis of right anterolateral impacts: the effect of trunk flexion on the cervical muscle whiplash response

    Directory of Open Access Journals (Sweden)

    Narayan Yogesh

    2006-05-01

    Full Text Available Abstract Background The cervical muscles are considered a potential site of whiplash injury, and there is a need to understand the cervical muscle response under non-conventional whiplash impact scenarios, including variable body position and impact direction. There is no data, however, on the effect of occupant position on the muscle response to frontal impacts. Therefore, the objective of the study was to measure cervical muscle response to graded right anterolateral impacts. Methods Twenty volunteers were subjected to right anterolateral impacts of 4.3, 7.8, 10.6, and 12.8 m/s2 acceleration with their trunk flexed forward 45 degrees and laterally flexed right or left by 45 degrees. Bilateral EMG of the sternocleidomastoids, trapezii, and splenii capitis and acceleration of the sled, torso, and head were measured. Results and discussion With either direction of trunk flexion at impact, the trapezius EMGs increased with increasing acceleration (p Conclusion When the subject sits with trunk flexed out of neutral posture at the time of anterolateral impact, the cervical muscle response is dramatically reduced compared to frontal impacts with the trunk in neutral posture. In the absence of bodily impact, the flexed trunk posture appears to produce a biomechanical response that would decrease the likelihood of cervical muscle injury in low velocity impacts.

  19. Effects of Jungsongouhyul Herbal Acupuncture(JSO Multi-treatment for Whiplash Injury by Traffic Accident

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    Seol Hyun

    2005-02-01

    Full Text Available Objectives : To examine the effects of JSO multi-treatment for whiplash injury patients by traffic accident. Interventions : Nonrandomized, Nonblinded compartson of the JSO+Acupuncture and Acupuncture Treatment. Main Outcome Measures : Subjective evaluation was followed by Clinical Grade and VAS after 5 times treatments. The SPSS 10.0 for windows was used to analyze the date and the Wilcoxon signed rank test and Mann-Whitney U-testwere used to verify the results. Results : The following results were obtained ; 1. Clinical Grade of the JSO+Acupuncture treatment was centralized to Gr II(50% before treatment. After 5 times treatments, it was centralized to Gr I(58.3%. Also Clinical Grade was significantly changed from GR ll to Gr I(p<0.0002. 2. Clinical Grade of the Acupuncture treatment was centralize(d to Gr II(54.2% before treament. After 5 times treament, it was tend to cenualize to Gr I(50%. But Clinical Grade was still remained at Gr II(p<0.001 3. VAS of change between JSO+Acupuncture and Acupuncture treatment, Vas of JSO+Acupuncture was significantly decreased (p<0.003. C onclusion : It is suggested that JSO multi-treatment has development-effectiveness on whiplash injury patients by traffic accident.

  20. The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: A randomized, controlled trial

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    Laura Amy Massee

    2015-05-01

    Full Text Available Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa’s effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n=40, age M= 24.13 years, SD = 4.47 years was conducted to investigate the effects of both acute (same-day and sub-chronic (daily for four-weeks 250mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-minute cycles of the Cognitive Demand Battery (CDB encompassing two serial subtraction tasks (Serial Threes and Sevens, a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerised Cognitive Assessment Battery (SUCCAB was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763. Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN126130006 26763&ddlSearch=Registered

  1. Do X-ray-occult fractures play a role in chronic pain following a whiplash injury?

    DEFF Research Database (Denmark)

    Hertzum-Larsen, Rasmus; Petersen, Henrik; Kasch, Helge

    2014-01-01

    symptoms following an MVA was invited to have a cervical SPECT shortly post injury and again 6 months later. Associations between occult fractures and pain levels at baseline, 6 and 12 months of follow-up were analyzed. Eighty-eight patients had baseline SPECT performed at median 15 days (range 3-28) post...... injury, but only 49 patients accepted to have the follow-up SPECT at 6 months. Abnormal SPECT, defined as minimum one area of focal uptake, was seen in 32 patients at baseline, reflecting an occult fracture. Occult fractures were not associated with pain levels, neither at baseline nor at follow...

  2. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial

    Directory of Open Access Journals (Sweden)

    Seo Byung-Kwan

    2013-01-01

    Full Text Available Abstract Background Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain. Methods/design This study is a randomized, double-blinded, sham-controlled clinical trial with two parallel arms. Fifty-four patients between 18 and 65 years of age with non-radicular chronic low back pain experiencing low back pain lasting for at least the previous three months and ≥4 points on a 10-cm visual analog scale for bothersomeness at the time of screening will be included in the study. Participants will be randomly allocated into the real or sham bee venom acupuncture groups and treated by the same protocol to minimize non-specific and placebo effects. Patients, assessors, acupuncturists and researchers who prepare the real or sham bee venom acupuncture experiments will be blinded to group allocation. All procedures, including the bee venom acupuncture increment protocol administered into predefined acupoints, are designed by a process of consensus with experts and previous researchers according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Bothersomeness measured using a visual analogue scale will be the primary outcome. Back pain-related dysfunction, pain, quality of life, depressive symptoms and adverse experiences will be measured using the visual analogue scale for pain intensity, the Oswestry Disability Index, the EuroQol 5-Dimension, and the Beck’s Depression Inventory. These measures will be recorded at baseline and 1, 2, 3, 4, 8 and 12 weeks. Discussion The results from this study

  3. A multidisciplinary cognitive behavioural programme for coping with chronic neuropathic pain following spinal cord injury: the protocol of the CONECSI trial

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    Dijkstra Catja A

    2010-10-01

    Full Text Available Abstract Background Most people with a spinal cord injury rate neuropathic pain as one of the most difficult problems to manage and there are no medical treatments that provide satisfactory pain relief in most people. Furthermore, psychosocial factors have been considered in the maintenance and aggravation of neuropathic spinal cord injury pain. Psychological interventions to support people with spinal cord injury to deal with neuropathic pain, however, are sparse. The primary aim of the CONECSI (COping with NEuropathiC Spinal cord Injury pain trial is to evaluate the effects of a multidisciplinary cognitive behavioural treatment programme on pain intensity and pain-related disability, and secondary on mood, participation in activities, and life satisfaction. Methods/Design CONECSI is a multicentre randomised controlled trial. A sample of 60 persons with chronic neuropathic spinal cord injury pain will be recruited from four rehabilitation centres and randomised to an intervention group or a waiting list control group. The control group will be invited for the programme six months after the intervention group. Main inclusion criteria are: having chronic (> 6 months neuropathic spinal cord injury pain as the worst pain complaint and rating the pain intensity in the last week as 40 or more on a 0-100 scale. The intervention consists of educational, cognitive, and behavioural elements and encompasses 11 sessions over a 3-month period. Each meeting will be supervised by a local psychologist and physical therapist. Measurements will be perfomed before starting the programme/entering the control group, and at 3, 6, 9, and 12 months. Primary outcomes are pain intensity and pain-related disability (Chronic Pain Grade questionnaire. Secondary outcomes are mood (Hospital Anxiety and Depression Scale, participation in activities (Utrecht Activities List, and life satisfaction (Life Satisfaction Questionnaire. Pain coping and pain cognitions will be

  4. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial.

    Science.gov (United States)

    Saper, Robert B; Boah, Ama R; Keosaian, Julia; Cerrada, Christian; Weinberg, Janice; Sherman, Karen J

    2013-01-01

    Background. Previous studies have demonstrated that once-weekly yoga classes are effective for chronic low back pain (cLBP) in white adults with high socioeconomic status. The comparative effectiveness of twice-weekly classes and generalizability to racially diverse low income populations are unknown. Methods. We conducted a 12-week randomized, parallel-group, dosing trial for 95 adults recruited from an urban safety-net hospital and five community health centers comparing once-weekly (n = 49) versus twice-weekly (n = 46) standardized yoga classes supplemented by home practice. Primary outcomes were change from baseline to 12 weeks in pain (11-point scale) and back-related function (23-point modified Roland-Morris Disability Questionnaire). Results. 82% of participants were nonwhite; 77% had annual household incomes back pain and impairment. Pain and back-related function improved within both groups (P yoga classes were similarly effective for predominantly low income minority adults with moderate to severe chronic low back pain. This trial is registered with ClinicalTrials.gov NCT01761617.

  5. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Using a Low-Frequency Magnetic Field in the Treatment of Musculoskeletal Chronic Pain

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    Alex W Thomas

    2007-01-01

    Full Text Available Exposure to a specific pulsed electromagnetic field (PEMF has been shown to produce analgesic (antinociceptive effects in many organisms. In a randomized, double-blind, sham-controlled clinical trial, patients with either chronic generalized pain from fibromyalgia (FM or chronic localized musculoskeletal or inflammatory pain were exposed to a PEMF (400 μT through a portable device fitted to their head during twice-daily 40 min treatments over seven days. The effect of this PEMF on pain reduction was recorded using a visual analogue scale. A differential effect of PEMF over sham treatment was noticed in patients with FM, which approached statistical significance (P=0.06 despite low numbers (n=17; this effect was not evident in those without FM (P=0.93; n=15. PEMF may be a novel, safe and effective therapeutic tool for use in at least certain subsets of patients with chronic, nonmalignant pain. Clearly, however, a larger randomized, double-blind clinical trial with just FM patients is warranted.

  6. Chronic Chagas cardiomyopathy: a review of the main pathogenic mechanisms and the efficacy of aetiological treatment following the BENznidazole Evaluation for Interrupting Trypanosomiasis (BENEFIT) trial

    Science.gov (United States)

    Rassi, Anis; Marin, José Antonio; Rassi, Anis

    2017-01-01

    Chagas cardiomyopathy is the most frequent and most severe manifestation of chronic Chagas disease, and is one of the leading causes of morbidity and death in Latin America. Although the pathogenesis of Chagas cardiomyopathy is incompletely understood, it may involve several mechanisms, including parasite-dependent myocardial damage, immune-mediated myocardial injury (induced by the parasite itself and by self-antigens), and microvascular and neurogenic disturbances. In the past three decades, a consensus has emerged that parasite persistence is crucial to the development and progression of Chagas cardiomyopathy. In this context, antiparasitic treatment in the chronic phase of Chagas disease could prevent complications related to the disease. However, according to the results of the BENEFIT trial, benznidazole seems to have no benefit for arresting disease progression in patients with chronic Chagas cardiomyopathy. In this review, we give an update on the main pathogenic mechanisms of Chagas disease, and re-examine and discuss the results of the BENEFIT trial, together with its limitations and implications. PMID:28225900

  7. Transcutaneous electrical nerve stimulation (TENS in the symptomatic management of chronic prostatitis/chronic pelvic pain syndrome: a placebo-control randomized trial

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    Sikiru Lamina

    2008-12-01

    Full Text Available OBJECTIVE: The aim of the study was to investigate the therapeutic efficacy of transcutaneous electrical nerve stimulation (TENS in the symptomatic management of chronic prostatitis pain/chronic pelvic pain syndrome. DESIGN: A pretest, posttest randomized double blind design was used in data collection. PARTICIPANT: Twenty-four patients diagnosed with chronic prostatitis- category IIIA and IIIB of the National Institute of Health Chronic Pain (NIH-CP were referred for physiotherapy from the Urology department. Intervention: Pre treatment pain level was assessed using the NIH-CP (pain domain index. The TENS group received TENS treatment, 5 times per week for a period of 4 weeks (mean treatment frequency, intensity, pulse width and duration of 60Hz, 100µS, 25mA and 20 minutes respectively. The Analgesic group received no TENS treatment but continued analgesics; the Control group received no TENS and Analgesic but placebo. All subjects were placed on antibiotics throughout the treatment period. Outcome measures: Post-treatment pain level was also assessed using NIH-CP pain index. RESULT: Findings of the study revealed significant effect of TENS on chronic prostatitis pain at p < 0.05. CONCLUSION: TENS is an effective means of non-invasive symptomatic management of chronic prostatitis pain.

  8. The Chronic Care for age-related macular degeneration study (CHARMED): Study protocol for a randomized controlled trial

    OpenAIRE

    Frei, A.; Woitzek, K; M. Wang; Held, U; Rosemann, T

    2011-01-01

    BACKGROUND: Neovascular age-related macular degeneration is the leading cause of irreversible blindness in people 50 years of age or older in the developed world. As in other chronic diseases, several effective treatments are available, but in clinical daily practice there is an evidence performance gap. The Chronic Care Model represents an evidence-based framework for the care of chronically ill patients and aims at closing that gap. However, no data are available regarding patients with neo...

  9. The chronic care for age-related macular degeneration study (CHARMED): Study protocol for a randomized controlled trial

    OpenAIRE

    Held Ulrike; Wang Mathyas; Woitzek Katja; Frei Anja; Rosemann Thomas

    2011-01-01

    Abstract Background Neovascular age-related macular degeneration is the leading cause of irreversible blindness in people 50 years of age or older in the developed world. As in other chronic diseases, several effective treatments are available, but in clinical daily practice there is an evidence performance gap. The Chronic Care Model represents an evidence-based framework for the care of chronically ill patients and aims at closing that gap. However, no data are available regarding patients ...

  10. Peginterferon alpha-2a is associated with higher sustained virological response than peginterferon alfa-2b in chronic hepatitis C: systematic review of randomized trials

    DEFF Research Database (Denmark)

    Awad, Tahany; Thorlund, Kristian; Hauser, Goran;

    2010-01-01

    A combination of weekly pegylated interferon (peginterferon) alpha and daily ribavirin represents the standard of care for the treatment of chronic hepatitis C according to current guidelines. It is not established which of the two licensed products (peginterferon alpha-2a or peginterferon alfa-2b......) is most effective. We performed a systematic review of head-to-head randomized trials to assess the benefits and harms of the two treatments. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and LILACS through July 2009. Using standardized forms, two reviewers independently......-2a is associated with higher SVR than peginterferon alfa-2b. However, the paucity of evidence on adverse events curbs the decision to definitively recommend one peginterferon over the other, because any potential benefit must outweigh the risk of harm....

  11. Simulated Pain and Cervical Motion in Patients with Chronic Disorders of the Cervical Spine

    OpenAIRE

    Zeevi Dvir; Noga Gal-Eshel; Boaz Shamir; Evgeny Pevzner; Chava Peretz; Nachshon Knoller

    2004-01-01

    The primary objective of the present study was to determine how simulated severe cervical pain affects cervical motion in patients suffering from two distinct chronic cervical disorders: whiplash (n=25) and degenerative changes (n=25). The second objective was to derive an index that would allow the differentiation of maximal from submaximal performances of cervical range of motion. Patients first performed maximal movement of the head (maximal effort) in each of the six primary directions an...

  12. A randomized, double-blind, placebo-controlled trial of the effect of subcutaneous immunoglobulin on muscular performance in chronic inflammatory demyelinating polyneuropathy

    DEFF Research Database (Denmark)

    Markvardsen, Lars Høj; Harbo, Thomas; Sindrup, Søren Hein;

    We hypothesized that subcutaneous administration of immunoglobulins (SCIG) in chronic inflammatory demyelinating polyneuropathy (CIDP) is feasible and safe and superior to treatment with saline for the performance of muscle strength. Patients with motor involvement in maintenance therapy with int......We hypothesized that subcutaneous administration of immunoglobulins (SCIG) in chronic inflammatory demyelinating polyneuropathy (CIDP) is feasible and safe and superior to treatment with saline for the performance of muscle strength. Patients with motor involvement in maintenance therapy...... with intravenous immunoglobulin (IVIg) fulfilling the EFNS/PNS criteria for CIDP, aged 18-80 years, were randomised either to SCIG at a dose determined from their pre-study IVIg dose or to subcutaneous saline given twice or thrice weekly for 12 weeks at home. At the start and end of the trial, as well as two weeks...... of immunoglobulins in CIDP is feasible, safe and effective and seems an attractive alternative to IVIg....

  13. D-cycloserine for treatment of numbing and avoidance in chronic post traumatic stress disorder: A randomized, double blind, clinical trial

    Directory of Open Access Journals (Sweden)

    Abbas Attari

    2014-01-01

    Full Text Available Background: Posttraumatic stress disorder (PTSD tends to follow a chronic and treatment resistant course. Avoidance and numbing are symptoms associated with chronicity and impaired life quality. As D-cycloserine (DCS can facilitate extinction of conditioned fear, we aimed to investigate the efficacy and tolerability of DCS for the treatment of numbing and avoidance in chronic PTSD. Materials and Methods: This was an 11-week, double-blind, cross-over trial conducted in 2012 and 2013, in out-patient University psychiatry clinics. The studied population was selected randomly among outpatients with chronic combat-related PTSD (based on DSM-IV-TR criteria for chronic PTSD, who were males over 18 and <65 years of age (n = 319. Seventy six eligible patients were randomly assigned to two groups. Patients entered a 1-week run-in period. The groups received either an add-on treatment of DCS (50 mg daily, or placebo (4-week. After a 2-week washout, the groups received cross-over treatments (4-week. Clinical, paraclinical assessments, and clinician administered PTSD scale (CAPS were performed at baseline, and at the end of the 1 st , 5 th , and 11 th week. Side-effects were also evaluated. The overall number of avoidance and numbing symptoms, symptom frequency, and symptom intensity were measured separately. Results: Neither frequency nor number of symptoms was significantly influenced. However, DCS treatment demonstrates a significant decrease in intensity of avoidance/numbing symptoms, and improvement in function (mean [standard error] = −4.2 [1.5], P = 0.008. Side-effects were not statistically remarkable. Conclusion: D-cycloserine can help as an adjunctive treatment to alleviate numbing and avoidance in combat-related chronic PTSD.

  14. Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: Rationale and protocol of a randomised trial

    NARCIS (Netherlands)

    Wilbrink, Leopoldine A.; Teernstra, Onno P.M.; Haan, Joost; Zwet, van Erik W.; Evers, Silvia M.A.A.; Spincemaille, Geert H.; Veltink, Peter H.; Mulleners, Wim; Brand, Ronald; Huygen, Frank J.P.M.; Jensen, Rigmor H.; Paemeleire, Koen; Goadsby, Peter J.; Visser-Vandewalle, Veerle; Ferrari, Michel D.

    2013-01-01

    Background: About 10% of cluster headache patients have the chronic form. At least 10% of this chronic group is intractable to or cannot tolerate medical treatment. Open pilot studies suggest that occipital nerve stimulation (ONS) might offer effective prevention in these patients. Controlled neurom

  15. Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial

    DEFF Research Database (Denmark)

    Iversen, Trond; Solberg, Tore K; Romner, Bertil;

    2011-01-01

    To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks).......To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks)....

  16. Autologous platelet-rich plasma compared with whole blood for the treatment of chronic plantar fasciitis; a comparative clinical trial

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    Babak Vahdatpour

    2016-01-01

    Conclusions: Significant improvement in pain and function, as well as decrease in plantar fascia thickness, was observed by intralesional injection of the PRP and WB in patients with chronic PF. The study results indicate similar effectiveness between PRP and WB for the treatment of chronic PF in short-term.

  17. Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo

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    Vos-Vromans Desirée CWM

    2012-05-01

    Full Text Available Abstract Background Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome. Methods One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators—self-efficacy, causal attributions and present-centred attention-awareness—will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life

  18. Efficacy and safety of Myofascial-meridian Release Acupuncture (MMRA) for chronic neck pain: a study protocol for randomized, patient- and assessor-blinded, sham controlled trial

    OpenAIRE

    Lee, Seunghoon; Nam, Dongwoo; Leem, Jungtae; Han, Gajin; Lee, Seungmin; Lee,Junhee

    2016-01-01

    Background The purpose of this study is to evaluate the efficacy and safety of myofascial-meridian release acupuncture (MMRA) in the treatment of chronic neck pain compared with sham acupuncture. Methods/design A protocol for a randomized, patient- and assessor-blinded, sham controlled parallel trial is presented. Seventy-four participants with a ≥3 month history of neck pain and a score of ≥4 on the 11-point pain intensity numerical rating scale (PI-NRS) will be randomly assigned to the MMRA...

  19. Efficacy and safety of bilateral continuous theta burst stimulation (cTBS for the treatment of chronic tinnitus: design of a three-armed randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Plontke Stefan K

    2009-08-01

    Full Text Available Abstract Background Tinnitus, the perception of sound and noise in absence of an auditory stimulus, has been shown to be associated with maladaptive neuronal reorganization and increased activity of the temporoparietal cortex. Transient modulation of tinnitus by repetitive transcranial magnetic stimulation (rTMS indicated that these areas are critically involved in the pathophysiology of tinnitus and suggested new treatment strategies. However, the therapeutic efficacy of rTMS in tinnitus is still unclear, individual response is variable, and the optimal stimulation area disputable. Recently, continuous theta burst stimulation (cTBS has been put forward as an effective rTMS protocol for the reduction of pathologically enhanced cortical excitability. Methods 48 patients with chronic subjective tinnitus will be included in this randomized, placebo controlled, three-arm trial. The treatment consists of two trains of cTBS applied bilaterally to the secondary auditory cortex, the temporoparietal associaction cortex, or to the lower occiput (sham condition every working day for four weeks. Primary outcome measure is the change of tinnitus distress as quantified by the Tinnitus Questionnaire (TQ. Secondary outcome measures are tinnitus loudness and annoyance as well as tinnitus change during and after treatment. Audiologic and speech audiometric measurements will be performed to assess potential side effects. The aim of the present trail is to investigate effectiveness and safety of a four weeks cTBS treatment on chronic tinnitus and to compare two areas of stimulation. The results will contribute to clarify the therapeutic capacity of rTMS in tinnitus. Trial registration The trial was registered with the clinical trials register of http://www.clinicaltrials.gov (NCT00518024.

  20. Acupuncture for chronic low back pain in long-term follow-up: a meta-analysis of 13 randomized controlled trials.

    Science.gov (United States)

    Xu, Mai; Yan, Shi; Yin, Xu; Li, Xiuyang; Gao, Shuguang; Han, Rui; Wei, Licheng; Luo, Wei; Lei, Guanghua

    2013-01-01

    Chronic low back pain is one of the most common reasons that people seek medical treatment, and the consequent disability creates a great financial burden on individuals and society. The etiology of chronic low back pain is not clear, which means it is often refractory to treatment. Acupuncture has been reported to be effective in providing symptomatic relief of chronic low back pain. However, it is not known whether the effects of acupuncture are due to the needling itself or nonspecific effects arising from the manipulation. To determine the effectiveness of acupuncture therapy, a meta-analysis was performed to compare acupuncture with sham acupuncture and other treatments. Overall, 2678 patients were identified from thirteen randomized controlled trials. The meta-analysis was performed by a random model (Cohen's test), using the I-square test for heterogeneity and Begg's test to assess for publication bias. Clinical outcomes were evaluated by pain intensity, disability, spinal flexion, and quality of life. Compared with no treatment, acupuncture achieved better outcomes in terms of pain relief, disability recovery and better quality of life, but these effects were not observed when compared to sham acupuncture. Acupuncture achieved better outcomes when compared with other treatments. No publication bias was detected. Acupuncture is an effective treatment for chronic low back pain, but this effect is likely to be produced by the nonspecific effects of manipulation.

  1. Assessing the effectiveness of ‘pulse radiofrequency treatment of dorsal root ganglion’ in patients with chronic lumbar radicular pain: study protocol for a randomized control trial

    Directory of Open Access Journals (Sweden)

    Shanthanna Harsha

    2012-04-01

    Full Text Available Abstract Background Chronic lumbar radicular pain can be described as neuropathic pain along the distribution of a particular nerve root. The dorsal root ganglion has been implicated in its pathogenesis by giving rise to abnormal impulse generation as a result of irritation, direct compression and sensitization. Chronic lumbar radicular pain is commonly treated with medications, physiotherapy and epidural steroid injections. Epidural steroid injections are associated with several common and rarer side effects such as spinal cord infarction and death. It is essential and advantageous to look for alternate interventions which could be effective with fewer side effects. Pulse radio frequency is a relatively new technique and is less destructive then conventional radiofrequency. Safety and effectiveness of pulse radio frequency in neuropathic pain has been demonstrated in animal and humans studies. Although its effects on dorsal root ganglion have been studied in animals there is only one randomized control trial in literature demonstrating its effectiveness in cervical radicular pain and none in lumbar radicular pain. Our primary objective is to study the feasibility of a larger trial in terms of recruitment and methodology. Secondary objectives are to compare the treatment effects and side effects. Methods/designs This is a single-center, parallel, placebo-controlled, triple-blinded (patients, care-givers, and outcome assessors, randomized control trial. Participants will have a history of chronic lumbar radicular pain for at least 4 months in duration. Once randomized, all patients will have an intervention involving fluoroscopy guided needle placement to appropriate dorsal root ganglion. After test stimulation in both groups; the study group will have a pulse radio frequency treatment at 42°C for 120 s to the dorsal root ganglion, with the control group having only low intensity test stimulation for the same duration. Primary outcome is to

  2. Multidisciplinary outpatient care program for patients with chronic low back pain: design of a randomized controlled trial and cost-effectiveness study [ISRCTN28478651

    Directory of Open Access Journals (Sweden)

    Anema Johannes R

    2007-09-01

    Full Text Available Abstract Background Chronic low back pain (LBP is a major public and occupational health problem, which is associated with very high costs. Although medical costs for chronic LBP are high, most costs are related to productivity losses due to sick leave. In general, the prognosis for return to work (RTW is good but a minority of patients will be absent long-term from work. Research shows that work related problems are associated with an increase in seeking medical care and sick leave. Usual medical care of patients is however, not specifically aimed at RTW. The objective is to present the design of a randomized controlled trial, i.e. the BRIDGE-study, evaluating the effectiveness in improving RTW and cost-effectiveness of a multidisciplinary outpatient care program situated in both primary and outpatient care setting compared with usual clinical medical care for patients with chronic LBP. Methods/Design The design is a randomized controlled trial with an economic evaluation alongside. The study population consists of patients with chronic LBP who are completely or partially sick listed and visit an outpatient clinic of one of the participating hospitals in Amsterdam (the Netherlands. Two interventions will be compared. 1. a multidisciplinary outpatient care program consisting of a workplace intervention based on participatory ergonomics, and a graded activity program using cognitive behavioural principles. 2. usual care provided by the medical specialist, the occupational physician, the patient's general practitioner and allied health professionals. The primary outcome measure is sick leave duration until full RTW. Sick leave duration is measured monthly by self-report during one year. Data on sick leave during one-year follow-up are also requested form the employers. Secondary outcome measures are pain intensity, functional status, pain coping, patient satisfaction and quality of life. Outcome measures are assessed before randomization and 3, 6

  3. Azithromycin and cough-specific health status in patients with chronic obstructive pulmonary disease and chronic cough : a randomised controlled trial

    NARCIS (Netherlands)

    Berkhof, Farida F.; Doornewaard-ten Hertog, Nynke E.; Uil, Steven M.; Kerstjens, Huib A. M.; van den Berg, Jan W. K.

    2013-01-01

    Background: Macrolides reduce exacerbations in patients with COPD. Their effects on health status has not been assessed as primary outcome and is less clear. This study assessed the effects of prophylactic azithromycin on cough-specific health status in COPD-patients with chronic productive cough. M

  4. Are People With Whiplash-Associated Neck Pain Different from People With Nonspecific Neck Pain?

    DEFF Research Database (Denmark)

    Anstey, Ricci; Kongsted, Alice; Kamper, Steven

    2016-01-01

    Study Design Secondary analysis of a prospective cohort study with cross sectional and longitudinal analyses. Background The clinical importance of a history of whiplash associated disorder (WAD) in people with neck pain remains uncertain. Objective To compare people with WAD to people with non......-specific neck pain, in terms of their baseline characteristics, and pain and disability outcomes over 1 year. Methods Consecutive patients with neck pain presenting to a secondary care spine centre answered a comprehensive self-report questionnaire and underwent a physical examination. Patients were classified...... into either WAD or non-specific neck pain groups. We compared the outcomes of baseline characteristics of the 2 groups, as well as pain intensity and activity limitation at 6 and 12-month follow-up. Results 2578 participants were included in the study. Of these 488 (19%) were classified as having WAD...

  5. Long acting β2 agonists for stable chronic obstructive pulmonary disease with poor reversibility: a systematic review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Mensinkai Shaila

    2004-08-01

    Full Text Available Abstract Background The long acting β2-agonists, salmeterol and formoterol, have been recommended, by some, as first line treatment of stable chronic obstructive pulmonary disease (COPD. We reviewed evidence of efficacy and safety when compared with placebo or anticholinergic agents in patients with poorly reversible COPD. Methods After searching MEDLINE, EMBASE, HealthSTAR, BIOSIS Previews, PASCAL, ToxFile, SciSearch, the Cochrane Library, and PubMed, as well as Web sites, selected journals, reference lists, and contacting drug manufacturers, two reviewers independently screened reports of randomised controlled trials of parallel or crossover design lasting four weeks or longer and including patients with a forced expiratory volume in one second (FEV1 ≤ 75% of predicted, a ratio of FEV1 to forced vital capacity (FVC ≤ 88% of predicted, and Results Twelve trials satisfied our inclusion criteria; eight were high quality (Jadad score >2 and four were low quality (≤ 2. The adequacy of allocation concealment was unclear in all of them. We did not perform a meta-analysis due to differences in trial design and how outcomes were reported. Two trials comparing salmeterol with ipratropium did not detect differences; one trial comparing formoterol and ipratropium described greater improvement with formoterol in morning PEFR (15.3 versus 7.1 l/min, p = 0.040. Of twelve trials comparing long acting β2 agonists with placebo, six reported no improvement in exercise capacity, eleven reported improvements in FEV1 lung function (one reported no improvement, six reported less rescue inhaler usage (one reported no difference and five reported improved dyspnea scores (two reported no improvement. Differences in quality of life were detected in one salmeterol trial ; however, two salmeterol, and one formoterol trial reported no differences. Adverse effects of interest were not reported. Conclusion In terms of clinical outcomes and safety, we could not find

  6. A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT) Trial).

    LENUS (Irish Health Repository)

    Hurley, Deirdre A

    2009-01-01

    BACKGROUND: Chronic low back pain (CLBP) is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief\\/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven. METHODS AND DESIGN: This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be embedded in the research

  7. Postmortem MSCT Diagnosis of Whiplash Injuries in a Traffic Accident:A Case Report and Review of the Literature

    Institute of Scientific and Technical Information of China (English)

    CHEN Min; CHEN Yi-jiu; HUANG Ping; WAN Lei; ZHANG Jian-hua; LIU Ning-guo; ZOU Dong-hua; LI Zheng-dong; SHAO Yu; QIN Zhi-qiang

    2014-01-01

    A 45-year-old male car driver died in a traffic accident of four cars rear-end collision on the highway. He was found to have died after a respiratory and cardiac arrest at the scene. No sign of skin injuries was observed from the external inspection. The autopsy was not permitted by the family members because of the local culture. Multislice computed tomography (MSCT) was applied to the current case, showing dislocation of C3~4 cervical vertebrae with Ⅱ degree, C4 vertebral plate fractures, and spinal stenosis. Post-mortem MSCT confirmed the diagnosis as whiplash injuries. MSCT was verified to be effective in showing the severity of whiplash injuries, thus providing certain objective evidence for medicolegal expertise.

  8. The relationship between insurance claim closure and recovery after traffic injuries for individuals with whiplash associated disorders

    DEFF Research Database (Denmark)

    Boyle, Eleanor; Cassidy, J. David; Côté, Pierre;

    2016-01-01

    PURPOSE: The purpose of this study was to determine if time to claim closure was similar to time to self-reported recovery in a no fault motor vehicle collision insurance system. METHOD: A prospective cohort of traffic injured adults with a whiplash-associated disorder (WAD) was assembled. We...... excluded participants who applied for benefits after 42 days of the collision, who were in hospital for more than two days and participants who were not followed up at least once after their injury. Questionnaires were completed at baseline, six weeks, three-, six-, nine- and 12-months after the collision...... Time to claim closure as an outcome measure for whiplash-associated disorders has been criticized in the literature because it is thought that closure is not reflective of the health status of the individual. We found that claim closure was associated with lower levels of disability, but the time...

  9. Postmortem MSCT diagnosis of whiplash injuries in a traffic accident: a case report and review of the literature.

    Science.gov (United States)

    Chen, Min; Huang, Ping; Wan, Lei; Zhang, Jian-Hua; Liu, Ning-Guo; Zou, Dong-Hua; Li, Zheng-Dong; Shao, Yu; Qin, Zhi-Qiang; Chen, Yi-Jiu

    2014-04-01

    A 45-year-old male car driver died in a traffic accident of four cars rear-end collision on the highway. He was found to have died after a respiratory and cardiac arrest at the scene. No sign of skin injuries was observed from the external inspection. The autopsy was not permitted by the family members because of the local culture. Multislice computed tomography (MSCT) was applied to the current case, showing dislocation of C3-4 cervical vertebrae with II degree, C4 vertebral plate fractures, and spinal stenosis. Post-mortem MSCT confirmed the diagnosis as whiplash injuries. MSCT was verified to be effective in showing the severity of whiplash injuries, thus providing certain objective evidence for medicolegal expertise.

  10. Tratamiento osteopático en una lesión por Whiplash. Caso clínico

    OpenAIRE

    Ruiz Morcillo, Irene

    2008-01-01

    Introducción: El caso que presentamos a continuación se trata de un hombre de 25 años. Acude a consulta a los diez días de sufrir un accidente de tráfico y con un diagnóstico médico de whiplash o latigazo cervical. El paciente refiere dolor y disminución de la movilidad en la región cervical, dorsal alta, lumbosacra y mareos leves desde el accidente. Objetivos: Explicar el mecanismo de la lesión por Whiplash; valoración de los resultados obtenidos tras el tratamiento osteopátic...

  11. Ziprasidone versus olanzapine, risperidone or quetiapine in patients with chronic schizophrenia: a 12-week open-label, multicentre clinical trial

    DEFF Research Database (Denmark)

    Lublin, Henrik; Haug, Hans-Joachim; Koponen, Hannu

    2009-01-01

    The efficacy, safety and tolerability of ziprasidone versus the comparators olanzapine, risperidone or quetiapine were investigated in adult patients with chronic schizophrenia, schizoaffective and schizophreniform disorders, with lack of efficacy or intolerance to their previous antipsychotic tr...

  12. Nonlinear Exercise Training in Advanced Chronic Obstructive Pulmonary Disease Is Superior to Traditional Exercise Training A Randomized Trial

    NARCIS (Netherlands)

    Klijn, Peter; van Keimpema, Anton; Legemaat, Monique; Gosselink, Rik; van Stel, Henk

    2013-01-01

    Rationale: The optimal exercise training intensity and strategy for individualized exercise training in chronic obstructive pulmonary disease (COPD) is not clear. Objectives: This study compares the effects of nonlinear periodized exercise (NLPE) training used in athletes to traditional endurance an

  13. Rationale and trial design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes

    DEFF Research Database (Denmark)

    de Zeeuw, Dick; Akizawa, Tadao; Agarwal, Rajiv

    2013-01-01

    Chronic kidney disease (CKD) associated with type 2 diabetes mellitus constitutes a global epidemic complicated by considerable renal and cardiovascular morbidity and mortality, despite the provision of inhibitors of the renin-angiotensin-aldosterone system (RAAS). Bardoxolone methyl, a synthetic...

  14. Inspiratory muscle training protocol for patients with chronic obstructive pulmonary disease (IMTCO study): a multicentre randomised controlled trial

    NARCIS (Netherlands)

    Charususin, N.; Gosselink, R.; Decramer, M.; McConnell, A.; Saey, D.; Maltais, F.; Derom, E.; Vermeersch, S.; Helvoort, H.A. van; Heijdra, Y.F.; Klaassen, M.; Glockl, R.; Kenn, K.; Langer, D.

    2013-01-01

    INTRODUCTION: Inspiratory muscle training (IMT) has been applied during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD). However, it remains unclear if the addition of IMT to a general exercise training programme leads to additional clinically relevant improvem

  15. Up-dosing of non-sedating antihistamines in chronic urticaria: Need for well-designed clinical trials in India

    OpenAIRE

    Anant D. Patil

    2014-01-01

    Urticaria is a heterogeneous group of diseases. Chronic urticaria significantly impacts quality-of-life of patients. Second generation, non-sedating antihistamines are recommended as first line treatment for chronic spontaneous urticaria. In patients with inadequate control of symptoms, increase in dosage of non-sedating antihistamines up to four fold has been recommended. This recommendation is based on low cost, good safety and good evidence of efficacy of non-sedating, second generation an...

  16. Helicobacter Pylori in periodontal pockets of chronic periodontitis patients with and without type II diabetes mellitus: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Savita Sambashivaiah

    2011-09-01

    Full Text Available This randomized controlled study evaluated the association of Helicobacter pylori (H. pylori with chronic periodontitis patients with and without type II Diabetes Mellitus. H. pylori is considered to be a pathogen responsible for gastritis, peptic ulcers and a risk factor for gastric cancer. The aim of the present study was to evaluate the association of H. pylori with chronic periodontitis patients with and without type II diabetes mellitus before and after treatment. The prevalence of H. pylori in periodontal pockets was determined by rapid urease test in a 36 patients, which were grouped as Group 1 (Healthy subjects, Group II (chronic periodontitis patients and Group III (Chronic periodontitis patients with Type II Diabetes Mellitus, 12 in each group before treatment by collecting plaque samples. After treatment, 12 plaque samples were collected and prevalence H. pylori was detected. Group II and Group III had a significantly higher rate of positive results for H. pylori compared to healthy subjects before treatment. After treatment, H. pylori were not detected in Group II and in Group III Only one of 12 chronic periodontitis patients with Type II diabetes mellitus had H. pylori in the periodontal pocket. The prevalence of H. pylori did not differ significantly between the chronic periodontitis patients with and without type II diabetes mellitus. Meticulous scaling and root planning will reduce the prevalence of H. pylori in periodontal pockets.

  17. Kinesio Taping to generate skin convolutions is not better than sham taping for people with chronic non-specific low back pain: a randomised trial

    Directory of Open Access Journals (Sweden)

    Patrícia do Carmo Silva Parreira

    2014-06-01

    Full Text Available Question: For people with chronic low back pain, does Kinesio Taping, applied according to the treatment manual to create skin convolutions, reduce pain and disability more than a simple application without convolutions? Design: Randomised trial with concealed allocation, intention-to-treat analysis and blinded assessment of some outcomes. Participants: 148 participants with chronic non-specific low back pain. Intervention: Experimental group participants received eight sessions (over four weeks of Kinesio Taping applied according to the Kinesio Taping Method treatment manual (ie, 10 to 15% tension applied in flexion to create skin convolutions in neutral. Control group participants received eight sessions (over four weeks of Kinesio Taping with no tension, creating no convolutions. Outcome measures: The primary outcome measures were pain intensity and disability after the four-week intervention. Secondary outcomes were pain intensity and disability 12 weeks after randomisation, and global perceived effect at both four and 12 weeks after randomisation. Results: Applying Kinesio Tape to create convolutions in the skin did not significantly change its effect on pain (MD–0.4 points, 95% CI–1.3 to 0.4 or disability (MD–0.3 points, 95% CI–1.9 to 1.3 at four weeks. There was a small difference in favour of the experimental group for the secondary outcome of global perceived effect (MD 1.4 points, 95% CI 0.3 to 2.5 at four weeks. No significant between-group differences were observed for the other secondary outcomes. Conclusion: Kinesio Taping applied with stretch to generate convolutions in the skin was no more effective than simple application of the tape without tension for the outcomes measured. These results challenge the proposed mechanism of action of this therapy. Trial registration: Brazilian Registry of Clinical Trials, RBR-7ggfkv. [Parreira PCS, Costa LCM, Takahashi R, Hespanhol Junior LC, da Luz Junior MA, da Silva TM, Costa LOP

  18. Primary care practice-based care management for chronically ill patients (PraCMan: study protocol for a cluster randomized controlled trial [ISRCTN56104508

    Directory of Open Access Journals (Sweden)

    Baldauf Annika

    2011-06-01

    Full Text Available Abstract Background Care management programmes are an effective approach to care for high risk patients with complex care needs resulting from multiple co-occurring medical and non-medical conditions. These patients are likely to be hospitalized for a potentially "avoidable" cause. Nurse-led care management programmes for high risk elderly patients showed promising results. Care management programmes based on health care assistants (HCAs targeting adult patients with a high risk of hospitalisation may be an innovative approach to deliver cost-efficient intensified care to patients most in need. Methods/Design PraCMan is a cluster randomized controlled trial with primary care practices as unit of randomisation. The study evaluates a complex primary care practice-based care management of patients at high risk for future hospitalizations. Eligible patients either suffer from type 2 diabetes mellitus, chronic obstructive pulmonary disease, chronic heart failure or any combination. Patients with a high likelihood of hospitalization within the following 12 months (based on insurance data will be included in the trial. During 12 months of intervention patients of the care management group receive comprehensive assessment of medical and non-medical needs and resources as well as regular structured monitoring of symptoms. Assessment and monitoring will be performed by trained HCAs from the participating practices. Additionally, patients will receive written information, symptom diaries, action plans and a medication plan to improve self-management capabilities. This intervention is addition to usual care. Patients from the control group receive usual care. Primary outcome is the number of all-cause hospitalizations at 12 months follow-up, assessed by insurance claims data. Secondary outcomes are health-related quality of life (SF12, EQ5D, quality of chronic illness care (PACIC, health care utilisation and costs, medication adherence (MARS, depression

  19. Engaging general practice nurses in chronic disease self-management support in Australia: insights from a controlled trial in chronic obstructive pulmonary disease.

    Science.gov (United States)

    Walters, Julia A E; Courtney-Pratt, Helen; Cameron-Tucker, Helen; Nelson, Mark; Robinson, Andrew; Scott, Jenn; Turner, Paul; Walters, E Haydn; Wood-Baker, Richard

    2012-01-01

    The growing burden of chronic disease will increase the role of primary care in supporting self-management and health behaviour change. This role could be undertaken to some extent by the increased practice nurse workforce that has occurred over recent years. Mixed methods were used to investigate the potential for general practice nurses to adopt this role during a 12-month randomised controlled study of telephone-delivered health mentoring in Tasmanian practices. Nurses (general practice and community health) were trained as health mentors to assist chronic obstructive pulmonary disease patients to identify and achieve personal health related goals through action plans. Of 21% of invited practices that responded, 19 were allocated to health mentoring; however, general practice nurses were unable to train as health mentors in 14 (74%), principally due to lack of financial compensation and/or workload pressure. For five general practice nurses trained as health mentors, their roles had previously included some chronic disease management, but training enhanced their understanding and skills of self-management approaches and increased the focus on patient partnership, prioritising patients' choices and achievability. Difficulties that led to early withdrawal of health mentors were competing demands, insufficient time availability, phone calls having lower priority than face-to-face interactions and changing employment. Skills gained were rated as valuable, applicable to all clinical practice and transferable to other health care settings. Although these results suggest that training can enhance general practice nurses' skills to deliver self-management support in chronic disease, there are significant system barriers that need to be addressed through funding models and organisational change.

  20. A Clinical Study on the Effects of Sweet Bee Venom Herbal Acupuncture for Patients with Whiplash Injury

    Directory of Open Access Journals (Sweden)

    Beom-Yong Song

    2007-12-01

    Full Text Available Objectives : The aim of this study is to investigate the effect of Sweet Bee Venom herbal acupuncture for patients with acute whiplash injury by Traffic Accident. Methods : This clinical study was carried out 25 cases of acute whiplash injury patients which had been treatment in Woosuk oriental hospital from March, 2007 to September, 2007. Sweet bee venom herbal acupuncture(N=15 and normal saline(N=10 injected on the acupoints that were cervical area. I checked the VAS for the pain and ROM(range of motion of the cervical. these were checked 3 times. one was before treatments, another was after 3 times treatments with sweet bee venom herbal acupuncture and normal saline injection, and the other was after 5 times treatments with sweet bee venom herbal acupuncture and normal saline injection. Results : VAS score was significantly improved after 5 times treatments with the sweet bee venom herbal acupuncture compared to normal saline I.M. on the acupoints that was cervical area. There were significant changes in the sweet bee venom herbal acupuncture group with VAS and ROM check. Conclusions : This study suggests that sweet bee venom herbal acupuncture can improve symptoms in patients with acute whiplash injury by traffic accident.

  1. Clinical management of cranio-vertebral instability after whiplash, when guidelines should be adapted: a case report.

    Science.gov (United States)

    Rebbeck, Trudy; Liebert, Ann

    2014-12-01

    Cranio-vertebral instability (CVI) due to loss of bony or ligamentous integrity is one of the sequelae that may result after a whiplash mechanism injury. Due to the lack of specificity of diagnostic tests, this condition is often missed and the default classification of whiplash associated disorder (WAD) is assigned. This case report describes a 14-year-old boy who was initially classified with WAD II after a rugby injury. He was initially advised to return to usual activity, a treatment recommended in clinical guidelines for WAD. Due to an adverse response to this course of action, his primary carer, a musculoskeletal physiotherapist, continued with facilitating secondary referrals that ultimately led to a specialist physiotherapist. The patient was subsequently found to have CVI arising from a loss of bony integrity due to spina bifida atlanto, a congenital defect in the atlas. Treatment thus was immobilization and stabilization, a treatment usually recommended against in WAD guidelines. The patient recovered and within 8 weeks had returned to school and non-contact sports. This case study, therefore, presents a scenario where current clinical guidelines for whiplash could not be followed, and where pursuing clinical reasoning led to accurate diagnosis as well as safe and tailored management. The case also highlights the integrated roles that primary and specialist health professionals should play in the clinical pathway of care after WAD. As a result, an expanded diagnostic algorithm and pathway of care for WAD are proposed.

  2. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Dekker Joost

    2009-02-01

    Full Text Available Abstract Background Patients with Chronic Tension Type Headache (CTTH report functional and emotional impairments (loss of workdays, sleep disturbances, emotional well-being and are at risk for overuse of medication. Manual therapy may improve symptoms through mobilisation of the spine, correction of posture, and training of cervical muscles. We present the design of a randomised clinical trial (RCT evaluating the effectiveness of manual therapy (MT compared to usual care by the general practitioner (GP in patients with CTTH. Methods and design Patients are eligible for participation if they present in general practice with CTTH according to the classification of the International Headache Society (IHS. Participants are randomised to either usual GP care according to the national Dutch general practice guidelines for headache, or manual therapy, consisting of mobilisations (high- and low velocity techniques, exercise therapy for the cervical and thoracic spine and postural correction. The primary outcome measures are the number of headache days and use of medication. Secondary outcome measures are severity of headache, functional status, sickness absence, use of other healthcare resources, active cervical range of motion, algometry, endurance of the neckflexor muscles and head posture. Follow-up assessments are conducted after 8 and 26 weeks. Discussion This is a pragmatic trial in which interventions are offered as they are carried out in everyday practice. This increases generalisability of results, but blinding of patients, GPs and therapists is not possible. The results of this trial will contribute to clinical decision making of the GP regarding referral to manual therapy in patients with chronic tension headache.

  3. Neuroplastic effects of transcranial direct current stimulation on painful symptoms reduction in chronic Hepatitis C: a phase II randomized, double blind, sham controlled trial

    Directory of Open Access Journals (Sweden)

    Aline Patricia Brietzke

    2016-01-01

    Full Text Available Introduction: Pegylated Interferon Alpha (Peg-IFN in combination with other drugs is the standard treatment for chronic hepatitis C infection (HCV and is related to severe painful symptoms. The aim of this study was access the efficacy of transcranial direct current stimulation (tDCS in controlling the painful symptoms related to Peg-IFN side effects. Material and Methods: In this phase II double-blind trial, twenty eight (n=28 HCV subjects were randomized to receive either five consecutive days of active tDCS (n=14 or sham (n=14 during five consecutive days with anodal stimulation over the primary motor cortex region using 2 mA for 20 minutes. The primary outcomes were visual analogue scale (VAS pain and brain-derived neurotrophic factor (BDNF serum levels. Secondary outcomes were the pressure-pain threshold (PPT, the Brazilian Profile of Chronic Pain: Screen (B-PCP:S and drug analgesics use. Results: tDCS reduced the VAS scores (P<0.003, with a mean pain drop of 56% (p<0.001. Furthermore, tDCS was able to enhance BDNF levels (p<0.01. The mean increase was 37.48% in the active group. Finally, tDCS raised PPT (p<0.001 and reduced the B-PCP:S scores and analgesic use (p<0.05. Conclusions: Five sessions of tDCS were effective in reducing the painful symptoms in HCV patients undergoing Peg-IFN treatment. These findings support the efficacy of tDCS as a promising therapeutic tool to improve the tolerance of the side effects related to the use of Peg-IFN. Future larger studies (phase III and IV trials are needed to confirm the clinical use of the therapeutic effects of tDCS in such condition. Trial registration: Brazilian Human Health Regulator for Research with the approval number CAAE 07802012.0.0000.5327

  4. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial

    Directory of Open Access Journals (Sweden)

    Robert B. Saper

    2013-01-01

    Full Text Available Background. Previous studies have demonstrated that once-weekly yoga classes are effective for chronic low back pain (cLBP in white adults with high socioeconomic status. The comparative effectiveness of twice-weekly classes and generalizability to racially diverse low income populations are unknown. Methods. We conducted a 12-week randomized, parallel-group, dosing trial for 95 adults recruited from an urban safety-net hospital and five community health centers comparing once-weekly (n=49 versus twice-weekly (n=46 standardized yoga classes supplemented by home practice. Primary outcomes were change from baseline to 12 weeks in pain (11-point scale and back-related function (23-point modified Roland-Morris Disability Questionnaire. Results. 82% of participants were nonwhite; 77% had annual household incomes <$40,000. The sample’s baseline mean pain intensity [6.9 (SD 1.6] and function [13.7 (SD 5.0] reflected moderate to severe back pain and impairment. Pain and back-related function improved within both groups (P<0.001. However, there were no differences between once-weekly and twice-weekly groups for pain reduction [-2.1 (95% CI -2.9, -1.3 versus −2.4 (95% CI -3.1, -1.8, P=0.62] or back-related function [-5.1 (95% CI -7.0, -3.2 versus −4.9 (95% CI -6.5, -3.3, P=0.83]. Conclusions. Twelve weeks of once-weekly or twice-weekly yoga classes were similarly effective for predominantly low income minority adults with moderate to severe chronic low back pain. This trial is registered with ClinicalTrials.gov NCT01761617.

  5. Participant experiences from chronic administration of a multivitamin versus placebo on subjective health and wellbeing: a double-blind qualitative analysis of a randomised controlled trial

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    Sarris Jerome

    2012-12-01

    group having minor digestive complaints. Conclusion This represents the first documented qualitative investigation of participants’ experience of chronic administration of a multivitamin. Results uncovered a range of subjective beneficial effects that are consistent with quantitative data from previously published randomised controlled trials examining the effects of multivitamins and B vitamin complexes on mood and well-being. Trial registration Prior to commencement this trial was registered with the Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au ACTRN12611000092998

  6. Effectiveness of home-based cupping massage compared to progressive muscle relaxation in patients with chronic neck pain--a randomized controlled trial.

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    Romy Lauche

    Full Text Available UNLABELLED: Chronic neck pain is a major public health problem with very few evidence-based complementary treatment options. This study aimed to test the efficacy of 12 weeks of a partner-delivered home-based cupping massage, compared to the same period of progressive muscle relaxation in patients with chronic non-specific neck pain. Patients were randomly assigned to self-directed cupping massage or progressive muscle relaxation. They were trained and asked to undertake the assigned treatment twice weekly for 12 weeks. Primary outcome measure was the current neck pain intensity (0-100 mm visual analog scale; VAS after 12 weeks. Secondary outcome measures included pain on motion, affective pain perception, functional disability, psychological distress, wellbeing, health-related quality of life, pressure pain thresholds and adverse events. Sixty one patients (54.1±12.7 years; 73.8%female were randomized to cupping massage (n = 30 or progressive muscle relaxation (n = 31. After treatment, both groups showed significantly less pain compared to baseline however without significant group differences. Significant effects in favor of cupping massage were only found for wellbeing and pressure pain thresholds. In conclusion, cupping massage is no more effective than progressive muscle relaxation in reducing chronic non-specific neck pain. Both therapies can be easily used at home and can reduce pain to a minimal clinically relevant extent. Cupping massage may however be better than PMR in improving well-being and decreasing pressure pain sensitivity but more studies with larger samples and longer follow-up periods are needed to confirm these results. TRIAL REGISTRATION: ClinicalTrials.gov NCT01500330.

  7. Effects of conventional versus multimodal vestibular rehabilitation on functional capacity and balance control in older people with chronic dizziness from vestibular disorders: design of a randomized clinical trial

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    Ricci Natalia

    2012-12-01

    Full Text Available Abstract Background There are several protocols designed to treat vestibular disorders that focus on habituation, substitution, adaptation, and compensation exercises. However, protocols that contemplate not only vestibular stimulation but also other components that are essential to the body balance control in older people are rare. This study aims to compare the effectiveness of two vestibular rehabilitation protocols (conventional versus multimodal on the functional capacity and body balance control of older people with chronic dizziness due to vestibular disorders. Methods/design A randomized, single-blind, controlled clinical trial with a 3 months follow-up period will be performed. The sample will be composed of older individuals with a clinical diagnosis of chronic dizziness resulting from vestibular disorders. The subjects will be evaluated at baseline, post-treatment and follow-up. Primary outcomes will be determined in accordance with the Dizziness Handicap Inventory (functional capacity and the Dynamic Gait Index (body balance. Secondary outcomes include dizziness features, functional records, body balance control tests, and psychological information. The older individuals (minimum sample n = 68 will be randomized to either the conventional or multimodal Cawthorne&Cooksey protocols. The protocols will be performed during individual 50-minute sessions, twice a week, for 2 months (a total of 16 sessions. The outcomes of both protocols will be compared according to the intention-to-treat analysis. Discussion Vestibular rehabilitation through the Cawthorne&Cooksey protocol has already proved to be effective. However, the addition of other components related to body balance control has been proposed to improve the rehabilitation of older people with chronic dizziness from vestibular disorders. Trial registration ACTRN12610000018011

  8. Rationale and Design for the Intramyocardial Injection of Autologous Bone Marrow Mononuclear Cells for Patients with Chronic Ischemic Heart Disease and Left Ventricular Dysfunction Trial (FOCUS)

    Science.gov (United States)

    Willerson, James T.; Perin, Emerson C.; Ellis, Stephen G.; Pepine, Carl J.; Henry, Timothy D.; Zhao, David X.M.; Lai, Dejian; Penn, Marc S.; Byrne, Barry J.; Silva, G; Gee, Adrian; Traverse, Jay H.; Hatzopoulos, Antonis K.; Forder, John R.; Martin, Daniel; Kronenberg, Marvin; Taylor, Doris A.; Cogle, Christopher R.; Baraniuk, Sarah; Westbrook, Lynette; Sayre, Shelly L.; Vojvodic, Rachel W.; Gordon, David J.; Skarlatos, Sonia I.; Moyé, Lemuel A.; Simari, Robert D.

    2010-01-01

    Background The increasing worldwide prevalence of coronary artery disease (CAD) continues to challenge the medical community. Management options include medical and revascularization therapy. Despite advances in these methods, CAD is a leading cause of recurrent ischemia and heart failure, posing significant morbidity and mortality risks along with increasing health costs in a large patient population worldwide. Trial Design The Cardiovascular Cell Therapy Research Network (CCTRN) was established by the National Institutes of Health to investigate the role of cell therapy in the treatment of chronic cardiovascular disease. FOCUS is a CCTRN-designed randomized Phase II, placebo-controlled clinical trial that will assess the effect of autologous bone marrow mononuclear cells delivered transendocardially to patients with left ventricular (LV) dysfunction and symptomatic heart failure or angina. All patients need to have limiting ischemia by reversible ischemia on SPECT assessment. Results After thoughtful consideration of both statistical and clinical principles, we will recruit 87 patients (58 cell treated and 29 placebo) to receive either bone marrow–derived stem cells or placebo. Myocardial perfusion, LV contractile performance, and maximal oxygen consumption are the primary outcome measures. Conclusions The designed clinical trial will provide a sound assessment of the effect of autologous bone marrow mononuclear cells in improving blood flow and contractile function of the heart. The target population is patients with CAD and LV dysfunction with limiting angina or symptomatic heat failure. Patient safety is a central concern of the CCTRN, and patients will be followed for at least 5 years. PMID:20691824

  9. Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: a randomized controlled trial.

    Science.gov (United States)

    Trompetter, Hester R; Bohlmeijer, Ernst T; Veehof, Martine M; Schreurs, Karlein M G

    2015-02-01

    Acceptance-based psychological interventions can potentially minimize the burden of chronic pain. This randomized controlled trial evaluated an internet-delivered, guided self-help intervention based on Acceptance and Commitment Therapy (ACT). A total of 238 chronic pain sufferers from the general population were randomly allocated to either ACT (n = 82), an internet-based control condition Expressive Writing (n = 79) or a waiting list condition (n = 77). Participants completed measures at baseline, posttreatment (3 months) and at a 3-month follow-up. At follow-up, ACT participants had improved in pain interference in daily life (primary outcome) compared to participants in Expressive Writing (Cohen's d = .47), but not compared to waiting list participants (p value = .11). Those who adhered to the ACT-intervention (48%) did improve significantly compared to waiting list participants (d = .49). ACT-participants also showed superior improvement on depression, pain intensity, psychological inflexibility and pain catastrophizing (d: .28-.60). Significant clinical improvement was present. Especially, 28% of ACT-participants showed general clinically relevant improvement in pain interference, as well as in pain intensity and depression (vs. Expressive Writing and waiting list 5%). Given these findings, internet-based ACT programs may be a promising treatment modality for chronic pain.

  10. Effects and Tolerance of Silymarin (Milk Thistle in Chronic Hepatitis C Virus Infection Patients: A Meta-Analysis of Randomized Controlled Trials

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    Zongguo Yang

    2014-01-01

    Full Text Available Objective. This study aimed to evaluate the efficacy and safety of silymarin on chronic hepatitis C virus- (HCV- infected patients. Methods. Randomized controlled trials (RCTs of silymarin in chronic HCV-infected patients up to April 1, 2014 were systematically identified in PubMed, Ovid, Web of Science, and Cochrane Library databases. Results. A total of 222 and 167 patients in five RCTs were randomly treated with silymarin (or intravenous silibinin and placebo, respectively. Serum HCV RNA relatively decreased in patients treated with silymarin compared with those administered with placebo, but no significance was found (P=0.09. Meta-analysis of patients orally treated with silymarin indicated that the changes of HCV RNA are similar in the two groups (P=0.19. The effect on alanine aminotransferase (ALT of oral silymarin is not different from that of placebo (P=0.45. Improvements in quality-of-life (Short Form-36 in both silymarin and placebo recipients were impressive but relatively identical (P=0.09. Conclusion. Silymarin is well tolerated in chronic HCV-infected patients. However, no evidence of salutary effects of oral silymarin has yet been reported based on intermediate endpoints (ALT and HCV RNA in this population. Moreover, intravenous administration of silymarin should be further studied.

  11. Radial extracorporeal shock-wave therapy in patients with chronic rotator cuff tendinitis: a prospective randomised double-blind placebo-controlled multicentre trial.

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    Kolk, A; Yang, K G Auw; Tamminga, R; van der Hoeven, H

    2013-11-01

    The aim of this study was to determine the effect of radial extracorporeal shock-wave therapy (rESWT) on patients with chronic tendinitis of the rotator cuff. This was a randomised controlled trial in which 82 patients (mean age 47 years (24 to 67)) with chronic tendinitis diagnosed clinically were randomly allocated to a treatment group who received low-dose rESWT (three sessions at an interval 10 to 14 days, 2000 pulses, 0.11 mJ/mm(2), 8 Hz) or to a placebo group, with a follow-up of six months. The patients and the treating orthopaedic surgeon, who were both blinded to the treatment, evaluated the results. A total of 44 patients were allocated to the rESWT group and 38 patients to the placebo group. A visual analogue scale (VAS) score for pain, a Constant-Murley (CMS) score and a simple shoulder test (SST) score significantly improved in both groups at three and six months compared with baseline (all p ≤ 0.012). The mean VAS was similar in both groups at three (p = 0.43) and six months (p = 0.262). Also, the mean CMS and SST scores were similar in both groups at six months (p = 0.815 and p = 0.834, respectively). It would thus seem that low-dose rESWT does not reduce pain or improve function in patients chronic rotator cuff tendinitis compared with placebo treatment.

  12. Antioxidant therapy for chronic hepatitis C after failure of interferon: Results of phase Ⅱ randomized, double-blind placebo controlled clinical trial

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    AIM: To assess the safety and efficacy of antioxidant therapy for patients with chronic hepatitis C virus (HCV) infection. METHODS: One hundred chronic HCV infection patients failed in interferon treatment were enrolled and randomly assigned to receive combined intravenous and oral antioxidants or placebo, or oral treatment alone. Primary end points were liver enzymes, HCV-RNA levels and histology. RESULTS: Combined oral and intravenous antioxidant therapy was associated with a significant decline in ALT levels in 52% of patients who received antioxidant therapy vs 20% of patients who received placebo (P = 0.05). Histology activity index (HAI) score at the end of treatment was reduced in 48% of patients who received antioxidant therapy vs 26% of patients who received placebo (P = 0.21). HCV-RNA levels decreased by 1-log or more in 28% of patients who received antioxidant therapy vs 12% who received placebo (P = NS). In part Ⅱ of the trial, oral administration of antioxidants was not associated with significant alterations in any of the end points. CONCLUSION: Antioxidant therapy has a mild beneficial effect on the inflammatory response of chronic HCV infection patients who are non-responders to interferon. Combined antiviral and antioxidant therapy may be beneficial for these patients.

  13. Effects of Aloe vera cream on chronic anal fissure pain, wound healing and hemorrhaging upon defection: a prospective double blind clinical trial.

    Science.gov (United States)

    Rahmani, N; Khademloo, M; Vosoughi, K; Assadpour, S

    2014-01-01

    Aloe vera is a medicinal plant that promotes wound healing in burn injuries. A prospective clinical trial was conducted to evaluate the effects of a topical cream containing 0.5% Aloe vera juice powder in the treatment of chronic anal fissures. The aloe cream was applied by the patients to the wound site 3 times per day for 6 weeks following the instructions of a physician. Pain was assessed with a visual analog scale before treatment and at the end of each week of treatment. Wound healing and the amount and severity of bleeding were examined and evaluated before and at the end of each week of treatment. There were statistically significant differences in chronic anal fissure pain, hemorrhaging upon defection and wound healing before and at the end of the first week of treatment also in comparison with control group (p aloe vera juice was an effective treatment for chronic anal fissures. This is a promising result indicating that further comparative studies are justified.

  14. Effectiveness of behavioural graded activity compared with physiotherapy treatment in chronic neck pain: design of a randomised clinical trial [ISRCTN88733332

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    Vos Cees J

    2004-10-01

    Full Text Available Abstract Background Chronic neck pain is a common complaint in the Netherlands with a point prevalence of 14.3%. Patients with chronic neck pain are often referred to a physiotherapist and, although many treatments are available, it remains unclear which type of treatment is to be preferred. The objective of this article is to present the design of a randomised clinical trial, Ephysion, which examines the clinical and cost effectiveness of behavioural graded activity compared with a physiotherapy treatment for patients with chronic non-specific neck pain. Methods Eligible patients with non-specific neck pain persisting longer than 3 months will be randomly allocated to either the behavioural graded activity programme or to the physiotherapy treatment. The graded activity programme is based on an operant approach, which uses a time-contingent method to increase the patient's activity level. This treatment is compared with physiotherapy treatment using a pain-contingent method. Primary treatment outcome is the patient's global perceived effect concerning recovery from the complaint. Global perceived effect on daily functioning is also explored as primary outcome to establish the impact of treatment on daily activity. Direct and indirect costs will also be assessed. Secondary outcomes include the patient's main complaints, pain intensity, medical consumption, functional status, quality of life, and psychological variables. Recruitment of patients will take place up to the end of the year 2004 and follow-up measurement will continue until end 2005.

  15. Botulinum toxin injection versus lateral internal sphincterotomy in the treatment of chronic anal fissure: a non-randomized controlled trial

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    Ulusoy Nefise B

    2004-03-01

    Full Text Available Abstract Background Although lateral internal sphincterotomy is the gold-standard treatment for chronic anal fissure, intrasphincteric injection of botulinum toxin seems to be a reliable new option. The aim of this non-randomized study is to compare the effect of lateral internal sphincterotomy and botulinum toxin injection treatments on the outcome and reduction of anal sphincter pressures in patients with chronic anal fissure. Methods Patients with chronic anal fissure were treated with either botulinum toxin injection or lateral internal sphincterotomy by their own choice. Maximal resting pressure and maximal squeeze pressure measurements were performed before and 2 weeks after treatments by anal manometry. Patients were followed for fissure relapse during 14 months. Results Twenty-one consecutive outpatients with posterior chronic anal fissure were enrolled. Eleven patients underwent surgery and ten patients received botulinum toxin injection treatment. Before the treatment, anal pressures were found to be similar in both groups. After the treatment, the maximal resting pressures were reduced from 104 ± 22 mmHg to 86 ± 15 mmHg in the surgery group (p 0.05 in the surgery group, and from 117 ± 62 mmHg to 76 ± 34 (p 0.05. There were no relapses during the 14 months of follow up. Conclusion Lateral internal sphincterotomy and botulinum toxin injection treatments both seem to be equally effective in the treatment of chronic anal fissure.

  16. Head position and impact direction in whiplash injuries: associations with MRI-verified lesions of ligaments and membranes in the upper cervical spine.

    Science.gov (United States)

    Kaale, Bertel Rune; Krakenes, Jostein; Albrektsen, Grethe; Wester, Knut

    2005-11-01

    In the present study, we compared magnetic resonance imaging (MRI) findings of soft tissue structures in the upper cervical spine between whiplash-associated disorder (WAD) patients and population-based control persons, and examined whether MRI-verified abnormalities in WAD patients were related to accident-related factors hypothesized to be of importance for severity of injury. A total of 92 whiplash patients and 30 control persons, randomly drawn, were included. Information on the accident-related factors (i.e., head position and impact direction) was obtained by a questionnaire that was answered within 1 week after the accident. The MRI examination was performed 2-9 (mean 6) years after the accident. Focus was on MRI abnormalities of the alar and the transverse ligaments, and the tectorial and posterior atlanto-occipital membranes, graded 0-3. For all neck structures, the whiplash patients had more high-grade lesions (grade 2 or 3) than the control persons (Chi-square test, p Whiplash patients who had been sitting with their head/neck turned to one side at the moment of collision more often had high-grade lesions of the alar and transverse ligaments (p whiplash trauma.

  17. Unlearning chronic pain: A randomized controlled trial to investigate changes in intrinsic brain connectivity following Cognitive Behavioral Therapy

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    Marina Shpaner

    2014-01-01

    Full Text Available Chronic pain is a complex physiological and psychological phenomenon. Implicit learning mechanisms contribute to the development of chronic pain and to persistent changes in the central nervous system. We hypothesized that these central abnormalities can be remedied with Cognitive Behavioral Therapy (CBT. Specifically, since regions of the anterior Default Mode Network (DMN are centrally involved in emotional regulation via connections with limbic regions, such as the amygdala, remediation of maladaptive behavioral and cognitive patterns as a result of CBT for chronic pain would manifest itself as a change in the intrinsic functional connectivity (iFC between these prefrontal and limbic regions. Resting-state functional neuroimaging was performed in patients with chronic pain before and after 11-week CBT (n = 19, as well as a matched (ages 19–59, both sexes active control group of patients who received educational materials (n = 19. Participants were randomized prior to the intervention. To investigate the differential impact of treatment on intrinsic functional connectivity (iFC, we compared pre–post differences in iFC between groups. In addition, we performed exploratory whole brain analyses of changes in fractional amplitude of low frequency fluctuations (fALFF. The course of CBT led to significant improvements in clinical measures of pain and self-efficacy for coping with chronic pain. Significant group differences in pre–post changes in both iFC and fALFF were correlated with clinical outcomes. Compared to control patients, iFC between the anterior DMN and the amygdala/periaqueductal gray decreased following CBT, whereas iFC between the basal ganglia network and the right secondary somatosensory cortex increased following CBT. CBT patients also had increased post-therapy fALFF in the bilateral posterior cingulate and the cerebellum. By delineating neuroplasticity associated with CBT-related improvements, these results add to

  18. Randomized, double-blind, placebo-controlled superiority trial of the Yiqigubiao pill for the treatment of patients with chronic obstructive pulmonary disease at a stable stage

    Science.gov (United States)

    Li, Feng-Sen; Zhang, Yan-Li; Li, Zheng; Xu, Dan; Liao, Chun-Yan; Ma, Huan; Gong, Li; Su, Jun; Sun, Qi; Xu, Qian; Gao, Zhen; Wang, Ling; Jing, Jing; Wang, Jing; Jiang, Min; Tian, Ge; Hasan, Bilal

    2016-01-01

    In traditional Chinese medicine (TCM), the Yiqigubiao pill is commonly used to enhance physical fitness. The current clinical trial was designed to evaluate the efficacy and safety of the Yiqigubiao pill as an adjuvant therapy for patients with stable chronic obstructive pulmonary disease (COPD). The current trial was a randomized, double-blind, placebo-controlled superiority trial. The participants were recruited from outpatients at the Traditional Chinese Medicine Hospital affiliated with Xinjiang Medical University (Ürümqi, China) between February and September 2012. All participants were patients with stable COPD that were randomized to the Yiqigubiao pill (YQGB; n=84) or placebo (Pb; n=87) groups. The occurrences of acute exacerbation (AE) of COPD during the trial were recorded. Lung function value assessments, scoring of life quality and exercise endurance, arterial blood gas analysis and serum inflammatory cytokines level determination were performed prior to and throughout the study. A total of 139 participants completed the intervention and 132 participants completed the study. The interval between the initial intervention and the first AECOPD was greater in the YQGB group compared with the Pb group (P<0.01). The incidence rate of AECOPD was lower in the YQGB group than in the Pb group (P<0.01). Subsequent to the intervention or at the end of the study, the 6-min walking distance difference was longer in the YQGB group compared with the Pb group (P<0.01). The scores reflecting life quality decline became lower in the YQGB group (P<0.01). The serum levels of proinflammatory factors were downregulated to a greater extent in the YQGB group compared with the Pb group. Thus, the Yiqigubiao pill is an efficient and safe adjuvant therapy for the treatment of stable patients with COPD. PMID:27698749

  19. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials : PedIMMPACT recommendations

    NARCIS (Netherlands)

    McGrath, Patrick J.; Walco, Gary A.; Turk, Dennis C.; Dworkin, Robert H.; Brown, Mark T.; Davidson, Karina; Eccleston, Christopher; Finley, G. Allen; Goldschneider, Kenneth; Haverkos, Lynne; Hertz, Sharon H.; Ljungman, Gustaf; Palermo, Tonya; Rappaport, Bob A.; Rhodes, Thomas; Schechter, Neil; Scott, Jane; Sethna, Navil; Svensson, Ola K.; Stinson, Jennifer; von Baeyer, Carl L.; Walker, Lynn; Weisman, Steven; White, Richard E.; Zajicek, Anne; Zeltzer, Lonnie

    2008-01-01

    Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains an

  20. Randomized Trial of Cognitive-Behavioral Therapy for Chronic Posttraumatic Stress Disorder in Adult Female Survivors of Childhood Sexual Abuse

    Science.gov (United States)

    McDonagh, Annmarie; Friedman, Matthew; McHugo, Gregory; Ford, Julian; Sengupta, Anjana; Mueser, Kim; Demment, Christine Carney; Fournier, Debra; Schnurr, Paula P.

    2005-01-01

    The authors conducted a randomized clinical trial of individual psychotherapy for women with posttraumatic stress disorder (PTSD) related to childhood sexual abuse (n = 74), comparing cognitive-behavioral therapy (CBT) with a problem-solving therapy (present-centered therapy; PCT) and to a wait-list (WL). The authors hypothesized that CBT would be…

  1. Blood pressure response to chronic intake of coffee and caffeine: a meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Noordzij, M.; Uiterwaal, C.S.P.M.; Arends, L.R.; Kok, F.J.; Grobbee, D.E.; Geleijnse, J.M.

    2005-01-01

    Purpose: Coffee is a widely consumed beverage and small health effects of substances in coffee may have large public health consequences. It has been suggested that caffeine in coffee increases the risk of hypertension. We performed a meta-analysis of randomized controlled trials of coffee or caffei

  2. Clinical effectiveness and safety of gemifloxacin versus cefpodoxime in acute exacerbation of chronic bronchitis: A randomized, controlled trial

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    S Chatterjee

    2011-01-01

    Conclusion : The results of this randomized, single-blind trial demonstrated that a 7-day course of gemifloxacin is therapeutically comparable to cefpodoxime in terms of both clinical effectiveness and safety for the treatment of type II Anthonisen category AECB patients.

  3. Amiodarone therapy in chronic heart failure and myocardial infarction: a review of the mortality trials with special attention to STAT-CHF and the GESICA trials. Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiaca en Argentina.

    Science.gov (United States)

    Pinto, J V; Ramani, K; Neelagaru, S; Kown, M; Gheorghiade, M

    1997-01-01

    Amiodarone appears to reduce sudden death in patients with left ventricular dysfunction resulting from an acute MI or a primary dilated cardiomyopathy, particularly if complex ventricular arrhythmias are present. Amiodarone's beneficial effect on mortality in these patients could be unrelated to its antiarrhythmic effects. Multiple factors could account for the improvement in mortality such as the drug's antiischemic effects, neuromodulating effects, its effect on left ventricular function and on heart rate. Moreover, patients with LV dysfunction who have survived an episode of sudden death would potentially benefit from amiodarone therapy. Future trials are needed to determine the precise subsets(s) of patients who would benefit from the drug and the most efficacious dosing regimen for the drug. Based on available data, amiodarone is the only antiarrhythmic agent which has not been shown to increase mortality in patients with chronic heart failure.

  4. Kinesio Taping® is not better than placebo in reducing pain and disability in patients with chronic non-specific low back pain: a randomized controlled trial

    Science.gov (United States)

    Luz, Maurício A.; Sousa, Manoel V.; Neves, Luciana A. F. S.; Cezar, Aline A. C.; Costa, Leonardo O. P.

    2015-01-01

    Background: Kinesio Taping ® has been widely used in clinical practice. However, it is unknown whether this type of tape is more effective than placebo taping in patients with chronic lower back pain. Objective: To compare the effectiveness of Kinesio Taping ® in patients with chronic non-specific low back pain against a placebo tape and a control group. Method: This is a 3-arm, randomized controlled trial with a blinded assessor. Sixty patients with chronic non-specific low back pain were randomized into one of the three groups: Kinesio Taping ® group (n=20), Micropore® (placebo) group (n=20) and control group (n=20). Patients allocated to both the Kinesio Taping ® group and the placebo group used the different types of tape for a period of 48 hours. The control group did not receive any intervention. The outcomes measured were pain intensity (measured by an 11-point numerical rating scale) and disability (measured by the 24-item Roland Morris Disability Questionnaire). A blinded assessor measured the outcomes at baseline, 48 hours and 7 days after randomization. Results: After 48 hours, there was a statistically significant difference between the Kinesio Taping ® group versus the control group (mean between-group difference = -3.1 points, 95% CI=-5.2 to -1.1, p=0.003), but no difference when compared to the placebo group (mean between-group difference= 1.9 points, 95% CI=-0.2 to 3.9, p=0.08). For the other outcomes no differences were observed. Conclusions: The Kinesio Taping ® is not better than placebo (Micropore®) in patients with chronic low back pain. PMID:26647750

  5. Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years

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    Talita Stessuk

    2013-01-01

    Full Text Available BACKGROUND Chronic obstructive pulmonary disease is a major inflammatory disease of the airways and an enormous therapeutic challenge. Within the spectrum of chronic obstructive pulmonary disease, pulmonary emphysema is characterized by the destruction of the alveolar walls with an increase in the air spaces distal to the terminal bronchioles but without significant pulmonary fibrosis. Therapeutic options are limited and palliative since they are unable to promote morphological and functional regeneration of the alveolar tissue. In this context, new therapeutic approaches, such as cell therapy with adult stem cells, are being evaluated. OBJECTIVE This article aims to describe the follow-up of up to 3 years after the beginning of a phase I clinical trial and discuss the spirometry parameters achieved by patients with advanced pulmonary emphysema treated with bone marrow mononuclear cells. METHODS Four patients with advanced pulmonary emphysema were submitted to autologous infusion of bone marrow mononuclear cells. Follow-ups were performed by spirometry up to 3 years after the procedure. RESULTS The results showed that autologous cell therapy in patients having chronic obstructive pulmonary disease is a safe procedure and free of adverse effects. There was an improvement in laboratory parameters (spirometry and a slowing down in the process of pathological degeneration. Also, patients reported improvements in the clinical condition and quality of life. CONCLUSIONS Despite being in the initial stage and in spite of the small sample, the results of the clinical protocol of cell therapy in advanced pulmonary emphysema as proposed in this study, open new therapeutic perspectives in chronic obstructive pulmonary disease. It is worth emphasizing that this study corresponds to the first study in the literature that reports a change in the natural history of pulmonary emphysema after the use of cell therapy with a pool of bone marrow mononuclear cells.

  6. Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years

    Science.gov (United States)

    Stessuk, Talita; Ruiz, Milton Artur; Greco, Oswaldo Tadeu; Bilaqui, Aldemir; Ribeiro-Paes, Maria José de Oliveira; Ribeiro-Paes, João Tadeu

    2013-01-01

    Background Chronic obstructive pulmonary disease is a major inflammatory disease of the airways and an enormous therapeutic challenge. Within the spectrum of chronic obstructive pulmonary disease, pulmonary emphysema is characterized by the destruction of the alveolar walls with an increase in the air spaces distal to the terminal bronchioles but without significant pulmonary fibrosis. Therapeutic options are limited and palliative since they are unable to promote morphological and functional regeneration of the alveolar tissue. In this context, new therapeutic approaches, such as cell therapy with adult stem cells, are being evaluated. Objective This article aims to describe the follow-up of up to 3 years after the beginning of a phase I clinical trial and discuss the spirometry parameters achieved by patients with advanced pulmonary emphysema treated with bone marrow mononuclear cells. Methods Four patients with advanced pulmonary emphysema were submitted to autologous infusion of bone marrow mononuclear cells. Follow-ups were performed by spirometry up to 3 years after the procedure. Results The results showed that autologous cell therapy in patients having chronic obstructive pulmonary disease is a safe procedure and free of adverse effects. There was an improvement in laboratory parameters (spirometry) and a slowing down in the process of pathological degeneration. Also, patients reported improvements in the clinical condition and quality of life. Conclusions Despite being in the initial stage and in spite of the small sample, the results of the clinical protocol of cell therapy in advanced pulmonary emphysema as proposed in this study, open new therapeutic perspectives in chronic obstructive pulmonary disease. It is worth emphasizing that this study corresponds to the first study in the literature that reports a change in the natural history of pulmonary emphysema after the use of cell therapy with a pool of bone marrow mononuclear cells. PMID:24255620

  7. Kinesio Taping® is not better than placebo in reducing pain and disability in patients with chronic non-specific low back pain: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Maurício A. Luz Júnior

    2015-12-01

    Full Text Available Background: Kinesio Taping® has been widely used in clinical practice. However, it is unknown whether this type of tape is more effective than placebo taping in patients with chronic lower back pain. Objective: To compare the effectiveness of Kinesio Taping® in patients with chronic non-specific low back pain against a placebo tape and a control group. Method: This is a 3-arm, randomized controlled trial with a blinded assessor. Sixty patients with chronic non-specific low back pain were randomized into one of the three groups: Kinesio Taping® group (n=20, Micropore® (placebo group (n=20 and control group (n=20. Patients allocated to both the Kinesio Taping® group and the placebo group used the different types of tape for a period of 48 hours. The control group did not receive any intervention. The outcomes measured were pain intensity (measured by an 11-point numerical rating scale and disability (measured by the 24-item Roland Morris Disability Questionnaire. A blinded assessor measured the outcomes at baseline, 48 hours and 7 days after randomization. Results: After 48 hours, there was a statistically significant difference between the Kinesio Taping® group versus the control group (mean between-group difference = -3.1 points, 95% CI=-5.2 to -1.1, p=0.003, but no difference when compared to the placebo group (mean between-group difference= 1.9 points, 95% CI=-0.2 to 3.9, p=0.08. For the other outcomes no differences were observed. Conclusions: The Kinesio Taping® is not better than placebo (Micropore® in patients with chronic low back pain.

  8. A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol

    Directory of Open Access Journals (Sweden)

    Bunker Jeremy M

    2012-09-01

    Full Text Available Abstract Background Chronic Obstructive Pulmonary Disease (COPD is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care. Design A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD. The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate, smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities. The primary outcome measure is health-related quality of life, assessed with the St George’s Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related

  9. The effect of ondansetron, a 5-HT3 receptor antagonist, in chronic fatigue syndrome: a randomized controlled trial.

    NARCIS (Netherlands)

    The, G.K.H.; Bleijenberg, G.; Buitelaar, J.K.; Meer, J.W.M. van der

    2010-01-01

    BACKGROUND: Accumulating data support the involvement of the serotonin (5-hydroxytryptamine [5-HT]) system in the pathophysiology of chronic fatigue syndrome. Neuropharmacologic studies point to a hyperactive 5-HT system, and open-label treatment studies with 5-HT(3) receptor antagonists have shown

  10. A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

    NARCIS (Netherlands)

    L. Scholten; A.M. Willemen; M.A. Grootenhuis; H. Maurice-Stam; C. Schuengel; B.F. Last

    2011-01-01

    Coping with a chronic illness (CI) challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the int

  11. Self-management of chronic pain in Malaysian patients: effectiveness trial with 1-year follow-up.

    Science.gov (United States)

    Cardosa, Mary; Osman, Zubaidah Jamil; Nicholas, Michael; Tonkin, Lois; Williams, Amanda; Abd Aziz, Khuzaimah; Mohd Ali, Ramli; Dahari, Norhana Mohd

    2012-03-01

    Self-management of chronic illnesses has been widely recognised as an important goal on quality of life, health service utilisation and cost grounds. This study describes the first published account on the application of this approach to people suffering from chronic pain conditions in a Southeast Asian country, Malaysia. A heterogeneous sample of chronic pain patients in Malaysia attended a 2-week cognitive-behavioural pain management programme (PMP) aimed at improving daily functional activities and general psychological well-being. Complete datasets from 70 patients out of 102 patients who attended 11 programmes conducted from 2002 to 2007, as well as the 1-month and 1-year follow-up sessions at the hospital clinic, are reported. The pre- to post-treatment results on self-report measures indicate that significant gains were achieved on the dimensions of pain, disability and psychological well-being. These gains were maintained at both 1-month and 1-year follow-ups. The results mirror those reported from similar interventions in Europe and North America and indicate the concept of self-management of a chronic illness is acceptable and meaningful to Asian patients. Importantly, the achieved outcomes were independent of gender and ethnic group status.

  12. A prospective randomized trial of open surgery versus endourological stone removal in patients of staghorn stones with chronic renal failure

    Directory of Open Access Journals (Sweden)

    Anant Kumar

    2001-01-01

    Conclusion: In view of the better clearance rate and lesser cost of treatment, open surgery still has a place in the management of staghorn stones with chronic renal failure even in a tertiary urological center. However postoperative pain and a larger scar cannot be ignored.

  13. Effect of Scapular Function Training on Chronic Pain in the Neck/Shoulder Region: A Randomized Controlled Trial

    OpenAIRE

    2013-01-01

    Purpose Neck and shoulder complaints are common among employees in occupations characterized by intensive computer use. Treatment has varied from passive rest to active treatments and active treatments have often been divided into either training of the painful area or the surrounding musculature avoiding direct training of the painful area. Our study investigates the effect of the latter approach. The purpose of this study was in a randomised controlled trial to investigate if intensive scap...

  14. Fatal subarachnoid hemorrhage associated with internal carotid artery dissection resulting from whiplash trauma.

    Science.gov (United States)

    Uhrenholt, Lars; Freeman, Michael D; Webb, Alexandra L; Pedersen, Michael; Boel, Lene Warner Thorup

    2015-12-01

    Spinal injury following inertial loading of the head and neck (whiplash) is a common sequel of low speed traffic crashes. A variety of non-musculoskeletal injuries have been described in association with injury to the spine following whiplash trauma, including traumatic brain injury, vestibular derangement, and cranial nerve injury, among others. Vascular injuries in the head and neck have, however, only rarely been described. We present the case of a middle-aged male who sustained an ultimately fatal injury that resulted from injury to the internal carotid artery (ICA) and intracerebral vascular structures following a hard braking maneuver, with no direct head- or neck contact with the vehicular interior. Based on this unusual mechanism of injury we reviewed hospital data from the United States nationwide inpatient database (NIS) to assess the frequency of similar injuries reportedly resulting from traffic crashes. The post-mortem examination revealed a left internal carotid artery dissection associated with subarachnoid hemorrhage (SAH). Based on the close temporal association, the absent prior history, and the plausibility of the injury mechanism, the injury was attributed to the braking maneuver. An analysis of NIS data demonstrated that the prevalence of subarachnoid hemorrhage is significantly higher when there is a traumatic etiology, and higher yet when the trauma is a traffic crash (odds ratio 3.3 and 4.3, respectively). The presented case, together with the hospital inpatient data analysis, indicate that although SAH in combination with ICA dissection is relatively rare, it is substantially more probable following a traffic crash. In a clinical or forensic setting the inference that magnitude of a trauma was low should not serve as a basis for either excluding a cervical artery dissection from a differential diagnosis, or for excluding the trauma as a cause of a diagnosed dissection. This case report illustrates a rare fatal outcome of inertial load to

  15. Workplace strength training prevents deterioration of work ability among workers with chronic pain and work disability: a randomized controlled trial

    DEFF Research Database (Denmark)

    Sundstrup, Emil; Jakobsen, Markus D; Brandt, Mikkel

    2014-01-01

    OBJECTIVE: Imbalance between work demands and individual resources can lead to musculoskeletal disorders and reduced work ability. The aim of this study was to evaluate the effect of two contrasting interventions on work ability among slaughterhouse workers with chronic pain and work disability....... METHODS: Sixty-six slaughterhouse workers with upper-limb chronic pain and work disability were randomly allocated to 10 weeks of either strength training for the shoulder, arm, and hand muscles (3 times per week, 10 minutes per session) or ergonomic training (usual care control group) from September...... to December 2012. The outcome measure was the change from baseline to 10-week follow-up in the work ability index (WAI). RESULTS: A priori hypothesis testing showed a group×time interaction for WAI (P

  16. Treatment of myofascial trigger points in female patients with chronic tension-type headache - A randomized controlled trial

    DEFF Research Database (Denmark)

    Berggreen, S.; Wiik, E.; Lund, Hans

    2012-01-01

    The aim of this study was to evaluate the efficacy of myofascial trigger point massage in the muscles of the head, neck and shoulders regarding pain in the treatment of females with chronic tension-type headache. They were randomized into either a treatment group (n = 20) (one session of trigger...... point massage per week for 10 weeks) or a control group receiving no treatment (n = 19). The patients kept a diary to record their pain on a visual analogue scale (VAS), and the daily intake of drugs (mg) during the 4 weeks before and after the treatment period. The McGill Pain Questionnaire......: 8.8 (95% CI 0.1117.4), p = 0.047). Furthermore, a significant decrease in the number of trigger points was observed in the treatment group compared with the control group. Myofascial trigger point massage has a beneficial effect on pain in female patients with chronic tension-type headache. © 2012...

  17. PLACEBO-DRIVEN CLINICAL TRIALS OF TRANSFER POINT GLUCAN #300 IN CHILDREN WITH CHRONIC RESPIRATORY PROBLEMS: ANTIBODY PRODUCTION

    Directory of Open Access Journals (Sweden)

    Vetvicka Vaclav

    2013-01-01

    Full Text Available The role of glucan in stimulation of immune reactions has been well-established. In this report, we focused on the antibody production in glucan-supplemented children with chronic respiratory problems. We measured the levels of salivary IgA, IgM and IgG in 40 children aged 8-12 years and evaluated the effects of 100 mg d-1 oral dose of glucan. We found a significant increase in production of all tested antibodies in the glucan-stimulated group, but a decrease of antibody production in the control group. A thirty-day oral application of yeast-based natural immunomodulator β-glucan strongly stimulated the mucosal immunity of children with chronic respiratory problems.

  18. Comparison of efficacy and safety between benidipine and hydrochlorothiazide in fosinopril-treated hypertensive patients with chronic kidney disease: protocol for a randomised controlled trial

    Science.gov (United States)

    Xue, Cheng; Zhou, Chenchen; Yang, Bo; Lv, Jiayi; Dai, Bing; Yu, Shengqiang; Wang, Yi; Zhao, Guanren; Mei, Changlin

    2017-01-01

    Introduction Co-administration of a diuretic or calcium channel blocker with an ACE inhibitor are both preferred combinations in patients with hypertensive chronic kidney disease (CKD). According to the available evidence, it is still unknown which combination plays a more active role in renal protection. We hypothesised that a combination of fosinopril and benidipine may delay the progression of CKD more effectively than a combination of fosinopril and hydrochlorothiazide (HCTZ). Methods and analysis This study will be a multicentred, prospective, double-blind, randomised parallel controlled trial for hypertensive CKD patients in China. Patients will be randomised to one of two treatment groups: a combination of benidipine 4–8 mg/day and fosinopril 20 mg/day; or a combination of HCTZ 12.5–25 mg/day and fosinopril 20 mg/day. Patients will be followed up for 24 months after a month's fosinopril run-in. There will be dose-titration after 1 and 2 months. The primary endpoint is changes in estimated glomerular filtration rate (eGFR) from baseline to month 24. Secondary endpoints include changes in home blood pressure (BP), ambulatory BP, proteinuria, urinary albumin/creatinine ratio, and composite renal events in 24 months. Inclusion criteria are: age 18–80 years, non-dialysis CKD patients with eGFR >30 mL/min/1.73 m2, home BP >130 mm Hg systolic or BP >80 mm Hg diastolic at the screening and randomisation, and 24 hour proteinuria power 1-β=0.90). Ethics and dissemination BEAHIT (Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients with Hypertension) was approved by Changzheng Hospital Ethics Committee (CZ-20160504-16). The outcomes will be published in a peer-reviewed journal. Trial registration number NCT02646397. PMID:28237959

  19. Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care

    Directory of Open Access Journals (Sweden)

    Sabes-Figuera Ramon

    2012-08-01

    Full Text Available Abstract Background Fatigue is common and has been shown to result in high economic costs to society. The aim of this study is to compare the cost-effectiveness of two active therapies, graded-exercise (GET and counselling (COUN with usual care plus a self-help booklet (BUC for people presenting with chronic fatigue. Methods A randomised controlled trial was conducted with participants consulting for fatigue of over three months’ duration recruited from 31 general practices in South East England and allocated to one of three arms. Outcomes and use of services were assessed at 6-month follow-up. The main outcome measure used in the economic evaluation was clinically significant improvements in fatigue, measured using the Chalder fatigue scale. Cost-effectiveness was assessed using the net-benefit approach and cost-effectiveness acceptability curves. Results Full economic and outcome data at six months were available for 163 participants; GET = 51, COUN = 58 and BUC = 54. Those receiving the active therapies (GET and COUN had more contacts with care professionals and therefore higher costs, these differences being statistically significant. COUN was more expensive and less effective than the other two therapies. The incremental cost-effectiveness ratio of GET compared to BUC was equal to £987 per unit of clinically significant improvement. However, there was much uncertainty around this result. Conclusion This study does not provide a clear recommendation about which therapeutic option to adopt, based on efficiency, for patients with chronic fatigue. It suggests that COUN is not cost-effective, but it is unclear whether GET represents value for money compared to BUC. Clinical Trial Registration number at ISRCTN register: 72136156

  20. Identification of Bone Marrow Cell Subpopulations Associated With Improved Functional Outcomes in Patients With Chronic Left Ventricular Dysfunction: An Embedded Cohort Evaluation of the FOCUS-CCTRN Trial

    Science.gov (United States)

    Taylor, Doris A.; Perin, Emerson C.; Willerson, James T.; Zierold, Claudia; Resende, Micheline; Carlson, Marjorie; Nestor, Belinda; Wise, Elizabeth; Orozco, Aaron; Pepine, Carl J.; Henry, Timothy D.; Ellis, Stephen G.; Zhao, David X. M.; Traverse, Jay H.; Cooke, John P.; Schutt, Robert C.; Bhatnagar, Aruni; Grant, Maria B.; Lai, Dejian; Johnstone, Brian H.; Sayre, Shelly L.; Moyé, Lem; Ebert, Ray F.; Bolli, Roberto; Simari, Robert D.; Cogle, Christopher R.

    2016-01-01

    In the current study, we sought to identify bone marrow-derived mononuclear cell (BM-MNC) subpopulations associated with a combined improvement in left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and maximal oxygen consumption (VO2 max) in patients with chronic ischemic cardiomyopathy 6 months after receiving transendocardial injections of autologous BM-MNCs or placebo. For this prospectively planned analysis, we conducted an embedded cohort study comprising 78 patients from the FOCUS-Cardiovascular Cell Therapy Research Network (CCTRN) trial. Baseline BM-MNC immunophenotypes and progenitor cell activity were determined by flow cytometry and colony-forming assays, respectively. Previously stable patients who demonstrated improvement in LVEF, LVESV, and VO2 max during the 6-month course of the FOCUS-CCTRN study (group 1, n = 17) were compared to those who showed no change or worsened in one to three of these endpoints (group 2, n = 61) and to a subset of patients from group 2 who declined in all three functional endpoints (group 2A, n = 11). Group 1 had higher frequencies of B-cell and CXCR4+ BM-MNC subpopulations at study baseline than group 2 or 2A. Furthermore, patients in group 1 had fewer endothelial colony-forming cells and monocytes/macrophages in their bone marrow than those in group 2A. To our knowledge, this is the first study to show that in patients with ischemic cardiomyopathy, certain bone marrow-derived cell subsets are associated with improvement in LVEF, LVESV, and VO2 max at 6 months. These results suggest that the presence of both progenitor and immune cell populations in the bone marrow may influence the natural history of chronic ischemic cardiomyopathy—even in stable patients. Thus, it may be important to consider the bone marrow composition and associated regenerative capacity of patients when assigning them to treatment groups and evaluating the results of cell therapy trials. PMID:26590374

  1. Effects of transcutaneous electrical nerve stimulation (TENS and interferential currents (IFC in patients with nonspecific chronic low back pain: randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ligia Maria Facci

    Full Text Available CONTEXT AND OBJECTIVE: Transcutaneous electrical nerve stimulation (TENS and interferential current are the most used electrotherapy methods, although there is little scientific evidence to support their use. The aim of this study was to compare the effects of TENS and interferential current among patients with nonspecific chronic low back pain. DESIGN AND SETTING: Single-blind randomized controlled trial in the Department of Physiotherapy, Centro Universitário de Maringá. METHODS: One hundred and fifty patients were randomly divided into three groups: TENS (group 1, interferential current (group 2 and controls (group 3. The patients designated for electrotherapy received ten 30-minute sessions, while the control group remained untreated. All patients and controls were evaluated before and after treatment using a visual analog scale and the McGill Pain and Roland Morris questionnaires, and regarding their use of additional medications. RESULTS: There was a mean reduction on the visual analog scale of 39.18 mm with TENS, 44.86 mm with interferential current and 8.53 mm among the controls. In the Roland Morris questionnaire, group 1 had a mean reduction of 6.59; group 2, 7.20; and group 3, 0.70 points. In group 1, 84% of the patients stopped using medications after the treatment; in group 2, 75%; and in group 3, 34%. There was no statistically significant difference between the TENS and interferential current groups (P > 0.05; a difference was only found between these groups and the controls (P < 0.0001. CONCLUSION: There was no difference between TENS and interferential current for chronic low back pain treatment. CLINICAL TRIAL REGISTRATION: NCT01017913.

  2. Targeting chronic lymphocytic leukemia cells in the tumor microenviroment: A review of the in vitro and clinical trials to date

    OpenAIRE

    2015-01-01

    Chronic lymphocytic leukemia (CLL) is the most common leukemia in the western world. Despite significant advances in therapy over the last decade CLL remains incurable. Current front-line therapy often consists of chemoimmunotherapy-based regimens, most commonly the fludarabine, cyclophosphamide plus rituximab combination, but rates of relapse and refractory disease are high among these patients. Several key signaling pathways are now known to mediate the survival and proliferation of CLL cel...

  3. Empowering employees with chronic diseases; development of an intervention aimed at job retention and design of a randomised controlled trial

    OpenAIRE

    Heutink Annelies; de Vries Gabe; Varekamp Inge; van Dijk Frank JH

    2008-01-01

    Abstract Background Persons with a chronic disease are less often employed than healthy persons. If employed, many of them experience problems at work. Therefore, we developed a training programme aimed at job retention. The objective of this paper is to describe this intervention and to present the design of a study to evaluate its effectiveness. Development and description of intervention A systematic review, a needs assessment and discussions with Dutch experts led to a pilot group trainin...

  4. Wii Fit balance training or progressive balance training in patients with chronic stroke: a randomised controlled trial

    OpenAIRE

    Yatar, Gozde Iyigun; Yildirim, Sibel Aksu

    2015-01-01

    [Purpose] The aim of this study was to compare the effects of Wii Fit balance training (WBT) and progressive balance training (PBT) approaches on balance functions, balance confidence, and activities of daily living in chronic stroke patients. [Subjects] A total of 30 patients were randomized into the WBT (n=15) and PBT (n=15) groups. [Methods] All of the subjects received exercise training based on a neurodevelopemental approach in addition to either Wii Fit or progressive balance training f...

  5. Ultrasound-Guided Miniscalpel-Needle Release versus Dry Needling for Chronic Neck Pain: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Yongjun Zheng

    2014-01-01

    Full Text Available Objective. To compare ultrasound-guided miniscalpel-needle (UG-MSN release versus ultrasound-guided dry needling (UG-DN for chronic neck pain. Methods. A total of 169 patients with chronic neck pain were randomized to receive either UG-MSN release or UG-DN. Before treatment and at 3 and 6 months posttreatment, pain was measured using a 10-point visual analogue scale (VAS. Neck function was examined using the neck disability index. Health-related quality of life was examined using the physical component score (PCS and mental component score (MCS of the SF-36 health status scale. Results. Patients in the UG-MSN release had greater improvement on the VAS (by 2 points at 3 months and 0.9 points at 6 months versus in the UG-DN arm; (both P<0.0001. Patients receiving UG-MSN release also showed significantly lower scores on the adjusted neck disability index, as well as significantly lower PCS. No severe complications were observed. Conclusion. UG-MSN release was superior to UG-DN in reducing pain intensity and neck disability in patients with chronic neck pain and was not associated with severe complications. The procedural aspects in the two arms were identical; however, we did not verify the blinding success. As such, the results need to be interpreted with caution.

  6. Efficacy of 1% acetic acid in the treatment of chronic wounds infected with Pseudomonas aeruginosa: prospective randomised controlled clinical trial.

    Science.gov (United States)

    Madhusudhan, V L

    2016-12-01

    Chronic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic wounds. In the present study, an attempt has been made to use 1% acetic acid as the sole antimicrobial agent for the treatment of pseudomonal wound infections. A control limb was used in which the wounds were treated with normal saline. Our objective was to evaluate the efficacy of acetic acid in low concentration of 1% in chronic wounds infected with P. aeruginosa. This was a prospective study conducted over a period of 6 months.

  7. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain

    Directory of Open Access Journals (Sweden)

    Descarreaux Martin

    2011-02-01

    Full Text Available Abstract Background Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP. The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program. Methods Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29, a SMT group (n = 36 or a SMT + exercise group (n = 33. The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group, 1 monthly SMT session (SMT group or 1 monthly SMT session combined with a home exercise program (SMT + exercise group. The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS, active cervical ranges of motion (cROM, the neck disability index (NDI and the Bournemouth questionnaire (BQ. Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ and the SF-12 Questionnaire. Results Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL was associated with the preventive phase. Conclusions This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the

  8. Influence of control group on effect size in trials of acupuncture for chronic pain: a secondary analysis of an individual patient data meta-analysis.

    Directory of Open Access Journals (Sweden)

    Hugh MacPherson

    Full Text Available BACKGROUND: In a recent individual patient data meta-analysis, acupuncture was found to be superior to both sham and non-sham controls in patients with chronic pain. In this paper we identify variations in types of sham and non-sham controls used and analyze their impact on the effect size of acupuncture. METHODS: Based on literature searches of acupuncture trials involving patients with headache and migraine, osteoarthritis, and back, neck and shoulder pain, 29 trials met inclusion criteria, 20 involving sham controls (n = 5,230 and 18 non-sham controls (n = 14,597. For sham controls, we analysed non-needle sham, penetrating sham needles and non-penetrating sham needles. For non-sham controls, we analysed non-specified routine care and protocol-guided care. Using meta-regression we explored impact of choice of control on effect of acupuncture. FINDINGS: Acupuncture was significantly superior to all categories of control group. For trials that used penetrating needles for sham control, acupuncture had smaller effect sizes than for trials with non-penetrating sham or sham control without needles. The difference in effect size was -0.45 (95% C.I. -0.78, -0.12; p = 0.007, or -0.19 (95% C.I. -0.39, 0.01; p = 0.058 after exclusion of outlying studies showing very large effects of acupuncture. In trials with non-sham controls, larger effect sizes associated with acupuncture vs. non-specified routine care than vs. protocol-guided care. Although the difference in effect size was large (0.26, it was not significant with a wide confidence interval (95% C.I. -0.05, 0.57, p = 0.1. CONCLUSION: Acupuncture is significantly superior to control irrespective of the subtype of control. While the choice of control should be driven by the study question, our findings can help inform study design in acupuncture, particularly with respect to sample size. Penetrating needles appear to have important physiologic activity. We recommend that this type of sham be avoided.

  9. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Arce Roger M

    2011-02-01

    Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

  10. Comparison of the effectiveness and safety of cefpodoxime and ciprofloxacin in acute exacerbation of chronic suppurative otitis media: A randomized, open-labeled, phase IV clinical trial

    Directory of Open Access Journals (Sweden)

    Arijit Ghosh

    2012-01-01

    Full Text Available Objective : To compare the effectiveness and safety of cefpodoxime and ciprofloxacin for the treatment of mild to moderate cases of acute exacerbation of chronic suppurative otitis media (AECSOM. Materials and Methods : Adult patients diagnosed with AECSOM were screened and patients fulfilling the inclusion criteria were randomized to receive either cefpodoxime 200 mg twice daily or ciprofloxacin 500 mg twice daily orally for 7 days. The primary outcome of this randomized, open-labeled, phase IV clinical trial (Registration Number - CTRI/2011/10/002079 was clinical success rate at day 14 visit and the secondary outcome was incidence of adverse events (AEs. Forty-six patients were enrolled: 23 in the cefpodoxime group and 23 in the ciprofloxacin group. Results : The clinical success rates were 95.6% in the cefpodoxime group versus 90.9% in the ciprofloxacin group. These rates are comparable, but no statistically significant difference was observed between the groups. Few mild and self-limiting AEs were observed and the tolerability of both the drugs was also good. Conclusion : The results of this randomized, open-labeled phase IV clinical trial showed that a 7-day course of cefpodoxime is therapeutically comparable to ciprofloxacin in terms of both clinical effectiveness and safety for the treatment of patients with AECSOM.

  11. Effects of qigong exercise on fatigue, anxiety, and depressive symptoms of patients with chronic fatigue syndrome-like illness: a randomized controlled trial.

    Science.gov (United States)

    Chan, Jessie S M; Ho, Rainbow T H; Wang, Chong-Wen; Yuen, Lai Ping; Sham, Jonathan S T; Chan, Cecilia L W

    2013-01-01

    Background. Anxiety/depressive symptoms are common in patients with chronic fatigue syndrome- (CFS-) like illness. Qigong as a modality of complementary and alternative therapy has been increasingly applied by patients with chronic illnesses, but little is known about the effect of Qigong on anxiety/depressive symptoms of the patients with CFS-like illness. Purpose. To investigate the effects of Qigong on fatigue, anxiety, and depressive symptoms in patients with CFS-illness. Methods. One hundred and thirty-seven participants who met the diagnostic criteria for CFS-like illness were randomly assigned to either an intervention group or a waitlist control group. Participants in the intervention group received 10 sessions of Qigong training twice a week for 5 consecutive weeks, followed by home-based practice for 12 weeks. Fatigue, anxiety, and depressive symptoms were assessed at baseline and postintervention. Results. Total fatigue score [F(1,135) = 13.888, P Qigong group compared to controls. The anxiety score was not significantly improved in the Qigong group. Conclusion. Qigong may not only reduce the fatigue symptoms, but also has antidepressive effect for patients with CFS-like illness. Trial registration HKCTR-1200.

  12. Effects of Qigong Exercise on Fatigue, Anxiety, and Depressive Symptoms of Patients with Chronic Fatigue Syndrome-Like Illness: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jessie S. M. Chan

    2013-01-01

    Full Text Available Background. Anxiety/depressive symptoms are common in patients with chronic fatigue syndrome- (CFS- like illness. Qigong as a modality of complementary and alternative therapy has been increasingly applied by patients with chronic illnesses, but little is known about the effect of Qigong on anxiety/depressive symptoms of the patients with CFS-like illness. Purpose. To investigate the effects of Qigong on fatigue, anxiety, and depressive symptoms in patients with CFS-illness. Methods. One hundred and thirty-seven participants who met the diagnostic criteria for CFS-like illness were randomly assigned to either an intervention group or a waitlist control group. Participants in the intervention group received 10 sessions of Qigong training twice a week for 5 consecutive weeks, followed by home-based practice for 12 weeks. Fatigue, anxiety, and depressive symptoms were assessed at baseline and postintervention. Results. Total fatigue score [F1,135=13.888, P<0.001], physical fatigue score [F1,135=20.852, P<0.001] and depression score [F1,135=9.918, P=0.002] were significantly improved and mental fatigue score [F1,135=3.902, P=0.050] was marginally significantly improved in the Qigong group compared to controls. The anxiety score was not significantly improved in the Qigong group. Conclusion. Qigong may not only reduce the fatigue symptoms, but also has antidepressive effect for patients with CFS-like illness. Trial registration HKCTR-1200.

  13. Chronic Effects of a Wild Green Oat Extract Supplementation on Cognitive Performance in Older Adults: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial

    Directory of Open Access Journals (Sweden)

    Narelle M. Berry

    2012-05-01

    Full Text Available Background and aim: Preliminary evaluation of a wild green oat extract (WGOE (Neuravena® ELFA®955, Frutarom, Switzerland revealed an acute cognitive benefit of supplementation. This study investigated whether regular daily WGOE supplementation would result in sustained cognitive improvements. Method: A 12-week randomised, double-blind, placebo-controlled cross-over trial of WGOE supplementation (1500 mg/day versus placebo was undertaken in 37 healthy adults aged 67 ± 0.8 years (mean ± SEM. Cognitive assessments included the Stroop colour-word test, letter cancellation, the rule-shift task, a computerised multi-tasking test battery and the trail-making task. All assessments were conducted in Week 12 and repeated in Week 24 whilst subjects were fasted and at least 18 h after taking the last dose of supplement. Result: Chronic WGOE supplementation did not affect any measures of cognition. Conclusion: It appears that the cognitive benefit of acute WGOE supplementation does not persist with chronic treatment in older adults with normal cognition. It remains to be seen whether sustained effects of WGOE supplementation may be more evident in those with mild cognitive impairment.

  14. Interferon β-1a alone or in combination with ribavirin: A randomized trial to compare efficacy and safety in chronic hepatitis C

    Institute of Scientific and Technical Information of China (English)

    Rinaldo Pellicano; Antonino Picciotto; Francesco Torre; Gaetano Ideo; Carlo Cattaneo; Mara Berrutti; Mario Rizzetto; Antonio Craxì; Piero Luigi Almasio; Mario Valenza; Giovanna Venezia; Alfredo Alberti; Silvia Boccato; Luigi Demelia; Orazio Sorbello

    2005-01-01

    AIM: To compare the efficacy and safety of recombinant human IFN β-1a alone or in combination with ribavirin in treatment-na(i)ve subjects with chronic hepatitis C.METHODS: Open, randomized