Evidence-based recommendations for analgesic efficacy to treat pain of endodontic origin: A systematic review of randomized controlled trials.

Science.gov (United States)

Aminoshariae, Anita; Kulild, James C; Donaldson, Mark; Hersh, Elliot V

2016-10-01

The purpose of this investigation was to identify evidence-based clinical trials to aid dental clinicians in establishing the efficacy for recommending or prescribing analgesics for pain of endodontic origin. The authors prepared and registered a protocol on PROSPERO and conducted electronic searches in MEDLINE, Scopus, the Cochrane Library, and ClinicalTrials.gov. In addition, the authors manually searched the bibliographies of all relevant articles, the gray literature, and textbooks for randomized controlled trials. Two authors selected the relevant articles independently. There were no disagreements between the authors. The authors analyzed 27 randomized, placebo-controlled trials. The authors divided the studies into 2 groups: preoperative and postoperative analgesic treatments. There was moderate evidence to support the use of steroids for patients with symptomatic irreversible pulpitis. Also, there was moderate evidence to support nonsteroidal anti-inflammatory drugs (NSAIDs) preoperatively or postoperatively to control pain of endodontic origin. When NSAIDs were not effective, a combination of NSAIDs with acetaminophen, tramadol, or an opioid appeared beneficial. NSAIDs should be considered as the drugs of choice to alleviate or minimize pain of endodontic origin if there are no contraindications for the patient to ingest an NSAID. In situations in which NSAIDs alone are not effective, the combination of an NSAID with acetaminophen or a centrally acting drug is recommended. Steroids appear effective in irreversible pulpitis. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

Imipramine and Pregabalin Combination for Painful Polyneuropathy. A Randomized Controlled Trial

DEFF Research Database (Denmark)

Holbech, Jakob V; Bach, Flemming W; Finnerup, Nanna B

2015-01-01

Monotherapy with first-line drugs for neuropathic pain often fails to provide sufficient pain relief or has unacceptable side effects because of the need for high doses. The aim of this trial was to test whether the combination of imipramine and pregabalin in moderate doses would relieve pain more...... effectively than monotherapy with either of the drugs. This was a randomized, double-blind, placebo-controlled, crossover, multicenter trial consisting of four 5-week treatment periods in patients with painful polyneuropathy. Treatment arms were imipramine 75 mg/d vs pregabalin 300 mg/d vs combination therapy...... randomized, and 69 patients were included in the data analysis. The effect on average pain in comparison with placebo was: combination (-1.67 NRS points, P pregabalin (-0.48 NRS points, P = 0.03). The combination therapy had significantly lower pain...

Comparative Effect of Collaborative Care, Pain Medication, and Duloxetine in the Treatment of Major Depressive Disorder and Comorbid (SubChronic Pain: Results of an Exploratory Randomized, Placebo-Controlled, Multicenter Trial (CC:PAINDIP

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Eric W. de Heer

2018-04-01

Full Text Available ObjectiveEvidence exists for the efficacy of collaborative care (CC for major depressive disorder (MDD, for the efficacy of the consequent use of pain medication against pain, and for the efficacy of duloxetine against both MDD and neuropathic pain. Their relative effectiveness in comorbid MDD and pain has never been established so far. This study explores the effectiveness of CC with pain medication and duloxetine, and CC with pain medication and placebo, compared with duloxetine alone, on depressive and pain symptoms. This study was prematurely terminated because of massive reorganizations and reimbursement changes in mental health care in the Netherlands during the study period and is therefore of exploratory nature.MethodsThree-armed, randomized, multicenter, placebo-controlled trial at three specialized mental health outpatient clinics with patients who screened positive for MDD. Interventions lasted 12 weeks. Pain medication was administered according to an algorithm that avoids opiate prescription as much as possible, where paracetamol, COX inhibitors, and pregabalin are offered as steps before opiates are considered. Patients who did not show up for three or more sessions were registered as non-compliant. Explorative, intention-to-treat and per protocol, multilevel regression analyses were performed. The trial is listed in the trial registration (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089; NTR number: NTR1089.ResultsSixty patients completed the study. Patients in all treatment groups reported significantly less depressive and pain symptoms after 12 weeks. CC with placebo condition showed the fastest decrease in depressive symptoms compared with the duloxetine alone group (b = −0.78; p = 0.01. Non-compliant patients (n = 31 did not improve over the 12-week period, in contrast to compliant patients (n = 29. Pain outcomes did not differ between the three groups.ConclusionIn MDD and pain, patient�

A randomized controlled trial of tai chi for long-term low back pain (TAI CHI: Study rationale, design, and methods

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Hall Amanda M

2009-05-01

Full Text Available Abstract Background Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain. Methods and design The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452 Discussion This study will be the first

Acupucture as pain relief during delivery - a randomized controlled trial

DEFF Research Database (Denmark)

Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

2009-01-01

Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... to existing pain relief methods. (BIRTH 36:1 March 2009)...

Reporting outcomes of back pain trials: a modified Delphi study

DEFF Research Database (Denmark)

Froud, R.; Eldridge, S.; Kovacs, F.

2011-01-01

trials. METHODS: We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi......BACKGROUND: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret. AIM: To facilitate consensus on a statement recommending reporting methods for future low back pain...... process and the RAND/UCLA appropriateness method as a formal framework for establishing appropriateness and quantifying panel disagreement. RESULTS: A group of 63 experts from 14 countries participated. Consensus was reached on a statement recommending that the continuous patient-reported outcomes...

Moxibustion for pain relief in patients with primary dysmenorrhea: A randomized controlled trial

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Bo, Linna; Lao, Lixing; Chen, Jiao; Yu, Siyi; Yu, Zheng; Tang, Hongzhi; Yi, Ling; Wu, Xi; Yang, Jie; Liang, Fanrong

2017-01-01

Background Though moxibustion is frequently used to treat primary dysmenorrhea in China, relevant evidence supporting its effectiveness is still scanty. Methods This study was a pragmatic randomized, conventional drug controlled, open-labeled clinical trial. After initial screen, 152 eligible participants were averagely randomized to receive two different treatment strategies: Moxibustion and conventional drugs. Participants and practitioners were not blinded in this study. The duration of each treatment was 3 months. The primary outcome was pain relief measured by the Visual Analogue Scale. The menstrual pain severity was recorded in a menstrual pain diary. Results 152 eligible patients were included but only 133 of them eventually completed the whole treatment course. The results showed that the menstrual pain intensity in experimental group and control group was reduced from 6.38±1.28 and 6.41±1.29, respectively, at baseline, to 2.54±1.41 and 2.47±1.29 after treatment. The pain reduction was not significantly different between these two groups (P = 0.76), however; the pain intensity was significantly reduced relative to baseline for each group (P<0.01). Three months after treatment, the effectiveness of moxibustion sustained and started to be superior to the drug’s effect (-0.87, 95%CI -1.32 to -0.42, P<0.01). Secondary outcome analyses showed that moxibustion was as effective as drugs in alleviating menstrual pain-related symptoms. The serum levels of pain mediators, such as PGF2α, OT, vWF, β-EP, PGE2, were significantly improved after treatment in both groups (P<0.05). No adverse events were reported in this trial. Conclusions Both moxibustion and conventional drug showed desirable merits in managing menstrual pain, given their treatment effects and economic costs. This study as a pragmatic trial only demonstrates the effectiveness, not the efficacy, of moxibustion for menstrual pain. It can’t rule out the effect of psychological factors during

Pain education to prevent chronic low back pain: a study protocol for a randomised controlled trial.

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Traeger, Adrian C; Moseley, G Lorimer; Hübscher, Markus; Lee, Hopin; Skinner, Ian W; Nicholas, Michael K; Henschke, Nicholas; Refshauge, Kathryn M; Blyth, Fiona M; Main, Chris J; Hush, Julia M; Pearce, Garry; McAuley, James H

2014-06-02

Low back pain (LBP) is the leading cause of disability worldwide. Of those patients who present to primary care with acute LBP, 40% continue to report symptoms 3 months later and develop chronic LBP. Although it is possible to identify these patients early, effective interventions to improve their outcomes are not available. This double-blind (participant/outcome assessor) randomised controlled trial will investigate the efficacy of a brief educational approach to prevent chronic LBP in 'at-risk' individuals. Participants will be recruited from primary care practices in the Sydney metropolitan area. To be eligible for inclusion participants will be aged 18-75 years, with acute LBP (education or 2×1 h sessions of sham education from a specially trained study physiotherapist. The study requires 101 participants per group to detect a 1-point difference in pain intensity 3 months after pain onset. Secondary outcomes include the incidence of chronic LBP, disability, pain intensity, depression, healthcare utilisation, pain attitudes and beliefs, global recovery and recurrence and are measured at 1 week post-intervention, and at 3, 6 and 12 months post LBP onset. Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 (ref number HC12664). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Pain relief and functional improvement in patients with neuropathic pain associated with spinal cord injury: an exploratory analysis of pregabalin clinical trials.

Science.gov (United States)

Sadosky, Alesia; Parsons, Bruce; Emir, Birol; Nieshoff, Edward C

2016-01-01

Characterizing relationships between pain relief and function can inform patient management decisions. This analysis explored graphically the relationship between pain relief and functional improvement in patients with neuropathic pain associated with spinal cord injury in two clinical trials of pregabalin. This was a post hoc analysis of two randomized, double-blind, clinical trials in patients who were treated with pregabalin (n=181) or placebo (n=172) for neuropathic pain associated with spinal cord injury. The bivariate relationship between percent pain relief and absolute change in the functional outcomes with placebo and pregabalin was evaluated graphically using scatter plots, and loess curves illustrated the extent of the relationship between pain and function. Linear trend analysis evaluated the statistical significance of these relationships using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)-based thresholds of pain reduction (Pain Inventory pain interference with function in one of the studies and the Medical Outcomes Study Sleep Scale (an 11-point Numeric Rating Scale) and the Hospital Anxiety and Depression Scale (HADS) for the pooled studies. Data ellipses showed a shift with pregabalin relative to placebo toward greater improvement with increasing pain relief for all outcome measures except HADS. Loess curves suggested a relationship between increased pain relief and improved function except for HADS, with the clearest relationship observed for sleep. Linear trend analysis showed significant relationships between pain and Medical Outcomes Study Sleep Scale (Ppain and function on the modified Brief Pain Inventory Interference Index and most individual items (Ppain reduction. Pregabalin resulted in shifts from placebo toward greater functional improvement with greater pain relief.

Escitalopram in painful polyneuropathy: A randomized, placebo-controlled, cross-over trial

DEFF Research Database (Denmark)

Otto, Marit; Bach, Flemming W; Jensen, Troels S

2008-01-01

Serotonin (5-HT) is involved in pain modulation via descending pathways in the central nervous system. The aim of this study was to test if escitalopram, a selective serotonin reuptake inhibitor (SSRI), would relieve pain in polyneuropathy. The study design was a randomized, double-blind, placebo......-controlled cross-over trial. The daily dose of escitalopram was 20mg once daily. During the two treatment periods of 5 weeks duration, patients rated pain relief (primary outcome variable) on a 6-point ordered nominal scale. Secondary outcome measures comprised total pain and different pain symptoms (touch...

Effectiveness of trigger point dry needling for plantar heel pain: study protocol for a randomised controlled trial

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Landorf Karl B

2011-01-01

Full Text Available Abstract Background Plantar heel pain (plantar fasciitis is a common and disabling condition, which has a detrimental impact on health-related quality of life. Despite the high prevalence of plantar heel pain, the optimal treatment for this disorder remains unclear. Consequently, an alternative therapy such as dry needling is increasingly being used as an adjunctive treatment by health practitioners. Only two trials have investigated the effectiveness of dry needling for plantar heel pain, however both trials were of a low methodological quality. This manuscript describes the design of a randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. Methods Eighty community-dwelling men and woman aged over 18 years with plantar heel pain (who satisfy the inclusion and exclusion criteria will be recruited. Eligible participants with plantar heel pain will be randomised to receive either one of two interventions, (i real dry needling or (ii sham dry needling. The protocol (including needling details and treatment regimen was formulated by general consensus (using the Delphi research method using 30 experts worldwide that commonly use dry needling for plantar heel pain. Primary outcome measures will be the pain subscale of the Foot Health Status Questionnaire and "first step" pain as measured on a visual analogue scale. The secondary outcome measures will be health related quality of life (assessed using the Short Form-36 questionnaire - Version Two and depression, anxiety and stress (assessed using the Depression, Anxiety and Stress Scale - short version. Primary outcome measures will be performed at baseline, 2, 4, 6 and 12 weeks and secondary outcome measures will be performed at baseline, 6 and 12 weeks. Data will be analysed using the intention to treat principle. Conclusion This study is the first randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. The trial will

The use of ginger (Zingiber officinale) for the treatment of pain: a systematic review of clinical trials.

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Terry, Rohini; Posadzki, Paul; Watson, Leala K; Ernst, Edzard

2011-12-01

  Zingiber officinale (Z. officinale), commonly known as ginger, has been widely used traditionally for a variety of medicinal purposes, one of which is for the treatment of pain. The aim of this systematic review was to evaluate the evidence from all human participant clinical trials that have assessed the efficacy of ginger for the treatment of any type of pain.   Following a protocol, multiple databases were sought using comprehensive search strategies for Z. officinale and pain together with a trial filter for randomized or controlled clinical trials. Trials testing the efficacy of Z. officinale, used as a sole oral treatment against a comparison condition in human adults suffering from any pain condition, were included.   Seven published articles, reporting a total of eight trials (481 participants), were included in the review. Six trials (two for osteoarthritis, one for dysmenorrhea, and three for experimentally induced acute muscle pain) found that the use of Z. officinale reduced subjective pain reports. The methodological quality of the included articles was variable. When assessed using the Jadad scale, which allows a score of between 0 and 5 to be given, included articles obtained Jadad ratings ranging from 2 to 5.   Due to a paucity of well-conducted trials, evidence of the efficacy of Z. officinale to treat pain remains insufficient. However, the available data provide tentative support for the anti-inflammatory role of Z. officinale constituents, which may reduce the subjective experience of pain in some conditions such as osteoarthritis. Further rigorous trials therefore seem to be warranted. Wiley Periodicals, Inc.

Blended-Learning Pain Neuroscience Education for People With Chronic Spinal Pain: Randomized Controlled Multicenter Trial.

Science.gov (United States)

Malfliet, Anneleen; Kregel, Jeroen; Meeus, Mira; Roussel, Nathalie; Danneels, Lieven; Cagnie, Barbara; Dolphens, Mieke; Nijs, Jo

2018-05-01

Available evidence favors the use of pain neuroscience education (PNE) in patients with chronic pain. However, PNE trials are often limited to small sample sizes and, despite the current digital era, the effects of blended-learning PNE (ie, the combination of online digital media with traditional educational methods) have not yet been investigated. The study objective was to examine whether blended-learning PNE is able to improve disability, catastrophizing, kinesiophobia, and illness perceptions. This study was a 2-center, triple-blind randomized controlled trial (participants, statistician, and outcome assessor were masked). The study took place at university hospitals in Ghent and Brussels, Belgium. Participants were 120 people with nonspecific chronic spinal pain (ie, chronic neck pain and low back pain). The intervention was 3 sessions of PNE or biomedically focused back/neck school education (addressing spinal anatomy and physiology). Measurements were self-report questionnaires (Pain Disability Index, Pain Catastrophizing Scale, Tampa Scale for Kinesiophobia, Illness Perception Questionnaire, and Pain Vigilance and Awareness Questionnaire). None of the treatment groups showed a significant change in the perceived disability (Pain Disability Index) due to pain (mean group difference posteducation: 1.84; 95% CI = -2.80 to 6.47). Significant interaction effects were seen for kinesiophobia and several subscales of the Illness Perception Questionnaire, including negative consequences, cyclical time line, and acute/chronic time line. In-depth analysis revealed that only in the PNE group were these outcomes significantly improved (9% to 17% improvement; 0.37 ≤ Cohen d ≥ 0.86). Effect sizes are small to moderate, which might raise the concern of limited clinical utility; however, changes in kinesiophobia exceed the minimal detectable difference. PNE should not be used as the sole treatment modality but should be combined with other treatment strategies

Controlled trial of balneotherapy in treatment of low back pain.

Science.gov (United States)

Konrad, K; Tatrai, T; Hunka, A; Vereckei, E; Korondi, I

1992-01-01

Three treatments for non-specific lumbar pain--balneotherapy, underwater traction bath, and underwater massage--were assessed in a randomised prospective controlled trial in 158 outpatients. Each group was treated for four weeks and patients were reviewed at the end of this period and at 12 months after entry to the trial. The prescription of analgesics and the pain score were significantly reduced in all three treated groups, but there was no difference between the three groups. No significant change occurred in spinal motion and the straight leg raising test. After one year only the analgesic consumption was significantly lower than in the control group. PMID:1535495

Core domain and outcome measurement sets for shoulder pain trials are needed: Systematic review of physical therapy trials

NARCIS (Netherlands)

M.J. Page (Matthew J.); J.E. McKenzie (Joanne E.); S.E. Green (Sally E.); D.E. Beaton (Dorcas E.); N.B. Jain (Nitin B.); M. Lenza (Mario); A.P. Verhagen (Arianne); S. Surace (Stephen); J. Deitch (Jessica); R. Buchbinder (Rachelle)

2015-01-01

textabstractObjectives To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain). Study Design and Setting We included

The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial.

Science.gov (United States)

Barr, Colin; Marois, Maria; Sim, Ida; Schmid, Christopher H; Wilsey, Barth; Ward, Deborah; Duan, Naihua; Hays, Ron D; Selsky, Joshua; Servadio, Joseph; Schwartz, Marc; Dsouza, Clyde; Dhammi, Navjot; Holt, Zachary; Baquero, Victor; MacDonald, Scott; Jerant, Anthony; Sprinkle, Ron; Kravitz, Richard L

2015-02-27

Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach. ClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.

Improving participation rates by providing choice of participation mode: two randomized controlled trials

NARCIS (Netherlands)

Heijmans, N.; Lieshout, J. van; Wensing, M.J.

2015-01-01

BACKGROUND: Low participation rates reduce effective sample size, statistical power and can increase risk for selection bias. Previous research suggests that offering choice of participation mode can improve participation rates. However, few head-to-head trials compared choice of participation mode

Pain in the Blood? Envisioning Mechanism-Based Diagnoses and Biomarkers in Clinical Pain Medicine

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Emmanuel Bäckryd

2015-03-01

Full Text Available Chronic pain is highly prevalent, and pain medicine lacks objective biomarkers to guide diagnosis and choice of treatment. The current U.S. “opioid epidemic” is a reminder of the paucity of effective and safe treatment options. Traditional pain diagnoses according to the International Classification of Diseases are often unspecific, and analgesics are often prescribed on a trial-and-error basis. In contrast to this current state of affairs, the vision of future mechanism-based diagnoses of chronic pain conditions is presented in this non-technical paper, focusing on the need for biomarkers and the theoretical complexity of the task. Pain is and will remain a subjective experience, and as such is not objectively measurable. Therefore, the concept of “noci-marker” is presented as an alternative to “pain biomarker”, the goal being to find objective, measurable correlates of the pathophysiological processes involved in different chronic pain conditions. This vision entails a call for more translational pain research in order to bridge the gap between clinical pain medicine and preclinical science.

Pain relief and functional improvement in patients with neuropathic pain associated with spinal cord injury: an exploratory analysis of pregabalin clinical trials

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Sadosky A

2016-06-01

Full Text Available Alesia Sadosky,1 Bruce Parsons,1 Birol Emir,1 Edward C Nieshoff2 1Pfizer Inc., New York, NY, 2Rehabilitation Institute of Michigan, Detroit, MI, USA Background: Characterizing relationships between pain relief and function can inform patient management decisions. This analysis explored graphically the relationship between pain relief and functional improvement in patients with neuropathic pain associated with spinal cord injury in two clinical trials of pregabalin. Methods: This was a post hoc analysis of two randomized, double-blind, clinical trials in patients who were treated with pregabalin (n=181 or placebo (n=172 for neuropathic pain associated with spinal cord injury. The bivariate relationship between percent pain relief and absolute change in the functional outcomes with placebo and pregabalin was evaluated graphically using scatter plots, and loess curves illustrated the extent of the relationship between pain and function. Linear trend analysis evaluated the statistical significance of these relationships using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT-based thresholds of pain reduction (<15%, 15% <30%, 30% to <50%, and ≥50%. Outcome measures included modified Brief Pain Inventory pain interference with function in one of the studies and the Medical Outcomes Study Sleep Scale (an 11-point Numeric Rating Scale and the Hospital Anxiety and Depression Scale (HADS for the pooled studies. Results: Data ellipses showed a shift with pregabalin relative to placebo toward greater improvement with increasing pain relief for all outcome measures except HADS. Loess curves suggested a relationship between increased pain relief and improved function except for HADS, with the clearest relationship observed for sleep. Linear trend analysis showed significant relationships between pain and Medical Outcomes Study Sleep Scale (P<0.0001 and between pain and function on the modified Brief Pain Inventory

Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial

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Guckenberger Matthias

2012-11-01

vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this two-centre phase II trial. Conclusions Results of this study will refine the methods of patient selection, target volume definition, treatment planning and delivery as well as quality assurance for radiosurgery. It is the intention of this study to form the basis for a future randomized controlled trial comparing conventional radiotherapy with fractionated radiosurgery for palliation of painful vertebral metastases. Trial registration ClinicalTrials.gov Identifier: NCT01594892

Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: A randomised clinical trial

Science.gov (United States)

Vicenzino, Bill; Collins, Natalie; Crossley, Kay; Beller, Elaine; Darnell, Ross; McPoil, Thomas

2008-01-01

Background Patellofemoral pain syndrome is a highly prevalent musculoskeletal overuse condition that has a significant impact on participation in daily and physical activities. A recent systematic review highlighted the lack of high quality evidence from randomised controlled trials for the conservative management of patellofemoral pain syndrome. Although foot orthoses are a commonly used intervention for patellofemoral pain syndrome, only two pilot studies with short term follow up have been conducted into their clinical efficacy. Methods/design A randomised single-blinded clinical trial will be conducted to investigate the clinical efficacy and cost effectiveness of foot orthoses in the management of patellofemoral pain syndrome. One hundred and seventy-six participants aged 18–40 with anterior or retropatellar knee pain of non-traumatic origin and at least six weeks duration will be recruited from the greater Brisbane area in Queensland, Australia through print, radio and television advertising. Suitable participants will be randomly allocated to receive either foot orthoses, flat insoles, physiotherapy or a combined intervention of foot orthoses and physiotherapy, and will attend six visits with a physiotherapist over a 6 week period. Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale. Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests. Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries

Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: A randomised clinical trial

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Darnell Ross

2008-02-01

Full Text Available Abstract Background Patellofemoral pain syndrome is a highly prevalent musculoskeletal overuse condition that has a significant impact on participation in daily and physical activities. A recent systematic review highlighted the lack of high quality evidence from randomised controlled trials for the conservative management of patellofemoral pain syndrome. Although foot orthoses are a commonly used intervention for patellofemoral pain syndrome, only two pilot studies with short term follow up have been conducted into their clinical efficacy. Methods/design A randomised single-blinded clinical trial will be conducted to investigate the clinical efficacy and cost effectiveness of foot orthoses in the management of patellofemoral pain syndrome. One hundred and seventy-six participants aged 18–40 with anterior or retropatellar knee pain of non-traumatic origin and at least six weeks duration will be recruited from the greater Brisbane area in Queensland, Australia through print, radio and television advertising. Suitable participants will be randomly allocated to receive either foot orthoses, flat insoles, physiotherapy or a combined intervention of foot orthoses and physiotherapy, and will attend six visits with a physiotherapist over a 6 week period. Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale. Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests. Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and

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

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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.

A physiotherapist-delivered integrated exercise and pain coping skills training intervention for individuals with knee osteoarthritis: a randomised controlled trial protocol

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Bennell Kim L

2012-07-01

Full Text Available Abstract Background Knee osteoarthritis (OA is a prevalent chronic musculoskeletal condition with no cure. Pain is the primary symptom and results from a complex interaction between structural changes, physical impairments and psychological factors. Much evidence supports the use of strengthening exercises to improve pain and physical function in this patient population. There is also a growing body of research examining the effects of psychologist-delivered pain coping skills training (PCST particularly in other chronic pain conditions. Though typically provided separately, there are symptom, resource and personnel advantages of exercise and PCST being delivered together by a single healthcare professional. Physiotherapists are a logical choice to be trained to deliver a PCST intervention as they already have expertise in administering exercise for knee OA and are cognisant of the need for a biopsychosocial approach to management. No studies to date have examined the effects of an integrated exercise and PCST program delivered solely by physiotherapists in this population. The primary aim of this multisite randomised controlled trial is to investigate whether an integrated 12-week PCST and exercise treatment program delivered by physiotherapists is more efficacious than either program alone in treating pain and physical function in individuals with knee OA. Methods/design This will be an assessor-blinded, 3-arm randomised controlled trial of a 12-week intervention involving 10 physiotherapy visits together with home practice. Participants with symptomatic and radiographic knee OA will be recruited from the community in two cities in Australia and randomized into one of three groups: exercise alone, PCST alone, or integrated PCST and exercise. Randomisation will be stratified by city (Melbourne or Brisbane and gender. Primary outcomes are overall average pain in the past week measured by a Visual Analogue Scale and physical function measured by

Acupuncture as pain relief during delivery: a randomized controlled trial

DEFF Research Database (Denmark)

Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

2009-01-01

BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... with the intention-to-treat principle. RESULTS: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin...

Open-label placebo treatment in chronic low back pain: a randomized controlled trial.

Science.gov (United States)

Carvalho, Cláudia; Caetano, Joaquim Machado; Cunha, Lidia; Rebouta, Paula; Kaptchuk, Ted J; Kirsch, Irving

2016-12-01

This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland-Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (-0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain.

Massage therapy decreases pain and perceived fatigue after long-distance Ironman triathlon: a randomised trial

Directory of Open Access Journals (Sweden)

Guilherme S Nunes

2016-04-01

Full Text Available Question: Can massage therapy reduce pain and perceived fatigue in the quadriceps of athletes after a long-distance triathlon race (Ironman? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis and blinded outcome assessors. Participants: Seventy-four triathlon athletes who completed an entire Ironman triathlon race and whose main complaint was pain in the anterior portion of the thigh. Intervention: The experimental group received massage to the quadriceps, which was aimed at recovery after competition, and the control group rested in sitting. Outcome measures: The outcomes were pain and perceived fatigue, which were reported using a visual analogue scale, and pressure pain threshold at three points over the quadriceps muscle, which was assessed using digital pressure algometry. Results: The experimental group had significantly lower scores than the control group on the visual analogue scale for pain (MD –7 mm, 95% CI –13 to –1 and for perceived fatigue (MD –15 mm, 95% CI –21 to –9. There were no significant between-group differences for the pressure pain threshold at any of the assessment points. Conclusion: Massage therapy was more effective than no intervention on the post-race recovery from pain and perceived fatigue in long-distance triathlon athletes. Trial registration: Brazilian Registry of Clinical Trials, RBR-4n2sxr. [Nunes GS, Bender PU, de Menezes FS, Yamashitafuji I, Vargas VZ, Wageck B (2016 Massage therapy decreases pain and perceived fatigue after long-distance Ironman triathlon: a randomised trial. Journal of Physiotherapy 62: 83–87

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

Directory of Open Access Journals (Sweden)

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

Moxibustion for pain relief in patients with primary dysmenorrhea: A randomized controlled trial.

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Yang, Mingxiao; Chen, Xiangzhu; Bo, Linna; Lao, Lixing; Chen, Jiao; Yu, Siyi; Yu, Zheng; Tang, Hongzhi; Yi, Ling; Wu, Xi; Yang, Jie; Liang, Fanrong

2017-01-01

Though moxibustion is frequently used to treat primary dysmenorrhea in China, relevant evidence supporting its effectiveness is still scanty. This study was a pragmatic randomized, conventional drug controlled, open-labeled clinical trial. After initial screen, 152 eligible participants were averagely randomized to receive two different treatment strategies: Moxibustion and conventional drugs. Participants and practitioners were not blinded in this study. The duration of each treatment was 3 months. The primary outcome was pain relief measured by the Visual Analogue Scale. The menstrual pain severity was recorded in a menstrual pain diary. 152 eligible patients were included but only 133 of them eventually completed the whole treatment course. The results showed that the menstrual pain intensity in experimental group and control group was reduced from 6.38±1.28 and 6.41±1.29, respectively, at baseline, to 2.54±1.41 and 2.47±1.29 after treatment. The pain reduction was not significantly different between these two groups (P = 0.76), however; the pain intensity was significantly reduced relative to baseline for each group (Ppain-related symptoms. The serum levels of pain mediators, such as PGF2α, OT, vWF, β-EP, PGE2, were significantly improved after treatment in both groups (Ppain, given their treatment effects and economic costs. This study as a pragmatic trial only demonstrates the effectiveness, not the efficacy, of moxibustion for menstrual pain. It can't rule out the effect of psychological factors during treatment process, because no blind procedure or sham control was used due to availability. In clinical practice, moxibustion should be used at the discretion of patients and their physicians. ClinialTrials.gov NCT01972906.

Understanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial.

Science.gov (United States)

Lee, Hopin; Moseley, G Lorimer; Hübscher, Markus; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; McAuley, James H

2015-07-01

Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions. To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs. Causal mediation analysis of the PREVENT randomised controlled trial. Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area. Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group). All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain. Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference. Mediation analysis of clinical trials can

Active Choice and Financial Incentives to Increase Rates of Screening Colonoscopy-A Randomized Controlled Trial.

Science.gov (United States)

Mehta, Shivan J; Feingold, Jordyn; Vandertuyn, Matthew; Niewood, Tess; Cox, Catherine; Doubeni, Chyke A; Volpp, Kevin G; Asch, David A

2017-11-01

Behavioral economic approaches could increase uptake for colorectal cancer screening. We performed a randomized controlled trial of 2245 employees to determine whether an email containing a phone number for scheduling (control), an email with the active choice to opt in or opt out (active choice), or the active choice email plus a $100 incentive (financial incentive) increased colonoscopy completion within 3 months. Higher proportions of participants in the financial incentive group underwent screening (3.7%) than in the control (1.6%) or active choice groups (1.5%) (P = .01 and P < .01). We found no difference in uptake of screening between the active choice and control groups (P = .88). The $100 conditional incentive modestly but significantly increased colonoscopy use. ClinicalTrials.gov no: NCT02660671. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Maintained physical activity and physiotherapy in the management of distal upper limb pain - a protocol for a randomised controlled trial (the arm pain trial).

Science.gov (United States)

Jones, Gareth T; Mertens, Kathrin; Macfarlane, Gary J; Palmer, Keith T; Coggon, David; Walker-Bone, Karen; Burton, Kim; Heine, Peter J; McCabe, Candy; McNamee, Paul; McConnachie, Alex

2014-03-10

Distal upper limb pain (pain affecting the elbow, forearm, wrist, or hand) can be non-specific, or can arise from specific musculoskeletal disorders. It is clinically important and costly, the best approach to clinical management is unclear. Physiotherapy is the standard treatment and, while awaiting treatment, advice is often given to rest and avoid strenuous activities, but there is no evidence base to support these strategies. This paper describes the protocol of a randomised controlled trial to determine, among patients awaiting physiotherapy for distal arm pain, (a) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability, compared with advice to rest; and (b) whether immediate physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered after a seven week waiting list period. Between January 2012 and January 2014, new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility. Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Patients were and followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaire and, at six weeks, patients who had not received physiotherapy were offered it at this time. The primary outcome is the proportion of patients free of disability at 26 weeks, as determined by the modified DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire.We hypothesise (a) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm; and (b) that fast-track physiotherapy will be superior to normal (waiting list) physiotherapy. These hypotheses will be examined using an intention-to-treat analysis. Results from this trial will contribute to the evidence base underpinning the

The effects of gait retraining in runners with patellofemoral pain: A randomized trial.

Science.gov (United States)

Roper, Jenevieve L; Harding, Elizabeth M; Doerfler, Deborah; Dexter, James G; Kravitz, Len; Dufek, Janet S; Mermier, Christine M

2016-06-01

Running popularity has increased resulting in a concomitant increase in running-related injuries with patellofemoral pain most commonly reported. The purpose of this study was to determine whether gait retraining by modifying footstrike patterns from rearfoot strike to forefoot strike reduces patellofemoral pain and improves associated biomechanical measures, and whether the modification influences risk of ankle injuries. Sixteen subjects (n=16) were randomly placed in the control (n=8) or experimental (n=8) group. The experimental group performed eight gait retraining running sessions over two weeks where footstrike pattern was switched from rearfoot strike to forefoot strike, while the control group performed running sessions with no intervention. Variables were recorded pre-, post-, and one-month post-running trials. Knee pain was significantly reduced post-retraining (Pforefoot strike pattern leads to reduced knee pain, and should be considered a possible strategy for management of patellofemoral pain in recreational runners. This trial is registered at the US National Institutes of Health (clinicaltrials.gov) #NCT02567123. Published by Elsevier Ltd.

Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen.

Science.gov (United States)

Hubacher, David; Reyes, Veronica; Lillo, Sonia; Zepeda, Ana; Chen, Pai-Lien; Croxatto, Horacio

2006-11-01

This study was undertaken to determine whether 400 mg of prophylactic ibuprofen can alleviate pain from insertion of an intrauterine device (IUD) and to measure level of pain with improved techniques. We conducted a randomized, double-blind, placebo-controlled trial of 2019 first-time IUD users: 1008 women received placebo and 1011 women received 400 mg of ibuprofen. Participants took the single tablet at least 45 minutes before IUD insertion. Immediately after insertion, participants recorded level of pain by using a 10-cm visual analog scale, with the value of 10 meaning "worst imaginable pain." Median level of pain was 1.0 for both ibuprofen and placebo participants; rank test statistics confirmed no difference. Some subgroups of women experienced higher pain (eg, nulliparous women), but ibuprofen still had no important impact on level of pain. Even among first-time users, pain from IUD insertion is generally low. Prophylactic ibuprofen as used in this protocol does not reduce IUD insertion pain.

Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial

International Nuclear Information System (INIS)

Guckenberger, Matthias; Hawkins, Maria; Flentje, Michael; Sweeney, Reinhart A

2012-01-01

will be included into this two-centre phase II trial. Results of this study will refine the methods of patient selection, target volume definition, treatment planning and delivery as well as quality assurance for radiosurgery. It is the intention of this study to form the basis for a future randomized controlled trial comparing conventional radiotherapy with fractionated radiosurgery for palliation of painful vertebral metastases. ClinicalTrials.gov Identifier: NCT01594892

Choice of design and outcomes in trials among children with moderate acute malnutrition

DEFF Research Database (Denmark)

Friis, Henrik; Michaelsen, Kim F.; Wells, Jonathan C

2015-01-01

There is a need for trials on the effects of food aid products for children with moderate acute malnutrition, to identify how best to restore body tissues and function. The choice of control intervention is a major challenge, with both ethical and scientific implications. While randomized trials...

Internet-mediated physiotherapy and pain coping skills training for people with persistent knee pain (IMPACT - knee pain): a randomised controlled trial protocol.

Science.gov (United States)

Dobson, Fiona; Hinman, Rana S; French, Simon; Rini, Christine; Keefe, Francis; Nelligan, Rachel; Abbott, J Haxby; Bryant, Christina; Staples, Margaret P; Dalwood, Andrew; Bennell, Kim L

2014-08-13

Persistent knee pain in people over 50 years of age is often attributable to knee osteoarthritis (OA), a common joint condition that causes physical and psychological dysfunction. Exercise and pain coping skills training (PCST) can help reduce the impact of persistent knee pain, however, access to health professionals who deliver these services can be challenging. With increasing access to the Internet, remotely delivered Internet-based treatment approaches may provide alternatives for healthcare delivery. This pragmatic randomised controlled trial will investigate whether an Internet-delivered intervention that combines PCST and physiotherapist-guided exercise (PCST + Ex) is more effective than online educational material (educational control) in people with persistent knee pain. We will recruit 148 people over 50 years of age with self-reported persistent knee pain consistent with knee OA from the Australian community. Following completion of baseline questionnaires, participants will be randomly allocated to access a 3-month intervention of either (i) online educational material, or (ii) the same online material plus an 8-module (once per week) Internet-based PCST program and seven Internet-delivered physiotherapy sessions with a home exercise programs to be performed 3 times per week. Outcomes will be measured at baseline, 3 months and 9 months with the primary time point at 3 months. Primary outcomes are average knee pain on walking (11-point numeric rating scale) and self-reported physical function (Western Ontario and McMaster Universities Osteoarthritis Index subscale). Secondary outcomes include additional measures of knee pain, health-related quality-of-life, perceived global change in symptoms, and potential moderators and mediators of outcomes including self-efficacy for pain management and function, pain coping attempts and pain catastrophising. Other measures of adherence, adverse events, harms, use of health services/co-interventions, and process

Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

Directory of Open Access Journals (Sweden)

Tulledge-Scheitel Sidna M

2009-12-01

Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

Addressing challenges of clinical trials in acute pain: The Pain Management of Vaso-occlusive Crisis in Children and Young Adults with Sickle Cell Disease Study.

Science.gov (United States)

Nottage, Kerri A; Hankins, Jane S; Faughnan, Lane G; James, Dustin M; Richardson, Julie; Christensen, Robbin; Kang, Guolian; Smeltzer, Matthew; Cancio, Maria I; Wang, Winfred C; Anghelescu, Doralina L

2016-08-01

Neuropathic pain is a known component of vaso-occlusive pain in sickle cell disease; however, drugs targeting neuropathic pain have not been studied in this population. Trials of acute pain are complicated by the need to obtain consent, to randomize participants expeditiously while optimally treating pain. We describe the challenges in designing and implementing the Pain Management of Vaso-occlusive Crisis in Children and Young Adults with Sickle Cell Disease Study (NCT01954927), a phase II, randomized, double-blind, placebo-controlled trial to determine the effect of gabapentin for vaso-occlusive crisis. In the Pain Management of Vaso-occlusive Crisis in Children and Young Adults with Sickle Cell Disease Study, we aim to assess the analgesic effect of gabapentin during vaso-occlusive crisis. Difficulties we identified included avoiding delay of notification of study staff of potential participants which we resolved by automated notification. Concern for rapid randomization and drug dispensation was addressed through careful planning with an investigational pharmacy and a single liquid formulation. We considered obtaining consent during well-visits to avoid the time constraints with acute presentations, but the large number of patients and limited duration that consent is valid made this impractical. In all, 79% of caregivers/children approached have agreed to participate. The trial is currently active, and enrollment is at 45.8% of that targeted (76 of 166) and expected to continue for two more years. Maintaining staff availability after-hours remains problematic, with 8% of screened patients missed for lack of available staff. Lessons learned in designing a trial to expedite procedures in the acute pain setting include (1) building study evaluations upon a standard-of-care backbone; (2) implementing a simple study design to facilitate consent and data capture; (3) assuring ample, well-trained study staff; and (4) utilizing technology to automate procedures

Pain physiology education improves health status and endogenous pain inhibition in fibromyalgia: a double-blind randomized controlled trial.

Science.gov (United States)

Van Oosterwijck, Jessica; Meeus, Mira; Paul, Lorna; De Schryver, Mieke; Pascal, Aurelie; Lambrecht, Luc; Nijs, Jo

2013-10-01

There is evidence that education on pain physiology can have positive effects on pain, disability, and catastrophization in patients with chronic musculoskeletal pain disorders. A double-blind randomized controlled trial (RCT) was performed to examine whether intensive pain physiology education is also effective in fibromyalgia (FM) patients, and whether it is able to influence the impaired endogenous pain inhibition of these patients. Thirty FM patients were randomly allocated to either the experimental (receiving pain physiology education) or the control group (receiving pacing self-management education). The primary outcome was the efficacy of the pain inhibitory mechanisms, which was evaluated by spatially accumulating thermal nociceptive stimuli. Secondary outcome measures included pressure pain threshold measurements and questionnaires assessing pain cognitions, behavior, and health status. Assessments were performed at baseline, 2 weeks, and 3 months follow-up. Repeated measures ANOVAS were used to reveal possible therapy effects and effect sizes were calculated. After the intervention the experimental group had improved knowledge of pain neurophysiology (Pphysiology. Pain physiology education seems to be a useful component in the treatment of FM patients as it improves health status and endogenous pain inhibition in the long term.

[The effectiveness of therapeutic touch on pain, depression and sleep in patients with chronic pain: clinical trial].

Science.gov (United States)

Marta, Ilda Estefani Ribeiro; Baldan, Sueli Santiago; Berton, Ani Fabiana; Pavam, Michele; da Silva, Maria Júlia Paes

2010-12-01

This research aimed to check the effectiveness of Therapeutic Touch on decreased pain intensity, depression self-assessment scores and improved sleep quality. A clinical before-after trial is presented. The study was carried out at a Basic Health Unit in Fernandópolis, SP-Brazil, involving 30 elderly patients with chronic non-oncologic pain who received 8 sessions of Therapeutic Touch in accordance with the Krieger-Kunz method. The Visual Analogue Scale for pain was applied before and after each session, and Beck Depression Inventory and the Pittsburgh Sleep Quality Index before the first and after the last session. Data analysis showed a significant decrease (p Touch was effective to decrease pain intensity and depressive attitudes and symptoms, as well as to improve sleep quality.

Improving pain treatment with a smartphone app: study protocol for a randomized controlled trial.

Science.gov (United States)

Suso-Ribera, Carlos; Mesas, Ángela; Medel, Javier; Server, Anna; Márquez, Esther; Castilla, Diana; Zaragozá, Irene; García-Palacios, Azucena

2018-02-27

Chronic pain has become a major health problem across the world, especially in older adults. Unfortunately, the effectiveness of medical interventions is modest. Some have argued that assessment strategies should be improved if the impact of medical interventions is to be improved. Ecological momentary assessment using smartphones is now considered the gold standard in monitoring in health settings, including chronic pain. However, to the best of our knowledge, there is no randomized controlled trial to show that telemonitoring using a smartphone app can indeed improve the effectiveness of medical treatments in adults with chronic pain. The goal of this study will be to explore the effects of using a smartphone app for telemonitoring adults with chronic pain. The study will be a randomized controlled trial with three groups: treatment as usual (TAU), TAU+app, and TAU+app+alarms. All groups will receive the adequate treatment for their pain, which will be prescribed the first day of study according to clinical guidelines. Assessment in the TAU group will be the usual at the Pain Clinic, that is, a paper-and-pencil evaluation at the onset of treatment (beginning of study) and at follow up (end of study, 30 days later). The other two groups (TAU+app and TAU+app+alarms) will be assessed daily using Pain Monitor, a smartphone app developed by our multidisciplinary team. Telemonitoring will only be made in the TAU+app+alarms group. For this group, physicians at the Pain Clinic may decide to adjust pain treatment in response to alarms. Telemonitoring is not the usual practice at the Pain Clinic and will not occur in the other two groups (TAU and TAU+app), so no changes in treatment are expected in these groups after the first appointment. The total sample size will be 150, with 50 patients in each group. The assessment protocol will be the same in all groups and will include pain intensity and side effects of the medication (primary outcomes), together with several pain

Core outcome measurement instruments for clinical trials in non-specific low back pain

NARCIS (Netherlands)

Chiarotto, Alessandro; Boers, Maarten; Deyo, Richard A; Buchbinder, Rachelle; Corbin, Terry P; Costa, Leonardo O P; Foster, Nadine E; Grotle, Margreth; Koes, Bart W; Kovacs, Francisco M; Christine Lin, Chung-Wei; Maher, Chris G; Pearson, Adam M; Peul, Wilco C; Schoene, Mark L; Turk, Dennis C; van Tulder, Maurits W; Terwee, Caroline B; Ostelo, Raymond W

2017-01-01

To standardize outcome reporting in clinical trials of patients with non-specific low back pain (LBP), an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of consensus on

Randomized Trial of Hypnosis as a Pain and Symptom Management Strategy in Adults with Sickle Cell Disease

Science.gov (United States)

Wallen, Gwenyth R; Middleton, Kimberly R; Ames, Nancy; Brooks, Alyssa T; Handel, Daniel

2014-01-01

Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality), anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION ClinicalTrials.gov: NCT00393250 PMID:25520557

Randomized Trial of Hypnosis as a Pain and Symptom Management Strategy in Adults with Sickle Cell Disease

Directory of Open Access Journals (Sweden)

Gwenyth R. Wallen

2014-01-01

Full Text Available Sickle cell disease (SCD is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality, anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00393250

The research gap in chronic paediatric pain: A systematic review of randomised controlled trials.

Science.gov (United States)

Boulkedid, R; Abdou, A Y; Desselas, E; Monégat, M; de Leeuw, T G; Avez-Couturier, J; Dugue, S; Mareau, C; Charron, B; Alberti, C; Kaguelidou, F

2018-02-01

Chronic pain is associated with significant functional and social impairment. The objective of this review was to assess the characteristics and quality of randomized controlled trials (RCTs) evaluating pain management interventions in children and adolescents with chronic pain. We performed a systematic search of PubMed, Embase and the Cochrane Library up to July 2017. We included RCTs that involved children and adolescents (3 months-18 years) and evaluated the use of pharmacological or non-pharmacological intervention(s) in the context of pain persisting or re-occurring for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias (ROB) Tool. A total of 58 RCTs were identified and numbers steadily increased over time. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 47.5 participants (Q1,Q3: 32, 70). Forty-five percent of RCTs included both adults and children and the median of the mean ages at inclusion was 12.9 years (Q1,Q3: 11, 15). Testing of non-pharmacological interventions was predominant and only 5 RCTs evaluated analgesics or co-analgesics. Abdominal pain, headache/migraine and musculoskeletal pain were the most common types of chronic pain among participants. Methodological quality was poor with 90% of RCTs presenting a high or unclear ROB. Evaluation of analgesics targeting chronic pain relief in children and adolescents through RCTs is marginal. Infants and children with long-lasting painful conditions are insufficiently represented in RCTs. We discuss possible research constraints and challenges as well as methodologies to circumvent them. There is a substantial research gap regarding analgesic interventions for children and adolescents with chronic pain. Most clinical trials in the field focus on the evaluation of non-pharmacological interventions and are of low methodological quality. There is also a specific lack of trials involving infants

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

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Cain Kevin C

2004-07-01

Full Text Available Abstract 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.

Post endodontic pain following single-visit root canal preparation with rotary vs reciprocating instruments: a meta-analysis of randomized clinical trials.

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Hou, Xiao-Mei; Su, Zheng; Hou, Ben-Xiang

2017-05-25

In endodontic therapy, continuous rotary instrumentation reduced debris compared to reciprocal instrumentation, which might affect the incidence of post-endodontic pain (PP). The aim of our study was to assess whether PP incidence and levels were influenced by the choice of rotary or reciprocal instruments. In this meta-analysis the Pubmed and EM databases were searched for prospective clinical randomized trials published before April 20, 2016, using combinations of the keywords: root canal preparation/instrumentation/treatment/therapy; post-operative/endodontic pain; reciprocal and rotary instruments. Three studies were included, involving a total of 1,317 patients, 659 treated with reciprocating instruments and 658 treated with rotary instruments. PP was reported in 139 patients in the reciprocating group and 172 in the rotary group. The PP incidence odds ratio was 1.27 with 95% confidence interval (CI) (0.25, 6.52) favoring rotary instruments. The mild, moderate and severe PP levels odds ratios were 0.31 (0.11, 0.84), 2.24 (0.66, 7.59) and 11.71 (0.63, 218.15), respectively. No evidence of publication bias was found. Rotary instrument choice in endodontic therapy is associated with a lower incidence of PP than reciprocating instruments, while reciprocating instruments are associated with less mild PP incidence.

Improvement in pain severity category in clinical trials of pregabalin

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Parsons B

2016-10-01

Full Text Available Bruce Parsons,1 Charles E Argoff,2 Andrew Clair,1 Birol Emir1 1Pfizer, New York, NY, USA; 2Albany Medical Center, Albany, NY, USA Background: Pregabalin is approved by the US Food and Drug Administration for the treatment of fibromyalgia (FM, diabetic peripheral neuropathy (DPN, postherpetic neuralgia (PHN, and neuropathic pain due to spinal cord injury (SCI. Approval was based on clinical trial data demonstrating statistically significant differences in pain scores versus placebo. However, statistically significant pain relief may not always equate to clinically meaningful pain relief. To further characterize the clinical benefit of pregabalin, this analysis examined shifts in pain severity categories in patients with FM, DPN/PHN (pooled in this analysis, and SCI treated with pregabalin.Methods: Data were pooled from 23 placebo-controlled trials in patients with FM (1,623 treated with pregabalin, 937 placebo, DPN/PHN (2,867 pregabalin, 1,532 placebo, or SCI (181 pregabalin, 175 placebo. Pain scores were assessed on an 11-point numeric rating scale and categorized as mild (0 to <4, moderate (4 to <7, or severe (7 to 10. Only patients with mean score ≥4 at baseline were randomized to treatment. The percentage of patients shifting pain category from baseline to endpoint for pregabalin and placebo was analyzed using a modified ridit transformation with the Cochran–Mantel–Haenszel procedure.Results: A higher proportion of patients shifted to a less severe pain category at endpoint with pregabalin compared with placebo. With flexible-dose pregabalin, the percentage of patients improving from: severe to mild (pregabalin versus placebo was 15.8 versus 13.4 in FM patients, 36.0 versus 16.6 in DPN/PHN patients, 14.3 versus 7.7 in SCI patients; severe to moderate was 28.7 versus 28.2 in FM patients, 32.5 versus 28.2 in DPN/PHN patients, 35.7 versus 28.2 in SCI patients; and moderate to mild was 38.3 versus 26.4 in FM patients, 59.5 versus 41.4 in

Pain management in cancer center inpatients: a cluster randomized trial to evaluate a systematic integrated approach—The Edinburgh Pain Assessment and Management Tool

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Fallon, M; Walker, J; Colvin, L; Rodriguez, A; Murray, G; Sharpe, M

2018-01-01

Purpose Pain is suboptimally managed in patients with cancer. We aimed to compare the effect of a policy of adding a clinician-delivered bedside pain assessment and management tool (Edinburgh Pain Assessment and management Tool [EPAT]) to usual care (UC) versus UC alone on pain outcomes. Patients and Methods In a two-arm, parallel group, cluster randomized (1:1) trial, we observed pain outcomes in 19 cancer centers in the United Kingdom and then randomly assigned the centers to eithe...

Perioperative Dextromethorphan as an Adjunct for Postoperative Pain: A Meta-analysis of Randomized Controlled Trials.

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King, Michael R; Ladha, Karim S; Gelineau, Amanda M; Anderson, T Anthony

2016-03-01

N-methyl-D-aspartate receptor antagonists have been shown to reduce perioperative pain and opioid use. The authors performed a meta-analysis to determine whether the use of perioperative dextromethorphan lowers opioid consumption or pain scores. PubMed, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Pubget, and EMBASE were searched. Studies were included if they were randomized, double-blinded, placebo-controlled trials written in English, and performed on patients 12 yr or older. For comparison of opioid use, included studies tracked total consumption of IV or intramuscular opioids over 24 to 48 h. Pain score comparisons were performed at 1, 4 to 6, and 24 h postoperatively. Difference in means (MD) was used for effect size. Forty studies were identified and 21 were eligible for one or more comparisons. In 848 patients from 14 trials, opioid consumption favored dextromethorphan (MD, -10.51 mg IV morphine equivalents; 95% CI, -16.48 to -4.53 mg; P = 0.0006). In 884 patients from 13 trials, pain at 1 h favored dextromethorphan (MD, -1.60; 95% CI, -1.89 to -1.31; P dextromethorphan (MD, -0.89; 95% CI, -1.11 to -0.66; P dextromethorphan (MD, -0.92; 95% CI, -1.24 to -0.60; P dextromethorphan use perioperatively reduces the postoperative opioid consumption at 24 to 48 h and pain scores at 1, 4 to 6, and 24 h.

Does suprascapular nerve block reduce shoulder pain following stroke: a double-blind randomised controlled trial with masked outcome assessment

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Crotty Maria

2010-09-01

Full Text Available Abstract Background Shoulder pain is a common complication of a stroke which can impede participation in rehabilitation programs and has been associated with poorer outcomes. The evidence base for current medical and therapeutic management options of hemiplegic shoulder pain is limited. This study will evaluate the use of suprascapular nerve block injection as part of an interdisciplinary approach to the treatment of shoulder pain following stroke. The technique has previously been proven safe and effective in the treatment of shoulder pain associated with rheumatoid arthritis and degenerative shoulder conditions but its usefulness in a stroke population is unclear. Methods/Design A double blind randomised placebo controlled trial will assess the effect of a suprascapular nerve block compared with placebo in a population of 66 stroke patients. The trial will measure effect of injection on the primary outcome of pain, and secondary outcomes of function and quality of life. Measurements will take place at baseline, and 1, 4 and 12 weeks post intervention. Both groups will continue to receive routine physiotherapy and standard ward care. Discussion The results of this study could reduce pain symptoms in persons with mechanical shoulder pain post stroke and provide improvement in upper limb function. Trial Registration This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR - ACTRN12609000621213.

Eligibility audits for the randomized neuropathic bone pain trial (TROG 96.05)

International Nuclear Information System (INIS)

Roos, D.E.; Turner, S.L.

2000-01-01

In February 1996 the Trans-Tasman Radiation Oncology Group (TROG) initiated a two-arm, multicentre, prospective randomized trial on radiotherapy for neuropathic pain due to bone metastases (TROG 96.05). This trial compares the response to a single 8-Gy fraction with 20 Gy in five fractions. The accrual target is 270 patients. In order to evaluate compliance with eligibility criteria after approximately 1 year of accrual, an independent audit of the first 42 randomized patients was commissioned. This found that only one of these patients did not have genuine neuropathic pain, but that this patient and seven others (19%) had infringements of other eligibility/exclusion criteria for the trial. Accordingly it was decided to continue the full audit up to 90 patients. This detected no further patients without genuine neuropathic pain, and found only one other eligibility infringement (1/48; 2%). It is concluded that this quality assurance (QA) measure undertaken early in the trial led to significantly improved clinician awareness of, and compliance with, eligibility/exclusion criteria. It also enabled an accurate comparison of outcome data for all randomized versus all eligible patients at the time of the preplanned first interim analysis at 90 patients. In view of the excellent compliance demonstrated in the second audit, a one-in-five sampling is proposed for future audits from centres that have already accrued at least five consecutive eligible patients. This is consistent with TROG QA guidelines now operational. Copyright (2000) Blackwell Science Pty Ltd

Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial.

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Schnelle, Christoph; Messerschmidt, Steffen; Minford, Eunice J; Greenaway-Twist, Kate; Szramka, Maxine; Masiorski, Marianna; Sheldrake, Michelle; Jones, Mark

2017-07-17

Low back pain causes more global disability than any other condition. Once the acute pain becomes chronic, about two-thirds of sufferers will not fully recover after 1-2 years. There is a paucity of effective treatments for non-specific, chronic low back pain. It has been noted that low back pain is associated with changes in the connective tissue in the affected area, and a very low-impact treatment, Esoteric Connective Tissue Therapy (ECTT), has been developed to restore flexibility in connective tissue. ECTT uses patterns of very small, circular movements, to the legs, arms, spine, sacrum and head, which anecdotally are effective in pain relief. In an unpublished single-arm phase I/II trial with chronic pain patients, ECTT showed a 56% reduction in pain after five treatments and 45% and 54% improvements at 6 months and 7-9 years of follow-up respectively. The aim of this randomised controlled trial is to compare ECTT with physiotherapy for reducing pain and improving physical function and physical and mental well-being in patients with chronic low back pain. The trial will be held at two hospitals in Vietnam. One hundred participants with chronic low back pain greater than or equal to 40/100 on the visual analogue scale will be recruited and randomised to either ECTT or physiotherapy. Four weekly treatments will be provided by two experienced ECTT practitioners (Treatment Group, 40 minutes each) and hospital-employed physiotherapy nurses (Control Group, 50 minutes). The primary outcomes will be changes in pain, physical function per the Quebec Pain Functionality Questionnaire and physical and mental well-being recorded by the Short Form Health Survey (SF-36), with mixed modelling used as the primary statistical tool because the data are longitudinal. Initial follow-up will be at either 4 or 8 months, with a second follow-up after 12 months. The trial design has important strengths, because it is to be conducted in hospitals under medical supervision

Pain education combined with neck- and aerobic training is more effective at relieving chronic neck pain than pain education alone--A preliminary randomized controlled trial.

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Brage, K; Ris, I; Falla, D; Søgaard, K; Juul-Kristensen, B

2015-10-01

To evaluate the effect of training and pain education vs pain education alone, on neck pain, neck muscle activity and postural sway in patients with chronic neck pain. Twenty women with chronic neck pain were randomized to receive pain education and specific training (neck-shoulder exercises, balance and aerobic training) (INV), or pain education alone (CTRL). Effect on neck pain, function and Global Perceived Effect (GPE) were measured. Surface electromyography (EMG) was recorded from neck flexor and extensor muscles during performance of the Cranio-Cervical Flexion Test (CCFT) and three postural control tests (two-legged: eyes open and closed, one-legged: eyes open). Sway parameters were calculated. Fifteen participants (CTRL: eight; INV: seven) completed the study. Per protocol analyses showed a larger pain reduction (p = 0.002) for the INV group with tendencies for increased GPE (p = 0.06), reduced sternocleidomastoid activity during the CCFT (p = 0.09), reduced sway length (p = 0.09), and increased neck extensor activity (p = 0.02) during sway compared to the CTRL group. Pain education and specific training reduce neck pain more than pain education alone in patients with chronic neck pain. These results provide encouragement for a larger clinical trial to corroborate these observations. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

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Lynch, Mary E; 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...

Pressure and pain In Systemic sclerosis/Scleroderma - an evaluation of a simple intervention (PISCES: randomised controlled trial protocol

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Alcacer-Pitarch Begonya

2012-02-01

Full Text Available Abstract Background Foot problems associated with Systemic Sclerosis (SSc/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122

The Effect of Entonox, Play Therapy and a Combination on Pain Relief in Children: A Randomized Controlled Trial.

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Mohan, Simi; Nayak, Ruma; Thomas, Reju Joseph; Ravindran, Vinitha

2015-12-01

Pediatric pain is often undertreated/neglected due to time constraints, difficulties in timing of oral analgesics, fear of side effects of opioids and anxiolytics, and apprehension of additional pain in the use of local anesthetic injections. In this study, the researcher was prompted to choose rapidly acting interventions that were low dose and allowed the child to stay alert, suitable for a quick discharge. The purpose of this study was to evaluate the effects of Entonox, play therapy, and a combination to relieve procedural pain in children aged 4-15 years. The study was designed as a randomized controlled trial; the subjects were divided into four groups using a sequential allocation plan from 123 total subjects. Group A received Entonox, Group B received play therapy, Group C received both Entonox and play therapy, and Group D received existing standard interventions. The study was vetted by the departmental study review committee. The pain level was assessed using FLACC scale for children aged 4-9 years and the Wong Bakers Faces Pain Scale for children aged 10-15 years; scores ranged from 0 to 10. All the data were analyzed using SPSS 16.0 with descriptive statistics and, inferential statistics. The mean pain scores were as follows: Entonox group, 2.87; Play therapy group, 4; combination group, 3; and control group, 5.87. When statistical testing was applied, a significant reduction in the pain score in all the three experimental groups when compared to the control group was found (p = .002), but not in the pain score among the three experimental groups (p = .350). The findings of this study indicated that all three interventions were effective in lowering pain scores when compared to the control group. Play therapy is as potent as Entonox in relieving procedural pain, though there was no additive effect on pain relief when play therapy and Entonox were combined. A protocol for age-related choice between play therapy and Entonox administration was introduced

Neurodynamic treatment did not improve pain and disability at two weeks in patients with chronic nerve-related leg pain: a randomised trial

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Giovanni Ferreira

2016-10-01

Full Text Available Question: In people with nerve-related leg pain, does adding neurodynamic treatment to advice to remain active improve leg pain, disability, low back pain, function, global perceived effect and location of symptoms? Design: Randomised trial with concealed allocation and intention-to-treat analysis. Participants: Sixty participants with nerve-related leg pain recruited from the community. Interventions: The experimental group received four sessions of neurodynamic treatment. Both groups received advice to remain active. Outcome measures: Leg pain and low back pain (0, none, to 10, worst, Oswestry Disability Index (0, none, to 100, worst, Patient-Specific Functional Scale (0, unable to perform, to 30, able to perform, global perceived effect (–5 to 5 and location of symptoms were measured at 2 and 4 weeks after randomisation. Continuous outcomes were analysed by linear mixed models. Location of symptoms was assessed by relative risk (95% CI. Results: At 2 weeks, the experimental group did not have significantly greater improvement than the control group in leg pain (MD –1.1, 95% CI –2.3 to 0.1 or disability (MD –3.3, 95% CI –9.6 to 2.9. At 4 weeks, the experimental group experienced a significantly greater reduction in leg pain (MD –2.4, 95% CI –3.6 to –1.2 and low back pain (MD –1.5, 95% CI –2.8 to –0.2. The experimental group also improved significantly more in function at 2 weeks (MD 5.2, 95% CI 2.2 to 8.2 and 4 weeks (MD 4.7, 95% CI 1.7 to 7.8, as well as global perceived effect at 2 weeks (MD 2.5, 95% CI 1.6 to 3.5 and 4 weeks (MD 2.9, 95% CI 1.9 to 3.9. No significant between-group differences occurred in disability at 4 weeks and location of symptoms. Conclusion: Adding neurodynamic treatment to advice to remain active did not improve leg pain and disability at 2 weeks. Trial registration: NCT01954199. [Ferreira G, Stieven F, Araujo F, Wiebusch M, Rosa C, Plentz R, et al. (2016 Neurodynamic treatment did not improve

Spinal manipulative therapy versus Graston Technique in the treatment of non-specific thoracic spine pain: Design of a randomised controlled trial

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Walker Bruce

2008-10-01

Full Text Available Abstract Background The one year prevalence of thoracic back pain has been estimated as 17% compared to 64% for neck pain and 67% for low back pain. At present only one randomised controlled trial has been performed assessing the efficacy of spinal manipulative therapy (SMT for thoracic spine pain. In addition no high quality trials have been performed to test the efficacy and effectiveness of Graston Technique® (GT, a soft tissue massage therapy using hand-held stainless steel instruments. The objective of this trial is to determine the efficacy of SMT and GT compared to a placebo for the treatment of non specific thoracic spine pain. Methods Eighty four eligible people with non specific thoracic pain mid back pain of six weeks or more will be randomised to one of three groups, either SMT, GT, or a placebo (de-tuned ultrasound. Each group will receive up to 10 supervised treatment sessions at the Murdoch University Chiropractic student clinic over a 4-week period. Treatment outcomes will be measured at baseline, one week after their first treatment, upon completion of the 4-week intervention period and at three, six and twelve months post randomisation. Outcome measures will include the Oswestry Back Pain Disability Index and the Visual Analogue Scale (VAS. Intention to treat analysis will be utilised in the statistical analysis of any group treatment effects. Trial Registration This trial was registered with the Australia and New Zealand Clinical Trials Registry on the 7th February 2008. Trial number: ACTRN12608000070336

Understanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial

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Hopin Lee

2015-07-01

Discussion and significance: Mediation analysis of clinical trials can estimate how much the total effect of the treatment on the outcome is carried through an indirect path. Using mediation analysis to understand these mechanisms can generate evidence that can be used to tailor treatments and optimise treatment effects. In this study, the causal mediation effects of a pain education intervention for acute non-specific low back pain will be estimated. This knowledge is critical for further development and refinement of interventions for conditions such as low back pain.

Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial.

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Saper, Robert B; Lemaster, Chelsey M; Elwy, A Rani; Paris, Ruth; Herman, Patricia M; Plumb, Dorothy N; Sherman, Karen J; Groessl, Erik J; Lynch, Susan; Wang, Shihwe; Weinberg, Janice

2016-04-29

Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations. This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records. This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities. ClinicalTrials.gov: NCT02224183.

Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials.

Science.gov (United States)

Pittler, M H; Karagülle, M Z; Karagülle, M; Ernst, E

2006-07-01

Low back pain is a major public health concern and complementary treatments are frequently used for this condition. The objective of this systematic review and meta-analysis was to assess the evidence for or against the effectiveness of spa therapy and balneotherapy for treating low back pain. Systematic searches were conducted on Medline, Embase, Amed Cochrane Central, the UK National Research Register and ClincalTrials.gov (all until July 2005). Hand searches were performed and experts contacted. Methodological quality was assessed using a standard scale. Five randomized clinical trials met all inclusion criteria. Quantitative data synthesis was performed. The data for spa therapy, assessed on a 100 mm visual analogue scale (VAS), suggest significant beneficial effects compared with waiting list control groups (weighted mean difference 26.6 mm, 95% confidence interval 20.4-32.8, n=442) for patients with chronic low back pain. For balneotherapy the data, assessed on a 100 mm VAS, also suggest beneficial effects compared with control groups (weighted mean difference 18.8 mm, 95% confidence interval 10.3-27.3, n=138). Even though the data are scarce, there is encouraging evidence suggesting that spa therapy and balneotherapy may be effective for treating patients with low back pain. These data are not compelling but warrant rigorous large-scale trials.

Manual and Electroacupuncture for Labour Pain: Study Design of a Longitudinal Randomized Controlled Trial

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Linda Vixner

2012-01-01

Full Text Available Introduction. Results from previous studies on acupuncture for labour pain are contradictory and lack important information on methodology. However, studies indicate that acupuncture has a positive effect on women’s experiences of labour pain. The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain as the primary outcome. This paper will present in-depth information on the design of the study, following the CONSORT and STRICTA recommendations. Methods. The study was designed as a randomized controlled trial based on western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture, or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. A Visual Analogue Scale was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment. This trial is registered at ClinicalTrials.gov: NCT01197950.

Participants' Understanding of Informed Consent in a Randomized Controlled Trial for Chronic Knee Pain.

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Guillemin, Marilys; Barnard, Emma; Walker, Hannah; Bennell, Kim; Hinman, Rana; Gillam, Lynn

2015-12-01

This study explored participants' experiences of randomized controlled trial (RCT) participation to examine their understanding of the trial design and whether their consent was indeed informed. A nested qualitative interview study was conducted with 38 participants from a sample of 282 who participated in a complex RCT evaluating the effectiveness of laser compared with needle acupuncture for chronic knee pain. Overall participants had a good understanding of the RCT, and concepts such as randomization and placebo. Their experiences of being in the trial were largely positive, even if they did not experience any knee pain improvement. Their responses to unblinding at the end of the study were accepting. Participants had a good functional understanding of the RCT, sufficient for valid informed consent. © The Author(s) 2015.

Effects of Natural Sounds on Pain: A Randomized Controlled Trial with Patients Receiving Mechanical Ventilation Support.

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Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Vaismoradi, Mojtaba; Jordan, Sue

2015-08-01

Nonpharmacologic pain management in patients receiving mechanical ventilation support in critical care units is under investigated. Natural sounds may help reduce the potentially harmful effects of anxiety and pain in hospitalized patients. The aim of this study was to examine the effect of pleasant, natural sounds on self-reported pain in patients receiving mechanical ventilation support, using a pragmatic parallel-arm, randomized controlled trial. The study was conducted in a general adult intensive care unit of a high-turnover teaching hospital, in Tehran, Iran. Between October 2011 and June 2012, we recruited 60 patients receiving mechanical ventilation support to the intervention (n = 30) and control arms (n = 30) of a pragmatic parallel-group, randomized controlled trial. Participants in both arms wore headphones for 90 minutes. Those in the intervention arm heard pleasant, natural sounds, whereas those in the control arm heard nothing. Outcome measures included the self-reported visual analog scale for pain at baseline; 30, 60, and 90 minutes into the intervention; and 30 minutes post-intervention. All patients approached agreed to participate. The trial arms were similar at baseline. Pain scores in the intervention arm fell and were significantly lower than in the control arm at each time point (p natural sounds via headphones is a simple, safe, nonpharmacologic nursing intervention that may be used to allay pain for up to 120 minutes in patients receiving mechanical ventilation support. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

A Pilot Randomized Controlled Trial of a Guided Self-Help Intervention to Manage Chronic Orofacial Pain.

Science.gov (United States)

Goldthorpe, Joanna; Lovell, Karina; Peters, Sarah; McGowan, Linda; Nemeth, Imola; Roberts, Christopher; Aggarwal, Vishal R

2017-01-01

To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain. A pilot randomized controlled trial was conducted to compare the intervention with usual treatment. A total of 37 patients with chronic orofacial pain were randomized into either the intervention group (n = 19) or the usual treatment (control) group (n = 18). Validated outcome measures were used to measure the potential effectiveness of the intervention over a number of domains: physical and mental functioning (Short Form 36 [SF-36]); anxiety and depression (Hospital Anxiety and Depression Scale [HADS]); pain intensity and interference with life (Brief Pain Inventory [BPI]); disability (Manchester Orofacial Pain Disability Scale [MOPDS]); and illness behavior (Revised Illness Perceptions Questionnaire [IPQr]). Bootstrap confidence intervals were computed for the treatment effect (ES) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance. At posttreatment and the 3-month follow-up, 11 participants in the intervention group and 7 in the control group failed to complete outcome measures. The intervention was acceptable and could be feasibly delivered face to face or over the telephone. Although the pilot trial was not powered to draw conclusions about the effectiveness, it showed significant (P orofacial pain. It showed potential effectiveness on outcome domains related to functioning and illness perception. Further research is needed to understand the cost effectiveness of the intervention for chronic orofacial pain.

Changed activation, oxygenation, and pain response of chronically painful muscles to repetitive work after training interventions: a randomized controlled trial

DEFF Research Database (Denmark)

Søgaard, Karen; Blangsted, Anne Katrine; Nielsen, Pernille Kofoed

2012-01-01

The aim of this randomized controlled trial was to assess changes in myalgic trapezius activation, muscle oxygenation, and pain intensity during repetitive and stressful work tasks in response to 10 weeks of training. In total, 39 women with a clinical diagnosis of trapezius myalgia were randomly...... levels of pain. SST lowered the relative EMG amplitude by 36%, and decreased pain during resting and working conditions by 52 and 38%, respectively, without affecting trapezius oxygenation. In conclusion, GFT performed as leg-bicycling decreased pain development during repetitive work tasks, possibly due...... assigned to: (1) general fitness training performed as leg-bicycling (GFT); (2) specific strength training of the neck/shoulder muscles (SST) or (3) reference intervention without physical exercise. Electromyographic activity (EMG), tissue oxygenation (near infrared spectroscopy), and pain intensity were...

Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

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Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

2013-01-01

Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P electroacupuncture group compared with the control group (P Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Cupping therapy versus acupuncture for pain-related conditions: a systematic review of randomized controlled trials and trial sequential analysis.

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Zhang, Ya-Jing; Cao, Hui-Juan; Li, Xin-Lin; Yang, Xiao-Ying; Lai, Bao-Yong; Yang, Guo-Yang; Liu, Jian-Ping

2017-01-01

Both cupping therapy and acupuncture have been used in China for a long time, and their target indications are pain-related conditions. There is no systematic review comparing the effectiveness of these two therapies. To compare the beneficial effectiveness and safety between cupping therapy and acupuncture for pain-related conditions to provide evidence for clinical practice. Protocol of this review was registered in PROSPERO (CRD42016050986). We conducted literature search from six electronic databases until 31st March 2017. We included randomized trials comparing cupping therapy with acupuncture on pain-related conditions. Methodological quality of the included studies was evaluated by risk of bias tool. Mean difference, risk ratio, risk difference and their 95% confidence interval were used to report the estimate effect of the pooled results through meta-analysis or the results from each individual study. Trial sequential analysis (TSA) was applied to adjust random errors and calculate the sample size. Twenty-three randomized trials with 2845 participants were included covering 12 pain-related conditions. All included studies were of poor methodological quality. Three meta-analyses were conducted, which showed similar clinical beneficial effects of cupping therapy and acupuncture for the rate of symptom improvement in cervical spondylosis (RR 1.13, 95% CI 1.01 to 1.26; n = 646), lateral femoral cutaneous neuritis (RR 1.10, 95% CI 1.00 to 1.22; n = 102) and scapulohumeral periarthritis (RR 1.31, 95% CI 1.15 to 1.51; n = 208). Results from other outcomes (such as visual analogue and numerical rating scale) in each study also showed no statistical significant difference between these two therapies for all included pain-related conditions. The results of TSA for cervical spondylosis demonstrated that the current available data have not reached a powerful conclusion. No serious adverse events related to cupping therapy or acupuncture was found in included

The implementation of the serial trial intervention for pain and challenging behaviour in advanced dementia patients (STA OP!: a clustered randomized controlled trial

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Francke Anneke L

2011-03-01

Full Text Available Abstract Background Pain (physical discomfort and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention (STI and established that this protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA OP! in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression, and quality of life. This article outlines the study protocol. Methods/Design The study is a cluster randomized controlled trial in 168 older people (aged >65 years with mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to either the intervention condition (training and implementation of the STA OP!-protocol or the control condition (general training focusing on challenging behaviour and pain, but without the step-wise approach. Measurements take place at baseline, after 3 months (end of the STA OP! training period and after 6 months. Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation Inventory (CMAI and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH, and pain (measure with the Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D and the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI pain scale. Secondary outcome measures include symptoms of depression (Cornell and MDS-RAI depression scale, Quality of Live (Qualidem, changes in prescriptions of analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen, reminiscence therapy. Discussion The transfer from the American design to

A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain

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Tamara J. Somers

2016-01-01

Full Text Available Psychosocial pain management interventions are efficacious for cancer pain but are underutilized. Recent advances in mobile health (mHealth technologies provide new opportunities to decrease barriers to access psychosocial pain management interventions. The objective of this study was to gain information about the accessibility and efficacy of mobile pain coping skills training (mPCST intervention delivered to cancer patients with pain compared to traditional in-person pain coping skills training intervention. This study randomly assigned participants (N=30 to receive either mobile health pain coping skills training intervention delivered via Skype or traditional pain coping skills training delivered face-to-face (PCST-trad. This pilot trial suggests that mPCST is feasible, presents low burden to patients, may lead to high patient engagement, and appears to be acceptable to patients. Cancer patients with pain in the mPCST group reported decreases in pain severity and physical symptoms as well as increases in self-efficacy for pain management that were comparable to changes in the PCST-trad group (p’s < 0.05. These findings suggest that mPCST, which is a highly accessible intervention, may provide benefits similar to an in-person intervention and shows promise for being feasible, acceptable, and engaging to cancer patients with pain.

A randomized, placebo-controlled trial of levetiracetam in central pain in multiple sclerosis

DEFF Research Database (Denmark)

Falah, M; Madsen, C; Holbech, J V

2012-01-01

sclerosis. This was a randomized, double-blind, placebo-controlled, cross-over trial with levetiracetam 3000 mg/day versus placebo (6-week treatment periods). Patients with multiple sclerosis, symptoms and signs complying with central neuropathic pain and pain symptoms for more than 6 months, as well....... Twenty-seven patients were included in the data analysis. There were no differences in the ratings of pain relief (levetiracetam 2.4 vs. placebo 2.1, p = 0.169), total pain intensity (levetiracetam 5.3 vs. placebo 5.7, p = 0.147) or any of the other outcome measures (p = 0.086-0.715) in the total sample...... of patients. However, there was significant reduction of pain, increased pain relief and/or more favourable pain relief with levetiracetam than with placebo in patients with lancinating or without touch-evoked pain (p = 0.025-0.046). This study found no effect of the anticonvulsant levetiracetam in non...

Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

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Macedo, Luciana G; Latimer, Jane; Maher, Chris G; Hodges, Paul W; Nicholas, Michael; Tonkin, Lois; McAuley, James H; Stafford, Ryan

2008-01-01

Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week) and function (patient-specific functional scale) at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415 PMID:18454877

Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

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McAuley James H

2008-05-01

Full Text Available Abstract Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week and function (patient-specific functional scale at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415

Marine Oil Supplements for Arthritis Pain: A Systematic Review and Meta-Analysis of Randomized Trials

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Ninna K. Senftleber

2017-01-01

Full Text Available Arthritis patients often take fish oil supplements to alleviate symptoms, but limited evidence exists regarding their efficacy. The objective was to evaluate whether marine oil supplements reduce pain and/or improve other clinical outcomes in patients with arthritis. Six databases were searched systematically (24 February 2015. We included randomized trials of oral supplements of all marine oils compared with a control in arthritis patients. The internal validity was assessed using the Cochrane Risk of Bias tool and heterogeneity was explored using restricted maximum of likelihood (REML-based meta-regression analysis. Grading of Recommendations Assessment, Development and Evaluation (GRADE was used to rate the overall quality of the evidence. Forty-two trials were included; 30 trials reported complete data on pain. The standardized mean difference (SMD suggested a favorable effect (−0.24; 95% confidence interval, CI, −0.42 to −0.07; heterogeneity, I2 = 63%. A significant effect was found in patients with rheumatoid arthritis (22 trials; −0.21; 95% CI, −0.42 to −0.004 and other or mixed diagnoses (3 trials; −0.63; 95% CI, −1.20 to −0.06, but not in osteoarthritis patients (5 trials; −0.17; 95% CI, −0.57–0.24. The evidence for using marine oil to alleviate pain in arthritis patients was overall of low quality, but of moderate quality in rheumatoid arthritis patients.

Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models

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Singla NK

2014-12-01

Full Text Available Neil K Singla,1 Jacques E Chelly,2 David R Lionberger,3 Joseph Gimbel,4 Luis Sanin,5 Jonathan Sporn,5 Ruoyong Yang,5 Raymond Cheung,5 Lloyd Knapp,6 Bruce Parsons5 1Lotus Clinical Research, Pasadena, CA, USA; 2Division of Acute Interventional Perioperative Pain, Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 3Department of Orthopedic Surgery, Baylor College of Medicine, Houston, TX, USA; 4Arizona Research Center, Phoenix, AZ, USA; 5Pfizer Inc., New York, NY, USA; 6Pfizer Inc., New London, CT, USA Purpose: To evaluate the efficacy and safety of pregabalin (150 or 300 mg/d as an adjunctive therapy for the treatment of postoperative pain. Patients and methods: This study reports findings from three separate, multicenter, randomized, double-blind, placebo-controlled trials of adjunctive pregabalin for the treatment of postoperative pain. Patients underwent one of three categories of surgical procedures (one procedure per study: elective inguinal hernia repair (post-IHR; elective total knee arthroplasty (post-TKA; or total abdominal hysterectomy (posthysterectomy. The primary endpoint in each trial, mean worst pain over the past 24 hours, was assessed 24 hours post-IHR and posthysterectomy, and 48 hours post-TKA. Patients rated their pain on a scale from 0 to 10, with higher scores indicating greater pain severity. Results: In total, 425 (post-IHR, 307 (post-TKA, and 501 (posthysterectomy patients were randomized to treatment. There were no statistically significant differences between the pregabalin and placebo groups with respect to the primary endpoint in any of the three trials. The least squares mean difference in worst pain, between 300 mg/d pregabalin and placebo, was -0.7 (95% confidence interval [CI] =-1.4, -0.1; Hochberg adjusted P=0.067 post-IHR; -0.34 (95% CI =-1.07, 0.39; P=0.362 post-TKA; and -0.2 (95% CI =-0.66, 0.31; P=0.471 posthysterectomy. Conclusion: There were no significant differences

Implementing the PAIN RelieveIt Randomized Controlled Trial in Hospice Care: Mechanisms for Success and Meeting PCORI Methodology Standards.

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Ezenwa, Miriam O; Suarez, Marie L; Carrasco, Jesus D; Hipp, Theresa; Gill, Anayza; Miller, Jacob; Shea, Robert; Shuey, David; Zhao, Zhongsheng; Angulo, Veronica; McCurry, Timothy; Martin, Joanna; Yao, Yingwei; Molokie, Robert E; Wang, Zaijie Jim; Wilkie, Diana J

2017-07-01

This purpose of this article is to describe how we adhere to the Patient-Centered Outcomes Research Institute's (PCORI) methodology standards relevant to the design and implementation of our PCORI-funded study, the PAIN RelieveIt Trial. We present details of the PAIN RelieveIt Trial organized by the PCORI methodology standards and components that are relevant to our study. The PAIN RelieveIt Trial adheres to four PCORI standards and 21 subsumed components. The four standards include standards for formulating research questions, standards associated with patient centeredness, standards for data integrity and rigorous analyses, and standards for preventing and handling missing data. In the past 24 months, we screened 2,837 cancer patients and their caregivers; 874 dyads were eligible; 223.5 dyads consented and provided baseline data. Only 55 patients were lost to follow-up-a 25% attrition rate. The design and implementation of the PAIN RelieveIt Trial adhered to PCORI's methodology standards for research rigor.

Dezocine for Preventing Postoperative Pain: A Meta-Analysis of Randomized Controlled Trials.

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Xuelong Zhou

Full Text Available Dezocine is considered to be an alternative medication for managing postoperative pain. The aim of this study was to assess the efficacy and safety of this drug in this regard.Medline, EMBASE and the Cochrane Central Register of Control Trials (CENTRAL were searched to identify all randomized controlled trials (RCTs that compare dezocine with placebo or dezocine with morphine on postoperative pain. The data were extracted and pooled using Mantel-Haenszel random effects model. Heterogeneity was tested using the I2 statistic with values >50% and Chi2 test with P ≤ 0.05 indicating obvious heterogeneity between the studies.Seven trials evaluating 665 patients were included. The number of patients with at least 50% pain relief was increased (N = 234; RR 3.04, 95% CI 2.27 to 4.08 and physician (N = 465; RR 2.84, 95% CI 1.66 to 4.84 and patient satisfaction (N = 390; RR 2.81, 95% CI 1.85 to 4.26 were improved following the administration of dezocine compared with the placebo. The effects of dezocine were similar to those of morphine in terms of the number of patients reporting at least 50% pain relief within 2-6 h after surgery (N = 235; RR 1.29, 95% CI 1.15 to 1.46 and physician (N = 234; RR 1.18, 95% CI 0.93 to 1.49 and patient (N = 158; RR 1.33, 95% CI 0.93 to 1.92 satisfaction. While, the number of patients with at least 50% pain relief within 0-1 h after surgery increased following dezocine compared with morphine treatment (N = 79; RR 1.45, 95% CI 1.18 to 1.77. There was no difference in the incidence of postoperative nausea and vomiting (PONV following dezocine treatment compared with the placebo (N = 391; RR 1.06, 95% CI 0.42 to 2.68 or morphine treatment (N = 235; RR 0.65, 95% CI 0.14 to 2.93.Dezocine is a promising analgesic for preventing postoperative pain, but further studies are required to evaluate its safety.

Headache and Pain in Guillain-Barré Syndrome.

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Farmakidis, Constantine; Inan, Seniha; Milstein, Mark; Herskovitz, Steven

2015-08-01

While moderate and severe back or extremity pain is frequent in Guillain-Barré syndrome (GBS), headache appears to be uncommon. Most of the reports of headache in GBS place it in the context of the posterior reversible encephalopathy syndrome (PRES) which is increasingly recognized as a likely dysautonomia-related GBS complication. There are also a few reports of headache in the setting of increased CSF pressure and papilledema and in association with the Miller Fisher GBS variant. In comparison, back and extremity pain is highly prevalent. Aching muscle pain and neuropathic pain are the two most common of several pain types. Pain may be a heralding feature and has been described in patients as long as 2 years after disease onset. Pain management is a major axis of treatment in GBS. Gabapentin is a reasonable first-line choice, and opioid medications can be added for more severe pain but there are few clinical trials to inform specific recommendations. While the understanding of pain pathophysiology in GBS is incomplete, its prevalence and clinical impact are increasingly recognized and studied. Pain should be considered a cardinal manifestation of GBS along with acute, mostly symmetric weakness and diminished reflexes.

Assessing a risk tailored intervention to prevent disabling low back pain - protocol of a cluster randomized controlled trial

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Marnitz Ulf

2010-01-01

Full Text Available Abstract Background Although most patients with low back pain (LBP recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking. Methods/Design This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave. Discussion This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice. Trial registration ISRCTN 68205910

Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial.

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Urquhart, Donna M; Wluka, Anita E; Sim, Malcolm R; van Tulder, Maurits; Forbes, Andrew; Gibson, Stephen J; Arnold, Carolyn; Fong, Chris; Anthony, Shane N; Cicuttini, Flavia M

2016-10-22

Low back pain is a major clinical and public health problem, with limited evidence-based treatments. Low-dose antidepressants are commonly used to treat pain in chronic low back pain. However, their efficacy is unproven. The aim of this pragmatic, double-blind, randomised, placebo-controlled trial is to determine whether low-dose amitriptyline (an antidepressant) is more effective than placebo in reducing pain in individuals with chronic low back pain. One hundred and fifty individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics, advertising in local media and posting of flyers in community locations. They will be randomly allocated to receive either low-dose amitriptyline (25 mg) or an active placebo (benztropine mesylate, 1 mg) for 6 months. The primary outcome measure of pain intensity will be assessed at baseline, 3 and 6 months using validated questionnaires. Secondary measures of self-reported low back disability, work absence and hindrance in the performance of paid/unpaid work will also be examined. Intention-to-treat analyses will be performed. This pragmatic, double-blind, randomised, placebo-controlled trial will provide evidence regarding the effectiveness of low-dose antidepressants compared with placebo in reducing pain, disability, work absenteeism and hindrance in work performance in individuals with chronic low back pain. This trial has major public health and clinical importance as it has the potential to provide an effective approach to the management of chronic low back pain. Australian New Zealand Clinical Trials Registry: ACTRN12612000131853 ; registered on 30 January 2012.

Prospective clinical trial of surgical intervention for painful rib fracture nonunion.

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Fabricant, Loic; Ham, Bruce; Mullins, Richard; Mayberry, John

2014-06-01

We performed a prospective clinical trial of resection with or without plate fixation for symptomatic rib fracture nonunion three or more months postinjury with 6-month postoperative followup. The McGill Pain Questionnaire (MPQ) and RAND 36 Health Survey were administered and activity level (sedentary, ambulatory, moderately active, vigorous), functional status (disabled, nonphysical labor, physical labor), and work status (employed, unemployed, retired, student) were queried pre- and postoperatively. Twenty-four patients 4 to 197 months (median, 16 months) postinjury underwent surgical intervention for one to four rib fracture nonunions (median, two nonunions). Evidence of intercostal nerve entrapment was present in nine patients (38%). MPQ Present Pain Intensity and Pain Rating Index and RAND 36 Physical Functioning, Role Physical, Social Functioning, Role Social, Bodily Pain, Vitality, Mental Health, and General Health were significantly improved at six months compared with study entry (P rib fracture nonunion may improve chronic pain and disability but without change in functional or work status. Resection of adjacent nonunions with significant gaps may lead to chest wall hernia.

A Controlled Pilot Trial of PainTracker Self-Manager, a Web-Based Platform Combined With Patient Coaching, to Support Patients' Self-Management of Chronic Pain.

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Sullivan, Mark; Langford, Dale J; Davies, Pamela Stitzlein; Tran, Christine; Vilardaga, Roger; Cheung, Gifford; Yoo, Daisy; McReynolds, Justin; Lober, William B; Tauben, David; Vowles, Kevin E

2018-03-29

The objective of this study was to develop and pilot test a chronic pain empowerment and self-management platform, derived from acceptance and commitment therapy, in a pain specialty setting. A controlled, sequential, nonrandomized study design was used to accommodate intervention development and to test the efficacy of the PainTracker Self-Manager (PTSM) intervention (Web-based educational modules and outcome tracking combined with tailored patient coaching sessions and provider guidance). Generalized estimating equations evaluated changes over time (baseline, 3 months, 6 months) in pain self-efficacy (primary outcome), chronic pain acceptance (activity engagement and pain willingness), perceived efficacy in patient-provider interactions, pain intensity and interference, and overall satisfaction with pain treatment (secondary outcomes) between intervention (n = 48) and usual care control groups (n = 51). The full study sample (N = 99) showed greater improvements over time (significant Group × Time interactions) in pain self-efficacy and satisfaction with pain treatment. Among study completers (n = 82), greater improvement in activity engagement as well as pain intensity and interference were also observed. These preliminary findings support the efficacy of the PTSM intervention in a pain specialty setting. Further research is needed to refine and expand the PTSM intervention and to test it in a randomized trial in primary care settings. We developed a Web-based patient empowerment platform that combined acceptance and commitment therapy-based educational modules and tailored coaching sessions with longitudinal tracking of treatments and patient-reported outcomes, named PTSM. Pilot controlled trial results provide preliminary support for its efficacy in improving pain self-efficacy, activity engagement, pain intensity and interference, and satisfaction with pain treatment. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All

Analgesia, nil or placebo to babies, in trials that test new analgesic treatments for procedural pain.

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Bellieni, Carlo V; Johnston, C Celeste

2016-02-01

This review assessed how often neonates in control groups experienced unnecessary pain during clinical trials involving procedural pain. We retrieved 45 studies in the 30 months up to June 2015 and found that in 29 (64%) the control babies received either placebos or no treatment. Placebos were used in 15/25 (60%) studies involving heel pricks and in 6/8 (75%) involving venepuncture. Despite international guidelines, neonates included in control groups during painful procedures do not receive analgesia in the majority of cases. Several historical reasons can explain this, but in the light of present knowledge, this should not continue. Ethical committees are thereof invited since now to not permit clinical trials that do not explicitly rule out pain during treatments and journals are invited to not publish them. ©2015 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

On choice of trial functions in integro-differential variational principles of transport theory

International Nuclear Information System (INIS)

Loyalka, S.K.; Cipolla, J.W. Jr.

1988-01-01

In several problems of particle transport, quantities of macroscopic interest can be related to stationary values of variational functionals based on general integro-differential equations and boundary conditions. Within the context of the jump (Milne's) problem, it is shown how highly accurate results can be obtained by using trial functions based on the eigenfunctions of the relevant integrodifferential equations. Such choices of trial functions should apply equally effectively to problems in curved geometries, both internal and external

An Educational Intervention to Reduce Pain and Improve Pain Management for Malawian People Living With HIV/AIDS and Their Family Carers: A Randomized Controlled Trial.

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Nkhoma, Kennedy; Seymour, Jane; Arthur, Antony

2015-07-01

Advances being made in improving access to HIV drugs in resource-poor countries mean HIV patients are living longer, and, therefore, experiencing pain over a longer period of time. There is a need to provide effective interventions for alleviating and managing pain. To assess whether a pain educational intervention compared with usual care reduces pain severity and improves pain management in patients with HIV/AIDS and their family carers. This was a randomized, parallel group, superiority trial conducted at HIV and palliative care clinics of two public hospitals in Malawi. A total of 182 adults with HIV/AIDS (Stage III or IV) and their family carers participated; carer participants were those individuals most involved in the patient's unpaid care. The educational intervention comprised a 30 minute face-to-face meeting, a leaflet, and a follow-up telephone call at two weeks. The content of the educational intervention covered definition, causes, and characteristics of pain in HIV/AIDS; beliefs and myths about pain and pain medication; assessment of pain; and pharmacological and nonpharmacological management. The primary outcome was average pain severity measured by the Brief Pain Inventory-Pain Severity subscale. Assessments were recorded at baseline before randomization and at eight weeks after randomization. Of the 182 patient/carer dyads randomly allocated, 157 patient/carer dyads completed the trial. Patients in the intervention group experienced a greater decrease in pain severity (mean difference = 21.09 points, 95% confidence interval = 16.56-25.63; P HIV/AIDS and their family carers. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

The implementation of the serial trial intervention for pain and challenging behaviour in advanced dementia patients (STA OP!): a clustered randomized controlled trial.

NARCIS (Netherlands)

Pieper, M.J.C.; Achterberg, W.P.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.A.; Kovach, C.R.

2011-01-01

BACKGROUND: Pain (physical discomfort) and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention

Massage therapy decreases pain and perceived fatigue after long-distance Ironman triathlon: a randomised trial.

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Nunes, Guilherme S; Bender, Paula Urio; de Menezes, Fábio Sprada; Yamashitafuji, Igor; Vargas, Valentine Zimermann; Wageck, Bruna

2016-04-01

Can massage therapy reduce pain and perceived fatigue in the quadriceps of athletes after a long-distance triathlon race (Ironman)? Randomised, controlled trial with concealed allocation, intention-to-treat analysis and blinded outcome assessors. Seventy-four triathlon athletes who completed an entire Ironman triathlon race and whose main complaint was pain in the anterior portion of the thigh. The experimental group received massage to the quadriceps, which was aimed at recovery after competition, and the control group rested in sitting. The outcomes were pain and perceived fatigue, which were reported using a visual analogue scale, and pressure pain threshold at three points over the quadriceps muscle, which was assessed using digital pressure algometry. The experimental group had significantly lower scores than the control group on the visual analogue scale for pain (MD -7 mm, 95% CI -13 to -1) and for perceived fatigue (MD -15 mm, 95% CI -21 to -9). There were no significant between-group differences for the pressure pain threshold at any of the assessment points. Massage therapy was more effective than no intervention on the post-race recovery from pain and perceived fatigue in long-distance triathlon athletes. Brazilian Registry of Clinical Trials, RBR-4n2sxr. Copyright © 2016 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Pain control in orthodontics using a micropulse vibration device: A randomized clinical trial.

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Lobre, Wendy D; Callegari, Brent J; Gardner, Gary; Marsh, Curtis M; Bush, Anneke C; Dunn, William J

2016-07-01

To investigate the relationship between a micropulse vibration device and pain perception during orthodontic treatment. This study was a parallel group, randomized clinical trial. A total of 58 patients meeting eligibility criteria were assigned using block allocation to one of two groups: an experimental group using the vibration device or a control group (n  =  29 for each group). Patients used the device for 20 minutes daily. Patients rated pain intensity on a visual analog scale at appropriate intervals during the weeks after the separator or archwire appointment. Data were analyzed using repeated measures analysis of variance at α  =  .05. During the 4-month test period, significant differences between the micropulse vibration device group and the control group for overall pain (P  =  .002) and biting pain (P  =  .003) were identified. The authors observed that perceived pain was highest at the beginning of the month, following archwire adjustment. The micropulse vibration device significantly lowered the pain scores for overall pain and biting pain during the 4-month study period.

Written pain neuroscience education in fibromyalgia: a multicenter randomized controlled trial.

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van Ittersum, Miriam W; van Wilgen, C Paul; van der Schans, Cees P; Lambrecht, Luc; Groothoff, Johan W; Nijs, Jo

2014-11-01

Mounting evidence supports the use of face-to-face pain neuroscience education for the treatment of chronic pain patients. This study aimed at examining whether written education about pain neuroscience improves illness perceptions, catastrophizing, and health status in patients with fibromyalgia. A double-blind, multicenter randomized controlled clinical trial with 6-month follow-up was conducted. Patients with FM (n = 114) that consented to participate were randomly allocated to receive either written pain neuroscience education or written relaxation training. Written pain neuroscience education comprised of a booklet with pain neuroscience education plus a telephone call to clarify any difficulties; the relaxation group received a booklet with relaxation education and a telephone call. The revised illness perception questionnaire, Pain Catastrophizing Scale, and fibromyalgia impact questionnaire were used as outcome measures. Both patients and assessors were blinded. Repeated-measures analyses with last observation carried forward principle were performed. Cohen's d effect sizes (ES) were calculated for all within-group changes and between-group differences. The results reveal that written pain neuroscience education does not change the impact of FM on daily life, catastrophizing, or perceived symptoms of patients with FM. Compared with written relaxation training, written pain neuroscience education improved beliefs in a chronic timeline of FM (P = 0.03; ES = 0.50), but it does not impact upon other domains of illness perceptions. Compared with written relaxation training, written pain neuroscience education slightly improved illness perceptions of patients with FM, but it did not impart clinically meaningful effects on pain, catastrophizing, or the impact of FM on daily life. Face-to-face sessions of pain neuroscience education are required to change inappropriate cognitions and perceived health in patients with FM. © 2013 World Institute of Pain.

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

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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 chronic pain from low back pain (SMD, -0.81; 95% CI, -1.11 to -0.52; P complementary and alternative medicine for chronic pain conditions.

Interventions for the prediction and management of chronic postsurgical pain after total knee replacement: systematic review of randomised controlled trials.

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Beswick, Andrew D; Wylde, Vikki; Gooberman-Hill, Rachael

2015-05-12

Total knee replacement can be a successful operation for pain relief. However, 10-34% of patients experience chronic postsurgical pain. Our aim was to synthesise evidence on the effectiveness of applying predictive models to guide preventive treatment, and for interventions in the management of chronic pain after total knee replacement. We conducted a systematic review of randomised controlled trials using appropriate search strategies in the Cochrane Library, MEDLINE and EMBASE from inception to October 2014. No language restrictions were applied. Adult patients receiving total knee replacement. Predictive models to guide treatment for prevention of chronic pain. Interventions for management of chronic pain. Reporting of specific outcomes was not an eligibility criterion but we sought outcomes relating to pain severity. No studies evaluated the effectiveness of predictive models in guiding treatment and improving outcomes after total knee replacement. One study evaluated an intervention for the management of chronic pain. The trial evaluated the use of a botulinum toxin A injection with antinociceptive and anticholinergic activity in 49 patients with chronic postsurgical pain after knee replacement. A single injection provided meaningful pain relief for about 40 days and the authors acknowledged the need for a large trial with repeated injections. No trials of multidisciplinary interventions or individualised treatments were identified. Our systematic review highlights a lack of evidence about the effectiveness of prediction and management strategies for chronic postsurgical pain after total knee replacement. As a large number of people are affected by chronic pain after total knee replacement, development of an evidence base about care for these patients should be a research priority. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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.

Repeated tender point injections of granisetron alleviate chronic myofascial pain--a randomized, controlled, double-blinded trial.

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Christidis, Nikolaos; Omrani, Shahin; Fredriksson, Lars; Gjelset, Mattias; Louca, Sofia; Hedenberg-Magnusson, Britt; Ernberg, Malin

2015-01-01

Serotonin (5-HT) mediates pain by peripheral 5-HT3-receptors. Results from a few studies indicate that intramuscular injections of 5-HT3-antagonists may reduce musculoskeletal pain. The aim of this study was to investigate if repeated intramuscular tender-point injections of the 5-HT3-antagonist granisetron alleviate pain in patients with myofascial temporomandibular disorders (M-TMD). This prospective, randomized, controlled, double blind, parallel-arm trial (RCT) was carried out during at two centers in Stockholm, Sweden. The randomization was performed by a researcher who did not participate in data collection with an internet-based application ( www.randomization.com ). 40 patients with a diagnose of M-TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were randomized to receive repeated injections, one week apart, with either granisetron (GRA; 3 mg) or isotonic saline as control (CTR). The median weekly pain intensities decreased significantly at all follow-ups (1-, 2-, 6-months) in the GRA-group (Friedman test; P  0.075). The numbers needed to treat (NNT) were 4 at the 1- and 6-month follow-ups, and 3.3 at the 2-month follow-up in favor of granisetron. Repeated intramuscular tender-point injections with granisetron provide a new pharmacological treatment possibility for myofascial pain patients with repeated intramuscular tender-point injections with the serotonin type 3 antagonist granisetron. It showed a clinically relevant pain reducing effect in the temporomandibular region, both in a short- and long-term aspect. European Clinical Trials Database 2005-006042-41 as well as at Clinical Trials NCT02230371 .

The effect of Neuragen PN® on Neuropathic pain: A randomized, double blind, placebo controlled clinical trial

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Li Li

2010-05-01

Full Text Available Abstract Background A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN®" for the treatment of neuropathic pain. Methods Sixty participants with plantar cutaneous (foot sole pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN® or placebo per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. Results There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN® led to significantly (p ® reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0% subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN® group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. Conclusions This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. Trial registration ISRCTN registered: ISRCTN13226601

PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

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Day Richard O

2010-07-01

Full Text Available Abstract Background Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN for recovery from acute LBP. Methods/Design The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol, PRN paracetamol (plus placebo time-contingent paracetamol or a double placebo study arm. The primary outcome will be time (days to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives. Discussion The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP. Trail registration ACTRN12609000966291.

Endoscopic or surgical intervention for painful obstructive chronic pancreatitis.

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Ahmed Ali, Usama; Pahlplatz, Johanna M; Nealon, Wiliam H; van Goor, Harry; Gooszen, Hein G; Boermeester, Marja A

2015-03-19

Endoscopy and surgery are the treatment modalities of choice for patients with chronic pancreatitis and dilated pancreatic duct (obstructive chronic pancreatitis). Physicians face, without clear consensus, the choice between endoscopy or surgery for this group of patients. To assess and compare the effects and complications of surgical and endoscopic interventions in the management of pain for obstructive chronic pancreatitis. We searched the following databases in The Cochrane Library: CENTRAL (2014, Issue 2), the Cochrane Database of Systematic Reviews (2014, Issue 2), and DARE (2014, Issue 2). We also searched the following databases up to 25 March 2014: MEDLINE (from 1950), Embase (from 1980), and the Conference Proceedings Citation Index - Science (CPCI-S) (from 1990). We performed a cross-reference search. Two review authors independently performed the selection of trials. All randomised controlled trials (RCTs) of endoscopic or surgical interventions in obstructive chronic pancreatitis. We included trials comparing endoscopic versus surgical interventions as well as trials comparing either endoscopic or surgical interventions to conservative treatment (i.e. non-invasive treatment modalities). We included relevant trials irrespective of blinding, the number of participants randomised, and the language of the article. We used standard methodological procedures expected by The Cochrane Collaboration. Two authors independently extracted data from the articles. We evaluated the methodological quality of the included trials and requested additional information from study authors in the case of missing data. We identified three eligible trials. Two trials compared endoscopic intervention with surgical intervention and included a total of 111 participants: 55 in the endoscopic group and 56 in the surgical group. Compared with the endoscopic group, the surgical group had a higher proportion of participants with pain relief, both at middle/long-term follow-up (two to

The Effect of Virtual Reality on Pain in Primiparity Women during Episiotomy Repair: A Randomize Clinical Trial

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Nahid JahaniShoorab

2015-05-01

Full Text Available Background: Pain is one of the side effects of episiotomy. The virtual reality (VR is a non-pharmacological method for pain relief. The purpose of this study was to determine the effect of using video glasses on pain reduction in primiparity women during episiotomy repair. Methods: This clinical trial was conducted on 30 primiparous parturient women having labor at Omolbanin Hospital (Mashhad, Iran during May-July 2012. Samples during episiotomy repair were randomly divided into two equal groups. The intervention group received the usual treatment with VR (video glasses and local infiltration 5 ml solution of lidocaine 2% and the control group only received local infiltration (5 ml solution of lidocaine 2%. Pain was measured using the Numeric Pain Rating Scale (0-100 scale before, during and after the episiotomy repair. Data were analyzed using Fisher’s exact test, Chi-square, Mann-Whitney and repeated measures ANOVA tests by SPSS 11.5 software. Results: There were statistically significant differences between the pain score during episiotomy repair in both groups (P=0.038. Conclusion: Virtual reality is an effective complementary non-pharmacological method to reduce pain during episiotomy repair. Trial Registration Number: IRCT138811063185N1.

Randomized controlled trial about pain medication flupirtine ignores recent pharmacovigilance warnings

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Puljak L

2018-01-01

Full Text Available Livia Puljak1,2 1Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia; 2Department for Development, Research and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, CroatiaOn October 16, 2017 in the Journal of Pain Research, a randomized controlled trial (RCT comparing efficacy and safety of flupirtine versus piroxicam in postoperative pain in patients undergoing lower limb surgery was published.1 However, this paper fails to report important information. Author’s reply Sowmya Chinnaiyan,1 Narayana Sarala,1 Heddur Shanthappa Arun21Department of Pharmacology, 2Department of Orthopedics, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India We thank Livia Puljak for the valuable insights on the article titled “A comparative study of efficacy and safety of flupirtine  versus piroxicam in postoperative pain in patients undergoing lower limb surgery” published in the Journal of Pain Research. The concerns highlighted in the Letter to the Editor have been answered.View the original paper by Chinnaiyan and colleagues. 

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

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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.

Cognitive behavior therapy for pediatric functional abdominal pain: a randomized controlled trial

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van der Veek, Shelley M. C.; Derkx, Bert H. F.; Benninga, Marc A.; Boer, Frits; de Haan, Else

2013-01-01

This randomized controlled trial investigated the effectiveness of a 6-session protocolized cognitive behavior therapy (CBT) compared with 6 visits to a pediatrician (intensive medical care; IMC) for the treatment of pediatric functional abdominal pain (FAP). One hundred four children aged 7 to 18

The Immediate Effects of Orthoses on Pain in People with Lateral Epicondylalgia

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Ebrahim Sadeghi-Demneh

2013-01-01

Full Text Available Objective. Tennis elbow is a common cause of upper limb dysfunction and a primary reason for pain at the lateral aspect of the elbow. The purpose of this study was to investigate the effects of three commonly used orthoses on pain severity. An elbow band, an elbow sleeve, and a wrist splint were assessed for their ability to reduce the level of reported pain. Method. A crossover randomized controlled trial was used. The orthoses were worn in a randomized order, and all participants were required to complete a control trial for which they wore a placebo orthosis. 52 participants with lateral epicondylalgia were recruited, and the level of pain at their elbow was recorded using the visual analogue scale (VAS. Results. The reported pain for all orthoses was lower than that of the placebo (. Pain reduction was significantly greater with a counterforce elbow band or a counterforce elbow sleeve compared to a wrist splint (. There was no significant difference between a counterforce elbow band and a counterforce elbow sleeve (. Conclusion. All the types of orthoses studied showed an immediate improvement on pain severity in people with lateral epicondylalgia. The counterforce elbow orthoses (elbow band and elbow sleeve presented the greatest improvement, suggesting that either of them can be used as a first treatment choice to alleviate the pain in people with tennis elbow.

The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial.

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Wilson, Matthew; MacArthur, Christine; Gao Smith, Fang; Homer, Leanne; Handley, Kelly; Daniels, Jane

2016-12-12

The commonest opioid used for pain relief in labour is pethidine (meperidine); however, its effectiveness has long been challenged and the drug has known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. Over a third of women receiving pethidine require an epidural due to inadequate pain relief. Epidural analgesia increases the risk of an instrumental vaginal delivery and its associated effects. Therefore, there is a clear need for a safe, effective, alternative analgesic to pethidine. Evidence suggests that remifentanil patient-controlled analgesia (PCA) reduces epidural conversion rates compared to pethidine; however, no trial has yet investigated this as a primary endpoint. We are, therefore, comparing pethidine intramuscular injection to remifentanil PCA in a randomised controlled trial. Women in established labour, requesting systemic opioid pain relief, will be randomised to either intravenously administered remifentanil PCA (intervention) or pethidine intramuscular injection (control) in an unblinded, 1:1 individual randomised trial. Following informed consent, 400 women in established labour, who request systemic opioid pain relief, from NHS Trusts across England will undergo a minimised randomisation by a computer or automated telephone system to either pethidine or remifentanil. In order to balance the groups this minimisation is based on four parameters; parity (nulliparous versus multiparous), maternal age (Asian (Pakistani/Indian/Bangladeshi) versus Other) and induced versus spontaneous labour. The effectiveness of pain relief provided by each technique will be recorded every 30 min after time zero, until epidural placement, delivery or transfer to theatre, quantified by Visual Analogue Scale. Incidence of maternal side effects including sedation, delivery mode, foetal distress requiring delivery, neonatal status at delivery and rate of initiation of breastfeeding within the first hour of birth

Efficacy of aromatherapy for reducing pain during labor: a randomized controlled trial.

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Tanvisut, Rajavadi; Traisrisilp, Kuntharee; Tongsong, Theera

2018-05-01

Many strategies for labor pain management have been studied, including aromatherapy, which is a noninvasive, alternative medicine used as an adjunct for labor pain control. Nevertheless, the results were contradictory. Therefore, we conducted this study to determine the effectiveness of aromatherapy for reducing pain during labor. A randomized controlled trial was carried out on Thai laboring primigravidae who were a low-risk singleton pregnancy undergoing vaginal delivery. All participants, both study and control group, received standard obstetric care. Aromatherapy was only provided to the study group during the first stage of labor. The women rated their pain intensity by rating scales at different stages of labor. The primary outcome was pain scores and the secondary outcomes were necessity of painkiller usage, labor time, aromatherapy-associated complications, route of delivery, and Apgar scores. A total of 104 women were recruited, 52 in each group. Baseline characteristics and baseline pain scores were comparable. The median pain score of latent and early active phase was lower in the aromatherapy group, 5 vs 6 and 7 vs 8, respectively. The mean differences of pain scores between latent and early active phase and the baseline were significantly lower in the aromatherapy group, 1.88 vs 2.6 (p = 0.010) and 3.82 vs 4.39 (p = 0.031), respectively. Late active phase pain scores and other perinatal outcomes were not significantly different. Aromatherapy is helpful in reducing pain in latent and early active phase, and can probably be used as an adjunctive method for labor pain control without serious side effects.

Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

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Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

2018-02-01

OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials

Influences shaping nurses' use of distraction for children's procedural pain.

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Olmstead, Deborah L; Scott, Shannon D; Mayan, Maria; Koop, Priscilla M; Reid, Kathy

2014-04-01

This study explored pediatric nurses' choices to use distraction for managing painful procedures. Using interpretive description approaches, interviews with pediatric nurses provided descriptions of choices to manage procedural pain. Nurses' distress influenced distraction use to mitigate the suffering of children and themselves. Newer nurses described task mastery as influencing distraction choices. Nurses' accounts of performing painful procedures on children mirrored children's descriptions of pain from the literature. Nurses' distress and competency performing painful procedures on children influenced practice. Future qualitative studies could extend understanding of pain management choices by pediatric nurses and the impact on undermanaged pain. © 2014, Wiley Periodicals, Inc.

Estimation of treatment preference effects in clinical trials when some participants are indifferent to treatment choice

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Stephen D. Walter

2017-02-01

Full Text Available Abstract Background In the two-stage randomised trial design, a randomly sampled subset of study participants are permitted to choose their own treatment, while the remaining participants are randomised to treatment in the usual way. Appropriate analysis of the data from both arms of the study allows investigators to estimate the impact on study outcomes of treatment preferences that patients may have, in addition to evaluating the usual direct effect of treatment. In earlier work, we showed how to optimise this design by making a suitable choice of the proportion of participants who should be assigned to the choice arm of the trial. However, we ignored the possibility of some participants being indifferent to the treatments under study. In this paper, we extend our earlier work to consider the analysis of two-stage randomised trials when some participants have no treatment preference, even if they are assigned to the choice arm and allowed to choose. Methods We compare alternative characterisations of the response profiles of the indifferent or undecided participants, and derive estimates of the treatment and preference effects on study outcomes. We also present corresponding test statistics for these parameters. The methods are illustrated with data from a clinical trial contrasting medical and surgical interventions. Results Expressions are obtained to estimate and test the impact of treatment choices on study outcomes, as well as the impact of the actual treatment received. Contrasts are defined between patients with stated treatment preferences and those with no preference. Alternative assumptions concerning the outcomes of undecided participants are described, and an approach leading to unbiased estimation and testing is identified. Conclusions Use of the two-stage design can provide important insights into determinants of study outcomes that are not identifiable with other designs. The design can remain attractive even in the presence of

Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: a cluster-randomized multicenter trial.

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Jahn, Patrick; Kuss, Oliver; Schmidt, Heike; Bauer, Alexander; Kitzmantel, Maria; Jordan, Karin; Krasemann, Susann; Landenberger, Margarete

2014-04-01

Patients' self-management skills are affected by their knowledge, activities, and attitudes toward pain management. This trial aimed to test the Self Care Improvement through Oncology Nursing (SCION)-PAIN program, a multimodular structured intervention to reduce patients' barriers to self-management of cancer pain. Two hundred sixty-three patients with diagnosed malignancy, pain>3 days, and average pain > or = 3/10 participated in a cluster-randomized trial on 18 wards in 2 German university hospitals. Patients on the intervention wards received, in addition to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic, nonpharmacologic pain management, and discharge management. The intervention was conducted by specially trained cancer nurses and included components of patient education, skills training, and counseling. Starting with admission, patients received booster sessions every third day and one follow-up telephone counseling session within 2 to 3 days after discharge. Patients in the control group received standard care. Primary end point was the group difference in patient-related barriers to self-management of cancer pain (Barriers Questionnaire-BQ II) 7 days after discharge. The SCION-PAIN program resulted in a significant reduction of patient-related barriers to pain management 1 week after discharge from the hospital: mean difference on BQ II was -0.49 points (95% confidence interval -0.87 points to -0.12 points; P=0.02). Furthermore, patients showed improved adherence to pain medication; odds ratio 8.58 (95% confidence interval 1.66-44.40; P=0.02). A post hoc analysis indicated reduced average and worst pain intensity as well as improved quality of life. This trial reveals the positive impact of a nursing intervention to improve patients' self-management of cancer pain. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Static magnetic therapy does not decrease pain or opioid requirements: a randomized double-blind trial.

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Cepeda, M Soledad; Carr, Daniel B; Sarquis, Tony; Miranda, Nelcy; Garcia, Ricardo J; Zarate, Camilo

2007-02-01

A growing multibillion dollar industry markets magnetic necklaces, bracelets, bands, insoles, back braces, mattresses, etc., for pain relief, although there is little evidence for their efficacy. We sought to evaluate the effect of magnetic therapy on pain intensity and opioid requirements in patients with postoperative pain. We designed a randomized, double-blind, controlled trial. One-hundred-sixty-five patients older than 12 yr of age were randomized to magnetic (n = 81) or sham therapy (n = 84) upon reporting moderate-to-severe pain in the postanesthesia care unit. Devices were placed over the surgical incision and left in place for 2 h. Patients rated their pain intensity on a 0-10 scale every 10 min and received incremental doses of morphine until pain intensity was Magnetic therapy lacks efficacy in controlling acute postoperative pain intensity levels or opioid requirements and should not be recommended for pain relief in this setting.

The effect of massage therapy and/or exercise therapy on subacute or long-lasting neck pain--the Stockholm neck trial (STONE): study protocol for a randomized controlled trial.

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Skillgate, Eva; Bill, Anne-Sylvie; Côté, Pierre; Viklund, Peter; Peterson, Anna; Holm, Lena W

2015-09-16

Neck pain is a major health problem in populations worldwide and an economic burden in modern societies due to its high prevalence and costs in terms of health care expenditures and lost productivity. Massage and exercise therapy are widely used management options for neck pain. However, there is a lack of scientific evidence regarding their effectiveness for subacute and long-lasting neck pain. This study protocol describes a randomized controlled trial aiming to determine the effect of massage and/or exercise therapy on subacute and long-lasting neck pain over the course of 1 year. A randomized controlled trial in which at least 600 study participants with subacute or long-lasting nonspecific neck pain will be recruited and randomly allocated to one of four treatment arms: massage therapy (A), exercise therapy (B), exercise therapy plus massage therapy (C) and advice to stay active (D). The study has an E-health approach, and study participants are being recruited through advertising with a mix of traditional and online marketing channels. Web-based self-report questionnaires measure the main outcomes at 7, 12, 26 and 52 weeks after inclusion. The primary outcomes are a clinically important improvement in pain intensity and pain-related disability at follow-up, measured with a modified version of the Chronic Pain Questionnaire (CPQ). The secondary outcomes are global improvement, health-related quality of life (EQ-5D), sick leave, drug consumption and healthcare utilization. Adverse events are measured by questionnaires at return visits to the clinic, and automated text messages (SMSes) survey neck pain intensity and pain-related disability every week over one year. The results of this study will provide clinicians and stakeholders much needed knowledge to plan medical care for subacute and long-lasting neck pain disorders. Current Controlled Trials ISRCTN01453590. Date of registration: 3 July 2014.

Managing cancer pain and symptoms of outpatients by rotation to sustained-release hydromorphone: a prospective clinical trial

NARCIS (Netherlands)

Wirz, Stefan; Wartenberg, Hans Christian; Elsen, Christian; Wittmann, Maria; Diederichs, Marta; Nadstawek, Joachim

2006-01-01

PURPOSE: In this prospective clinical trial we examined the technique of opioid rotation to oral sustained-release hydromorphone for controlling pain and symptoms in outpatients with cancer pain. METHODS: Before and after rotation, 50 patients were assessed by Numerical Analog Scales [Numerical

Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

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Thoke-Colberg Anette

2010-03-01

Full Text Available Abstract Background Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN program, a multi modular structured intervention to improve self management in cancer patients with pain. Methods 240 patients with diagnosed malignancy and pain > 3 days and average pain ≥ 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients from the intervention wards will receive, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, nonpharmacologic pain management and discharge management. The intervention will be conducted by specially trained oncology nurses and includes components of patient education, skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group will receive standard care. Primary endpoint is the group difference in patient related barriers to management of cancer pain (BQII, 7 days after discharge. Secondary endpoints are: pain intensity & interference, adherence, coping and HRQoL. Discussion The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital. It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain. Trial Registration ClinicalTrials NCT

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

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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

Effect of pain neurophysiology education on physiotherapy students' understanding of chronic pain, clinical recommendations and attitudes towards people with chronic pain: a randomised controlled trial.

Science.gov (United States)

Colleary, G; O'Sullivan, K; Griffin, D; Ryan, C G; Martin, D J

2017-12-01

To investigate the effect of pain neurophysiology education (PNE) on student physiotherapists': (1) knowledge of chronic pain; (2) attitudes towards patients with chronic pain; and (3) clinical recommendations for patients with chronic pain. Multicentre single-blind randomised controlled trial. One UK and one Irish university. Seventy-two student physiotherapists. Participants received either PNE (intervention) or a control education. Both were delivered in a 70-minute group lecture. (1) The Revised Pain Neurophysiology Quiz to assess knowledge; (2) the Health Care Pain Attitudes and Impairment Relationship Scale (HC-PAIRS) to assess attitudes; and (3) a case vignette to assess the appropriateness of clinical recommendations. Post education, the PNE group had a greater increase in pain neurophysiology knowledge [mean difference 4.0 (95% confidence interval 3.2 to 4.7), Pstudents in the PNE group were more likely to make appropriate recommendations regarding work (94% vs 56%), exercise (92% vs 56%), activity (94% vs 67%) and bed rest (69% vs 33%) compared with those in the control group (Pphysiotherapy students, and could be used on a more widespread basis. There is a need to investigate whether these findings can be replicated in other healthcare professions, and how well these reported changes lead to changes in actual clinical behaviour and the clinical outcomes of patients. Copyright © 2017 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial.

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Heapy, Alicia A; Higgins, Diana M; Goulet, Joseph L; LaChappelle, Kathryn M; Driscoll, Mary A; Czlapinski, Rebecca A; Buta, Eugenia; Piette, John D; Krein, Sarah L; Kerns, Robert D

2017-06-01

Recommendations for chronic pain treatment emphasize multimodal approaches, including nonpharmacologic interventions to enhance self-management. Cognitive behavioral therapy (CBT) is an evidence-based treatment that facilitates management of chronic pain and improves outcomes, but access barriers persist. Cognitive behavioral therapy delivery assisted by health technology can obviate the need for in-person visits, but the effectiveness of this alternative to standard therapy is unknown. The Cooperative Pain Education and Self-management (COPES) trial was a randomized, noninferiority trial comparing IVR-CBT to in-person CBT for patients with chronic back pain. To assess the efficacy of interactive voice response-based CBT (IVR-CBT) relative to in-person CBT for chronic back pain. We conducted a noninferiority randomized trial in 1 Department of Veterans Affairs (VA) health care system. A total of 125 patients with chronic back pain were equally allocated to IVR-CBT (n = 62) or in-person CBT (n = 63). Patients treated with IVR-CBT received a self-help manual and weekly prerecorded therapist feedback based on their IVR-reported activity, coping skill practice, and pain outcomes. In-person CBT included weekly, individual CBT sessions with a therapist. Participants in both conditions received IVR monitoring of pain, sleep, activity levels, and pain coping skill practice during treatment. The primary outcome was change from baseline to 3 months in unblinded patient report of average pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes included changes in pain-related interference, physical and emotional functioning, sleep quality, and quality of life at 3, 6, and 9 months. We also examined treatment retention. Of the 125 patients (97 men, 28 women; mean [SD] age, 57.9 [11.6] years), the adjusted average reduction in NRS with IVR-CBT (-0.77) was similar to in-person CBT (-0.84), with the 95% CI for the difference between groups (-0.67 to 0

Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

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Jae-Young Shin

2015-01-01

Full Text Available Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n=28 or the sham laser acupuncture group (n=28. Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

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

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Bablis, Peter; Pollard, Henry; Bonello, Rod

2008-05-21

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. 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.

The use of transcutaneous electrical nerve stimulation (TENS) for pain relief in labour: a review of the evidence.

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Bedwell, Carol; Dowswell, Therese; Neilson, James P; Lavender, Tina

2011-10-01

to assess the effects of transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. studies were identified from a search of the Cochrane Pregnancy and Childbirth Group's Trials Register (November 2008). randomised controlled trials comparing women receiving TENS for pain relief in labour vs routine care or placebo devices. All types of TENS machines were included. two review authors assessed all trials identified by the search strategy, carried out data extraction and assessed risk of bias. 14 studies including 1256 women were included: 11 examined TENS applied to the back, two to acupuncture points and one to the cranium. Overall, there was little difference in satisfaction with pain relief or in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (risk ratio 0.41, 95% confidence interval 0.32-0.55). The majority of women using TENS would use it again in a future labour. There was no evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and infants. No adverse events were reported. there is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact on other outcomes for mothers or infants. The use of TENS at home in early labour has not been evaluated. Although the guidelines of the National Institute for Health and Clinical Excellence recommend that TENS should not be offered to women in labour, women appear to be choosing it and midwives are supporting them in their choice. Given the absence of adverse effects and the limited evidence base, it seems unreasonable to deny women that choice. More robust studies of effectiveness are needed. Copyright © 2009 Elsevier Ltd. All rights reserved.

Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial.

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Saper, Robert B; Lemaster, Chelsey; Delitto, Anthony; Sherman, Karen J; Herman, Patricia M; Sadikova, Ekaterina; Stevans, Joel; Keosaian, Julia E; Cerrada, Christian J; Femia, Alexandra L; Roseen, Eric J; Gardiner, Paula; Gergen Barnett, Katherine; Faulkner, Carol; Weinberg, Janice

2017-07-18

Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain. To determine whether yoga is noninferior to PT for cLBP. 12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927). Academic safety-net hospital and 7 affiliated community health centers. 320 predominantly low-income, racially diverse adults with nonspecific cLBP. Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice. Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life. One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups. Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up. A manualized yoga program for nonspecific cLBP was noninferior to PT for

Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial.

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MacPherson, Hugh; Tilbrook, Helen; Richmond, Stewart; Woodman, Julia; Ballard, Kathleen; Atkin, Karl; Bland, Martin; Eldred, Janet; Essex, Holly; Hewitt, Catherine; Hopton, Ann; Keding, Ada; Lansdown, Harriet; Parrott, Steve; Torgerson, David; Wenham, Aniela; Watt, Ian

2015-11-03

Management of chronic neck pain may benefit from additional active self-care-oriented approaches. To evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain. Three-group randomized, controlled trial. (Current Controlled Trials: ISRCTN15186354). U.K. primary care. Persons with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology. 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. NPQ score (primary outcome) at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes). 517 patients were recruited, and the median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained. Arthritis Research UK.

Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial.

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Williams, Amanda; Wiggers, John; OʼBrien, Kate M; Wolfenden, Luke; Yoong, Sze Lin; Hodder, Rebecca K; Lee, Hopin; Robson, Emma K; McAuley, James H; Haskins, Robin; Kamper, Steven J; Rissel, Chris; Williams, Christopher M

2018-06-01

We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial, embedded within a cohort multiple randomised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and body mass index ≥27 kg/m and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks, and monthly for 6 months. Data analysis was by intention-to-treat according to a prepublished analysis plan. Between May 13, 2015, and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference = 6.5, 95% confidence interval -8.0 to 21.0; P = 0.38) or any secondary outcome. In the intervention group, 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared with usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

Ultramicronized Palmitoylethanolamide (PEA) in spinal cord injury neuropathic pain: a randomized controlled trial

DEFF Research Database (Denmark)

Andresen, Sven Robert; Bing, Jette; Hansen, Rikke Bod Middelhede

2015-01-01

. Methods  A randomized, double-blind, placebo-controlled parallel multicenter study. Study population of at least 66 patients must complete the 12 week trial.Questionnaires regarding neuropathic pain, spasticity, insomnia, anxiety and depression are completed before and after treatment. A numeric...

A randomized controlled intervention trial to relieve and prevent neck/shoulder pain

DEFF Research Database (Denmark)

Andersen, Lars L; Jørgensen, Marie B; Blangsted, Anne Katrine

2008-01-01

PURPOSE: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS: A 1-yr randomized controlled intervention trial was done with three groups: specific...... resistance training (SRT, n = 180), all-round physical exercise (APE, n = 187), and reference intervention (REF, n = 182) with general health counseling. Physical tests were performed and questionnaires answered at pre-, mid-, and postintervention. The main outcome measures were compliance, changes......: Compliance was highest in SRT but generally decreased over time. SRT and APE caused increased shoulder elevation strength, were more effective than REF to decrease neck pain among those with symptoms at baseline, and prevent development of shoulder pain in those without symptoms at baseline....

Vapocoolant Spray Effectiveness on Arterial Puncture Pain: A Randomized Controlled Clinical Trial

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Shervin Farahmand

2017-02-01

Full Text Available Arterial blood gas (ABG sampling is a painful procedure with no perfect technique for quelling the discomfort. An ideal local anesthesia should be rapid, easy to learn, inexpensive, and noninvasive. This study was aimed to compare pain levels from ABG sampling performed with vapocoolant spray in comparison to placebo. We hypothesized that pretreatment with the vapocoolant would reduce the pain of arterial puncture by at least 1 point on a 10 point verbal numeric scale. We have evaluated the effectiveness of a vapocoolant spray in achieving satisfactory pain control in patients undergoing ABG sampling in this randomized placebo controlled trial. Eighty patients were randomized to 2 groups: group A, who received vapocoolant spray, and group B, who received water spray as placebo (Control group. Puncture and spray application pain was assessed with numerical rating scale (0, the absence of pain; 10, greatest imaginable pain and number of attempts was recorded. The pain score during ABG sampling was not lower in group A compared with group B significantly (4.78±1.761 vs. 4.90±1.837; P:0.945. This study showed that while the spray exerts more application pain, the number of attempts required for ABG sampling was not significantly lower in group A compared with group B (1.38±0.54 vs. 1.53±0.68; P=0.372. Vapocoolant spray was not effective in ABG pain reduction, had milder application pain compared to placebo (P<0.05, but did not reduce sampling attempts. At present, this spray cannot be recommended for arterial puncture anesthesia, and further study on different timing is necessary.

Tolvaptan and Kidney Pain in Patients With Autosomal Dominant Polycystic Kidney Disease : Secondary Analysis From a Randomized Controlled Trial

NARCIS (Netherlands)

Casteleijn, Niek F.; Blais, Jaime D.; Chapman, Arlene B.; Czerwiec, Frank S.; Devuyst, Olivier; Higashihara, Eiji; Leliveld, Anna M.; Ouyang, John; Perrone, Ronald D.; Torres, Vicente E.; Gansevoort, Ron T.

Background: Kidney pain is a common complication in patients with autosomal dominant polycystic kidney disease (ADPKD), and data from the TEMPO 3: 4 trial suggested that tolvaptan, a vasopressin V2 receptor antagonist, may have a positive effect on kidney pain in this patient group. Because pain is

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

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Cherkin, Daniel C; Sherman, Karen J; Kahn, Janet; Erro, Janet H; Deyo, Richard A; Haneuse, Sebastien J; Cook, Andrea J

2009-10-20

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. 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. Results of this trial will help clarify the value of two types of massage therapy for chronic low back pain.

Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial.

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Mecklenburg, Gabriel; Smittenaar, Peter; Erhart-Hledik, Jennifer C; Perez, Daniel A; Hunter, Simon

2018-04-25

Chronic knee pain, most commonly caused by knee osteoarthritis, is a prevalent condition which in most cases can be effectively treated through conservative, non-surgical care involving exercise therapy, education, psychosocial support, and weight loss. However, most people living with chronic knee pain do not receive adequate care, leading to unnecessary use of opiates and surgical procedures. Assess the efficacy of a remotely delivered digital care program for chronic knee pain. We enrolled 162 participants into a randomized controlled trial between January and March 2017. Participants were recruited from participating employers using questionnaires for self-assessment of their knee pain, and randomized into treatment (n=101) and control (n=61) groups. Participants in the treatment group were enrolled in the Hinge Health digital care program for chronic knee pain. This is a remotely delivered, home-based 12-week intervention that includes sensor-guided exercise therapy, education, cognitive behavioral therapy, weight loss, and psychosocial support through a personal coach and team-based interactions. The control group received three education pieces regarding self-care for chronic knee pain. Both groups had access to treatment-as-usual. The primary outcome was the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale and KOOS Physical Function Shortform (KOOS-PS). Secondary outcomes were visual analog scales (VAS) for pain and stiffness respectively, surgery intent, and self-reported understanding of the condition and treatment options. Outcome measures were analyzed by intention to treat (excluding 7 control participants who received the digital care program due to administrative error) and per protocol. In an intent-to-treat analysis the digital care program group had a significantly greater reduction in KOOS Pain compared to the control group at the end of the program (greater reduction of 7.7, 95% CI 3.0 to 12.3, P=.002), as well as a

Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial.

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Comachio, Josielli; Oliveira Magalhães, Mauricio; Nogueira Burke, Thomaz; Vidal Ramos, Luiz Armando; Peixoto Leão Almeida, Gabriel; Silva, Ana Paula M C C; Ferreira de Meneses, Sarah Rúbia; Costa-Frutuoso, Jecilene Rosana; Santos Miotto Amorim, Cinthia; Pasqual Marques, Amélia

2015-10-15

Previous studies have shown that acupuncture and electroacupuncture (EA) are effective in the treatment of patients with low back pain. However, there is little evidence to support the use of one intervention over the other. The aim of this study is to compare the effect of acupuncture and electroacupuncture in the treatment of pain and disability in patients with chronic nonspecific low back pain. The study design is a randomized controlled trial. Patients with nonspecific chronic low back pain of more than three months duration are recruited at Rehabilitation Center of Taboao da Serra - SP (Brazil). After examination, sixty-six patients will be randomized into one of two groups: acupuncture group (AG) (n = 33) and electroacupuncture group (EG) (n = 33). Interventions will last one hour, and will happen twice a week for 6 weeks. The primary clinical outcomes will be pain intensity as measured and functional disability. quality of pain, quality of life. perception of the overall effect, depressive state, flexibility and kinesiophobia. All the outcomes will be assessed will be assessed at baseline, at treatment end, and three months after treatment end. Significance level will be determined at the 5 % level. Results of this trial will help clarify the value of acupuncture and electroacupuncture as a treatment for chronic low back pain and if they are different. Results of this trial will help clarify the value of acupuncture needling and electroacupuncture stimulation of specific points on the body as a treatment for chronic low back pain. Clinicaltrials.gov: NCT02039037 . Register October 30, 2013.

Krill Oil Improves Mild Knee Joint Pain: A Randomized Control Trial.

Science.gov (United States)

Suzuki, Yoshio; Fukushima, Minoru; Sakuraba, Keishoku; Sawaki, Keisuke; Sekigawa, Kazuaki

2016-01-01

Krill oil is an edible oil extracted from krill, a small red-colored crustacean found in the Antarctic Ocean. The administration of krill oil is reported to mitigate inflammation in patients with cardiac disease, rheumatoid arthritis, or osteoarthritis. However, the effect of krill oil on mild knee pain has not yet been determined. To assess the effect of krill oil on mild knee pain. A randomized, double-blind, parallel-group, placebo-controlled trial of fifty adults (38-85 years old) with mild knee pain attending the Fukushima Orthopedic Clinic (Tochigi, Japan) between September 2014 and March 2015. Participants were randomized to receive 2 g per day of either krill oil or an identical placebo for 30 days. The primary outcome was improvement in subjective symptoms of knee pain as assessed by the Japanese Knee Osteoarthritis Measure (JKOM) and Japanese Orthopaedic Association score (JOA). Secondary outcomes included blood and urine biochemical parameters. Both the placebo and krill oil groups showed significant improvements in the questions in the JKOM and JOA questionnaires after administration. After the intervention, krill oil group showed more improvements than placebo group in two questions regarding the pain and stiffness in knees in JKOM. Controlling for age, sex, weight, and smoking and drinking habits, krill oil significantly mitigated knee pain in sleeping (P knees (both P = 0.011) compared to placebo. Krill oil administration raised plasma EPA (P = 0.048) and EPA/AA ratio (P = 0.003). This study indicates that krill oil administration (2 g/day, 30 days) improved the subjective symptoms of knee pain in adults with mild knee pain. UMIN-CTR; ID UMIN000014413.

One-year evaluation of the effect of physical therapy for masticatory muscle pain : A randomized controlled trial

NARCIS (Netherlands)

Craane, B.; Dijkstra, P. U.; Stappaerts, K.; De Laat, A.

Physical therapy is widely used to decrease pain and restore function in patients suffering from masticatory muscle pain. Controlled studies on its efficacy are scarce. This study evaluated the 1-year effect of a 6-week physical therapy programme in a single blind, randomized, controlled trial.

Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice

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Verhaar Jan AN

2007-09-01

Full Text Available Abstract Background Regional pain in the hip in adults is a common cause of a general practitioner visit. A considerable part of patients suffer from (greater trochanteric pain syndrome or trochanteric bursitis. Local corticosteroid injections is one of the treatment options. Although clear evidence is lacking, small observational studies suggest that this treatment is effective in the short-term follow-up. So far, there are no randomised controlled trials available evaluating the efficacy of injection therapy. This study will investigate the efficacy of local corticosteroid injections in the trochanter syndrome in the general practice, using a randomised controlled trial design. The cost effectiveness of the corticosteroid injection therapy will also be assessed. Secondly, the role of co-morbidity in relation to the efficacy of local corticosteroid injections will be investigated. Methods/Design This study is a pragmatic, open label randomised trial. A total of 150 patients (age 18–80 years visiting the general practitioner with complaints suggestive of trochanteric pain syndrome will be allocated to receive local corticosteroid injections or to receive usual care. Usual care consists of analgesics as needed. The randomisation is stratified for yes or no co-morbidity of low back pain, osteoarthritis of the hip, or both. The treatment will be evaluated by means of questionnaires at several time points within one year, with the 3 month and 1 year evaluation of pain and recovery as primary outcome. Analyses of primary and secondary outcomes will be made according to the intention-to-treat principle. Direct and indirect costs will be assessed by questionnaires. The cost effectiveness will be estimated using the following ratio: CE ratio = (cost of injection therapy minus cost of usual care/(effect of injection therapy minus effect of usual care. Discussion This study design is appropriate to estimate effectiveness and cost-effectiveness of the

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

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Hooten, W Michael; Warner, David O

2015-03-01

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

Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial

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Rydén Anna

2009-09-01

Full Text Available Abstract Background A model for integrative medicine (IM adapted to Swedish primary care was previously developed. The aim of this study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain. Specific objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial. Methods Eighty patients with back/neck pain of at least two weeks duration were randomised to the two types of care. Outcome measures were standardised health related quality of life (the eight domains of SF-36 complemented by a set of exploratory "IM tailored" outcomes targeting self-rated disability, stress and well-being (0-10 scales; days in pain (0-14; and the use of analgesics and health care over the last two weeks (yes/no. Data on clinical management were derived from medical records. Outcome changes from baseline to follow-up after 16 weeks were used to explore the differences between the groups. Results Seventy-five percent (80/107 of screened patients in general practice were eligible and feasible to enrol into the trial. Eighty-two percent (36/44 of the integrative and 75% (27/36 of the conventional care group completed follow-up after 16 weeks. Most patients had back/neck pain of at least three months duration. Conventional care typically comprised advice and prescription of analgesics, occasionally complemented with sick leave or a written referral to physiotherapy. IM care generally integrated seven treatment sessions from two different types of complementary therapies with conventional care over ten weeks. The study was underpowered to detect any statistically significant differences between the groups. One SF-36 domain

A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol.

Science.gov (United States)

Slater, Rebeccah; Hartley, Caroline; Moultrie, Fiona; Adams, Eleri; Juszczak, Ed; Rogers, Richard; Norman, Jane E; Patel, Chetan; Stanbury, Kayleigh; Hoskin, Amy; Green, Gabrielle

2016-11-15

Infant pain has both immediate and long-term negative consequences, yet in clinical practice it is often undertreated. To date, few pain-relieving drugs have been tested in infants. Morphine is a potent analgesic that provides effective pain relief in adults, but there is inconclusive evidence for its effectiveness in infants. The purpose of this study is to establish whether oral morphine provides effective analgesia for procedural pain in infants. A blinded, placebo-controlled, parallel-group randomized, phase II, clinical trial will be undertaken to determine whether morphine sulphate administered orally prior to clinically-required retinopathy of prematurity (ROP) screening and heel lancing provides effective analgesia. 
156 infants between 34 and 42 weeks' gestational age who require a clinical heel lance and ROP screening on the same test occasion will be included in the trial. Infants will be randomised to receive either a single dose of morphine sulphate (100 μg/kg) or placebo. Each infant will be monitored for 48 hours and safety data will be collected during the 24 hours following drug administration. The primary outcome will be the Premature Infant Pain Profile-revised (PIPP-R) score 30 seconds after ROP screening. The co-primary outcome will be the magnitude of nociceptive-specific brain activity evoked by a clinically-required heel lance. Infant clinical stability will be assessed by comparing the number of episodes of bradycardia, tachycardia, desaturation and apnoea, and changes in respiratory support requirements in the 24-hour periods before and after the clinical intervention. In addition, drug safety will be assessed by considering the occurrence of apnoeic and hypotensive episodes requiring intervention in the 24-hour period following drug administration. This study has been published as an Accepted Protocol Summary by The Lancet .

Social Norms and Financial Incentives to Promote Employees’ Healthy Food Choices: A Randomized Controlled Trial

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Thorndike, Anne N.; Riis, Jason; Levy, Douglas E.

2016-01-01

Population-level strategies to improve healthy food choices are needed for obesity prevention. We conducted a randomized controlled trial of 2,672 employees at Massachusetts General Hospital who were regular customers of the hospital cafeteria with all items labeled green (healthy), yellow (less healthy), or red (unhealthy) to determine if social norm (peer-comparison) feedback with or without financial incentives increased employees’ healthy food choices. Participants were randomized in 2012 to three arms: 1) monthly letter with social norm feedback about healthy food purchases, comparing employee to “all” and to “healthiest” customers (feedback-only); 2) monthly letter with social norm feedback plus small financial incentive for increasing green purchases (feedback-incentive); or 3) no contact (control). The main outcome was change in proportion of green-labeled purchases at end of 3-month intervention. Post-hoc analyses examined linear trends. At baseline, the proportion of green-labeled purchases (50%) did not differ between arms. At end of the 3-month intervention, the percentage increase in green-labeled purchases was larger in the feedback-incentive arm compared to control (2.2% vs. 0.1%, P=0.03), but the two intervention arms were not different. The rate of increase in green-labeled purchases was higher in both feedback-only (P=0.04) and feedback-incentive arms (P=0.004) compared to control. At end of a 3-month wash-out, there were no differences between control and intervention arms. Social norms plus small financial incentives increased employees’ healthy food choices over the short-term. Future research will be needed to assess the impact of this relatively low-cost intervention on employees’ food choices and weight over the long-term. Trial Registration: Clinical Trials.gov NCT01604499 PMID:26827617

Ear Acupuncture versus  local anaestethic for pain relief during perineal repair - a randomised controlled trial

DEFF Research Database (Denmark)

Kindberg, Sara

2007-01-01

ACUPUNCTURE OR LOCAL ANAESTETICS FOR PAIN RELIEF DURING PERINEAL REPAIR AFTER VAGINAL DELIVERY: A RANDOMISED CONTROLLED TRIAL.   By:  Sara Kindberg. Midwife and PhD student, Sønderborg Hospital, Denmark. Objective: To evaluate acupuncture as a new method of pain relief for postpartum perineal...... as photos of the acupuncture points. Perspectives:  Basic midwifery services such as providing sufficient pain relief during perineal repair still need improvement. Clinical practice should be improved continuously and thus produce reliable evidence on different pain relief methods. Website:        http...

A new analgesic method, two-minute sciatic nerve press, for immediate pain relief: a randomized trial

Directory of Open Access Journals (Sweden)

Zhang Fenglin

2008-01-01

Full Text Available Abstract Background Current analgesics have drawbacks such as delays in acquisition, lag-times for effect, and side effects. We recently presented a preliminary report of a new analgesic method involving a two-minute sciatic nerve press, which resulted in immediate short-term relief of pain associated with dental and renal diseases. The present study investigated whether this technique was effective for pain associated with other disease types, and whether the relief was effective for up to one hour. Methods This randomized, placebo-controlled, parallel-group trial was conducted in four hospitals in Anhui Province, China. Patients with pain were sequentially recruited by participating physicians during clinic visits, and 135 patients aged 15 – 80 years were enrolled. Dental disease patients included those with acute pulpitis and periapical abscesses. Renal disease patients included those with kidney infections and/or stones. Tumor patients included those with nose, breast, stomach and liver cancers, while Emergency Room patients had various pathologies. Patients were randomly assigned to receive a "sciatic nerve press" in which pressure was applied simultaneously to the sciatic nerves at the back of both thighs, or a "placebo press" in which pressure was applied to a parallel region on the front of the thighs. Each fist applied a pressure of 11 – 20 kg for 2 minutes. Patients rated their level of pain before and after the procedure. Results The "sciatic nerve press" produced immediate relief of pain in all patient groups. Emergency patients reported a 43.5% reduction in pain (p th minutes, and the relief decreased 47% by the 60th minutes. Conclusion Two minutes of pressure on both sciatic nerves produced immediate significant short-term conduction analgesia. This technique is a convenient, safe and powerful method for the short-term treatment of clinical pain associated with a diverse range of pathologies. Trial registration Current

Improving the quality of depression and pain care in multiple sclerosis using collaborative care: The MS-care trial protocol.

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Ehde, Dawn M; Alschuler, Kevin N; Sullivan, Mark D; Molton, Ivan P; Ciol, Marcia A; Bombardier, Charles H; Curran, Mary C; Gertz, Kevin J; Wundes, Annette; Fann, Jesse R

2018-01-01

Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care, which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting. We describe a 16-week randomized controlled trial comparing the MS Care collaborative care intervention to usual care in an outpatient MS specialty center. Eligible participants with chronic pain of at least moderate intensity (≥3/10) and/or major depressive disorder are randomly assigned to MS Care or usual care. MS Care utilizes a care manager to implement and coordinate guideline-based medical and behavioral treatments with the patient, clinic providers, and pain/depression treatment experts. We will compare outcomes at post-treatment and 6-month follow up. We hypothesize that participants randomly assigned to MS Care will demonstrate significantly greater control of both pain and depression at post-treatment (primary endpoint) relative to those assigned to usual care. Secondary analyses will examine quality of care, patient satisfaction, adherence to MS care, and quality of life. Study findings will aid patients, clinicians, healthcare system leaders, and policy makers in making decisions about effective care for pain and depression in MS healthcare systems. (PCORI- IH-1304-6379; clinicaltrials.gov: NCT02137044). This trial is registered at ClinicalTrials.gov, protocol NCT02137044. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of auriculotherapy on labour pain: a randomized clinical trial.

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Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

2016-01-01

Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de

Paradoxical choice in rats: Subjective valuation and mechanism of choice.

Science.gov (United States)

Ojeda, Andrés; Murphy, Robin A; Kacelnik, Alex

2018-07-01

Decision-makers benefit from information only when they can use it to guide behavior. However, recent experiments found that pigeons and starlings value information that they cannot use. Here we show that this paradox is also present in rats, and explore the underlying decision process. Subjects chose between two options that delivered food probabilistically after a fixed delay. In one option ("info"), outcomes (food/no-food) were signaled immediately after choice, whereas in the alternative ("non-info") the outcome was uncertain until the delay lapsed. Rats sacrificed up to 20% potential rewards by preferring the info option, but reversed preference when the cost was 60%. This reversal contrasts with the results found with pigeons and starlings and may reflect species' differences worth of further investigation. Results are consistent with predictions of the Sequential Choice Model (SCM), that proposes that choices are driven by the mechanisms that control action in sequential encounters. As expected from the SCM, latencies to respond in single-option trials predicted preferences in choice trials, and latencies in choice trials were the same or shorter than in single-option trials. We argue that the congruence of results in distant vertebrates probably reflects evolved adaptations to shared fundamental challenges in nature, and that the apparently paradoxical overvaluing of information is not sub-optimal as has been claimed, even though its functional significance is not yet understood. Copyright © 2018 Elsevier B.V. All rights reserved.

Contributions of myofascial pain in diagnosis and treatment of shoulder pain. A randomized control trial

Directory of Open Access Journals (Sweden)

Gaspar-Calvo Elena

2009-07-01

Full Text Available Abstract Background Rotator cuff tendinopathy and subacromial impingement syndrome present complex patomechanical situations, frequent difficulties in clinical diagnosis and lack of effectiveness in treatment. Based on clinical experience, we have therefore considered the existence of another pathological entity as the possible origin of pain and dysfunction. The hypothesis of this study is to relate subacromial impingement syndrome (SIS with myofascial pain syndrome (MPS, since myofascial trigger points (MTrPs cause pain, functional limitation, lack of coordination and alterations in quality of movement, even prior to a tendinopathy. MTrPs can coexist with any degenerative subacromial condition. If they are not taken into consideration, they could perpetuate and aggravate the problem, hindering diagnosis and making the applied treatments ineffective. The aims and methods of this study are related with providing evidence of the relationship that may exist between this condition and MPS in the diagnosis and treatment of rotator cuff tendonitis and/or SIS. Method/design A descriptive transversal study will be made to find the correlation between the diagnosis of SIS and rotator cuff tendonitis, positive provocation test responses, the existence of active MTrPs and the results obtained with ultrasonography (US and Magnetic Renonance Imaging (MRI. A randomized double blinded clinical trial will be carried out in experimental conditions: A Protocolized treatment based on active and passive joint repositioning, stabilization exercises, stretching of the periarticular shoulder muscles and postural reeducation. B. The previously described protocolized treatment, with the addition of dry needling applied to active MTrPs with the purpose of isolating the efficacy of dry needling in treatment. Discussion This study aims to provide a new vision of shoulder pain, from the perspective of MPS. This syndrome can, by itself, account for shoulder pain and

Duloxetine in patients with central neuropathic pain caused by spinal cord injury or stroke: a randomized, double-blind, placebo-controlled trial

NARCIS (Netherlands)

Vranken, J. H.; Hollmann, M. W.; van der Vegt, M. H.; Kruis, M. R.; Heesen, M.; Vos, K.; Pijl, A. J.; Dijkgraaf, M. G. W.

2011-01-01

The mechanisms underlying central neuropathic pain are poorly understood. Pain inhibitory mechanisms including sertononergic and norepinephrine systems may be dysfunctional. In this randomized, double-blinded, placebo-controlled trial we evaluated the effects of duloxetine on pain relief

Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.

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Kelleher, Sarah A; Dorfman, Caroline S; Plumb Vilardaga, Jen C; Majestic, Catherine; Winger, Joseph; Gandhi, Vicky; Nunez, Christine; Van Denburg, Alyssa; Shelby, Rebecca A; Reed, Shelby D; Murphy, Susan; Davidian, Marie; Laber, Eric B; Kimmick, Gretchen G; Westbrook, Kelly W; Abernethy, Amy P; Somers, Tamara J

2017-06-01

Pain is common in cancer patients and results in lower quality of life, depression, poor physical functioning, financial difficulty, and decreased survival time. Behavioral pain interventions are effective and nonpharmacologic. Traditional randomized controlled trials (RCT) test interventions of fixed time and dose, which poorly represent successive treatment decisions in clinical practice. We utilize a novel approach to conduct a RCT, the sequential multiple assignment randomized trial (SMART) design, to provide comparative evidence of: 1) response to differing initial doses of a pain coping skills training (PCST) intervention and 2) intervention dose sequences adjusted based on patient response. We also examine: 3) participant characteristics moderating intervention responses and 4) cost-effectiveness and practicality. Breast cancer patients (N=327) having pain (ratings≥5) are recruited and randomly assigned to: 1) PCST-Full or 2) PCST-Brief. PCST-Full consists of 5 PCST sessions. PCST-Brief consists of one 60-min PCST session. Five weeks post-randomization, participants re-rate their pain and are re-randomized, based on intervention response, to receive additional PCST sessions, maintenance calls, or no further intervention. Participants complete measures of pain intensity, interference and catastrophizing. Novel RCT designs may provide information that can be used to optimize behavioral pain interventions to be adaptive, better meet patients' needs, reduce barriers, and match with clinical practice. This is one of the first trials to use a novel design to evaluate symptom management in cancer patients and in chronic illness; if successful, it could serve as a model for future work with a wide range of chronic illnesses. Copyright © 2016. Published by Elsevier Inc.

Nonpharmacologic Pain Management Interventions in German Nursing Homes: A Cluster Randomized Trial.

Science.gov (United States)

Kalinowski, Sonja; Budnick, Andrea; Kuhnert, Ronny; Könner, Franziska; Kissel-Kröll, Angela; Kreutz, Reinhold; Dräger, Dagmar

2015-08-01

The reported prevalence of pain among nursing home residents (NHRs) is high. Insufficient use of analgesics, the conventional pain management strategy, is often reported. Whether and to what extent nonpharmacologic therapies (NPTs) are used to manage the pain of NHRs in Germany is largely unknown. The aim of this cluster-randomized trial was to assess the NPTs provided and to enhance the application and prescription of NPTs in NHRs on an individual level. There were six nursing homes in the intervention group and six in the control group. There were 239 NHRs, aged ≥65 years, with an average Mini-Mental State Examination score of at least 18 at baseline. Pain management interventions (cluster level) included an online course for physicians and 1-day seminar for nurses. Data on NPT applied by nurses and therapeutic NPT prescribed by physicians were obtained from residents' nursing documentation. Face-to-face interviews with NHRs assessed the NPT received. At baseline, 82.6% of NHR (mean age 83 years) were affected by pain, but less than 1 in 10 received NPT. The intervention did not result in a significant increase in the NPT applied by nurses, but did significantly increase the therapeutic NPT prescribed by physicians. Residents were active in using NPT to self-manage their pain. Given the prevalence of pain in NHRs, there is a clear need to improve pain management in this population. Extended use of NPT offers a promising approach. We recommend that nurses provide residents with education on pain-management techniques to support them in taking a proactive role in managing their pain. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

The Power of Low Back Pain Trials: A Systematic Review of Power, Sample Size, and Reporting of Sample Size Calculations Over Time, in Trials Published Between 1980 and 2012.

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Froud, Robert; Rajendran, Dévan; Patel, Shilpa; Bright, Philip; Bjørkli, Tom; Eldridge, Sandra; Buchbinder, Rachelle; Underwood, Martin

2017-06-01

A systematic review of nonspecific low back pain trials published between 1980 and 2012. To explore what proportion of trials have been powered to detect different bands of effect size; whether there is evidence that sample size in low back pain trials has been increasing; what proportion of trial reports include a sample size calculation; and whether likelihood of reporting sample size calculations has increased. Clinical trials should have a sample size sufficient to detect a minimally important difference for a given power and type I error rate. An underpowered trial is one within which probability of type II error is too high. Meta-analyses do not mitigate underpowered trials. Reviewers independently abstracted data on sample size at point of analysis, whether a sample size calculation was reported, and year of publication. Descriptive analyses were used to explore ability to detect effect sizes, and regression analyses to explore the relationship between sample size, or reporting sample size calculations, and time. We included 383 trials. One-third were powered to detect a standardized mean difference of less than 0.5, and 5% were powered to detect less than 0.3. The average sample size was 153 people, which increased only slightly (∼4 people/yr) from 1980 to 2000, and declined slightly (∼4.5 people/yr) from 2005 to 2011 (P pain trials and the reporting of sample size calculations may need to be increased. It may be justifiable to power a trial to detect only large effects in the case of novel interventions. 3.

Optimising conservative management of chronic low back pain: study protocol for a randomised controlled trial.

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Simson, Katherine J; Miller, Clint T; Ford, Jon; Hahne, Andrew; Main, Luana; Rantalainen, Timo; Teo, Wei-Peng; Teychenne, Megan; Connell, David; Trudel, Guy; Zheng, Guoyan; Thickbroom, Gary; Belavy, Daniel L

2017-04-20

Lower back pain is a global health issue affecting approximately 80% of people at some stage in their life. The current literature suggests that any exercise is beneficial for reducing back pain. However, as pain is a subjective evaluation and physical deficits are evident in low back pain, using it as the sole outcome measure to evaluate superiority of an exercise protocol for low back pain treatment is insufficient. The overarching goal of the current clinical trial is to implement two common, conservative intervention approaches and examine their impact on deficits in chronic low back pain. Forty participants, 25-45 years old with chronic (>3 months), non-specific low back pain will be recruited. Participants will be randomised to receive either motor control and manual therapy (n = 20) or general strength and conditioning (n = 20) exercise treatments for 6 months. The motor control/manual therapy group will receive twelve 30-min sessions, ten in the first 3 months (one or two per week) and two in the last 3 months. The general exercise group will attend two 1-hour sessions weekly for 3 months, and one or two a week for the following 3 months. Primary outcome measures are average lumbar spine intervertebral disc T2 relaxation time and changes in thickness of the transversus abdominis muscle on a leg lift using magnetic resonance imaging (MRI). Secondary outcomes include muscle size and fat content, vertebral body fat content, intervertebral disc morphology and water diffusion measured by MRI, body composition using dual energy X-ray absorptiometry, physical function through functional tests, changes in corticospinal excitability and cortical motor representation of the spinal muscles using transcranial magnetic stimulation and self-reported measure of pain symptoms, health and disability. Outcome measures will be conducted at baseline, at the 3-month follow-up and at 6 months at the end of intervention. Pain, depressive symptomology and emotions will be

Efficacy and adverse effects of medical marijuana for chronic noncancer pain: Systematic review of randomized controlled trials.

Science.gov (United States)

Deshpande, Amol; Mailis-Gagnon, Angela; Zoheiry, Nivan; Lakha, Shehnaz Fatima

2015-08-01

To determine if medical marijuana provides pain relief for patients with chronic noncancer pain (CNCP) and to determine the therapeutic dose, adverse effects, and specific indications. In April 2014, MEDLINE and EMBASE searches were conducted using the terms chronic noncancer pain, smoked marijuana or cannabinoids, placebo and pain relief, or side effects or adverse events. An article was selected for inclusion if it evaluated the effect of smoked or vaporized cannabinoids (nonsynthetic) for CNCP; it was designed as a controlled study involving a comparison group, either concurrently or historically; and it was published in English in a peer-review journal. Outcome data on pain, function, dose, and adverse effects were collected, if available. All articles that were only available in abstract form were excluded. Synthesis A total of 6 randomized controlled trials (N = 226 patients) were included in this review; 5 of them assessed the use of medical marijuana in neuropathic pain as an adjunct to other concomitant analgesics including opioids and anticonvulsants. The 5 trials were considered to be of high quality; however, all of them had challenges with masking. Data could not be pooled owing to heterogeneity in delta-9-tetrahydrocannabinol potency by dried weight, differing frequency and duration of treatment, and variability in assessing outcomes. All experimental sessions in the studies were of short duration (maximum of 5 days) and reported statistically significant pain relief with nonserious side effects. There is evidence for the use of low-dose medical marijuana in refractory neuropathic pain in conjunction with traditional analgesics. However, trials were limited by short duration, variability in dosing and strength of delta-9-tetrahydrocannabinol, and lack of functional outcomes. Although well tolerated in the short term, the long-term effects of psychoactive and neurocognitive effects of medical marijuana remain unknown. Generalizing the use of medical

Long-term pain prevalence and health-related quality of life outcomes for patients enrolled in a ketamine versus morphine for prehospital traumatic pain randomised controlled trial.

Science.gov (United States)

Jennings, Paul A; Cameron, Peter; Bernard, Stephen; Walker, Tony; Jolley, Damien; Fitzgerald, Mark; Masci, Kevin

2014-10-01

Improved early pain control may affect the longer-term prevalence of persistent pain. In a previous randomised, controlled trial, we found that the administration of ketamine on hospital arrival decreased pain scores to a greater extent than morphine alone in patients with prehospital traumatic pain. In this follow-up study, we sought to determine the prevalence of persistent pain and whether there were differences in patients who received ketamine or morphine. This study was a long-term follow-up study of the prehospital, prospective, randomised, controlled, open-label study comparing ketamine with morphine in patients with trauma and a verbal pain score of >5 after 5 mg intravenous morphine. Patients were followed-up by telephone 6-12 months after enrollment, and a questionnaire including the SF-36 (V.2) health-related quality of life survey and the Verbal Numerical Rating Scale for pain was administered. A total of 97/135 (72%) patients were able to be followed-up 6-12 months after enrollment between July 2008 and July 2010. Overall, 44/97 (45%) participants reported persistent pain related to their injury, with 3/97 (3%) reporting persistent severe pain. The prevalence of persistent pain was the same between study groups (22/50 (44%) for the ketamine group vs 22/47 (46%) for the morphine group). There was no difference in the SF-36 scores between study arms. There is a high incidence of persistent pain after traumatic injury, even in patients with relatively minor severity of injury. Although decreased pain scores at hospital arrival are achieved with ketamine compared with morphine, this difference does not affect the prevalence of persistent pain or health-related quality of life 6 months after injury. Further larger studies are required to confirm this finding. Australian and New Zealand Clinical Trials Registry (ACTRN12607000441415). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

NARCIS (Netherlands)

Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

Are Pain-Related Fears Mediators for Reducing Disability and Pain in Patients with Complex Regional Pain Syndrome Type 1? An Explorative Analysis on Pain Exposure Physical Therapy

Science.gov (United States)

Barnhoorn, Karlijn J.; Staal, J. Bart; van Dongen, Robert T. M.; Frölke, Jan Paul M.; Klomp, Frank P.; van de Meent, Henk; Samwel, Han; Nijhuis-van der Sanden, Maria W. G.

2015-01-01

Objective To investigate whether pain-related fears are mediators for reducing disability and pain in patients with Complex Regional Pain Syndrome type 1 when treating with Pain Exposure Physical Therapy. Design An explorative secondary analysis of a randomised controlled trial. Participants Fifty-six patients with Complex Regional Pain Syndrome type 1. Interventions The experimental group received Pain Exposure Physical Therapy in a maximum of five treatment sessions; the control group received conventional treatment following the Dutch multidisciplinary guideline. Outcome measures Levels of disability, pain, and pain-related fears (fear-avoidance beliefs, pain catastrophizing, and kinesiophobia) were measured at baseline and after 3, 6, and 9 months follow-up. Results The experimental group had a significantly larger decrease in disability of 7.77 points (95% CI 1.09 to 14.45) and in pain of 1.83 points (95% CI 0.44 to 3.23) over nine months than the control group. The potential mediators pain-related fears decreased significantly in both groups, but there were no significant differences between groups, which indicated that there was no mediation. Conclusion The reduction of pain-related fears was comparable in both groups. We found no indication that pain-related fears mediate the larger reduction of disability and pain in patients with Complex Regional Pain Syndrome type 1 treated with Pain Exposure Physical Therapy compared to conventional treatment. Trial registration International Clinical Trials Registry NCT00817128 PMID:25919011

Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial

Directory of Open Access Journals (Sweden)

Hayes Loran P

2011-05-01

at 4 month follow-up to see if improvements persist. Measures of treatment adherence, pain, disability, and anxiety and depression will be assessed throughout study participation. Qualitative interviews for mentors, mentored participants, and control subjects will also be administered. Trial registration ClinicalTrials.gov NCT01118988.

Massage therapy decreases pain and perceived fatigue after long-distance Ironman triathlon: a randomised trial

OpenAIRE

Guilherme S Nunes; Paula Urio Bender; Fábio Sprada de Menezes; Igor Yamashitafuji; Valentine Zimermann Vargas; Bruna Wageck

2016-01-01

Question: Can massage therapy reduce pain and perceived fatigue in the quadriceps of athletes after a long-distance triathlon race (Ironman)? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis and blinded outcome assessors. Participants: Seventy-four triathlon athletes who completed an entire Ironman triathlon race and whose main complaint was pain in the anterior portion of the thigh. Intervention: The experimental group received massage to the quadri...

Krill Oil Improves Mild Knee Joint Pain: A Randomized Control Trial.

Directory of Open Access Journals (Sweden)

Yoshio Suzuki

Full Text Available Krill oil is an edible oil extracted from krill, a small red-colored crustacean found in the Antarctic Ocean. The administration of krill oil is reported to mitigate inflammation in patients with cardiac disease, rheumatoid arthritis, or osteoarthritis. However, the effect of krill oil on mild knee pain has not yet been determined.To assess the effect of krill oil on mild knee pain.A randomized, double-blind, parallel-group, placebo-controlled trial of fifty adults (38-85 years old with mild knee pain attending the Fukushima Orthopedic Clinic (Tochigi, Japan between September 2014 and March 2015.Participants were randomized to receive 2 g per day of either krill oil or an identical placebo for 30 days.The primary outcome was improvement in subjective symptoms of knee pain as assessed by the Japanese Knee Osteoarthritis Measure (JKOM and Japanese Orthopaedic Association score (JOA. Secondary outcomes included blood and urine biochemical parameters.Both the placebo and krill oil groups showed significant improvements in the questions in the JKOM and JOA questionnaires after administration. After the intervention, krill oil group showed more improvements than placebo group in two questions regarding the pain and stiffness in knees in JKOM. Controlling for age, sex, weight, and smoking and drinking habits, krill oil significantly mitigated knee pain in sleeping (P < 0.001, standing (P < 0.001 and the range of motion of both right and left knees (both P = 0.011 compared to placebo. Krill oil administration raised plasma EPA (P = 0.048 and EPA/AA ratio (P = 0.003.This study indicates that krill oil administration (2 g/day, 30 days improved the subjective symptoms of knee pain in adults with mild knee pain.UMIN-CTR; ID UMIN000014413.

A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol.

Science.gov (United States)

Williams, Amanda; Wiggers, John; O'Brien, Kate M; Wolfenden, Luke; Yoong, Serene; Campbell, Elizabeth; Robson, Emma; McAuley, James; Haskins, Robin; Kamper, Steven J; Williams, Christopher M

2016-02-11

Low back pain is a highly prevalent condition with a significant global burden. Management of lifestyle factors such as overweight and obesity may improve low back pain patient outcomes. Currently there are no randomised controlled trials that have been conducted to assess the effectiveness of lifestyle behavioural interventions in managing low back pain. The aim of this trial is to determine if a telephone-based lifestyle behavioural intervention is effective in reducing pain intensity in overweight or obese patients with low back pain, compared to usual care. A randomised controlled trial will be conducted with patients waiting for an outpatient consultation with an orthopaedic surgeon at a public tertiary referral hospital within New South Wales, Australia for chronic low back pain. Patients will be randomly allocated in a 1:1 ratio to receive a lifestyle behavioural intervention (intervention group) or continue with usual care (control group). After baseline data collection, patients in the intervention group will receive a clinical consultation followed by a 6-month telephone-based lifestyle behavioural intervention (10 individually tailored sessions over a 6-month period) and patients in the control group will continue with usual care. Participants will be followed for 26 weeks and asked to undertake three self-reported questionnaires at baseline (pre-randomisation), week 6 and 26 post randomisation to collect primary and secondary outcome data. The study requires a sample of 80 participants per group to detect a 1.5 point difference in pain intensity (primary outcome) 26 weeks post randomisation. The primary outcome, pain intensity, will be measured using a 0-10 numerical rating scale. The study will provide robust evidence regarding the effectiveness of a lifestyle behavioural intervention in reducing pain intensity in overweight or obese patients with low back pain and inform management of these patients. Australian New Zealand Clinical Trials Registry

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

Science.gov (United States)

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

2017-03-01

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

Oral morphine versus ibuprofen administered at home for postoperative orthopedic pain in children: a randomized controlled trial.

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Poonai, Naveen; Datoo, Natasha; Ali, Samina; Cashin, Megan; Drendel, Amy L; Zhu, Rongbo; Lepore, Natasha; Greff, Michael; Rieder, Michael; Bartley, Debra

2017-10-10

Oral morphine for postoperative pain after minor pediatric surgery, while increasingly popular, is not supported by evidence. We evaluated whether oral morphine was superior to ibuprofen for at-home management of children's postoperative pain. We conducted a randomized superiority trial comparing oral morphine (0.5 mg/kg) with ibuprofen (10 mg/kg) in children 5 to 17 years of age who had undergone minor outpatient orthopedic surgery (June 2013 to September 2016). Participants took up to 8 doses of the intervention drug every 6 hours as needed for pain at home. The primary outcome was pain, according to the Faces Pain Scale - Revised, for the first dose. Secondary outcomes included additional analgesic requirements, adverse effects, unplanned health care visits and pain scores for doses 2 to 8. We analyzed data for 77 participants in each of the morphine and ibuprofen groups. Both interventions decreased pain scores with no difference in efficacy. The median difference in pain score before and after the first dose of medication was 1 (interquartile range 0-1) for both morphine and ibuprofen ( p = 0.2). For doses 2 to 8, the median differences in pain score before and after the dose were not significantly different between groups. Significantly more participants taking morphine reported adverse effects (45/65 [69%] v. 26/67 [39%], p ibuprofen groups, respectively; p = 0.003). Morphine was not superior to ibuprofen, and both drugs decreased pain with no apparent difference in efficacy. Morphine was associated with significantly more adverse effects, which suggests that ibuprofen is a better first-line option after minor surgery. ClinicalTrials.gov, no. NCT01686802. © 2017 Canadian Medical Association or its licensors.

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

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

2017-01-01

Abstract 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 ...

A phase III randomized three-arm trial of physical therapist delivered pain coping skills training for patients with total knee arthroplasty: the KASTPain protocol

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Riddle Daniel L

2012-08-01

Full Text Available Abstract Background Approximately 20% of patients report persistent and disabling pain following total knee arthroplasty (TKA despite an apparently normally functioning prosthesis. One potential risk factor for unexplained persistent pain is high levels of pain catastrophizing. We designed a three-arm trial to determine if a pain coping skills training program, delivered prior to TKA, effectively reduces function-limiting pain following the procedure in patients with high levels of pain catastrophizing. Methods/design The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. Discussion The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. Trial Registration NCT

How Effective Is the Use of Metaphor Therapy on Reducing Psychological Symptoms and Pain Discomfort in Patients with Non-Cardiac Chest Pain: A Randomized, Controlled Trial

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Mostafa Bahremand

2016-06-01

Full Text Available Introduction: Psychological symptoms of non-cardiac chest pain (NCCP including perceptual, emotional, and behavioral problems can effect patient perception of chest pain. This study was conducted to determine the effect of metaphor therapy on mitigating depression, anxiety, stress, and pain discomfort in patients with NCCP. Materials and Methods: This randomized, controlled, trial was conducted on 28 participants, who had visited the emergency department of Kermanshah Imam Ali Heart Hospital because of experiencing NCCP during the June to September 2014. The patients were randomly assigned to metaphor therapy and control groups (n=14 for each group during a four-week period. Our data collection questionnaires included Pain Discomfort Scale (PDS and Depression, Anxiety and Stress Scale (DASS. Chi-square and MANCOVA tests were run, using SPSS version 20. Results: Twenty patients (71.4% completed the trial period until the final assessment. Our findings showed that metaphor therapy couldn’t lower depression, anxiety, stress, and pain discomfort; In fact, there was not a significant difference between the metaphor therapy and control groups regarding the aforementioned variables (P>0.05. Conclusions: Although the study results did not support the effectiveness of metaphor therapy for NCCP, further studies on the potential role of metaphor therapy in attenuating NCCP symptoms seem to be necessary.

Immediate changes in widespread pressure pain sensitivity, neck pain, and cervical range of motion after cervical or thoracic thrust manipulation in patients with bilateral chronic mechanical neck pain: a randomized clinical trial.

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Martínez-Segura, Raquel; De-la-Llave-Rincón, Ana I; Ortega-Santiago, Ricardo; Cleland, Joshua A; Fernández-de-Las-Peñas, César

2012-09-01

Randomized clinical trial. To compare the effects of cervical versus thoracic thrust manipulation in patients with bilateral chronic mechanical neck pain on pressure pain sensitivity, neck pain, and cervical range of motion (CROM). Evidence suggests that spinal interventions can stimulate descending inhibitory pain pathways. To our knowledge, no study has investigated the neurophysiological effects of thoracic thrust manipulation in individuals with bilateral chronic mechanical neck pain, including widespread changes on pressure sensitivity. Ninety patients (51% female) were randomly assigned to 1 of 3 groups: cervical thrust manipulation on the right, cervical thrust manipulation on the left, or thoracic thrust manipulation. Pressure pain thresholds (PPTs) over the C5-6 zygapophyseal joint, lateral epicondyle, and tibialis anterior muscle, neck pain (11-point numeric pain rating scale), and cervical spine range of motion (CROM) were collected at baseline and 10 minutes after the intervention by an assessor blinded to the treatment allocation of the patients. Mixed-model analyses of covariance were used to examine the effects of the treatment on each outcome variable, with group as the between-subjects variable, time and side as the within-subject variables, and gender as the covariate. The primary analysis was the group-by-time interaction. No significant interactions were found with the mixed-model analyses of covariance for PPT level (C5-6, P>.210; lateral epicondyle, P>.186; tibialis anterior muscle, P>.268), neck pain intensity (P = .923), or CROM (flexion, P = .700; extension, P = .387; lateral flexion, P>.672; rotation, P>.192) as dependent variables. All groups exhibited similar changes in PPT, neck pain, and CROM (all, P.10). The results of the current randomized clinical trial suggest that cervical and thoracic thrust manipulation induce similar changes in PPT, neck pain intensity, and CROM in individuals with bilateral chronic mechanical neck pain

The Effect of Ketamine on Posttonsillectomy Pain in Children: A Clinical Trial

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Akbar Pirzadeh

2012-01-01

Full Text Available Introduction: Tonsillectomy is one of the most common surgical operations and has such complications as pain, hemorrhage and laryngospasm. Pain management is of vital importance in order to reduce the suffering and restlessness in children having undergone tonsillectomy. Different studies differ in their findings as to the use of ketamine for postoperative analgesia. The aim of this study was to investigate the effect of peritonsillar injection of ketamine preoperatively on postoperative pain relief.  Materials and Methods: This was a randomized controlled trial (RCT on sixty 3-12-year-old children. Children were randomly assigned to the intervention and control groups. Peritonsillar injection consisted of 1 mg/kg ketamine in the intervention group and of normal saline in the control group. An injection of 1 cc was administered on each side five minutes prior to tonsillectomy. Pain assessment was performed using the self-report Oucher Scale and CHEOPS (Children's Hospital of Eastern Ontario Pain Scale and sedative state assessment was performed using the Wilson Sedation Scale. Pain, medication and complications were studied for 24 hours. Data analysis was performed using chi-squared test and t-test. Results: The ketamine group had a lower pain score compared with the control group (1.40±1.003 compared with 1.53±1.074. The average pain was less in the control group two hours after the surgery. The difference was statistically significant. There was no difference between the two groups in terms of nausea and vomiting incidence.  Conclusion: The peritonsillar injection of ketamine five minutes prior to the surgery reduces the post-tonsillectomy pain without causing any complications.

Postoperative pain after manual and mechanical glide path: a randomized clinical trial.

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Pasqualini, Damiano; Mollo, Livio; Scotti, Nicola; Cantatore, Giuseppe; Castellucci, Arnaldo; Migliaretti, Giuseppe; Berutti, Elio

2012-01-01

This prospective randomized clinical trial evaluated the incidence of postoperative pain after glide path performed with PathFile (PF) (Dentsply Maillefer, Ballaigues, Switzerland) versus stainless-steel K-file (KF). In 149 subjects, the mechanical glide path was performed with nickel-titanium (NiTi) rotary PF; in 146 subjects, the manual glide path was performed with stainless-steel KFs. Postoperative pain, analgesics consumption, and the number of days to complete pain resolution were evaluated in the following 7 days. An analysis of variance model for repeated measures was used to compare the variation of pain-scale values (P < .05). The Student's t test for continuous variables normally distributed, the nonparametric Mann-Whitney U test for the nonnormally distributed variables, and the chi-square test for dichotomous variables were used (P < .05). Despite homogeneous baseline conditions at diagnosis, tooth type, pain prevalence, and scores, the postoperative pain prevalence curves in PF group evidenced a more favorable trend in terms of time to pain resolution compared with the KF group (P = .004). The difference was also evident in the model adjusted for analgesics consumption in both groups (P = .012). The mean analgesics intake per subject was significantly higher in the KF group (3.7 ± 2.2) compared with the PF group (2 ± 1.7) (P < .001). Mean pain stop values were also significantly higher in the KF group (2.7) compared with the PF group (1.7) (P = .001). The glide path with NiTi Rotary PF leads to less postoperative pain and faster symptom resolution. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Core outcome domains for clinical trials in non-specific low back pain.

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Chiarotto, Alessandro; Deyo, Richard A; Terwee, Caroline B; Boers, Maarten; Buchbinder, Rachelle; Corbin, Terry P; Costa, Leonardo O P; Foster, Nadine E; Grotle, Margreth; Koes, Bart W; Kovacs, Francisco M; Lin, Chung-Wei Christine; Maher, Chris G; Pearson, Adam M; Peul, Wilco C; Schoene, Mark L; Turk, Dennis C; van Tulder, Maurits W; Ostelo, Raymond W

2015-06-01

Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP. An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions. A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45%. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: 'physical functioning', 'pain intensity' and 'health-related quality of life'. Consensus on 'physical functioning' and 'pain intensity' was consistent across all stakeholders, 'health-related quality of life' was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and

Feasibility randomized-controlled trial of online Acceptance and Commitment Therapy for patients with complex chronic pain in the United Kingdom.

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Scott, W; Chilcot, J; Guildford, B; Daly-Eichenhardt, A; McCracken, L M

2018-04-28

Acceptance and Commitment Therapy (ACT) has growing support for chronic pain. However, more accessible treatment delivery is needed. This study evaluated the feasibility of online ACT for patients with complex chronic pain in the United Kingdom to determine whether a larger trial is justified. Participants with chronic pain and clinically meaningful disability and distress were randomly assigned to ACT online plus specialty medical pain management, or specialty medical management alone. Participants completed questionnaires at baseline, and 3- and 9-month post-randomization. Primary feasibility outcomes included recruitment, retention and treatment completion rates. Secondary outcomes were between-groups effects on treatment outcomes and psychological flexibility. Of 139 potential participants, 63 were eligible and randomized (45% recruitment rate). Retention rates were 76-78% for follow-up assessments. Sixty-one per cent of ACT online participants completed treatment. ACT online was less often completed by employed (44%) compared to unemployed (80%) participants. Fifty-six per cent of ACT online participants rated themselves as 'much improved' or better on a global impression of change rating, compared to only 20 per cent of control participants. Three-month effects favouring ACT online were small for functioning, medication and healthcare use, committed action and decentring, medium for mood, and large for acceptance. Small-to-medium effects were maintained for functioning, healthcare use and committed action at 9 months. Online ACT for patients with chronic pain in the United Kingdom appears feasible to study in a larger efficacy trial. Some adjustments to treatment and trial procedures are warranted, particularly to enhance engagement among employed participants. This study supports the feasibility of online Acceptance and Commitment Therapy for chronic pain in the United Kingdom and a larger efficacy trial. Refinements to treatment delivery, particularly to

Altering Knee Abduction Angular Impulse Using Wedged Insoles for Treatment of Patellofemoral Pain in Runners: A Six-Week Randomized Controlled Trial.

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Ryan T Lewinson

Full Text Available Determine if a change in internal knee abduction angular impulse (KAAI is related to pain reduction for runners with patellofemoral pain (PFP by comparing lateral and medial wedge insole interventions, and increased KAAI and decreased KAAI groups.Randomized controlled clinical trial (ClinicalTrials.gov ID# NCT01332110.Biomechanics laboratory and community.Thirty-six runners with physician-diagnosed PFP enrolled in the trial, and 27 were analyzed.Runners with PFP were randomly assigned to either an experimental 3 mm lateral wedge or control 6 mm medial wedge group. Participants completed a biomechanical gait analysis to quantify KAAIs with their assigned insole, and then used their assigned insole for six-weeks during their regular runs. Usual pain during running was measured at baseline and at six-week follow-up using a visual analog scale. Statistical tests were performed to identify differences between wedge types, differences between biomechanical response types (i.e. increase or decrease KAAI, as well as predictors of pain reduction.Percent change in KAAI relative to neutral, and % change in pain over six weeks.Clinically meaningful reductions in pain (>33% were measured for both footwear groups; however, no significant differences between footwear groups were found (p = 0.697. When participants were regrouped based on KAAI change (i.e., increase or decrease, again, no significant differences in pain reduction were noted (p = 0.146. Interestingly, when evaluating absolute change in KAAI, a significant relationship between absolute % change in KAAI and % pain reduction was observed (R2 = 0.21; p = 0.030, after adjusting for baseline pain levels.The greater the absolute % change in KAAI during running, the greater the % reduction in pain over six weeks, regardless of wedge type, and whether KAAIs increased or decreased. Lateral and medial wedge insoles were similar in effectiveness for treatment of PFP.Altering KAAI should be a focus of future

Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial

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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

Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: Study protocol for a randomized controlled trial

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Cohen Marc

2011-11-01

Full Text Available Abstract Background Pain is the most common reason that patients present to an emergency department (ED and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED. The current study aims to assess the efficacy of acupuncture for providing effective analgesia to patients presenting with acute low back pain, migraine and ankle sprain at the EDs of four hospitals in Melbourne, Australia. Method The study is a multi-site, randomized, assessor-blinded, controlled trial of acupuncture analgesia in patients who present to an ED with low back pain, migraine or ankle sprain. Patients will be block randomized to receive either acupuncture alone, acupuncture as an adjunct to pharmacotherapy or pharmacotherapy alone. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA. Pain after one hour, measured using a visual analogue scale (VAS, is the primary outcome. Secondary outcomes measures include the following instruments; the Oswestry low back pain disability questionnaire, 24-hour Migraine Quality of Life questionnaire and Patient's Global Assessment of Ankle Injury Scale. These measures will be recorded at baseline, 1 hour after intervention, each hour until discharge and 48 ± 12 hours of ED discharge. Data will also be collected on the safety and acceptability of acupuncture and health resource utilization. Discussion The results of this study will determine if acupuncture, alone or as an adjunct to pharmacotherapy provides effective, safe and acceptable pain relief for patients presenting to EDs with acute back pain, migraine or ankle sprain. The results will also identify the impact that acupuncture treatment may have upon health resource utilisation in the ED setting. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12609000989246

A Randomized, Double-Blind, Placebo-Controlled Trial of Eszopiclone for the Treatment of Insomnia in Patients with Chronic Low Back Pain

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Goforth, Harold W.; Preud'homme, Xavier A.; Krystal, Andrew D.

2014-01-01

Study Objectives: Insomnia, which is very common in patients with chronic low back pain (LBP), has long been viewed as a pain symptom that did not merit specific treatment. Recent data suggest that adding insomnia therapy to pain-targeted treatment should improve outcome; however, this has not been empirically tested in LBP or in any pain condition treated with a standardized pain medication regimen. We sought to test the hypothesis that adding insomnia therapy to pain-targeted treatment might improve sleep and pain in LBP. Design: Double-blind, placebo-controlled, parallel-group, 1-mo trial. Setting: Duke University Medical Center Outpatient Sleep Clinic. Patients: Fifty-two adult volunteers with LBP of at least 3 mo duration who met diagnostic criteria for insomnia (mean age: 42.5 y; 63% females). Interventions: Subjects were randomized to eszopiclone (ESZ) 3 mg plus naproxen 500 mg BID or matching placebo plus naproxen 500 mg twice a day. Measurements and Results: ESZ significantly improved total sleep time (mean increase: ESZ, 95 min; placebo, 9 min) (primary outcome) and nearly all sleep measures as well as visual analog scale pain (mean decrease: ESZ, 17 mm; placebo, 2 mm) (primary pain outcome), and depression (mean Hamilton Depression Rating Scale improvement ESZ, 3.8; placebo, 0.4) compared with placebo. Changes in pain ratings were significantly correlated with changes in sleep. Conclusions: The addition of insomnia-specific therapy to a standardized naproxen pain regimen significantly improves sleep, pain, and depression in patients with chronic low back pain (LBP). The findings indicate the importance of administering both sleep and pain-directed therapies to patients with LBP in clinical practice and provide strong evidence that improving sleep disturbance may improve pain. Trial Registration: clinicaltrials.gov identifier: NCT00365976 Citation: Goforth HW, Preud'homme XA, Krystal AD. A randomized, double-blind, placebo-controlled trial of eszopiclone

Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach

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Evans Roni L

2010-03-01

Full Text Available Abstract Background Low back pain (LBP is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM and conventional therapies, while also incorporating patient choice, has yet to be tested for chronic LBP. The primary aim of this study is to determine the relative clinical effectiveness of 1 monodisciplinary chiropractic care and 2 multidisciplinary integrative care in 200 adults with non-acute LBP, in both the short-term (after 12 weeks and long-term (after 52 weeks. The primary outcome measure is patient-rated back pain. Secondary aims compare the treatment approaches in terms of frequency of symptoms, low back disability, fear avoidance, self-efficacy, general health status, improvement, satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods, and cost-effectiveness and cost utility will be assessed. Methods and Design This paper describes the design of a randomized clinical trial (RCT, with cost-effectiveness and qualitative studies conducted alongside the RCT. Two hundred participants ages 18 and older are being recruited and randomized to one of two 12-week treatment interventions. Patient-rated outcome measures are collected via self-report questionnaires at baseline, and at 4, 12, 26, and 52 weeks post-randomization. Objective outcome measures are assessed at baseline and 12 weeks by examiners blinded to treatment assignment. Health care cost data is collected by self-report questionnaires and treatment records during the intervention phase and by monthly phone interviews thereafter. Qualitative interviews

Lumiracoxib for acute postoperative dental pain: a systematic review of randomized clinical trials

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Ricardo Carvalho Lopes Silva

Full Text Available CONTEXT AND OBJECTIVE: Lumiracoxib is an anti-inflammatory drug that has been used to treat acute dental pain, mainly in postsurgical settings, in which the greatest levels of pain and discomfort are experienced during the first 24 hours. This study aimed to assess the efficacy and safety of lumiracoxib for treating acute postsurgical dental pain. DESIGN AND SETTING: Systematic review developed at the Brazilian Cochrane Centre, Universidade Federal de São Paulo. METHODS: An electronic search was conducted in the PubMed, Cochrane Library, Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde, SciELO (Scientific Electronic Library Online and Embase databases. A manual search was also performed. Only randomized controlled trials were included, and these were selected and assessed by two researchers with regard to the risk of bias. RESULTS: Three clinical trials with 921 participants were included. Lumiracoxib 400 mg produced onset of analgesia in a shorter time than shown by lumiracoxib 100 mg, celecoxib 200 mg and ibuprofen 400 mg. There was no difference between lumiracoxib 400 mg and rofecoxib 50 mg. In two studies, the mean time taken to attain onset of analgesia for the placebo was not estimated because the number of participants who reached onset was too small. CONCLUSION: There is evidence with a moderate risk of bias that recommends the use of lumiracoxib for acute postoperative dental pain. However, the adverse effects are not completely known. Given that lumiracoxib is currently available in only three countries, further studies are likely to be rare and discouraged.

A Randomized Controlled Trial Evaluating the Effects of Diosmin in the Treatment of Radicular Pain

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Yinhe Wang

2017-01-01

Full Text Available Diosmin has been widely used to treat patients with vascular pain for its potent anti-inflammatory and analgesic effects. To evaluate the therapeutic effects of Diosmin in the treatment of radicular pain, we conducted an investigator-initiated, randomized, active-controlled noninferiority trial between January 1, 2009, and December 1, 2010. Diosmin (50 mg/kg/day was orally administered to treat the radicular pain in 150 patients for one month. Another 150 patients with the same symptom were given 20% 250 ml mannitol (1 g/kg/day for 7 days and dexamethasone (10 mg/day for 3 days intravenously guttae. Short-term relief and long-term relief were measured. Secondary outcomes include improvement in functional and psychological status, return to work, and reduction in anti-inflammatory analgesic drugs intake. Patients treated with oral Diosmin achieved reduction in radicular pain. The total satisfaction rate of Diosmin group was 84.7% [95% confidence interval (CI: 77.9%, 90.0%], and the complete satisfaction rate was 50.7% (95% CI: 42.4%, 58.9%. No statistically significant difference was found between the Diosmin group and the active-control group regarding patient satisfaction. No adverse effects were found during the study period. Our study suggests that clinical application of Diosmin with a dose of 50 mg/kg/day might reduce the radicular pain. This trial is registered with ISRCTN97157037.

Hydrotherapy for the Treatment of Pain in People with Multiple Sclerosis: A Randomized Controlled Trial

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Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A.; Lara-Palomo, Inmaculada; Saavedra-Hernández, Manuel; Arroyo-Morales, Manuel; Moreno-Lorenzo, Carmen

2011-01-01

Background. Multiple sclerosis (MS) is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients. Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients. Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-we...

Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I - A randomized trial

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Kemler, MA; Reulen, JPH; Barendse, GAM; van Kleef, M; de Vet, HCW; van den Wildenberg, FAJM

Background: A randomized trial was performed to assess the effect of spinal cord stimulation (SCS) on detection and pain thresholds for pressure, warmth, and cold and on the extent of mechanical hyperalgesia in patients with chronic complex regional pain syndrome type I. Methods: Fifty-four chronic

Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial

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de Bie Rob A

2010-06-01

Full Text Available Abstract Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. Methods/Design This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants

Efficacy of a modern neuroscience approach versus usual care evidence-based physiotherapy on pain, disability and brain characteristics in chronic spinal pain patients: protocol of a randomized clinical trial

Science.gov (United States)

2014-01-01

Background Among the multiple conservative modalities, physiotherapy is a commonly utilized treatment modality in managing chronic non-specific spinal pain. Despite the scientific progresses with regard to pain and motor control neuroscience, treatment of chronic spinal pain (CSP) often tends to stick to a peripheral biomechanical model, without targeting brain mechanisms. With a view to enhance clinical efficacy of existing physiotherapeutic treatments for CSP, the development of clinical strategies targeted at ‘training the brain’ is to be pursued. Promising proof-of-principle results have been reported for the effectiveness of a modern neuroscience approach to CSP when compared to usual care, but confirmation is required in a larger, multi-center trial with appropriate evidence-based control intervention and long-term follow-up. The aim of this study is to assess the effectiveness of a modern neuroscience approach, compared to usual care evidence-based physiotherapy, for reducing pain and improving functioning in patients with CSP. A secondary objective entails examining the effectiveness of the modern neuroscience approach versus usual care physiotherapy for normalizing brain gray matter in patients with CSP. Methods/Design The study is a multi-center, triple-blind, two-arm (1:1) randomized clinical trial with 1-year follow-up. 120 CSP patients will be randomly allocated to either the experimental (receiving pain neuroscience education followed by cognition-targeted motor control training) or the control group (receiving usual care physiotherapy), each comprising of 3 months treatment. The main outcome measures are pain (including symptoms and indices of central sensitization) and self-reported disability. Secondary outcome measures include brain gray matter structure, motor control, muscle properties, and psychosocial correlates. Clinical assessment and brain imaging will be performed at baseline, post-treatment and at 1-year follow-up. Web

Rational pain management in complex regional pain syndrome 1 (CRPS 1)--a network meta-analysis.

Science.gov (United States)

Wertli, Maria M; Kessels, Alphons G H; Perez, Roberto S G M; Bachmann, Lucas M; Brunner, Florian

2014-09-01

Guidelines for complex regional pain syndrome (CRPS) 1 advocate several substance classes to reduce pain and support physical rehabilitation, but guidance about which agent should be prioritized when designing a therapeutic regimen is not provided. Using a network meta-analytic approach, we examined the efficacy of all agent classes investigated in randomized clinical trials of CRPS 1 and provide a rank order of various substances stratified by length of illness duration. In this study a network meta-analysis was conducted. The participants of this study were patients with CRPS 1. Searches in electronic, previous systematic reviews, conference abstracts, book chapters, and the reference lists of relevant articles were performed. Eligible studies were randomized controlled trials comparing at least one analgesic agent with placebo or with another analgesic and reporting efficacy in reducing pain. Summary efficacy stratified by symptom duration and length of follow-up was computed across all substance classes. Two authors independently extracted data. In total, 16 studies were included in the analysis. Bisphosphonates appear to be the treatment of choice in early stages of CRPS 1. The effects of calcitonin surpass that of bisphosphonates and other substances as a short-term medication in more chronic stages of the illness. While most medications showed some efficacy on short-term follow-up, only bisphosphonates, NMDA analogs, and vasodilators showed better long-term pain reduction than placebo. For some drug classes, only a few studies were available and many studies included a small group of patients. Insufficient data were available to analyze efficacy on disability. This network meta-analysis indicates that a rational pharmacological treatment strategy of pain management should consider bisphosphonates in early CRPS 1 and a short-term course of calcitonin in later stages. While most medications showed some efficacy on short-term follow-up, only bisphosphonates

A randomized controlled trial of brief Somatic Experiencing for chronic low back pain and comorbid post-traumatic stress disorder symptoms

DEFF Research Database (Denmark)

Andersen, Tonny Elmose; Lahav, Yael; Ellegaard, Hanne

2017-01-01

Background: It is well documented that comorbid post-traumatic stress disorder (PTSD) in chronic pain is associated with a more severe symptom profile with respect to pain, disability and psychological distress. However, very few intervention studies exist targeting both PTSD and pain. The current...... study is the first randomized controlled trial evaluating the effect of the body-oriented trauma approach of Somatic Experiencing (SE) for comorbid PTSD and low back pain. Although the method is well recognized by clinicians and widely used, SE still needs to be tested in a randomized clinical trial...... in comparison with an active control group. Objective: The aim of the current study was to compare the effect of an SE intervention in addition to treatment-as-usual (TAU) for patients with chronic low back pain and comorbid PTSD compared to TAU alone. Method: The study was a two-group randomized controlled...

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

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

Science.gov (United States)

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs

Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial

NARCIS (Netherlands)

Eadie, J.; van de Water, A.T.; Lonsdale, C.; Tully, M.A.; van Mechelen, W.; Boreham, C.A.; Daly, L.; McDonough, S.M.; Hurley, D.A.

2013-01-01

Objective: To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks). Design: Randomized controlled trial with evaluations at baseline, 3 months, and 6 months. Setting: Outpatient

Randomized-controlled trial of esomeprazole in functional dyspepsia patients with epigastric pain or burning

DEFF Research Database (Denmark)

Talley, N J; Vakil, N; Lauritsen, K

2007-01-01

BACKGROUND: Early identification of true responders to acid suppression in functional dyspepsia patients with symptoms of epigastric pain or burning may enable clinicians to optimally tailor treatment. AIM: To evaluate whether a 1-w acid suppression trial is useful for identifying true responders...

A Randomized Double-Blind Placebo-Controlled Trial of Lactobacillus reuteri for Chronic Functional Abdominal Pain in Children

OpenAIRE

Kambiz Eftekhari; Zahra Vahedi; Mojtaba Kamali Aghdam; Diana Noemi Diaz

2015-01-01

Background: Functional abdominal pain (FAP) is one of the most common diseases, and large percentages of children suffer from it. Objectives: The purpose of the study was to evaluate the effect of Lactobacillus reuteri in treatment of children with functional abdominal pain. Patients and Methods: This study was a randomized double-blind placebo-controlled trial. Children aged 4 to ...

Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design

Directory of Open Access Journals (Sweden)

Hinman Rana S

2012-09-01

Full Text Available Abstract Background Chronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause. Acupuncture is a popular form of complementary and alternative medicine for treating pain and dysfunction associated with musculoskeletal conditions. This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain. Methods/Design Two hundred and eighty two people aged over 50 years with chronic knee pain have been recruited from metropolitan Melbourne and regional Victoria, Australia. Participants originally consented to participate in a longitudinal natural history study but were then covertly randomised into one of four treatment groups. One group continued as originally consented (ie natural history group and received no acupuncture treatment. The other three were treatment groups: i laser acupuncture, ii sham laser or, iii needle acupuncture. Acupuncture treatments used a combined Western and Traditional Chinese Medicine style, were delivered by general practitioners and comprised 8–12 visits over 12 weeks. Follow-up is currently ongoing. The primary outcomes are pain measured by an 11-point numeric rating scale (NRS and self-reported physical function measured by the Western Ontario and McMaster (WOMAC Universities Osteoarthritis Index subscale at the completion of treatment at 12 weeks. Secondary outcomes include quality of life, global rating of change scores and additional measures of pain (other NRS and WOMAC subscale and physical function (NRS. Additional parameters include a range of psychosocial measures in order to evaluate potential relationships with acupuncture treatment outcomes. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12�

A systematic review of randomized controlled trials on exercise parameters in the treatment of patellofemoral pain: what works?

Directory of Open Access Journals (Sweden)

Kumar S

2011-10-01

Full Text Available Daniel Harvie, Timothy O'Leary, Saravana Kumar International Centre for Allied Health Evidence (iCAHE, City East Campus, University of South Australia, Adelaide, Australia Purpose: There is research evidence which supports the effectiveness of exercise in reducing pain and increasing function in patients with patellofemoral pain syndrome. However, what is unclear are the parameters underpinning this intervention. This has led to uncertainty when operationalizing exercises for patients with patellofemoral pain syndrome in clinical practice. The aim of this review was to evaluate the parameters of exercise programs reported in primary research, to provide clinicians with evidence-based recommendations for exercise prescription for patellofemoral pain. Methods: A systematic review of randomized controlled trials was undertaken. Only trials that identified exercise to be effective in treating patellofemoral pain were included. Appropriate databases and reference lists were searched using established keywords. Data relating to common exercise parameters such as the type of exercise, length, and frequency of intervention, intensity, repetitions, sets, and specific technique were extracted, along with details of co-interventions that may have been used. Results: A total of ten randomized controlled trials were included in this review and from these trials 14 interventions arms were evaluated. All 14 interventions focused on active exercises, all but two of which also included a passive stretching component. The current body of evidence demonstrates positive results with exercise interventions such as knee extension, squats, stationary cycling, static quadriceps, active straight leg raise, leg press, and step-up and down exercises for patients with patellofemoral pain syndrome. A progressive regime of daily exercises of two to four sets of ten or more repetitions over an intervention period of 6 weeks or more, combined with exercises to address

Effects on musculoskeletal pain, work ability and sickness absence in a 1-year randomised controlled trial among cleaners

DEFF Research Database (Denmark)

Jørgensen, Marie B.; Faber, Anne; Hansen, Jørgen V.

2011-01-01

Only a few workplace initiatives among cleaners have been reported, even though they constitute a job group in great need of health promotion. The purpose of this trial was to evaluate the effect of either physical coordination training or cognitive behavioural training on musculoskeletal pain......, work ability and sickness absence among cleaners. A cluster-randomised controlled trial was conducted among 294 female cleaners allocated to either physical coordination training (PCT), cognitive behavioural training (CBTr) or a reference group (REF). Questionnaires about musculoskeletal pain and work...... intervention appeared effective for reducing chronic neck/shoulder pain among the female cleaners. It is recommended that future interventions among similar high-risk job groups focus on the implementation aspects of the interventions to maximise outcomes more distal from the intervention such as work ability...

Effects of Functional Fascial Taping on pain and function in patients with non-specific low back pain: a pilot randomized controlled trial.

Science.gov (United States)

Chen, Shu-Mei; Alexander, Ron; Lo, Sing Kai; Cook, Jill

2012-10-01

To compare the short-term and medium-term effect of Functional Fascial Taping to placebo taping on pain and function in people with non-specific low back pain. A pilot randomized controlled trial with a 2-week intervention, and 2-, 6- and 12-week follow-up. Individuals with non-specific low back pain recruited from local communities. Forty-three participants with non-specific low back pain for more than 6 weeks were randomized into either Functional Fascial Taping group (n = 21) or placebo group (n = 22). The intervention group was treated with Functional Fascial Taping while the control group was treated with placebo taping. Both groups received four treatments over 2 weeks. Worst and average pain and function were assessed at baseline, after the 2-week intervention, and at 6 and 12 weeks follow-up. The Functional Fascial Taping group demonstrated significantly greater reduction in worst pain compared to placebo group after the 2-week intervention (P = 0.02, effect size = 0.74; 95% confidence interval 0.11-1.34). A higher proportion of participants in Functional Fascial Taping group attained the minimal clinically important difference in worst pain (P = 0.007) and function (P = 0.007) than those in placebo group after the 2-week intervention. There were no significant differences in either group's disability rating or clinically important difference in average pain at any time. Functional Fascial Taping reduced worst pain in patients with non-acute non-specific low back pain during the treatment phase. No medium-term differences in pain or function were observed.

Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial.

Science.gov (United States)

Yang, Mingxiao; Feng, Yue; Pei, Hong; Deng, Shufang; Wang, Minyu; Xiao, Xianjun; Zheng, Hui; Lai, Zhenhong; Chen, Jiao; Li, Xiang; He, Xiaoguo; Liang, Fanrong

2014-10-29

Low back pain is a common, disabling musculoskeletal disorder in both developing and developed countries. Although often recommended, the potential efficacy of massage therapy in general, and Chinese massage (tuina) in particular, for relief of chronic low back pain (CLBP) has not been fully established due to inadequate sample sizes, low methodological quality, and subclinical dosing regimens of trials to date. Thus, the purpose of this randomized controlled trial (RCT) is to evaluate the comparative effectiveness of tuina massage therapy versus conventional analgesics for CLBP. The present study is a single center, two-arm, open-label RCT. A total of 150 eligible CLBP patients will be randomly assigned to either a tuina treatment group or a conventional drug control group in a 1:1 ratio. Patients in the tuina group receive a 20 minutes, 4-step treatment protocol which includes both structural and relaxation massage, administered in 20 sessions over a period of 4 weeks. Patients in the conventional drug control group are instructed to take a specific daily dose of ibuprofen. The primary outcome measure is the change from baseline back pain and function, measured by Roland-Morris Disability Questionnaire, at two months. Secondary outcome measures include the visual analogue scale, Japanese orthopedic association score (JOAS), and McGill pain questionnaire. The design and methodological rigor of this trial will allow for collection of valuable data to evaluate the efficacy of a specific tuina protocol for treating CLBP. This trial will therefore contribute to providing a solid foundation for clinical treatment of CLBP, as well as future research in massage therapy. This trial was registered with ClinicalTrials.gov of the National Institute of Health on 22 October 2013 (http://NCT01973010).

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

Transcutaneous electrical nerve stimulation (TENS) for pain management in labour

Science.gov (United States)

Dowswell, Therese; Bedwell, Carol; Lavender, Tina; Neilson, James P

2014-01-01

Background Transcutaneous nerve stimulation (TENS) has been proposed as a means of reducing pain in labour. The TENS unit emits low-voltage electrical impulses which vary in frequency and intensity. During labour, TENS electrodes are generally placed on the lower back, although TENS may be used to stimulate acupuncture points or other parts of the body. The physiological mechanisms whereby TENS relieves pain are uncertain. TENS machines are frequently operated by women, which may increase a sense of control in labour. Objectives To assess the effects of TENS on pain in labour. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 April 2011) and reference lists of retrieved papers. Selection criteria Randomised controlled trials comparing women receiving TENS for pain management in labour versus routine care, alternative non-pharmacological methods of pain relief, or placebo devices. We included all types of TENS machines. Data collection and analysis Two review authors assessed for inclusion all trials identified by the search strategy, carried out data extraction and assessed risk of bias. We have recorded reasons for excluding studies. Main results Seventeen trials with 1466 women contribute data to the review. Thirteen examined TENS applied to the back, two to acupuncture points, and two to the cranium. Overall, there was little difference in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (average risk ratio 0.41, 95% confidence interval 0.31 to 0.54; measured in two studies). The majority of women using TENS said they would be willing to use it again in a future labour. Where TENS was used as an adjunct to epidural analgesia there was no evidence that it reduced pain. There was no consistent evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and babies. No

Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial.

Science.gov (United States)

Seo, Byung-Kwan; Lee, Jun-Hwan; Sung, Won-Suk; Song, Eun-Mo; Jo, Dae-Jean

2013-01-14

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. 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. The results from this study will provide clinical evidence on the efficacy and safety of bee

Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-Related Pain: The EQUIMETH2 Trial (Methadone for Cancer-Related Pain).

Science.gov (United States)

Poulain, Philippe; Berleur, Marie-Pierre; Lefki, Shimsi; Lefebvre, Danièle; Chvetzoff, Gisèle; Serra, Eric; Tremellat, Fibra; Derniaux, Alain; Filbet, Marilène

2016-11-01

In the European Association for Palliative Care recommendations for cancer pain management, there was no consensus regarding the indications, titration, or monitoring of methadone. This national, randomized, multicenter trial aimed to compare two methadone titration methods (stop-and-go vs. progressive) in patients with cancer-related pain who were inadequately relieved by or intolerant to Level 3 opioids. The primary end point was the rate of success/failure at Day 4, defined as pain relief (reduction of at least two points on the visual scale and a pain score methods were considered equally easy to perform by nearly 60% of the clinicians. Methadone is an effective and sustainable second-line alternative opioid for the treatment of cancer-related pain. The methods of titration are comparable in terms of efficacy, safety, and ease of use. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial

Directory of Open Access Journals (Sweden)

Schulz Craig A

2011-03-01

Full Text Available Abstract Background Back-related leg pain (BRLP is a common variation of low back pain (LBP, with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP. In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care. Methods/Design This study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT. A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122 and Quad Cities area in Iowa and Illinois (n = 70 to the research clinics at WHCCS and PCCR, respectively. It compares two interventions: chiropractic spinal manipulative therapy (SMT plus home exercise program (HEP to HEP alone (minimal intervention comparison for patients with subacute or chronic back-related leg pain. Discussion Back-related leg pain (BRLP is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP. This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important patient-oriented and objective biomechanical outcome measures. Trial Registration ClinicalTrials.gov NCT00494065

Impact of pregabalin on the occurrence of postthoracotomy pain syndrome: a randomized trial.

Science.gov (United States)

Brulotte, Véronique; Ruel, Monique M; Lafontaine, Edwin; Chouinard, Philippe; Girard, François

2015-01-01

Postthoracotomy pain syndrome (PTPS) is a frequent cause of chronic postoperative pain. Pregabalin might reduce the incidence of chronic postoperative pain. The goal of this study was to evaluate the impact of perioperative pregabalin on the occurrence of PTPS, defined as any surgical site pain 3 months after surgery. We conducted a randomized, placebo-controlled, double-blind trial in patients undergoing elective thoracotomy. Patients received either pregabalin 150 mg orally twice a day initiated 1 hour before thoracotomy and continued until 4 days after thoracotomy (10 doses total) or a placebo using the same protocol. All patients received preincision thoracic epidural analgesia. Postthoracotomy pain syndrome was evaluated using the Brief Pain Inventory questionnaire through a telephone interview. Secondary outcomes included evaluation of neuropathic characteristics through the Leeds Assessment of Neuropathic Symptoms and Signs questionnaire, analgesic use 3 months after surgery, and evaluation of acute postoperative pain and opioid consumption. One hundred fourteen patients were randomized, and 99 patients completed the study (placebo, n = 49; pregabalin, n = 50). Postthoracotomy pain syndrome occurred in 49 (49.5%) of 99 patients and more frequently in the pregabalin group (31/50 [62%] vs 18/49 [37%] in the placebo group, P = 0.01). However, among patients with PTPS, those in the pregabalin group required significantly less analgesics, reported less moderate to severe average pain, and presented significantly less neuropathic characteristics than patients in the placebo group 3 months after surgery. Pregabalin did not reduce the incidence of PTPS in this study. Future research on PTPS should focus on the impact of regional analgesia on central sensitization.

Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: A Randomized Controlled Trial.

Science.gov (United States)

Meissner, Karin; Schweizer-Arau, Annemarie; Limmer, Anna; Preibisch, Christine; Popovici, Roxana M; Lange, Isabel; de Oriol, Barbara; Beissner, Florian

2016-11-01

To evaluate whether psychotherapy with somatosensory stimulation is effective for the treatment of pain and quality of life in patients with endometriosis-related pain. Patients with a history of endometriosis and chronic pelvic pain were randomized to either psychotherapy with somatosensory stimulation (ie, different techniques of acupuncture point stimulation) or wait-list control for 3 months, after which all patients were treated. The primary outcome was brain connectivity assessed by functional magnetic resonance imaging. Prespecified secondary outcomes included pain on 11-point numeric rating scales (maximal and average global pain, pelvic pain, dyschezia, and dyspareunia) and physical and mental quality of life. A sample size of 30 per group was planned to compare outcomes in the treatment group and the wait-list control group. From March 2010 through March 2012, 67 women (mean age 35.6 years) were randomly allocated to intervention (n=35) or wait-list control (n=32). In comparison with wait-list controls, treated patients showed improvements after 3 months in maximal global pain (mean group difference -2.1, 95% confidence interval [CI] -3.4 to -0.8; P=.002), average global pain (-2.5, 95% CI -3.5 to -1.4; P<.001), pelvic pain (-1.4, 95% CI -2.7 to -0.1; P=.036), dyschezia (-3.5, 95% CI -5.8 to -1.3; P=.003), physical quality of life (3.8, 95% CI 0.5-7.1, P=.026), and mental quality of life (5.9, 95% CI 0.6-11.3; P=.031); dyspareunia improved nonsignificantly (-1.8, 95% CI -4.4 to 0.7; P=.150). Improvements in the intervention group remained stable at 6 and 24 months, and control patients showed comparable symptom relief after delayed intervention. Psychotherapy with somatosensory stimulation reduced global pain, pelvic pain, and dyschezia and improved quality of life in patients with endometriosis. After 6 and 24 months, when all patients were treated, both groups showed stable improvements. ClinicalTrials.gov, https://clinicaltrials.gov, NCT01321840.

Effects of a Tailored Positive Psychology Intervention on Well-Being and Pain in Individuals With Chronic Pain and a Physical Disability: A Feasibility Trial.

Science.gov (United States)

Müller, Rachel; Gertz, Kevin J; Molton, Ivan R; Terrill, Alexandra L; Bombardier, Charles H; Ehde, Dawn M; Jensen, Mark P

2016-01-01

To determine the feasibility, acceptability, and efficacy of a computer-based positive psychology intervention in individuals with a physical disability and chronic pain. Individuals with spinal cord injury, multiple sclerosis, neuromuscular disease, or postpolio syndrome and chronic pain were randomly assigned to a positive psychology or a control condition. Participants in the intervention group were instructed to practice 4 personalized positive psychology exercises. Participants in the control group were instructed to write about life details for 8 weeks. Participants completed online well-being and pain-related questionnaires at baseline, posttreatment, and at the 2.5-month follow-up, and rated treatment satisfaction at posttreatment. Ninety-six participants were randomized and 68 (70%) completed follow-up assessments. Participants in the positive psychology intervention group reported significant pretreatment to posttreatment improvements in pain intensity, pain control, pain catastrophizing, pain interference, life satisfaction, positive affect, and depression. Improvements in life satisfaction, depression, pain intensity, pain interference, and pain control were maintained to the 2.5-month follow-up. Participants in the control group reported significant pretreatment to posttreatment improvements in life satisfaction, and pretreatment to follow-up improvements in pain intensity and pain control. Significant between-group differences, favoring the treatment group, emerged for pretreatment to posttreatment improvements in pain intensity and pain control. Participants were similarly satisfied with both treatments. The results support the feasibility, acceptability, and potential efficacy of a computer-based positive psychology intervention for improving well-being and pain-related outcomes in individuals with physical disabilities and chronic pain, and indicate that a full trial of the intervention is warranted.

Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life.

Science.gov (United States)

Lambeek, Ludeke C; van Mechelen, Willem; Knol, Dirk L; Loisel, Patrick; Anema, Johannes R

2010-03-16

To evaluate the effectiveness of an integrated care programme, combining a patient directed and a workplace directed intervention, for patients with chronic low back pain. Population based randomised controlled trial. Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals). 134 adults aged 18-65 sick listed for at least 12 weeks owing to low back pain. Patients were randomly assigned to usual care (n=68) or integrated care (n=66). Integrated care consisted of a workplace intervention based on participatory ergonomics, involving a supervisor, and a graded activity programme based on cognitive behavioural principles. The primary outcome was the duration of time off work (work disability) due to low back pain until full sustainable return to work. Secondary outcome measures were intensity of pain and functional status. The median duration until sustainable return to work was 88 days in the integrated care group compared with 208 days in the usual care group (P=0.003). Integrated care was effective on return to work (hazard ratio 1.9, 95% confidence interval 1.2 to 2.8, P=0.004). After 12 months, patients in the integrated care group improved significantly more on functional status compared with patients in the usual care group (P=0.01). Improvement of pain between the groups did not differ significantly. The integrated care programme substantially reduced disability due to chronic low back pain in private and working life. Trial registration Current Controlled Trials ISRCTN28478651.

The long-term effects of naprapathic manual therapy on back and neck pain - Results from a pragmatic randomized controlled trial

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Bohman Tony

2010-02-01

Full Text Available Abstract Background Back and neck pain are very common, disabling and recurrent disorders in the general population and the knowledge of long-term effect of treatments are sparse. The aim of this study was to compare the long-term effects (up to one year of naprapathic manual therapy and evidence-based advice on staying active regarding non-specific back and/or neck pain. Naprapathy, a health profession mainly practiced in Sweden, Finland, Norway and in the USA, is characterized by a combination of manual musculoskeletal manipulations, aiming to decrease pain and disability in the neuromusculoskeletal system. Methods Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409, recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group, and advice to stay active and on how to cope with pain, provided by a physician (Control Group. Pain intensity, disability and health status were measured by questionnaires. Results 89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD = 21%, 95% CI: 10-30 and disability (RD = 11%, 95% CI: 4-22 at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28. The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p ≤ 0.005. There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status favoring the Index Group. Conclusions Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck

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.

The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials

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Ting-Hao Chen

2016-01-01

Full Text Available Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cancer, tumor, and carcinoma. There were 7 studies which met the selection criteria and 3 studies were eventually included among 63 eligible publications. Results. This meta-analysis included three randomized controlled trials with a total of 278 participants (135 participants in the massage with essential oil group and 143 participants in the control (usual care group. Compared with the control group, the massage with essential oil group had nonsignificant effect on reducing the pain (standardized mean difference = 0.01; 95% CI [-0.23,0.24]. Conclusion. Aromatherapy massage does not appear to reduce pain of the cancer patients. Further rigorous studies should be conducted with more objective measures.

Treatment of pregnancy-related pelvic girdle and/or low back pain after delivery design of a randomized clinical trial within a comprehensive prognostic cohort study [ISRCTN08477490

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Klabbers Aldegonda BA

2004-12-01

Full Text Available Abstract Background Pregnancy-related pelvic girdle and/or low back pain is a controversial syndrome because insight in etiology and prognosis is lacking. The controversy relates to factors eliciting pain and some prognostic factors such as the interpretation of pain at the symphysis. Recent research about treatment strategies also reflects those various opinions, in fact suggesting there is professional uncertainty about the optimal approach. Currently, physiotherapists often prescribe a pain-contingent treatment regime of relative rest and avoiding several day-to-day activities. Additionally, treatment more often includes an exercise program to guide rectification of the muscle imbalance and alignment of the pelvic girdle. Effectiveness of those interventions is not proven and the majority of the studies are methodologically flawed. Investigators draw particular attention to biomedical factors but there is growing evidence that important prognostic issues such as biopsychosocial factors appear to be even more important as point of action in a treatment program. Methods/design This pragmatic randomized controlled trial is designed to evaluate the effectiveness of a tailor-made treatment program with respect to biopsychosocial factors in primary care. The effect of the experimental intervention and usual care are evaluated as they are applied in primary health care. The trial is embedded in a cohort study that is designed as a longitudinal, prospective study, which studies prevalence, etiology, severity and prognosis during pregnancy until one year after delivery. The present paper focuses on choices regarding recruitment procedures, in-/exclusion criteria and the development of a well-timed intervention. Discussion This section briefly discusses the actions taken to minimize bias in the design, the proper time-window for the experimental intervention and the contrast between the experimental intervention and usual care.

A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

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Cherkin, Daniel C.; Sherman, Karen J.; Avins, Andrew L.; Erro, Janet H.; Ichikawa, Laura; Barlow, William E.; Delaney, Kristin; Hawkes, Rene; Hamilton, Luisa; Pressman, Alice; Khalsa, Partap S.; Deyo, Richard A.

2009-01-01

Background Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. Methods 638 adults with chronic mechanical low back pain were randomized to: individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland Disability score, range: 0 to 23) and symptom bothersomeness (0 to 10 scale). Outcomes were assessed at baseline and after 8, 26 and 52 weeks. Results At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P0.05). Conclusions Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture’s purported mechanisms of action. It remains unclear whether acupuncture, or our simulated method of acupuncture, provide physiologically important stimulation or represent placebo or non-specific effects. PMID:19433697

The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial.

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Cruz-Díaz, David; Romeu, Marta; Velasco-González, Carmen; Martínez-Amat, Antonio; Hita-Contreras, Fidel

2018-04-01

To assess the effectiveness of 12 weeks of Pilates practice on disability, pain and kinesiophobia in patients with chronic non-specific low back pain. This is a randomized controlled trial. This study was conducted in the university laboratory. A total of 64 participants with chronic non-specific low back pain were included. Participants were randomly allocated to intervention group consisted in Pilates intervention during 12 weeks ( n = 32) or control group who received no treatment ( n = 32). Disability, pain and kinesiophobia were assessed by Roland Morris Disability Questionnaire, visual analogue scale and Tampa Scale of Kinesiophobia, respectively. Measurements were performed at baseline, at 6 and 12 weeks after study completion. There were significant differences between groups with observed improvement in Pilates intervention group in all variables after treatment ( P Pilates intervention in patients with chronic non-specific low back pain is effective in the management of disability, pain and kinesiophobia.

Effectiveness of transcranial direct current stimulation preceding cognitive behavioural management for chronic low back pain: sham controlled double blinded randomised controlled trial.

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Luedtke, Kerstin; Rushton, Alison; Wright, Christine; Jürgens, Tim; Polzer, Astrid; Mueller, Gerd; May, Arne

2015-04-16

To evaluate the effectiveness of transcranial direct current stimulation alone and in combination with cognitive behavioural management in patients with non-specific chronic low back pain. Double blind parallel group randomised controlled trial with six months' follow-up conducted May 2011-March 2013. Participants, physiotherapists, assessors, and analyses were blinded to group allocation. Interdisciplinary chronic pain centre. 135 participants with non-specific chronic low back pain >12 weeks were recruited from 225 patients assessed for eligibility. Participants were randomised to receive anodal (20 minutes to motor cortex at 2 mA) or sham transcranial direct current stimulation (identical electrode position, stimulator switched off after 30 seconds) for five consecutive days immediately before cognitive behavioural management (four week multidisciplinary programme of 80 hours). Two primary outcome measures of pain intensity (0-100 visual analogue scale) and disability (Oswestry disability index) were evaluated at two primary endpoints after stimulation and after cognitive behavioural management. Analyses of covariance with baseline values (pain or disability) as covariates showed that transcranial direct current stimulation was ineffective for the reduction of pain (difference between groups on visual analogue scale 1 mm (99% confidence interval -8.69 mm to 6.3 mm; P=0.68)) and disability (difference between groups 1 point (-1.73 to 1.98; P=0.86)) and did not influence the outcome of cognitive behavioural management (difference between group 3 mm (-10.32 mm to 6.73 mm); P=0.58; difference between groups on Oswestry disability index 0 point (-2.45 to 2.62); P=0.92). The stimulation was well tolerated with minimal transitory side effects. This results of this trial on the effectiveness of transcranial direct current stimulation for the reduction of pain and disability do not support its clinical use for managing non-specific chronic low back pain.Trial

Sequential and simultaneous choices: testing the diet selection and sequential choice models.

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Freidin, Esteban; Aw, Justine; Kacelnik, Alex

2009-03-01

We investigate simultaneous and sequential choices in starlings, using Charnov's Diet Choice Model (DCM) and Shapiro, Siller and Kacelnik's Sequential Choice Model (SCM) to integrate function and mechanism. During a training phase, starlings encountered one food-related option per trial (A, B or R) in random sequence and with equal probability. A and B delivered food rewards after programmed delays (shorter for A), while R ('rejection') moved directly to the next trial without reward. In this phase we measured latencies to respond. In a later, choice, phase, birds encountered the pairs A-B, A-R and B-R, the first implementing a simultaneous choice and the second and third sequential choices. The DCM predicts when R should be chosen to maximize intake rate, and SCM uses latencies of the training phase to predict choices between any pair of options in the choice phase. The predictions of both models coincided, and both successfully predicted the birds' preferences. The DCM does not deal with partial preferences, while the SCM does, and experimental results were strongly correlated to this model's predictions. We believe that the SCM may expose a very general mechanism of animal choice, and that its wider domain of success reflects the greater ecological significance of sequential over simultaneous choices.

Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour.

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Dowswell, Therese; Bedwell, Carol; Lavender, Tina; Neilson, James P

2009-04-15

Transcutaneous nerve stimulation (TENS) has been proposed as a means of reducing pain in labour. The TENS unit emits low-voltage electrical impulses which vary in frequency and intensity. During labour, TENS electrodes are generally placed on the lower back, although TENS may be used to stimulate acupuncture points or other parts of the body. The physiological mechanisms whereby TENS relieves pain are uncertain. The TENS unit is frequently operated by women, which may increase sense of control in labour. To assess the effects of TENS on pain in labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (November 2008). Randomised controlled trials comparing women receiving TENS for pain relief in labour versus routine care, alternative pharmacological methods of pain relief, or placebo devices. We included all types of TENS machines. Two review authors assessed for inclusion all trials identified by the search strategy, carried out data extraction and assessed risk of bias. We have recorded reasons for excluding studies. The search identified 25 studies; we excluded six and included 19 studies including 1671 women. Fifteen examined TENS applied to the back, two to acupuncture points and two to the cranium. Overall, there was little difference in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (risk ratio 0.41, 95% confidence interval 0.32 to 0.55). The majority of women using TENS said they would be willing to use it again in a future labour. Where TENS was used as an adjunct to epidural analgesia there was no evidence that it reduced pain. There was no consistent evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and babies. No adverse events were reported. There is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact (either positive or

Bisphosphonates for treatment of Complex Regional Pain Syndrome type 1: A systematic literature review and meta-analysis of randomized controlled trials versus placebo.

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Chevreau, Maxime; Romand, Xavier; Gaudin, Philippe; Juvin, Robert; Baillet, Athan

2017-07-01

Complex Regional Pain Syndrome Type 1 is a severely disabling pain syndrome with no definite established treatment. We have performed a systematic literature review and meta-analysis of all randomized controlled trials to assess the benefit of bisphosphonates on pain and function in patients with Complex Regional Pain Syndrome Type 1. A systematic literature search was performed in the Medline, Embase and Cochrane databases. Two authors selected independently blinded randomized trials comparing bisphosphonates to placebo on short-term (J30 to J40) and medium term pain (M2-M3), safety and function in patients with CRPS 1. The methodological quality of the studies was analyzed. Data were aggregated using the method of the inverse of the variance. 258 articles were identified. Four trials of moderate to good quality comprising 181 patients (90 in the bisphosphonate group and 91 in the placebo group) were included in this meta-analysis. Short-term pain Visual Analog Scale was significantly lower in the bisphosphonate group versus the placebo group (SMD=-2.6, 95%CI [-1.8, -3.4], Ppain (SMD=-2.5, 95%CI [-1.4, -3.6], Ppain in patients with Complex Regional Pain Syndrome type 1. Other studies are needed to determine their effectiveness. Copyright © 2017. Published by Elsevier SAS.

Vicarious pain experiences while observing another in pain: an experimental approach

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Sophie eVandenbroucke

2013-06-01

Full Text Available Objective: This study aimed at developing an experimental paradigm to assess vicarious pain experiences. We further explored the putative moderating role of observer’s characteristics such as hypervigilance for pain and dispositional empathy. Methods: Two experiments are reported using a similar procedure. Undergraduate students were selected based upon whether they reported vicarious pain in daily life, and categorized into a pain responder group or a comparison group. Participants were presented a series of videos showing hands being pricked whilst receiving occasionally pricking (electrocutaneous stimuli themselves. In congruent trials, pricking and visual stimuli were applied to the same spatial location. In incongruent trials, pricking and visual stimuli were in the opposite spatial location. Participants were required to report on which location they felt a pricking sensation. Of primary interest was the effect of viewing another in pain upon vicarious pain errors, i.e., the number of trials in which an illusionary sensation was reported. Furthermore, we explored the effect of individual differences in hypervigilance to pain, dispositional empathy and the rubber hand illusion (RHI upon vicarious pain errors. Results: Results of both experiments indicated that the number of vicarious pain errors was overall low. In line with expectations, the number of vicarious pain errors was higher in the pain responder group than in the comparison group. Self-reported hypervigilance for pain lowered the probability of reporting vicarious pain errors in the pain responder group, but dispositional empathy and the RHI did not. Conclusion: Our paradigm allows measuring vicarious pain experiences in students. However, the prevalence of vicarious experiences of pain is low, and only a small percentage of participants display the phenomenon. It remains however unknown which variables affect its occurrence.

Amount of health care and self-care following a randomized clinical trial comparing flexion-distraction with exercise program for chronic low back pain

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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.

Oxcarbazepine for neuropathic pain.

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Zhou, Muke; Chen, Ning; He, Li; Yang, Mi; Zhu, Cairong; Wu, Fengbo

2017-12-02

Several anticonvulsant drugs are used in the management of neuropathic pain. Oxcarbazepine is an anticonvulsant drug closely related to carbamazepine. Oxcarbazepine has been reported to be efficacious in the treatment of neuropathic pain, but evidence from randomised controlled trials (RCTs) is conflicting. Oxcarbazepine is reportedly better tolerated than carbamazepine. This is the first update of a review published in 2013. To assess the benefits and harms of oxcarbazepine for different types of neuropathic pain. On 21 November 2016, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE and Embase. We searched the Chinese Biomedical Retrieval System (January 1978 to November 2016). We searched the US National Institutes of Health (NIH) databases and the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing trials in January 2017, and we wrote to the companies who make oxcarbazepine and to pain experts requesting additional information. All RCTs and randomised cross-over studies of oxcarbazepine for the treatment of people of any age or sex with any neuropathic pain were eligible. We planned to include trials of oxcarbazepine compared with placebo or any other intervention with a treatment duration of at least six weeks, regardless of administration route and dose. We used standard methodological procedures expected by Cochrane. Five multicentre, randomised, placebo-controlled, double-blind trials with a total of 862 participants were eligible for inclusion in this updated review. Three trials involved participants with painful diabetic peripheral neuropathy (DPN) (n = 634), one included people with neuropathic pain due to radiculopathy (n = 145), and one, which was newly identified at this update, involved participants with peripheral neuropathic pain of mixed origin (polyneuropathy, peripheral nerve injury or postherpetic neuralgia) (n = 83). Some studies did not report all outcomes of interest. For

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

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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.

Electroacupuncture for postoperative pain and gastrointestinal motility after laparoscopic appendectomy (AcuLap): study protocol for a randomized controlled trial.

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Kim, Gangmi

2015-10-14

Acupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal motility and controlling pain after laparoscopic surgery. This study is a prospective randomized controlled trial with a three-arm, parallel-group structure evaluating the efficacy of electroacupuncture for gastrointestinal motility and postoperative pain after laparoscopic appendectomy. Patients with appendicitis undergoing laparoscopic surgery are included and randomized into three groups: 1) electroacupuncture group, 2) sham acupuncture group, and 3) control group. Patients receive 1) acupuncture with electrostimulation or 2) fake electroacupuncture with sham device twice a day or 3) no acupuncture after laparoscopic appendectomy. The primary outcome is time to first passing flatus after operation. Secondary outcomes include postoperative pain, analgesics, nausea/vomiting, bowel motility, time to tolerable diet, complications, hospital stay, readmission rates, time to recovery, quality of life, medical costs, and protocol failure rate. Patients and hospital staff (physicians and nurses) are blinded to which group the patient is assigned, electroacupuncture or sham acupuncture. Data analysis personnel are blinded to group assignment among all three groups. Estimated sample size to detect a minimum difference of time to first flatus with 80 % power, 5 % significance, and 10 % drop rate is 29 × 3 groups = 87 patients. Analysis will be performed according to the intention-to-treat principle. The AcuLap trial will provide evidence on the merits and/or demerits of electroacupuncture for bowel motility recovery and pain relief after laparoscopic appendectomy. The trial was registered in Clinical Research Information Service (CRiS), Republic of Korea ( KCT0001486

Integrative treatment for low back pain: An exploratory systematic review and meta-analysis of randomized controlled trials.

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Hu, Xiao-Yang; Chen, Ni-Ni; Chai, Qian-Yun; Yang, Guo-Yan; Trevelyan, Esmé; Lorenc, Ava; Liu, Jian-Ping; Robinson, Nicola

2015-10-26

Low back pain (LBP) is a common musculoskeletal condition often treated using integrative medicine (IM). Most reviews have focused on a single complementary and alternative medicine (CAM) therapy for LBP rather than evaluating wider integrative approaches. This exploratory systematic review aimed to identify randomized controlled trials (RCTs) and provide evidence on the effectiveness, cost effectiveness and adverse effects of integrative treatment for LBP. A literature search was conducted in 12 English and Chinese databases. RCTs evaluating an integrative treatment for musculoskeletal related LBP were included. Reporting, methodological quality and relevant clinical characteristics were assessed and appraised. Metaanalyses were performed for outcomes where trials were sufficiently homogenous. Fifty-six RCTs were identified evaluating integrative treatment for LBP. Although reporting and methodological qualities were poor, meta-analysis showed a favourable effect for integrative treatment over conventional and CAM treatment for back pain and function at 3 months or less follow-up. Two trials investigated costs, reporting £ 5332 per quality adjusted life years with 6 Alexander technique lessons plus exercise at 12 months follow-up; and an increased total costs of $244 when giving an additional up to 15 sessions of CAM package of care at 12 weeks. Sixteen trials mentioned safety; no severe adverse effects were reported. Integrative treatment that combines CAM with conventional therapies appeared to have beneficial effects on pain and function. However, evidence is limited due to heterogeneity, the relatively small numbers available for subgroup analyses and the low methodological quality of the included trials. Identification of studies of true IM was not possible due to lack of reporting of the intervention details (registration No. CRD42013003916).

Treatment of the sacroiliac joint in patients with leg pain : A randomized-controlled trial

NARCIS (Netherlands)

Visser, L.H.; Woudenberg, N.P.; de Bont, J.; van Eijs, F.; Verwer, K.; Jenniskens, H.; den Oudsten, B.L.

2013-01-01

Purpose The sacroiliac joint (SIJ) may be a cause of sciatica. The aim of this study was to assess which treatment is successful for SIJ-related back and leg pain. Methods Using a single-blinded randomised trial, we assessed the short-term therapeutic efficacy of physiotherapy, manual therapy, and

A randomized controlled trial to assess the pain associated with the debond of orthodontic fixed appliances

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Mangnall, Louise A R; Dietrich, Thomas; Scholey, John M

2013-01-01

Objective: To determine patient experience of pain during treatment with fixed orthodontic appliances, expectations of pain during debond and whether biting on a soft acrylic wafer during debond decreases pain experience. Design: Multicentre randomized controlled trial. Setting: Three UK hospital based orthodontic departments: Mid-Staffordshire NHS Foundation Trust, Birmingham Dental Hospital and University Hospital of North Staffordshire. Materials and methods: Ninety patients were randomly allocated to either the control (n = 45) or wafer group (n = 45). A visual analogue scale-based questionnaire was completed pre-debond to determine pain experience during treatment and expectations of pain during debond. The appliances were debonded and those in the wafer group bit on a soft acrylic wafer. A second questionnaire was completed post-debond to assess the pain experienced. Results: Biting on an acrylic wafer significantly reduced the pain experienced when debonding the posterior teeth (P≤0·05). Thirty-nine per cent found the lower anterior teeth the most painful. The expected pain was significantly greater than that actually experienced (P≤0·0001). Greater pain during treatment correlated with increased expectations and increased actually experienced pain (P≤0·0001). Conclusions: Biting on a soft acrylic wafer during debond of the posterior teeth reduces the pain experienced. The lower anterior teeth are the most painful. The pain expected is significantly greater than actually experienced. Patients who had greater pain during treatment expected and experienced greater pain at debond. PMID:24009318

Evidence of Physiotherapy Interventions for Patients with Chronic Neck Pain: A Systematic Review of Randomised Controlled Trials

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Damgaard, Pia; Bartels, Else Marie; Ris, Inge; Christensen, Robin; Juul-Kristensen, Birgit

2013-01-01

Chronic neck pain (CNP) is common and costly, and the effect of physiotherapeutic interventions on the condition is unclear. We reviewed the literature for evidence of effect of physiotherapy interventions on patients with CNP. Five bibliographic databases (MEDLINE, EMBASE, CINAHL, Cochrane Library, and PEDro) were systematically searched. Randomised, placebo and active-treatment-controlled trials including physiotherapy interventions for adults with CNP were selected. Data were extracted primary outcome was pain. Risk of bias was appraised. Effect of an intervention was assessed, weighted to risk of bias. 42 trials reporting on randomised comparisons of various physiotherapy interventions and control conditions were eligible for inclusion involving 3919 patients with CNP. Out of these, 23 were unclear or at high risk of bias, and their results were considered moderate- or low-quality evidence. Nineteen were at low risk of bias, and here eight trials found effect on pain of a physiotherapy intervention. Only exercise therapy, focusing on strength and endurance training, and multimodal physiotherapy, cognitive-behavioural interventions, massage, manipulations, laser therapy, and to some extent also TNS appear to have an effect on CNP. However, sufficient evidence for application of a specific physiotherapy modality or aiming at a specific patient subgroup is not available. PMID:27335877

Aromatherapy for pain management in labour.

Science.gov (United States)

Smith, Caroline A; Collins, Carmel T; Crowther, Caroline A

2011-07-06

Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of aromatherapy for pain management in labour. To examine the effects of aromatherapy for pain management in labour on maternal and perinatal morbidity. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2010), The Cochrane Complementary Medicine Field's Trials Register (October 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 4), MEDLINE (1966 to 31 October 2010), CINAHL (1980 to 31 October 2010), the Australian and New Zealand Trials Registry (31 October 2010), Chinese Clinical Trial Register (31 October 2010), Current Controlled Trials (31 October 2010), ClinicalTrials.gov (31 October 2010), ISRCTN Register (31 October 2010), National Center for Complementary and Alternative Medicine (NCCAM) (31 October 2010) and the WHO International Clinical Trials Registry Platform (31 October 2010). Randomised controlled trials comparing aromatherapy with placebo, no treatment or other non-pharmacological forms of pain management in labour. Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We included two trials (535 women) in the review. The trials found no difference between groups for the primary outcomes of pain intensity, assisted vaginal birth (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.48 to 2.28, one trial, 513 women; RR 0.83, 95% CI 0.06 to 11.70, one trial, 22 women), and caesarean section (RR 0.98, 95% CI 0.49 to 1.94, one trial, 513 women; RR 2.54, 95% CI 0.11 to 56.25, one trial, 22 women); there were more babies admitted to neonatal intensive care in the control group of one trial (RR 0.08, 95% CI 0.00 to 1.42, one trial, 513 women) but this

Effectiveness of manual therapy versus surgery in pain processing due to carpal tunnel syndrome: A randomized clinical trial.

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Fernández-de-Las-Peñas, C; Cleland, J; Palacios-Ceña, M; Fuensalida-Novo, S; Alonso-Blanco, C; Pareja, J A; Alburquerque-Sendín, F

2017-08-01

People with carpal tunnel syndrome (CTS) exhibit widespread pressure pain and thermal pain hypersensitivity as a manifestation of central sensitization. The aim of our study was to compare the effectiveness of manual therapy versus surgery for improving pain and nociceptive gain processing in people with CTS. The trial was conducted at a local regional Hospital in Madrid, Spain from August 2014 to February 2015. In this randomized parallel-group, blinded, clinical trial, 100 women with CTS were randomly allocated to either manual therapy (n = 50), who received three sessions (once/week) of manual therapies including desensitization manoeuvres of the central nervous system, or surgical intervention (n = 50) group. Outcomes including pressure pain thresholds (PPT), thermal pain thresholds (HPT or CPT), and pain intensity which were assessed at baseline, and 3, 6, 9 and 12 months after the intervention by an assessor unaware of group assignment. Analysis was by intention to treat with mixed ANCOVAs adjusted for baseline scores. At 12 months, 95 women completed the follow-up. Patients receiving manual therapy exhibited higher increases in PPT over the carpal tunnel at 3, 6 and 9 months (all, p < 0.01) and higher decrease of pain intensity at 3 month follow-up (p < 0.001) than those receiving surgery. No significant differences were observed between groups for the remaining outcomes. Manual therapy and surgery have similar effects on decreasing widespread pressure pain sensitivity and pain intensity in women with CTS. Neither manual therapy nor surgery resulted in changes in thermal pain sensitivity. The current study found that manual therapy and surgery exhibited similar effects on decreasing widespread pressure pain sensitivity and pain intensity in women with carpal tunnel syndrome at medium- and long-term follow-ups investigating changes in nociceptive gain processing after treatment in carpal tunnel syndrome. © 2017 European Pain Federation - EFIC®.

The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol.

Science.gov (United States)

Boitor, Madalina; Martorella, Géraldine; Laizner, Andréa Maria; Maheu, Christine; Gélinas, Céline

2016-11-07

Postoperative pain is common in the intensive care unit despite the administration of analgesia. Some trials suggest that massage can be effective at reducing postoperative pain in acute care units; however, its effects on pain relief in the intensive care unit and when pain severity is highest remain unknown. The objective is to evaluate the effectiveness of hand massage on the pain intensity (primary outcome), unpleasantness and interference, muscle tension, anxiety, and vital signs of critically ill patients after cardiac surgery. A 3-arm randomized controlled trial will be conducted. A total of 79 patients who are 18 years or older, able to speak French or English and self-report symptoms, have undergone elective cardiac surgery, and do not have a high risk of postoperative complications and contraindications to hand massage will be recruited. They will be randomly allocated (1:1:1) to standard care plus either 3 20-minute hand massages (experimental), 3 20-minute hand holdings (active control), or 3 20-minute rest periods (passive control). Pain intensity, unpleasantness, anxiety, muscle tension, and vital signs will be evaluated before, immediately after, and 30 minutes later for each intervention administered within 24 hours postoperatively. Peer-reviewed competitive funding was received from the Quebec Nursing Intervention Research Network and McGill University in December 2015, and research ethics approval was obtained February 2016. Recruitment started in April 2016, and data collection is expected to be complete by January 2017. To date, 24 patients were randomized and had data collection done. This study will be one of the first randomized controlled trials to examine the effect of hand massage on the pain levels of critically ill patients after cardiac surgery and to provide empirical evidence for the use of massage among this population. ClinicalTrials.gov NCT02679534; https://clinicaltrials.gov/ct2/show/NCT02679534 (Archived by WebCite at http

Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: a protocol for a methodological survey.

Science.gov (United States)

Mazzei, Lauren Giustti; Bergamaschi, Cristiane de Cássia; Silva, Marcus Tolentino; Lopes, Luciane Cruz

2017-09-27

Pain is one of the most common and most debilitating complaints among patients. It affects the individual, their relationship with friends and family, their ability to function at work, and their sociability. Acupuncture is one of the therapeutic resources for managing chronic pain. Given the variability of outcome measures in controlled randomised clinical trials on non-oncologicchronic pain (CRCT-NOCP), the Initiative in Methods, Measurements and Pain Assessment in Clinical Trials (IMMPACT) recommends six domains to be covered in evaluating the effectiveness of treatments for chronic pain. To check whether the methodological quality of outcome reporting in published trials has used IMMPACT recommendations in measuring CRCT-NOCP outcomes when acupuncture was used as a treatment. This is a methodological study. We will systematically search for eligible studies in specific databases with a defined strategy. We will use the MeSHterms of 'acupuncture', 'chronic pain' and similar terms, without restrictions on idiom. Eligible studies will include those which are randomised and chose NOCP patients to be treated with acupuncture or control (sham acupuncture or no acupuncture), recruited after September 2004, with ≥100 patients. The measured outcomes are to be the presence of outcome domains recommended by IMMPACT, domains reported by the patient or clinician, tools used to measure such domains, as well as other features of the studies. We shall conduct a regression analysis to explore factors which can be associated with the presence of outcome domains according to IMMPACT recommendations. This survey will be submitted for presentation at congresses and for publication in a scientific journal. The findings obtained in this study will allow us to measure the quality of the evidence and provide greater transparency in decisions regarding the use of acupuncture as a viable alternative to managing chronic pain. © Article author(s) (or their employer(s) unless otherwise

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

and activities of daily living (ADL) were used, and strength and endurance measurements of the cervical and shoulder muscles were carried out at baseline and completion of the study. Follow-up measurements were carried out by postal questionnaire at 6 and 12 months after inclusion, and included pain, ADL......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...

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].

Science.gov (United States)

2003-12-08

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 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 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-year follow-up, although the medium-term and longer-term risks and benefits of LUNA will also be

Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol.

Science.gov (United States)

Bennell, Kim L; Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Abbott, J Haxby; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S

2015-10-01

Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist-instructed home exercise leads to greater reductions in pain and improvements in function. An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. The study will be conducted in a community setting. The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. A self-reported diagnosis of persistent hip pain will be used. The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist-instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative

Cost effectiveness of physiotherapy, manual therapy, and general practitioner care for neck pain: economic evaluation alongside a randomised controlled trial

NARCIS (Netherlands)

Korthals-de Bos, Ingeborg B. C.; Hoving, Jan L.; van Tulder, Maurits W.; Rutten-van Mölken, Maureen P. M. H.; Adèr, Herman J.; de Vet, Henrica C. W.; Koes, Bart W.; Vondeling, Hindrik; Bouter, Lex M.

2003-01-01

OBJECTIVE: To evaluate the cost effectiveness of physiotherapy, manual therapy, and care by a general practitioner for patients with neck pain. DESIGN: Economic evaluation alongside a randomised controlled trial. SETTING: Primary care. PARTICIPANTS: 183 patients with neck pain for at least two weeks

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

Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.

Science.gov (United States)

Cherkin, Daniel C; Sherman, Karen J; Balderson, Benjamin H; Turner, Judith A; Cook, Andrea J; Stoelb, Brenda; Herman, Patricia M; Deyo, Richard A; Hawkes, Rene J

2014-06-07

The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options

Manipulation and mobilisation for neck pain contrasted against an inactive control or another active treatment.

Science.gov (United States)

Gross, Anita; Langevin, Pierre; Burnie, Stephen J; Bédard-Brochu, Marie-Sophie; Empey, Brian; Dugas, Estelle; Faber-Dobrescu, Michael; Andres, Cristy; Graham, Nadine; Goldsmith, Charles H; Brønfort, Gert; Hoving, Jan L; LeBlanc, Francis

2015-09-23

Manipulation and mobilisation are commonly used to treat neck pain. This is an update of a Cochrane review first published in 2003, and previously updated in 2010. To assess the effects of manipulation or mobilisation alone compared wiith those of an inactive control or another active treatment on pain, function, disability, patient satisfaction, quality of life and global perceived effect in adults experiencing neck pain with or without radicular symptoms and cervicogenic headache (CGH) at immediate- to long-term follow-up. When appropriate, to assess the influence of treatment characteristics (i.e. technique, dosage), methodological quality, symptom duration and subtypes of neck disorder on treatment outcomes. Review authors searched the following computerised databases to November 2014 to identify additional studies: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). We also searched ClinicalTrials.gov, checked references, searched citations and contacted study authors to find relevant studies. We updated this search in June 2015, but these results have not yet been incorporated. Randomised controlled trials (RCTs) undertaken to assess whether manipulation or mobilisation improves clinical outcomes for adults with acute/subacute/chronic neck pain. Two review authors independently selected studies, abstracted data, assessed risk of bias and applied Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods (very low, low, moderate, high quality). We calculated pooled risk ratios (RRs) and standardised mean differences (SMDs). We included 51 trials (2920 participants, 18 trials of manipulation/mobilisation versus control; 34 trials of manipulation/mobilisation versus another treatment, 1 trial had two comparisons). Cervical manipulation versus inactive control: For subacute and chronic neck pain, a single manipulation (three trials, no meta

The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials.

Science.gov (United States)

Liu, Hua; Zeng, Chao; Gao, Shu-guang; Yang, Tuo; Luo, Wei; Li, Yu-sheng; Xiong, Yi-lin; Sun, Jin-peng; Lei, Guang-hua

2013-10-01

A meta-analysis was conducted to examine the effect of mud therapy on pain relief in patients with knee osteoarthritis (OA). A detailed search of PubMed®/MEDLINE® was undertaken to identify randomized controlled trials and prospective comparative studies published before 9 March 2013 that compared mud therapy with control group treatments in patients with knee OA. A quantitative meta-analysis of seven studies (410 patients) was performed. There was a significant difference between the groups in the visual analogue scale pain score (standardized mean difference [SMD] -0.73) and Western Ontario and McMaster Universities Osteoarthritis Index pain score (SMD -0.30), with differences in favour of mud therapy. Mud therapy is a favourable option for pain relief in patients with knee OA. Additional high-quality randomized controlled trials need to be conducted to explore this issue further and to confirm this conclusion.

"I was a little surprised": Qualitative Insights from Patients Enrolled in a 12-Month Trial Comparing Opioids to Non-Opioid Medications for Chronic Musculoskeletal Pain.

Science.gov (United States)

Marianne S Matthias; Donaldson, Melvin T; Jensen, Agnes C; Krebs, Erin E

2018-04-28

Chronic musculoskeletal pain is a major public health problem. Although opioid prescribing for chronic pain has increased dramatically since the 1990s, this practice has come under scrutiny because of increases in opioid-related harms and lack of evidence for long-term effectiveness. The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial was a pragmatic 12-month randomized trial comparing benefits and harms of opioid versus non-opioid medications for chronic musculoskeletal pain. The current qualitative study was designed to better understand trial results by exploring patients' experiences, including perceptions of medications, experiences with the intervention, and whether expectations were met. Thirty-four participants who were purposefully sampled based on treatment group and intervention response participated in semi-structured interviews. The constant comparison method guided analysis. Results revealed that participants often held strong beliefs about opioid medications, which sometimes changed during the trial as they gained experience with medications; participants described a wide variety of experiences with treatment effectiveness, regardless of study group or their response to the intervention; and participants highly valued the personalized pain care model used in SPACE. SPACE trial results indicated no advantage for opioid over non-opioid medications. Qualitative findings suggest that, for patients in both treatment groups, pre-existing expectations of medications and of anticipated improvement in pain shaped experiences with and responses to medications. In addition, the personalized pain care model was described as contributing to positive outcomes in both groups. Copyright © 2018. Published by Elsevier Inc.

Ibuprofen Versus Fennel for the Relief of Postpartum Pain: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Parvin Asti

2011-06-01

Full Text Available Objective: The present study aimed to compare the value of ibuprofen and fennel for postpartum painrelief in women with normal vaginal delivery.Materials and methods:In this randomized clinical trial we studied 90 women referring to obstetricsward for Normal Vaginal Delivery (NVD in Assali hospital in Khoramabad. Women were randomlyallocated to receive either oral ibuprofen or oral fennel by stratified random sampling technique. Allwomen were asked to give pain score by visual analogue scale before and at 1, 2, 3 and 4 hours aftertreatment.Results: Difference between fennel and ibuprofen groups was not significant considering severity of painbefore (P=0.22. Difference between two groups considering mean severity of pain one hour aftertreatment (P=0.57 was not significant. But comparing the mean of pain severity in two groups, showedsignificant difference after two (p<0.023, three (p<0.001 and four (p<0.001 hours after treatment.Conclusion: Ibuprofen and fennel were effective for relief of postpartum pain without any notable sideeffects, but in general ibuprofen was more effective than fennel. More studies are needed to confirm theefficacy of fennel in pain relief especially in postpartum women which must be compared to a notreatment control group.

The efficacy of chiropractic manipulation for back pain : Blinded review of relevant randomized clinical trials

NARCIS (Netherlands)

Assendelft, W. J J; Koes, B. W.; Van der Heijden, G. J M G; Bouter, L. M.

1992-01-01

Objective: To assess the efficacy of chiropractic for patients with back pain. Data Sources: Randomized clinical trials (RCTs) on spinal manipulation were identified with a Medline search (1966-1990), by citation tracking, and by manual examination of the relevant chiropractic reference systems

Pain perception in healthy volunteers

DEFF Research Database (Denmark)

Janum, Susanne; Nielsen, Signe Tellerup; Werner, Mads U

2016-01-01

We aimed to study the relationship between pain perception and cytokine release during systemic inflammation. We present a randomized crossover trial in healthy volunteers (n = 17) in 37 individual trials. Systemic inflammation was induced by an i.v. bolus of Escherichia coli LPS (2 ng/kg) on two...... separate trial days, with or without a nicotine patch applied 10 h previously. Pain perception at baseline, and 2 and 6 h after LPS was assessed by pressure algometry and tonic heat stimulation at an increasing temperature (45-48℃) during both trials. Compared with baseline, pain pressure threshold...... was reduced 2 and 6 h after LPS, while heat pain perception was accentuated at all testing temperatures after 2 but not 6 h. The magnitude of changes in pain perception did not correlate to cytokine release. No effect of transdermal nicotine or training status was observed. In conclusion, LPS administration...

Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial

Science.gov (United States)

2013-01-01

Background A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention. Methods/design To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention. Discussion Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been

Treatment of pain associated to knee osteoarthritis in the elderly: a randomized double-blind clinical trial with lysine clonixinate

OpenAIRE

Santos,Fânia Cristina; Souza,Polianna Mara Rodrigues de; Toniolo Neto,João; Atallah,Álvaro Nagib

2011-01-01

BACKGROUND AND OBJECTIVES: Osteoarthritis (OA) is the most common arthropathy and one of the major causes of chronic pain in the elderly population, which may lead to major functional incapacity of these individuals. Aiming at treating pain of elderly patients with knee OA, we have used lysine clonixinate (LC) and have evaluated its effectiveness METHOD: Randomized, double-blind, placebo-controlled clinical trial with 109 elderly patients with knee OA-related pain. Participants were distribut...

Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial.

Science.gov (United States)

Malfliet, Anneleen; Kregel, Jeroen; Coppieters, Iris; De Pauw, Robby; Meeus, Mira; Roussel, Nathalie; Cagnie, Barbara; Danneels, Lieven; Nijs, Jo

2018-04-16

Effective treatments for chronic spinal pain are essential to reduce the related high personal and socioeconomic costs. To compare pain neuroscience education combined with cognition-targeted motor control training with current best-evidence physiotherapy for reducing pain and improving functionality, gray matter morphologic features, and pain cognitions in individuals with chronic spinal pain. Multicenter randomized clinical trial conducted from January 1, 2014, to January 30, 2017, among 120 patients with chronic nonspecific spinal pain in 2 outpatient hospitals with follow-up at 3, 6, and 12 months. Participants were randomized into an experimental group (combined pain neuroscience education and cognition-targeted motor control training) and a control group (combining education on back and neck pain and general exercise therapy). Primary outcomes were pain (pressure pain thresholds, numeric rating scale, and central sensitization inventory) and function (pain disability index and mental health and physical health). There were 22 men and 38 women in the experimental group (mean [SD] age, 39.9 [12.0] years) and 25 men and 35 women in the control group (mean [SD] age, 40.5 [12.9] years). Participants in the experimental group experienced reduced pain (small to medium effect sizes): higher pressure pain thresholds at primary test site at 3 months (estimated marginal [EM] mean, 0.971; 95% CI, -0.028 to 1.970) and reduced central sensitization inventory scores at 6 months (EM mean, -5.684; 95% CI, -10.589 to -0.780) and 12 months (EM mean, -6.053; 95% CI, -10.781 to -1.324). They also experienced improved function (small to medium effect sizes): significant and clinically relevant reduction of disability at 3 months (EM mean, -5.113; 95% CI, -9.994 to -0.232), 6 months (EM mean, -6.351; 95% CI, -11.153 to -1.550), and 12 months (EM mean, -5.779; 95% CI, -10.340 to -1.217); better mental health at 6 months (EM mean, 36.496; 95% CI, 7.998-64.995); and better physical

The effects of an unsupervised water exercise program on low back pain and sick leave among healthy pregnant women - A randomised controlled trial

DEFF Research Database (Denmark)

Backhausen, Mette G; Tabor, Ann; Albert, Hanne

2017-01-01

BACKGROUND: Low back pain is highly prevalent among pregnant women, but evidence of an effective treatment are still lacking. Supervised exercise-either land or water based-has shown benefits for low back pain, but no trial has investigated the evidence of an unsupervised water exercise program...... on low back pain. We aimed to assess the effect of an unsupervised water exercise program on low back pain intensity and days spent on sick leave among healthy pregnant women. METHODS: In this randomised, controlled, parallel-group trial, 516 healthy pregnant women were randomly assigned to either...... unsupervised water exercise twice a week for a period of 12 weeks or standard prenatal care. Healthy pregnant women aged 18 years or older, with a single fetus and between 16-17 gestational weeks were eligible. The primary outcome was low back pain intensity measured by the Low Back Pain Rating scale at 32...

Efficacy, tolerability, and safety of non-pharmacological therapies for chronic pain: An umbrella review on various CAM approaches.

Science.gov (United States)

Houzé, Bérengère; El-Khatib, Héjar; Arbour, Caroline

2017-10-03

Complementary and alternative medicine (CAM) therapies may be used as a non-pharmacological approach to chronic pain management. While hundreds of trials about individual CAM modality have been conducted, a comprehensive overview of their results is currently lacking for pain clinicians and researchers. This umbrella review synthesized the quality of meta-analytic evidence supporting the efficacy, tolerability and safety of CAM therapies for the management of chronic pain. MEDLINE, EMBASE, CINAHL, and CENTRAL were searched from October 1991 to November 2016. Reviews of clinical trials (randomized and non-randomized) with meta-analysis investigating the utility of any CAM modality for chronic pain were eligible. Pain relief post-intervention was the main outcome and secondary outcomes included patients' adherence and incidence of adverse effects during CAM protocol. Twenty-six reviews (207 clinical trials, >12,000 participants) about 18 CAM modalities, falling under natural products, mind and body practices or other complementary health approaches were included. Inhaled cannabis, graded motor imagery, and Compound Kushen injection (a form of Chinese medicine) were found the most efficient (with moderate-to-high effect sizes and low heterogeneity) and tolerable (≥80% of adherence to study protocols) for chronic pain relief. When reported, adverse effects related to these CAM were minor. Although several CAM were found effective for chronic pain relief, it remains unclear when these modalities are a reasonable choice against or in conjunction with mainstream treatments. In that sense, future research with a clear emphasis on concurrent evaluation of CAM overall efficacy and patient adherence/tolerance is needed. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of Transcutaneous Electric Nerve Stimulation on Pain after Total Knee Arthroplasty: A Blind Randomized Controlled Trial.

Science.gov (United States)

Beckwée, David; Bautmans, Ivan; Lefeber, Nina; Lievens, Pierre; Scheerlinck, Thierry; Vaes, Peter

2018-02-01

Transcutaneous electric nerve stimulation (TENS) has proven to be effective for postsurgical pain relief. However, there is a lack of well-constructed clinical trials investigating the effect of TENS after total knee arthroplasty (TKA). In addition, previous investigations reported that low- and high-frequency TENSs produced analgesic tolerance after 4 or 5 days of treatment. The aim of this study is to explore the effect of burst TENS on pain during hospitalization after TKA and to investigate whether burst TENS produces analgesic tolerance after 4 or 5 days of treatment. This stratified, triple blind, randomized controlled trial was approved by the University Hospital Brussels. Sixty-eight subjects were screened for eligibility before surgery; 54 were found eligible and 53 were included in the analyses. Patients were allocated to either a burst TENS or sham burst TENS group. TENS was applied daily during continuous passive mobilization. Knee pain intensity, knee range of motion, and analgesic consumption were assessed daily. Patients received burst TENS ( N  = 25) or sham burst TENS ( N  = 28). No significant differences in knee pain intensity were found between the groups ( p  > 0.05). Within the TENS and the sham TENS groups, the difference in knee pain before and after treatment did not evolve over time ( p  > 0.05). This study found no effects of burst TENS compared with sham burst TENS on pain during hospitalization after TKA. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Acupuncture in the management of chronic low back pain: a blinded randomized controlled trial.

Science.gov (United States)

Kerr, Daniel P; Walsh, Deirdre M; Baxter, David

2003-01-01

To assess the efficacy of acupuncture in the treatment of chronic low back pain. Patients (n = 60) with chronic low back pain were recruited and randomly allocated to either Acupuncture therapy or Placebo transcutaneous electrical nerve stimulation (TENS) groups. Patients were treated weekly for 6 weeks, and blinded assessments were carried out pre- and post-treatment using the McGill Pain Questionnaire (MPQ) and visual analog scales (VAS) for pain, the Short-form 36 quality-of-life questionnaire, and a simple range of motion measurement. A total of 46 patients completed the trial and were followed up at 6 months. Analysis of results using t tests showed that in both groups there were significant pre-post improvements for all scores, except for MPQ scores in the Placebo-TENS group. There was no significant difference between the 2 groups for any of the outcome measures at the end of treatment. Results from the 6-month follow-up would suggest that the response was better in the acupuncture group. Further research is necessary to fully assess the efficacy of this treatment in combating chronic low back pain using larger sample sizes or alternative control groups.

Patient directed self management of pain (PaDSMaP compared to treatment as usual following total knee replacement: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Donell Simon

2012-11-01

Full Text Available Abstract Background In 2009, 665 patients underwent total knee replacements (TKRs at the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH, representing nearly 1% of the national total. Pain control following the operation can be poor, and this can cause poor mobilization and potential long-term adverse events. Although high levels of pain are not associated with patient dissatisfaction, brief periods of pain may lead to neuronal remodeling and sensitization. Patient controlled oral analgesia (PCOA may improve pain relief; however, the evidence to date has been inconclusive. Patient directed self management of pain (PaDSMaP is a single center randomized controlled trial, which aims to establish if patient self-medication improves, or is equivalent to, treatment as usual and to create an educational package to allow implementation elsewhere. Methods/design Patients eligible for a TKR will be recruited and randomized in the outpatient clinic. All patients will undergo their operations according to normal clinical practice but will be randomized into two groups. Once oral medication has commenced, one group will have pain relief administered by nursing staff in the usual way (treatment as usual; TAU, whilst the second group will self manage their pain medication (patient directed self management of pain; PaDSMaP. Those recruited for self-medication will undergo a training program to teach the use of oral analgesics according to the World Health Organization (WHO pain cascade and how to complete the study documentation. The primary endpoint of the trial is the visual analogue scale (VAS pain score at 3 days or discharge, whichever is sooner. The follow-up time is 6 weeks with a planned trial period of 3 years. The secondary objectives are satisfaction with the management of patient pain post-operatively whilst an inpatient after primary TKR; overall pain levels and pain on mobilization; satisfaction with pain management information

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

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Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

2016-06-02

The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation

Comparison of granisetron and metoclopramide in the treatment of pain and emesis in migraine patients: A randomized controlled trial study

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Hassan Amiri

2017-06-01

Full Text Available Objectives: One of the irritating features of migraine is emesis that can compromise taking oral medications. We designed this study to compare the effectiveness of granisetron and metoclopramide in reducing pain and treating emesis in migraine patients. Methods: We included a total of 148 patients with migraine headache presenting to two referral hospitals in a prospective, double-blinded randomized controlled trial. We compared the effect of granisetron (2 mg intravenous with metoclopramide (10 mg intravenous. Pain intensity and emesis episodes were recorded before drug administration, one, two and four 4 h after drug administration. Results: Of the 148 patients, 47 were male and 101 were female. 75 patients received granisetron and 73 metoclopramide. Mean pain intensity before the administration of the medications was 7.67 ± 1.30 in granisetron group and 7.68 ± 1.13 in metoclopramide group with an insignificant difference. Mean pain intensity at one, two, and 4 h after drug administration was 3.20 ± 1.37, 2.39 ± 1.28, and 1.31 ± 0.52 in granisetron group and 5.04 ± 1.77, 4.1 ± 1.8, and 1.56 ± 0.68 in metoclopramide group (P = 0.03. Mean emesis episodes before drug administration were 1.85 ± 0.81 and 1.80 ± 0.77 in granisetron and metoclopramide groups, respectively. These episodes were 1.33 ± 0.66, 0.25 ± 0.49, and 0.04 ± 0.19 in granisetron group and 1.38 ± 0.73, 0.21 ± 0.47, and 0.41 ± 0.19 in metoclopramide group at one, two, and 4 h after the drug administration (P = 0.7. Conclusion: To came in conclusion, compared to metoclopramide, granisetron is a better choice in acute migraine ATTACK because it decreases the patients' pain as well as their emesis. Keywords: Migraine, Headache, Granisetron, Metoclopramide, Pain

Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

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Gudavalli, M Ram; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Corber, Lance; Patwardhan, Avinash G; Goertz, Christine M

2015-06-05

Manual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain. We conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions. We randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were

Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA: A randomised placebo-controlled crossover trial

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Richmond Stewart J

2008-09-01

Full Text Available Abstract Background Rheumatoid arthritis is a common inflammatory autoimmune disease. Although disease activity may be managed effectively with prescription drugs, unproven treatments such as magnet therapy are sometimes used as an adjunct for pain control. Therapeutic devices incorporating permanent magnets are widely available and easy to use. Magnets may also be perceived as a more natural and less harmful alternative to analgesic compounds. Of interest to health service researchers is the possibility that magnet therapy might help to reduce the economic burden of managing chronic musculoskeletal disorders. Magnets are extremely cheap to manufacture and prolonged treatment involves a single cost. Despite this, good quality scientific evidence concerning the safety, effectiveness and cost-effectiveness of magnet therapy is scarce. The primary aim of the CAMBRA trial is to investigate the effectiveness of magnet therapy for relieving pain and inflammation in rheumatoid arthritis. Methods/Design The CAMBRA trial employs a randomised double-blind placebo-controlled crossover design. Participant will each wear four devices: a commercially available magnetic wrist strap; an attenuated wrist strap; a demagnetised wrist strap; and a copper bracelet. Device will be allocated in a randomised sequence and each worn for five weeks. The four treatment phases will be separated by wash out periods lasting one week. Both participants and researchers will be blind, as far as feasible, to the allocation of experimental and control devices. In total 69 participants will be recruited from general practices within the UK. Eligible patients will have a verified diagnosis of rheumatoid arthritis that is being managed using drugs, and will be experiencing chronic pain. Outcomes measured will include pain, inflammation, disease activity, physical function, medication use, affect, and health related costs. Data will be collected using questionnaires, diaries, manual

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

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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.

Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

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Kate M. O’Brien

Full Text Available ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

Science.gov (United States)

O’Brien, Kate M.; Williams, Amanda; Wiggers, John; Wolfenden, Luke; Yoong, Serene; Campbell, Elizabeth; Kamper, Steven J.; McAuley, James; Attia, John; Oldmeadow, Chris; Williams, Christopher M.

2016-01-01

ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to. PMID:27683839

Effectiveness of different exercises and stretching physiotherapy on pain and movement in patellofemoral pain syndrome: a randomized controlled trial.

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Moyano, F Revelles; Valenza, M C; Martin, L Martin; Caballero, Y Castellote; Gonzalez-Jimenez, E; Demet, G Valenza

2013-05-01

To compare the effectiveness of proprioceptive neuromuscular facilitation combined with exercise, classic stretching physiotherapy intervention, and educational intervention at improving patient function and pain in patients with patellofemoral pain syndrome. Randomized, controlled, blind trial over four months. Urban population, Spain. Patients undergoing primary care for retropatellar pain. Subjects were allocated on three different treatment options: a proprioceptive neuromuscular facilitation and aerobic exercise group, a classic stretching group, and a control treatment were applied over four months under the supervision of a physiotherapist. Knee Society Score, pain reported (Visual analogue scale) and knee range of motion. Assessments were completed at baseline and after four months. 74 patients were enrolled in the study and distributed between groups. Both the proprioceptive neuromuscular facilitation and classic stretching group showed significant changes in all variables after four months intervention (p < 0.001). The difference in mean Kujala knee score changes between groups (classic stretching group vs. proprioceptive neuromuscular facilitation group vs. control group) at four months was -24.05 (95% confidence interval (CI) -30.19, -17.90), p ≤ 0.001; vs. -39.03 (95% confidence interval (CI) -42.5, -35.5), p ≤ 0.001; vs. -0.238 (95% confidence interval (CI) -1.2, 0.726), p = 0.621, respectively. A proprioceptive neuromuscular facilitation intervention protocol combined with aerobic exercise showed a better outcome than a classic stretching protocol after four months.

Non-pharmacological interventions during childbirth for pain relief, anxiety, and neuroendocrine stress parameters: A randomized controlled trial.

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Henrique, Angelita José; Gabrielloni, Maria Cristina; Rodney, Patricia; Barbieri, Márcia

2018-03-07

This study aimed to investigate the effect of warm shower hydrotherapy and perineal exercises with a ball on pain, anxiety, and neuroendocrine stress parameters during childbirth. This randomized controlled trial was conducted with 128 women during childbirth, admitted for hospital birth in São Paulo, Brazil, from June 2013 to February 2014. The participants were randomly assigned into one of the following intervention groups: received warm shower hydrotherapy (GA); performed perineal exercises with a ball (GB); and combined intervention group, which received warm shower hydrotherapy and perineal exercises with a ball (GC) (n = 39). Pre-and post-intervention parameters were evaluated using visual analogue scales for pain and anxiety, and salivary samples were collected for the stress hormones analysis. Pain, anxiety, and epinephrine release decreased in the group performing perineal exercises with a ball (GB). β-endorphin levels increased in this group (GB) after the intervention and showed significant difference in capacity to cause this effect (P = .007). However, no significant differences were observed in cortisol, epinephrine, and norepinephrine levels. Warm showers and perineal exercises could be considered as adjunct therapy for women suffering from pain, anxiety, and stress during childbirth. Clinical Trial Registry RBR-84xprt. © 2018 John Wiley & Sons Australia, Ltd.

Topical Ketamine 10% for Neuropathic Pain in Spinal Cord Injury Patients: An Open-Label Trial.

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Rabi, Joseph; Minori, Joshua; Abad, Hasan; Lee, Ray; Gittler, Michelle

2016-01-01

Topical ketamine, an N-methyl-D-aspartate antagonist, has been shown to be effective in certain neuropathic pain syndromes. The objective of this study was to determine the efficacy of topical ketamine in spinal cord injury patients with neuropathic pain. An open label trial enrolled five subjects at an outpatient rehabilitation hospital with traumatic spinal cord injuries who had neuropathic pain at or below the level of injury. Subjects applied topical ketamine 10% three times a day for a two-week duration. Subjects recorded their numerical pain score-ranging from 0 to 10, with 0 representing "no pain, 5 representing "moderate pain," and 10 being described as "worst possible pain"-in a journal at the time of application of topical ketamine and one hour after application. Using a numerical pain scale allows for something as subjective as pain to be given an objective quantification. Subjects also recorded any occurrence of adverse events and level of satisfaction. All five subjects had a decrease in their numerical pain scale by the end of two weeks, ranging from 14% to 63%. The duration ranged from one hour in one subject to the next application in other subjects. There were no adverse effects. Overall, four out of the five subjects stated they were satisfied. Topical ketamine 10% is an effective neuropathic pain medicine in patients with spinal cord injuries; however, further studies need to be done with a placebo and larger sample size. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain.

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Girandola, Robert N; Srivastava, Shalini; Loullis, Costas C

2016-04-06

To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg). The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief. Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours. The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study. Clinical trials.gov NCT02417506 . 21 January 2015.

Calcitonin gene-related peptide and pain

DEFF Research Database (Denmark)

Schou, Wendy Sophie; Ashina, Sait; Amin, Faisal Mohammad

2017-01-01

and cerebrospinal fluid in subjects with musculoskeletal pain. A randomized clinical trial on monoclonal antibody, which selectively binds to and inhibits the activity of CGRP (galcanezumab) in patients with osteoarthritis knee pain, failed to demonstrate improvement of pain compared with placebo. No studies......BACKGROUND: Calcitonin gene-related peptide (CGRP) is widely distributed in nociceptive pathways in human peripheral and central nervous system and its receptors are also expressed in pain pathways. CGRP is involved in migraine pathophysiology but its role in non-headache pain has not been...... clarified. METHODS: We performed a systematic literature search on PubMed, Embase and ClinicalTrials.gov for articles on CGRP and non-headache pain covering human studies including experimental studies and randomized clinical trials. RESULTS: The literature search identified 375 citations of which 50...

Core outcome measurement instruments for clinical trials in nonspecific low back pain

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Chiarotto, Alessandro; Boers, Maarten; Deyo, Richard A.; Buchbinder, Rachelle; Corbin, Terry P.; Costa, Leonardo O.P.; Foster, Nadine E.; Grotle, Margreth; Koes, Bart W.; Kovacs, Francisco M.; Lin, C.-W. Christine; Maher, Chris G.; Pearson, Adam M.; Peul, Wilco C.; Schoene, Mark L.; Turk, Dennis C.; van Tulder, Maurits W.; Terwee, Caroline B.; Ostelo, Raymond W.

2018-01-01

Abstract To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments. PMID:29194127

Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial

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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.

Pain following foraminal enlargement in mandibular molars with necrosis and apical periodontitis: A randomized controlled trial.

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Saini, H R; Sangwan, P; Sangwan, A

2016-12-01

This randomized controlled trial was conducted to evaluate the effect of foraminal enlargement during chemomechanical root canal preparation on postoperative pain. Seventy mandibular first molars with asymptomatic pulp necrosis and chronic apical periodontitis were randomized into two groups - foraminal enlargement (FE) and conventional nonforaminal enlargement (NFE). Canals were prepared according to the respective protocols, and the teeth were restored temporarily. Postoperatively, the patients were prescribed ibuprofen 400 mg, to be taken if required. Pain experience and analgesic intake were recorded for 7 days following chemomechanical preparation. The data were analysed using Mann-Whitney U-test and chi-square tests. Pain experience was higher with foraminal enlargement than when using a conventional technique. A significant difference was observed in postoperative pain during the first 4 days and the sixth day (P  0.05). Enlargement of the apical foramen during root canal treatment increased the incidence and intensity of postoperative pain. © 2015 International Endodontic Journal. Published by John Wiley & Sons Ltd.

Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

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Freeman Liv M

2012-07-01

effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day. Trial registration number Dutch Trial Register NTR2551, http://www.trialregister.nl

Acupuncture or low frequency infrared treatment for low back pain in Chinese patients: a discrete choice experiment.

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Li-Chia Chen

Full Text Available Acupuncture is a popular but controversial treatment option for low back pain. In China, it is practised as traditional Chinese medicine; other treatment strategies for low back pain are commonly practised as Western medicine. Research on patient preference for low back-pain treatment options has been mainly conducted in Western countries and is limited to a willingness-to-pay approach. A stated-preference, discrete choice experiment was conducted to determine Chinese patient preferences and trade-offs for acupuncture and low frequency infrared treatment in low back pain from September 2011 to August 2012 after approval from the Department of Scientific Research in the study settings. Eight-six adult outpatients who visited the 'traditional medicine department' at a traditional Chinese medicine hospital and the 'rehabilitation department' at a Western medicine hospital in Guangdong Province of China for chronic low back pain during study period participated in an interview survey. A questionnaire containing 10 scenarios (5 attributes in each scenario was used to ask participants' preference for acupuncture, low frequency infrared treatment or neither option. Validated responses were analysed using a nested-logit model. The decision on whether to receive a therapy was not associated with the expected utility of receiving therapy, female gender and higher out-of-pocket payment significantly decreased chance to receive treatments. Of the utility of receiving either acupuncture or low frequency infrared treatment, the treatment sensation was the most important attribute as an indicator of treatment efficacy, followed by the maximum efficacy, maintenance duration and onset of efficacy, and the out-of-pocket payment. The willingness-to-pay for acupuncture and low frequency infrared treatment were about $618.6 and $592.4 USD per course respectively, demonstrated patients' demand of pain management. The treatment sensation was regarded as an indicator

Design and rational for the precision medicine guided treatment for cancer pain pragmatic clinical trial.

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Mosley, Scott A; Hicks, J Kevin; Portman, Diane G; Donovan, Kristine A; Gopalan, Priya; Schmit, Jessica; Starr, Jason; Silver, Natalie; Gong, Yan; Langaee, Taimour; Clare-Salzler, Michael; Starostik, Petr; Chang, Young D; Rajasekhara, Sahana; Smith, Joshua E; Soares, Heloisa P; George, Thomas J; McLeod, Howard L; Cavallari, Larisa H

2018-05-01

Pain is one of the most burdensome symptoms associated with cancer and its treatment, and opioids are the cornerstone of pain management. Opioid therapy is empirically selected, and patients often require adjustments in therapy to effectively alleviate pain or ameliorate adverse drug effects that interfere with quality of life. There are data suggesting CYP2D6 genotype may contribute to inter-patient variability in response to opioids through its effects on opioid metabolism. Therefore, we aim to determine if CYP2D6 genotype-guided opioid prescribing results in greater reductions in pain and symptom severity and interference with daily living compared to a conventional prescribing approach in patients with cancer. Patients with solid tumors with metastasis and a self-reported pain score ≥ 4/10 are eligible for enrollment and randomized to a genotype-guided or conventional pain management strategy. For patients in the genotype-guided arm, CYP2D6 genotype information is integrated into opioid prescribing decisions. Patients are asked to complete questionnaires regarding their pain, symptoms, and quality of life at baseline and 2, 4, 6, and 8 weeks after enrollment. The primary endpoint is differential change in pain severity by treatment strategy (genotype-guided versus conventional pain management). Secondary endpoints include change in pain and symptom interference with daily living. Pharmacogenetic-guided opioid selection for cancer pain management has potential clinical utility, but current evidence is limited to retrospective and observational studies. Precision Medicine Guided Treatment for Cancer Pain is a pragmatic clinical trial that seeks to determine the utility of CYP2D6 genotype-guided opioid prescribing in patients with cancer. Copyright © 2018 Elsevier Inc. All rights reserved.

A bio-psycho-social exercise program (RÜCKGEWINN for chronic low back pain in rehabilitation aftercare - Study protocol for a randomised controlled trial

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Pfeifer Klaus

2010-11-01

Full Text Available Abstract Background There is strong, internationally confirmed evidence for the short-term effectiveness of multimodal interdisciplinary specific treatment programs for chronic back pain. However, the verification of long-term sustainability of achieved effects is missing so far. For long-term improvement of pain and functional ability high intervention intensity or high volume seems to be necessary (> 100 therapy hours. Especially in chronic back pain rehabilitation, purposefully refined aftercare treatments offer the possibility to intensify positive effects or to increase their sustainability. However, quality assured goal-conscious specific aftercare programs for the rehabilitation of chronic back pain are absent. Methods/Design This study aims to examine the efficacy of a specially developed bio-psycho-social chronic back pain specific aftercare intervention (RÜCKGEWINN in comparison to the current usual aftercare (IRENA and a control group that is given an educational booklet addressing pain-conditioned functional ability and back pain episodes. Overall rehabilitation effects as well as predictors for compliance to the aftercare programs are analysed. Therefore, a multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation. Aftercare programs are assessed at ten month follow up after dismissal form rehabilitation. Discussion Special methodological and logistic challenges are to be mastered in this trial, which accrue from the interconnection of aftercare interventions to their residential district and the fact that the proportion of patients who take part in aftercare programs is low. The usability of the aftercare program is based on the transference into the routine care and is also reinforced by developed manuals with structured

Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial.

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Cambron, Jerrilyn A; Dexheimer, Jennifer M; Duarte, Manuel; Freels, Sally

2017-09-01

To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. Randomized controlled trial. Integrative medicine teaching clinic at a university. Adult subjects (N=225) with symptomatic low back pain of ≥3 months were recruited from a volunteer sample. Subjects were randomized into 1 of 3 treatment groups (shoe orthotic, plus, and waitlist groups). The shoe orthotic group received custom-made shoe orthotics. The plus group received custom-made orthotics plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage. The waitlist group received no care. The primary outcome measures were change in perceived back pain (numerical pain rating scale) and functional health status (Oswestry Disability Index) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months. After 6 weeks, all 3 groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus groups had significant within-group improvement in function. When compared with the waitlist group, the shoe orthotic group demonstrated significantly greater improvements in pain (Ppain (P=.3431). Group differences at 12 weeks and later were not significant. Six weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared with no treatment. The addition of chiropractic care led to higher improvements in function. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

An educational and physical program to reduce headache, neck/shoulder pain in a working community: a cluster-randomized controlled trial.

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Franco Mongini

Full Text Available Noninvasive physical management is often prescribed for headache and neck pain. Systematic reviews, however, indicate that the evidence of its efficacy is limited. Our aim was to evaluate the effectiveness of a workplace educational and physical program in reducing headache and neck/shoulder pain.Cluster-randomized controlled trial. All municipal workers of the City of Turin, Italy, were invited to participate. Those who agreed were randomly assigned, according to their departments, to the intervention group (IG or to the control group and were given diaries for the daily recording of pain episodes for 1 month (baseline. Subsequently, only the IG (119 departments, 923 workers began the physical and educational program, whereas the control group (117 departments, 990 workers did not receive any intervention. All participants were again given diaries for the daily recording of pain episodes after 6 months of intervention. The primary outcome was the change in the frequency of headache (expressed as the proportion of subjects with a ≥50% reduction of frequency; responder rate; among the secondary outcomes there were the absolute reduction of the number of days per month with headache and neck/shoulder pain. Differences between the two groups were evaluated using mixed-effect regression models. The IG showed a higher responder rate [risk ratio, 95% confidence interval (CI] for headache (1.58; 1.28 to 1.92 and for neck/shoulder pain (1.53; 1.27 to 1.82, and a larger reduction of the days per month (95% CI with headache (-1.72; -2.40 to -1.04 and with neck/shoulder pain (-2.51; -3.56 to -1.47.The program effectively reduced headache and neck/shoulder pain in a large working community and appears to be easily transferable to primary-care settings. Further trials are needed to investigate the program effectiveness in a clinical setting, for highly selected patients suffering from specific headache types.ClinicalTrials.gov NCT00551980.

Adding ketamine to morphine for intravenous patient-controlled analgesia for acute postoperative pain: a qualitative review of randomized trials

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Carstensen, M; Møller, A M

2010-01-01

In experimental trials, ketamine has been shown to reduce hyperalgesia, prevent opioid tolerance, and lower morphine consumption. Clinical trials have found contradictory results. We performed a review of randomized, double-blinded clinical trials of ketamine added to opioid in i.v. patient......-controlled analgesia (PCA) for postoperative pain in order to clarify this controversy. Our primary aim was to compare the effectiveness and safety of postoperative administered ketamine in addition to opioid for i.v. PCA compared with i.v. PCA with opioid alone. Studies were identified from the Cochrane Library 2003...... of 4.5. Pain was assessed using visual analogue scales or verbal rating scales. Six studies showed significant improved postoperative analgesia with the addition of ketamine to opioids. Five studies showed no significant clinical improvement. For thoracic surgery, the addition of ketamine to opioid...

Protocol for Shoulder function training reducing musculoskeletal pain in shoulder and neck: a randomized controlled trial

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Andersen, Christoffer H; Andersen, Lars L; Mortensen, Ole S

2011-01-01

treated by physical therapists. The exact mechanism of neck pain is rarely revealed by clinical examination and the treatment has varied from passive rest to active treatments. 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. METHODS/DESIGN: A randomized controlled trial of 10 weeks duration is currently being conducted. Employed office workers with severe neck-shoulder pain are randomized to 3 × 20 min shoulder function training...... with training supervision or to a reference group receiving advice to stay physically active. Shoulder function training primarily focuses on the serratus anterior and lower trapezius muscle with only minimal activation the upper trapezius.An announcement was sent to the administrative section of the university...

Postoperative Pain after Endodontic Retreatment Using Rotary or Reciprocating Instruments: A Randomized Clinical Trial.

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Comparin, Daniel; Moreira, Edson Jorge Lima; Souza, Erick M; De-Deus, Gustavo; Arias, Ana; Silva, Emmanuel João Nogueira Leal

2017-07-01

The aim of this randomized clinical trial was to evaluate the influence of rotary or reciprocating retreatment techniques on the incidence, intensity, duration of postoperative pain, and medication intake. After power analysis calculations, 65 patients who needed endodontic retreatment were randomly assigned to 1 of 2 groups according to the instrumentation system used: Mtwo (VDW, Munich, Germany) or Reciproc (VDW). Retreatments were performed in a single visit by an endodontic specialist. Participants were asked to rate the incidence and intensity of the postoperative pain on a verbal rating scale 24, 48, and 72 hours after treatment. Patients were also asked to record the number of prescribed analgesic medication tablets (ibuprofen 400 mg) taken. A logistic regression analysis was used to assess both the incidence and duration of pain. Differences in the intensity of pain were analyzed using the ordinal (linear) chi-square test, and the Mann-Whitney U test was used to assess differences in the intake of analgesic medication between groups. No statistically significant difference was found among the 2 groups in relation to postoperative pain or analgesic medication intake at the 3 time points assessed (P > .05). Multivariate analysis showed a significantly higher incidence of pain after 24 hours when preoperative pain was present and a significantly longer duration of pain for men than women independently of the retreatment technique used. The reciprocating system and the continuous rotary system were found to be equivalent regarding the incidence, intensity, duration of postoperative pain, and intake of analgesic medication. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge.

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Andrade, Nicholas S; Flynn, John P; Bartanusz, Viktor

2013-11-01

After decades of clinical research, the role of surgery for chronic nonspecific low back pain (CNLBP) remains equivocal. Despite significant intellectual, human, and economic investments into randomized controlled trials (RCTs) in the past two decades, the role of surgery in the treatment for CNLBP has not been clarified. To delineate the historical research agenda of surgical RCTs for CNLBP performed between 1993 and 2012 investigating whether conclusions from earlier published trials influenced the choice of research questions of subsequent RCTs on elucidating the role of surgery in the management of CNLBP. Literature review. We searched the literature for all RCTs involving surgery for CNLBP. We reviewed relevant studies to identify the study question, comparator arms, and sample size. Randomized controlled trials were classified as "indication" trials if they evaluated the effectiveness of surgical therapy versus nonoperative care or as "technical" if they compared different surgical techniques, adjuncts, or procedures. We used citation analysis to determine the impact of trials on subsequent research in the field. Altogether 33 technical RCTs (3,790 patients) and 6 indication RCTs (981 patients) have been performed. Since 2007, despite the unclear benefits of surgery reported by the first four indication trials published in 2001 to 2006, technical trials have continued to predominate (16 vs. 2). Of the technical trials, types of instrumentation (13 trials, 1,332 patients), bone graft materials and substitutes (11 trials, 833 patients), and disc arthroplasty versus fusion (5 trials, 1,337 patients) were the most common comparisons made. Surgeon authors have predominantly cited one of the indication trials that reported more favorable results for surgery, despite a lack of superior methodology or sample size. Trials evaluating bone morphogenic protein, instrumentation, and disc arthroplasty were all cited more frequently than the largest trial of surgical versus

Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial

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Johannsen, Maja; O Connor, Maja; OToole, Mia Skytte

2016-01-01

PURPOSE: To assess the efficacy of mindfulness-based cognitive therapy (MBCT) for late post-treatment pain in women treated for primary breast cancer. METHODS: A randomized wait list-controlled trial was conducted with 129 women treated for breast cancer reporting post-treatment pain (score ≥ 3...... pain rehabilitation strategy for women treated for breast cancer. In addition, the effect on neuropathic pain, a pain type reported by women treated for breast cancer, further suggests the potential of MBCT but should be considered preliminary....

Low-Dose Intravenous Immunoglobulin Treatment for Long-Standing Complex Regional Pain Syndrome: A Randomized Trial.

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Goebel, Andreas; Bisla, Jatinder; Carganillo, Roy; Frank, Bernhard; Gupta, Rima; Kelly, Joanna; McCabe, Candy; Murphy, Caroline; Padfield, Nick; Phillips, Ceri; Sanders, Mark; Serpell, Mick; Shenker, Nick; Shoukrey, Karim; Wyatt, Lynne; Ambler, Gareth

2017-10-03

Two small trials suggest that low-dose intravenous immunoglobulin (IVIg) may improve the symptoms of complex regional pain syndrome (CRPS), a rare posttraumatic pain condition. To confirm the efficacy of low-dose IVIg compared with placebo in reducing pain during a 6-week period in adult patients who had CRPS from 1 to 5 years. 1:1 parallel, randomized, placebo-controlled, multicenter trial for 6 weeks, with an optional 6-week open extension. Patients were randomly assigned to 1 of 2 study groups between 27 August 2013 and 28 October 2015; the last patient completed follow-up on 21 March 2016. Patients, providers, researchers, and outcome assessors were blinded to treatment assignment. (ISRCTN42179756). 7 secondary and tertiary care pain management centers in the United Kingdom. 111 patients with moderate or severe CRPS of 1 to 5 years' duration. IVIg, 0.5 g/kg of body weight, or visually indistinguishable placebo of 0.1% albumin in saline on days 1 and 22 after randomization. The primary outcome was 24-hour average pain intensity, measured daily between days 6 and 42, on an 11-point (0- to 10-point) rating scale. Secondary outcomes were pain interference and quality of life. The primary analysis sample consisted of 108 eligible patients, 103 of whom had outcome data. Mean (average) pain scores were 6.9 points (SD, 1.5) for placebo and 7.2 points (SD, 1.3) for IVIg. The adjusted difference in means was 0.27 (95% CI, -0.25 to 0.80; P = 0.30), which excluded the prespecified, clinically important difference of -1.2. No statistically significant differences in secondary outcomes were found between the groups. In the open extension, 12 of the 67 patients (18%) who received 2 IVIg infusions had pain reduction of at least 2 points compared with their baseline score. Two patients in the blinded phase (1 in the placebo and 1 in the IVIg group) and 4 in the open IVIg phase had serious events. Results do not apply to patients who have had CRPS for less than 1 year or more

Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial

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2012-01-01

Background Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents. Methods/Design This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months. Discussion This study is designed to investigate the effectiveness of patient education compared with patient

Information and Choice of A-Level Subjects: A Cluster Randomised Controlled Trial with Linked Administrative Data

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Davies, Peter; Davies, Neil M.; Qiu, Tian

2017-01-01

We estimated the effects of an intervention which provided information about graduate wages to 5593 students in England, using a blinded cluster randomised controlled trial in 50 schools (registration: AEARCTR-0000468). Our primary outcome was students' choice of A-level subjects at age 16. We also recorded the students' expectations of future…

Social redistribution of pain and money.

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Story, Giles W; Vlaev, Ivo; Metcalfe, Robert D; Crockett, Molly J; Kurth-Nelson, Zeb; Darzi, Ara; Dolan, Raymond J

2015-10-30

People show empathic responses to others' pain, yet how they choose to apportion pain between themselves and others is not well understood. To address this question, we observed choices to reapportion social allocations of painful stimuli and, for comparison, also elicited equivalent choices with money. On average people sought to equalize allocations of both pain and money, in a manner which indicated that inequality carried an increasing marginal cost. Preferences for pain were more altruistic than for money, with several participants assigning more than half the pain to themselves. Our data indicate that, given concern for others, the fundamental principle of diminishing marginal utility motivates spreading costs across individuals. A model incorporating this assumption outperformed existing models of social utility in explaining the data. By implementing selected allocations for real, we also found that while inequality per se did not influence pain perception, altruistic behavior had an intrinsic analgesic effect for the recipient.

Intermittent Cervical Traction for Treating Neck Pain: A Meta-analysis of Randomized Controlled Trials.

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Yang, Jheng-Dao; Tam, Ka-Wai; Huang, Tsai-Wei; Huang, Shih-Wei; Liou, Tsan-Hon; Chen, Hung-Chou

2017-07-01

A meta-analysis. The aim of this study was to perform a comprehensive search of current literature and conduct a meta-analysis of randomized controlled trials (RCTs) to assess the neck pain relieving effect of intermittent cervical traction (ICT). Neck pain is a common and disabling problem with a high prevalence in general population. It causes a considerable burden on the health care system with a substantial expenditure. ICT is a common component of physical therapy for neck pain in the outpatient clinic. However, the evidence regarding the effectiveness of ICT for neck pain is insufficient. Data were obtained from the PubMed, Cochrane Library, Embase, and Scopus databases from the database inception date to July 02, 2016. RCTs reporting the effects of ICT on neck pain, including those comparing the effects of ICT with those of a placebo treatment, were included. Two reviewers independently reviewed the studies, conducted a risk of bias assessment, and extracted data. The data were pooled in a meta-analysis by using a random-effects model. The meta-analysis included seven RCTs. The results indicated that patients who received ICT for neck pain had significantly lower pain scores than those receiving placebos did immediately after treatment (standardized mean difference = -0.26, 95% confidence interval = -0.46 to -0.07). The pain scores during the follow-up period and the neck disability index scores immediately after treatment and during the follow-up period did not differ significantly. ICT may have a short-term neck pain-relieving effect. Some risks of bias were noted in the included studies, reducing the evidence level of this meta-analysis. Additional high-quality RCTs are required to clarify the long-term effects of ICT on neck pain. 1.

Barriers to Physical Activity in Low Back Pain Patients following Rehabilitation: A Secondary Analysis of a Randomized Controlled Trial

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Andrea Schaller

2017-01-01

Full Text Available Background. Promoting health-enhancing physical activity following rehabilitation is a well-known challenge. This study analysed the barriers to leisure time activity among low back pain patients. Methods. A subset of 192 low back pain patients who participated in a randomized controlled trial promoting physical activity was analysed. Physical activity, barriers, and sociodemographic and indication-related variables were assessed by a questionnaire. Differences in barriers between active and inactive participants were tested by Pearson’s chi squared test. A logistic regression model was fitted to identify influencing factors on physical activity at six months following rehabilitation. Results. Inactive and active participants differed significantly in nine of the 19 barriers assessed. The adjusted regression model showed associations of level of education (OR = 5.366 [1.563; 18.425]; p value = 0.008 and fear of pain (OR = 0.612 [0.421; 0.889]; p value = 0.010 with physical activity. The barriers included in the model failed to show any statistically significant association after adjustment for sociodemographic factors. Conclusions. Low back pain patients especially with a low level of education and fear of pain seem to need tailored support in overcoming barriers to physical activity. This study is registered at German Clinical Trials Register (DRKS00004878.

Pharmacological Treatment of Painful HIV-Associated Sensory Neuropathy: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

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Phillips, Tudor J. C.; Cherry, Catherine L.; Cox, Sarah; Marshall, Sarah J.; Rice, Andrew S. C.

2010-01-01

Background Significant pain from HIV-associated sensory neuropathy (HIV-SN) affects ∼40% of HIV infected individuals treated with antiretroviral therapy (ART). The prevalence of HIV-SN has increased despite the more widespread use of ART. With the global HIV prevalence estimated at 33 million, and with infected individuals gaining increased access to ART, painful HIV-SN represents a large and expanding world health problem. There is an urgent need to develop effective pain management strategies for this condition. Method and Findings Objective: To evaluate the clinical effectiveness of analgesics in treating painful HIV-SN. Design: Systematic review and meta-analysis. Data sources: Medline, Cochrane central register of controlled trials, www.clinicaltrials.gov, www.controlled-trials.com and the reference lists of retrieved articles. Selection criteria: Prospective, double-blinded, randomised controlled trials (RCTs) investigating the pharmacological treatment of painful HIV-SN with sufficient quality assessed using a modified Jadad scoring method. Review methods: Four authors assessed the eligibility of articles for inclusion. Agreement of inclusion was reached by consensus and arbitration. Two authors conducted data extraction and analysis. Dichotomous outcome measures (≥30% and ≥50% pain reduction) were sought from RCTs reporting interventions with statistically significant efficacies greater than placebo. These data were used to calculate RR and NNT values. Results Of 44 studies identified, 19 were RCTs. Of these, 14 fulfilled the inclusion criteria. Interventions demonstrating greater efficacy than placebo were smoked cannabis NNT 3.38 95%CI(1.38 to 4.10), topical capsaicin 8%, and recombinant human nerve growth factor (rhNGF). No superiority over placebo was reported in RCTs that examined amitriptyline (100mg/day), gabapentin (2.4g/day), pregabalin (1200mg/day), prosaptide (16mg/day), peptide-T (6mg/day), acetyl-L-carnitine (1g/day), mexilitine (600mg

Pharmacological treatment of painful HIV-associated sensory neuropathy: a systematic review and meta-analysis of randomised controlled trials.

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Tudor J C Phillips

Full Text Available BACKGROUND: Significant pain from HIV-associated sensory neuropathy (HIV-SN affects ∼40% of HIV infected individuals treated with antiretroviral therapy (ART. The prevalence of HIV-SN has increased despite the more widespread use of ART. With the global HIV prevalence estimated at 33 million, and with infected individuals gaining increased access to ART, painful HIV-SN represents a large and expanding world health problem. There is an urgent need to develop effective pain management strategies for this condition. METHOD AND FINDINGS: OBJECTIVE: To evaluate the clinical effectiveness of analgesics in treating painful HIV-SN. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Cochrane central register of controlled trials, www.clinicaltrials.gov, www.controlled-trials.com and the reference lists of retrieved articles. SELECTION CRITERIA: Prospective, double-blinded, randomised controlled trials (RCTs investigating the pharmacological treatment of painful HIV-SN with sufficient quality assessed using a modified Jadad scoring method. REVIEW METHODS: Four authors assessed the eligibility of articles for inclusion. Agreement of inclusion was reached by consensus and arbitration. Two authors conducted data extraction and analysis. Dichotomous outcome measures (≥ 30% and ≥ 50% pain reduction were sought from RCTs reporting interventions with statistically significant efficacies greater than placebo. These data were used to calculate RR and NNT values. RESULTS: Of 44 studies identified, 19 were RCTs. Of these, 14 fulfilled the inclusion criteria. Interventions demonstrating greater efficacy than placebo were smoked cannabis NNT 3.38 95%CI(1.38 to 4.10, topical capsaicin 8%, and recombinant human nerve growth factor (rhNGF. No superiority over placebo was reported in RCTs that examined amitriptyline (100mg/day, gabapentin (2.4 g/day, pregabalin (1200 mg/day, prosaptide (16 mg/day, peptide-T (6 mg/day, acetyl-L-carnitine (1g

Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale.

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Kean, Jacob; Monahan, Patrick O; Kroenke, Kurt; Wu, Jingwei; Yu, Zhangsheng; Stump, Tim E; Krebs, Erin E

2016-04-01

To compare the sensitivity to change and the responsiveness to intervention of the PROMIS Pain Interference short forms, Brief Pain Inventory (BPI), 3-item PEG scale, and SF-36 Bodily Pain subscale in a sample of patients with persistent musculoskeletal pain of moderate severity. Standardized response means, standardized effect sizes, and receiver operating curve analyses were used to assess change between baseline and 3-month assessments in 250 participants who participated in a randomized clinical effectiveness trial of collaborative telecare management for moderate to severe and persistent musculoskeletal pain. The BPI, PEG, and SF-36 Bodily Pain measures were more sensitive to patient-reported global change than the PROMIS Pain Interference short forms, especially for the clinically improved group, for which the change detected by the PROMIS short forms was not statistically significant. The BPI was more responsive to the clinical intervention than the SF-36 Bodily Pain and PROMIS Pain Interference measures. Post hoc analyses exploring these findings did not suggest that differences in content or rating scale structure (number of response options or anchoring language) adequately explained the observed differences in the detection of change. In this clinical trial, the BPI and PEG measures were better able to detect change than the SF-36 Bodily Pain and PROMIS Pain Interference measures.

Conditioned pain modulation: a predictor for development and treatment of neuropathic pain.

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Granovsky, Yelena

2013-09-01

Psychophysical evaluation of endogenous pain inhibition via conditioned pain modulation (CPM) represents a new generation of laboratory tests for pain assessment. In this review we discuss recent findings on CPM in neuropathic pain and refer to psychophysical, neurophysiological, and methodological aspects of its clinical implications. Typically, chronic neuropathic pain patients express less efficient CPM, to the extent that incidence of acquiring neuropathic pain (e.g. post-surgery) and its intensity can be predicted by a pre-surgery CPM assessment. Moreover, pre-treatment CPM evaluation may assist in the correct choice of serotonin-noradrenalin reuptake inhibitor analgesic agents for individual patients. Evaluation of pain modulation capabilities can serve as a step forward in individualizing pain medicine.

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

Assessment of postoperative pain after reciprocating or rotary NiTi instrumentation of root canals: a randomized, controlled clinical trial.

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Relvas, João Bosko Formigas; Bastos, Mariana Mena Barreto; Marques, André Augusto Franco; Garrido, Angela Delfina Bitencourt; Sponchiado, Emílio Carlos

2016-11-01

The aim of this study was to assess postoperative pain in a prospective randomized clinical trial comparing two groups, using the Reciproc® system in one group and the ProTaper® rotary system in the other. The study included 78 male patients, aged 18-64 years (mean age of 26 years), with asymptomatic pulp necrosis in mandibular molar teeth (n = 78). The single-session endodontic treatment was performed by a single operator specialized in Endodontics. Mechanical preparation of the root canals was performed using the ProTaper® and Reciproc® instrumentation techniques. Postoperative pain was recorded using a verbal rating scale (VRS) and verbal description with well-defined categories at the three following time intervals: 24 h, 72 h, and 7 days after the endodontic procedure. The assessment of postoperative pain was recorded as no pain, mild pain, moderate pain, and severe pain or flare-up. Data were analyzed using the nonparametric Mann-Whitney test with the aid of the STATA® software. The incidence of postoperative pain in the ProTaper group (PT) 24 h after the endodontic procedure was 17.9 and 5.1 % after 72 h. In the Reciproc group (RP), the incidence after 24 h was 15.3 and 2.5 % after 72 h. No patients presented severe pain at the time intervals assessed. No significant difference (p > 0.05) in postoperative pain was found between the ProTaper® and Reciproc® instrumentation technique during endodontic treatment in this study. According to our findings and the results of the clinical trial, the occurrence of postoperative pain was low and similar between the reciprocating and rotary techniques during the time intervals assessed. These results are different from basic laboratory studies that affirm that the reciprocating techniques tend to promote more postoperative pain since extrusion of debris is greater.

Transcutaneous electrical nerve stimulation (TENS reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial

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Licia Santos Santana

2016-01-01

Full Text Available Questions: In the active phase of the first stage of labour, does transcutaneous electrical nerve stimulation (TENS relieve pain or change its location? Does TENS delay the request for neuraxial analgesia during labour? Does TENS produce any harmful effects in the mother or the foetus? Are women in labour satisfied with the care provided? Design: Randomised trial with concealed allocation, assessor blinding for some outcomes, and intention-to-treat analysis. Participants: Forty-six low-risk, primigravida parturients with a gestational age > 37 weeks, cervical dilation of 4 cm, and without the use of any medications from hospital admission until randomisation. Intervention: The principal investigator applied TENS to the experimental group for 30 minutes starting at the beginning of the active phase of labour. A second investigator assessed the outcomes in both the control and experimental groups. Both groups received routine perinatal care. Outcome measures: The primary outcome was pain severity after the intervention period, which was assessed using the 100-mm visual analogue scale. Secondary outcomes included: pain location, duration of the active phase of labour, time to pharmacological labour analgesia, mode of birth, neonatal outcomes, and the participant's satisfaction with the care provided. Results: After the intervention, a significant mean difference in change in pain of 15 mm was observed favouring the experimental group (95% CI 2 to 27. The application of TENS did not alter the location or distribution of the pain. The mean time to pharmacological analgesia after the intervention was 5.0 hours (95% CI 4.1 to 5.9 longer in the experimental group. The intervention did not significantly impact the other maternal and neonatal outcomes. Participants in both groups were satisfied with the care provided during labour. Conclusion: TENS produces a significant decrease in pain during labour and postpones the need for pharmacological

The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations.

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Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin

2016-09-01

Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy's efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = -0.79] and anxiety (SMD = -0.57) compared to active comparators. Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. © 2016 American Academy of Pain Medicine.

Problem Solving Skills Training for Parents of Children with Chronic Pain: A Pilot Randomized Controlled Trial

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

2016-01-01

This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem solving skills training (PSST) compared to treatment as usual (TAU) 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 10–17 years with chronic pain randomized to PSST (n = 31) or TAU (n = 30). Parents receiving PSST participated in 4–6 individual sessions of training in problem solving skills. Outcomes were assessed at pre-treatment, immediately post-treatment, and at 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 post-treatment 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 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youth 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. PMID:26845525

Video-game based exercises for older people with chronic low back pain: a protocol for a feasibility randomised controlled trial (the GAMEBACK trial).

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Zadro, Joshua Robert; Shirley, Debra; Simic, Milena; Mousavi, Seyed Javad; Ceprnja, Dragana; Maka, Katherine; Ferreira, Paulo

2017-06-01

To investigate the feasibility of implementing a video-game exercise programme for older people with chronic low back pain (LBP). Single-centred single-blinded randomised controlled trial (RCT). Physiotherapy outpatient department in a public hospital in Western Sydney, Australia. We will recruit 60 participants over 55 years old with chronic LBP from the waiting list. Participants will be randomised to receive video-game exercise (n=30) or to remain on the waiting list (n=30) for 8 weeks, with follow up at 3 and 6 months. Participants engaging in video-game exercises will be unsupervised and will complete video-game exercise for 60minutes, 3 times per week. Participants allocated to remain on the waiting list will be encouraged to maintain their usual levels of physical activity. The primary outcomes for this feasibility study will be study processes (recruitment and response rates, adherence to and experience with the intervention, and incidence of adverse events) relevant to the future design of a large RCT. Estimates of treatment efficacy (point estimates and 95% confidence intervals) on pain self-efficacy, care seeking, physical activity, fear of movement/re-injury, pain, physical function, disability, falls-efficacy, strength, and walking speed, will be our secondary outcome measures. Recruitment for this trial began in November 2015. This study describes the rationale and processes of a feasibility study investigating a video-game exercise programme for older people with chronic LBP. Results from the feasibility study will inform on the design and sample required for a large multicentre RCT. Australian New Zealand Clinical Trials Registry: ACTRN12615000703505. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

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

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Thiyapha Verayachankul

2016-01-01

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

Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial.

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Licciardone, John C; Gatchel, Robert J; Aryal, Subhash

2016-03-01

Little is known about recovery after spinal manipulation in patients with low back pain (LBP). To assess recovery from chronic LBP after a short regimen of osteopathic manipulative treatment (OMT) in a responder analysis of the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. A randomized double-blind, sham-controlled trial was conducted to determine the efficacy of 6 OMT sessions over 8 weeks. Recovery was assessed at week 12 using a composite measure of pain recovery (10 mm or less on a 100-mm visual analog scale) and functional recovery (2 or less on the Roland-Morris Disability Questionnaire for back-specific functioning). The RRs and numbers-needed-to-treat (NNTs) for recovery with OMT were measured, and corresponding cumulative distribution functions were plotted according to baseline LBP intensity and back-specific functioning. Multiple logistic regression was used to compute the OR for recovery with OMT while simultaneously controlling for potential confounders. Sensitivity analyses were performed to corroborate the primary results. There were 345 patients who met neither of the recovery criteria at baseline in the primary analyses and 433 patients who met neither or only 1 of these criteria in the sensitivity analyses. There was a large treatment effect for recovery with OMT (RR, 2.36; 95% CI, 1.31-4.24; P=.003), which was associated with a clinically relevant NNT (8.9; 95% CI, 5.4-25.5). This significant finding persisted after adjustment for potential confounders (OR, 2.92; 95% CI, 1.43-5.97; P=.003). There was also a significant interaction effect between OMT and comorbid depression (P=.02), indicating that patients without depression were more likely to recover from chronic LBP with OMT (RR, 3.21; 95% CI, 1.59-6.50; Pback-specific dysfunction at baseline. Similar results were observed in the sensitivity analyses. The OMT regimen was associated with significant and clinically relevant measures for recovery from chronic LBP. A

Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial.

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Mejuto-Vázquez, María J; Salom-Moreno, Jaime; Ortega-Santiago, Ricardo; Truyols-Domínguez, Sebastián; Fernández-de-Las-Peñas, César

2014-04-01

Randomized clinical trial. To determine the effects of trigger point dry needling (TrPDN) on neck pain, widespread pressure pain sensitivity, and cervical range of motion in patients with acute mechanical neck pain and active trigger points in the upper trapezius muscle. TrPDN seems to be effective for decreasing pain in individuals with upper-quadrant pain syndromes. Potential effects of TrPDN for decreasing pain and sensitization in individuals with acute mechanical neck pain are needed. Methods Seventeen patients (53% female) were randomly assigned to 1 of 2 groups: a single session of TrPDN or no intervention (waiting list). Pressure pain thresholds over the C5-6 zygapophyseal joint, second metacarpal, and tibialis anterior muscle; neck pain intensity; and cervical spine range-of-motion data were collected at baseline (pretreatment) and 10 minutes and 1 week after the intervention by an assessor blinded to the treatment allocation of the patient. Mixed-model analyses of variance were used to examine the effects of treatment on each outcome variable. Patients treated with 1 session of TrPDN experienced greater decreases in neck pain, greater increases in pressure pain threshold, and higher increases in cervical range of motion than those who did not receive an intervention at both 10 minutes and 1 week after the intervention (Ppain intensity and widespread pressure pain sensitivity, and also increase active cervical range of motion, in patients with acute mechanical neck pain. Changes in pain, pressure pain threshold, and cervical range of motion surpassed their respective minimal detectable change values, supporting clinically relevant treatment effects. Level of Evidence Therapy, level 1b-.

A Preliminary Study on the Effect of Computer-Aided Designed and Manufactured Orthoses on Chronic Plantar Heel Pain.

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Gatt, Alfred; Grech, Mark; Chockalingam, Nachiappan; Formosa, Cynthia

2018-04-01

Chronic plantar heel pain (CPHP) is a significant, painful condition referring to a range of undifferentiated foot conditions that affect the heel of the foot. Participants presenting with CPHP of more than 6 months' duration were recruited on a first through the door basis. Computer-Aided Design and Computer-Aided Manufactured (CAD-CAM) orthoses were designed and constructed for each participant, then dispensed as per normal practice. Pre- and postintervention assessment of pain was performed at baseline and after 6 weeks of use, utilizing the pain subset of the Foot Function Index (FFI). There was a significant reduction in the mean pain scores for all participants in all constructs of the FFI. Total FFI score was also significant ( P = .003). CAD-CAM orthoses have the potential to become a treatment modality of choice in CPHP since they have resulted in a significant improvement in heel pain after only 6 weeks' use. Therapeutic, Level IV: Prospective, comparative trial.

Neuropathic Pain Medication Use Does Not Alter Outcomes of Spinal Cord Stimulation for Lower Extremity Pain.

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Maher, Dermot P; Martins, Yuri Chaves; Doshi, Tina; Bicket, Mark; Zhang, Kui; Hanna, George; Ahmed, Shihab

2018-01-01

Spinal cord stimulation (SCS) for the treatment of lower extremity pain is believed to the result of increased activity in the descending inhibitory and decreased activity in the ascending excitatory tracts. Evidence suggests that the analgesia afforded by SCS may be altered using certain neuropathic pain medications that also modulate neurotransmitters in these sensory tracts. We hypothesize that neuropathic pain medications may alter the response to SCS therapy. One hundred and fifteen subjects undergoing SCS therapy for lower extremity pain were retrospectively examined. The pharmacologic profile, including stable use of neuropathic and opioid medications, were recorded. Three separate logistic regression models examined the odds ratio of primary outcomes; a successful SCS trial, a 50% decrease in pain or a 50% reduction in opioid use one year after implant. Neither the use of opioids or neuropathic pain medications were associated with changes in the odds of a successful SCS trial or a 50% pain reduction. A higher dose of chronic opioids use prior to a trial was associated with greater odds of having a 50% reduction in opioid use following implant. OR 1.02, 95% CI 1.01-1.02, p-value neuropathic pain medications did not change the odds of either a successful SCS trial, or of experiencing a 50% reduction in pain at one year. The association between higher opioid doses and greater odds of a 50% reduction in opioid use may be the reflective of SCS's ability to reduce opioid reliance in chronic pain patients. © 2017 International Neuromodulation Society.

Statistical significance versus clinical importance: trials on exercise therapy for chronic low back pain as example.

NARCIS (Netherlands)

van Tulder, M.W.; Malmivaara, A.; Hayden, J.; Koes, B.

2007-01-01

STUDY DESIGN. Critical appraisal of the literature. OBJECIVES. The objective of this study was to assess if results of back pain trials are statistically significant and clinically important. SUMMARY OF BACKGROUND DATA. There seems to be a discrepancy between conclusions reported by authors and

Acupuncture for musculoskeletal pain: A meta-analysis and meta-regression of sham-controlled randomized clinical trials

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Yuan, Qi-ling; Wang, Peng; Liu, Liang; Sun, Fu; Cai, Yong-song; Wu, Wen-tao; Ye, Mao-lin; Ma, Jiang-tao; Xu, Bang-bang; Zhang, Yin-gang

2016-01-01

The aims of this systematic review were to study the analgesic effect of real acupuncture and to explore whether sham acupuncture (SA) type is related to the estimated effect of real acupuncture for musculoskeletal pain. Five databases were searched. The outcome was pain or disability immediately (≤1 week) following an intervention. Standardized mean differences (SMDs) with 95% confidence intervals were calculated. Meta-regression was used to explore possible sources of heterogeneity. Sixty-three studies (6382 individuals) were included. Eight condition types were included. The pooled effect size was moderate for pain relief (59 trials, 4980 individuals, SMD −0.61, 95% CI −0.76 to −0.47; P acupuncture has a moderate effect (approximate 12-point reduction on the 100-mm visual analogue scale) on musculoskeletal pain. SA type did not appear to be related to the estimated effect of real acupuncture. PMID:27471137

Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports

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R. Andrew Moore

2018-01-01

Full Text Available We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, n=519, gynaecological surgery (3 trials, n=679, and dysmenorrhoea (2 trials, n=711 conducted in 1988–1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal. Greater methodological information in CSRs contributed to lesser risk of bias than published trials. Numbers needed to treat (NNT from CSRs for all six postoperative trials for at least 50% of maximum pain relief over 6 h were 2.2 (95% confidence interval, 1.9–2.6 and 2.1 (1.8–2.4 for 50 and 100 mg diclofenac potassium, respectively. A Cochrane review of published trial data reported NNTs of 2.1 and 1.9, and one comprehensive analysis reported NNTs of 2.2 and 2.1, respectively. All analyses had similar results for patients remedicating within 8 h. No data from dysmenorrhoea CSRs appeared in a Cochrane review. CSRs provide useful information and increase confidence. Stable efficacy estimates with standard study designs reduce the need for updating reviews.

Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial.

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Groeneweg, Ruud; van Assen, Luite; Kropman, Hans; Leopold, Huco; Mulder, Jan; Smits-Engelsman, Bouwien C M; Ostelo, Raymond W J G; Oostendorp, Rob A B; van Tulder, Maurits W

2017-01-01

Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. ClinicalTrials.gov Identifier: NCT00713843.

Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial.

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McGinnis, Kate; Murray, Eileen; Cherven, Brooke; McCracken, Courtney; Travers, Curtis

2016-12-01

Applied mechanical vibration in pediatric and adult populations has been shown to be an effective analgesic for acute and chronic pain, including needle pain. Studies among the neonatal population are lacking. According to the Gate Control Theory, it is expected that applied mechanical vibration will have a summative effect with standard nonpharmacologic pain control strategies, reducing behavioral and physiologic pain responses to heel lancing. To determine the safety and efficacy of mechanical vibration for relief of heel lance pain among neonates. In this parallel design randomized controlled trial, eligible enrolled term or term-corrected neonates (n = 56) in a level IV neonatal intensive care unit were randomized to receive either sucrose and swaddling or sucrose, swaddling, and vibration for heel lance analgesia. Vibration was applied using a handheld battery-powered vibrator (Norco MiniVibrator, Hz = 92) to the lateral aspect of the lower leg along the sural dermatome throughout the heel lance procedure. Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores, heart rate, and oxygen saturations were collected at defined intervals surrounding heel lancing. Infants in the vibration group (n = 30) had significantly lower N-PASS scores and more stable heart rates during heel stick (P = .006, P = .037) and 2 minutes after heel lance (P = .002, P = .016) than those in the nonvibration group. There were no adverse behavioral or physiologic responses to applied vibration in the sample. Applied mechanical vibration is a safe and effective method for managing heel lance pain. This pilot study suggests that mechanical vibration warrants further exploration as a nonpharmacologic pain management tool among the neonatal population.

The Effect of Foot Reflexology on Acute Pain in Infants: A Randomized Controlled Trial.

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Koç, Tuba; Gözen, Duygu

2015-10-01

This study was a randomized controlled trial designed to evaluate the effect of foot reflexology applied on infants on acute pain that may arise after vaccine injection. The sample consisted of 1- to 12-month-old infants registered in a family health center in Istanbul, Turkey, for healthcare follow-up. A total of 60 infants who met the criteria of the sample group were included in the study; 30 infants constituted the reflexology group and the other 30 constituted the control group. Although questionnaire forms were used to determine the descriptive characteristics of infant-mother pairs, the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale was used to evaluate pain level. Infants in the reflexology group received reflexology treatment for an average of 20-30 minutes before vaccination, depending on the physical size of the infant's foot. Pain, heart rate, oxygen saturation levels, and crying periods of infants in the reflexology and control groups were evaluated before and after vaccination. The FLACC pain score was observed to be statistically similar between groups. After reflexology was applied to infants in the reflexology group before vaccination, it was determined that the pain score was reduced to .50 ± 1.14. In the examination performed after vaccination, FLACC pain score was found to be 5.47 ± 2.11 in the reflexology group and 9.63 ± .85 in the control group. A statistically significant difference was observed between the mean FLACC pain scores of infants in the reflexology and control groups (p = .000). The infants in the reflexology group also had lower heart rates, higher oxygen saturation, and shorter crying periods than the infants in the control group (p Reflexology before vaccine reduced the pain level experienced after vaccination. Future research needs to explore different interventional practices. © 2015 Sigma Theta Tau International.

Topical sucralfate for pain after oral CO2 laser surgery: a prospective, randomized, controlled trial.

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Guo, Chau-Shiang; Chuang, Hui-Ching; Chien, Chih-Yen

2012-01-01

The aim of this study was to assess the effect of topical sucralfate on postoperative pain scores and other secondary outcomes including the frequency and duration of analgesic use and postoperative bleeding episodes after CO(2) laser treatment of oral leukoplakia. In this prospective trial, a total of 80 patients were randomized into the sucralfate group (n = 40) or the control group (n = 40). Postoperative pain scores, the frequency and duration of analgesic requirements, and postoperative wound bleeding episodes were compared between the 2 groups from the operative day to postoperative day 6. Patients in the sucralfate group experienced significantly less postoperative pain on postoperative days 1 and 2. Although there was no significant difference in frequency and duration of analgesic use between the 2 groups, a trend toward lower frequency and fewer days of analgesic use in the sucralfate group was observed. This study demonstrated the efficacy of topical sucralfate application in diminishing postoperative pain after CO(2) laser therapy for oral leukoplakia. Topical sucralfate can be considered a feasible adjuvant medication for the control of pain after CO(2) laser treatment of oral leukoplakia. Copyright © 2012 Elsevier Inc. All rights reserved.

Pain management strategies for neuropathic pain in Fabry disease--a systematic review

NARCIS (Netherlands)

Schuller, Y.; Linthorst, G. E.; Hollak, C. E. M.; van Schaik, I. N.; Biegstraaten, M.

2016-01-01

Neuropathic pain is one of the key features of (classical) Fabry disease (FD). No randomized clinical trials comparing effectiveness of different pain management strategies have been performed. This review aims to give an overview of existing pain management strategies. PubMed and Embase were

Pain in the Frail or Elderly Patient: Does Tapentadol Have a Role?

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Veal, Felicity C; Peterson, Gregory M

2015-06-01

Persistent pain affects the elderly disproportionally, occurring in 50% of elderly community-dwelling patients and 80% of aged care residents. The management of pain in the elderly and frail patient is complicated because of the risks posed by changes in pharmacokinetics and pharmacodynamics, polypharmacy, and drug-disease interactions. Trials evaluating the efficacy of analgesics have often excluded elderly patients and universally excluded frail patients; therefore, the true efficacy and side-effect profiles in these population groups are largely unknown, especially for long-term use. A stepwise approach is recommended to managing pain, commencing with paracetamol and adding on opioids when needed to manage pain. However, because of the short duration of clinical trials, exclusion of frail patients, and minimal inclusion of elderly patients, the decision as to which opioid should be added on to paracetamol is a difficult one. This article reviews the evidence surrounding a newer opioid, tapentadol. Tapentadol acts on both the mu receptors and on neuronal reuptake of noradrenaline, and has no significant analgesically active metabolites, which theoretically presents some advantages, particularly in comparison with tramadol. However, the evidence to support tapentadol is weak and the trials were often methodologically poor and sponsored almost universally by the drug company. Currently, there is insufficient evidence to support the use of tapentadol over other opioids, which have been on the market longer, are less expensive, and have better established safety profiles. As a first-line agent after the failure of paracetamol alone, morphine, oxycodone, fentanyl, or buprenorphine are still the preferred evidence-based choices for add-on opioid therapy for elderly or frail patients.

Systematic pain assessment in nursing homes: a cluster-randomized trial using mixed-methods approach.

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Mamhidir, Anna-Greta; Sjölund, Britt-Marie; Fläckman, Birgitta; Wimo, Anders; Sköldunger, Anders; Engström, Maria

2017-02-28

Chronic pain affects nursing home residents' daily life. Pain assessment is central to adequate pain management. The overall aim was to investigate effects of a pain management intervention on nursing homes residents and to describe staffs' experiences of the intervention. A cluster-randomized trial and a mixed-methods approach. Randomized nursing home assignment to intervention or comparison group. The intervention group after theoretical and practical training sessions, performed systematic pain assessments using predominately observational scales with external and internal facilitators supporting the implementation. No measures were taken in the comparison group; pain management continued as before, but after the study corresponding training was provided. Resident data were collected baseline and at two follow-ups using validated scales and record reviews. Nurse group interviews were carried out twice. Primary outcome measures were wellbeing and proxy-measured pain. Secondary outcome measures were ADL-dependency and pain documentation. Using both non-parametric statistics on residential level and generalized estimating equation (GEE) models to take clustering effects into account, the results revealed non-significant interaction effects for the primary outcome measures, while for ADL-dependency using Katz-ADL there was a significant interaction effect. Comparison group (n = 66 residents) Katz-ADL values showed increased dependency over time, while the intervention group demonstrated no significant change over time (n = 98). In the intervention group, 13/44 residents showed decreased pain scores over the period, 14/44 had no pain score changes ≥ 30% in either direction measured with Doloplus-2. Furthermore, 17/44 residents showed increased pain scores ≥ 30% over time, indicating pain/risk for pain; 8 identified at the first assessment and 9 were new, i.e. developed pain over time. No significant changes in the use of drugs was found in any of

Is the experience of pain in patients with temporomandibular disorder associated with the presence of comorbidity?

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Visscher, Corine M; van Wesemael-Suijkerbuijk, Erin A; Lobbezoo, Frank

2016-10-01

The aim of this study was to explore the association between the presence of comorbidities and the pain experience in individual patients with temporomandibular disorder (TMD). This clinical trial comprised 112 patients with TMD pain. For all participants the presence of the following comorbid factors was assessed: pain in the neck; somatization; impaired sleep; and depression. Pain experience was evaluated using the McGill Pain Questionnaire (MPQ). For each subject the TMD-pain experience was assessed for three dimensions - sensory, affective, and evaluative - as specified in the MPQ. The association between comorbid factors and these three dimensions of TMD-pain experience was then evaluated using linear regression models. Univariable regression analyses showed that all comorbid factors, except for one factor, were positively associated with the level of pain, as rated by the sensory description of pain, the affective component of pain, and the evaluative experience of pain. The multivariable regression analyses showed that for all MPQ dimensions, depression showed the strongest associations with pain experience. It was found that in the presence of comorbid disorders, patients with TMD experience elevated levels of TMD pain. This information should be taken into consideration in the diagnostic process, as well as in the choice of treatment. © 2016 Eur J Oral Sci.

Flip-flop footwear with a moulded foot-bed for the treatment of foot pain: a randomised controlled trial.

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Chuter, Vivienne Helaine; Searle, Angela; Spink, Martin J

2016-11-11

Foot pain is a common problem affecting up to 1 in 5 adults and is known to adversely affect activities of daily living and health related quality of life. Orthopaedic footwear interventions are used as a conservative treatment for foot pain, although adherence is known to be low, in part due to the perception of poor comfort and unattractiveness of the footwear. The objective of this trial was to assess the efficacy of flip-flop style footwear (Foot Bio-Tec©) with a moulded foot-bed in reducing foot pain compared to participant's usual footwear. Two-arm parallel randomised controlled trial using computer generated random allocation schedule at an Australian university podiatry clinic. 108 volunteers with disabling foot pain were enrolled after responding to an advertisement and eligibility screening. Participants were randomly allocated to receive footwear education and moulded flip-flop footwear to wear as much as they were comfortable with for the next 12 weeks (n = 54) or footwear education and instructions to wear their normal footwear for the next 12 weeks (n = 54). Primary outcome was the pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcomes were the foot function and general foot health domains of the FHSQ, a visual analogue scale (VAS) for foot pain and perceived comfort of the intervention footwear. Compared to the control group, the moulded flip-flop group showed a significant improvement in the primary outcome measure of the FHSQ pain domain (adjusted mean difference 8.36 points, 95 % CI 5.58 to 13.27, p footwear and six (footwear group = 4) were lost to follow up. Our results demonstrate that flip-flop footwear with a moulded foot-bed can have a significant effect on foot pain, function and foot health and might be a valuable adjunct therapy for people with foot pain. ACTRN12614000933651 . Retrospectively registered: 01/09/2014.

Pilot Randomized Trial Comparing Intersession Scheduling of Biofeedback Results to Individuals with Chronic Pain: Influence on Psychologic Function and Pain Intensity.

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Weeks, Douglas L; Whitney, Anthony A; Tindall, Angelique G; Carter, Gregory T

2015-10-01

The objective of this study was to compare the effectiveness of two biofeedback schedules on long-term improvement in physical and psychologic reactivity to chronic nonmalignant pain. This study is a prospective, randomized pilot trial. Twenty adults with chronic pain engaged in heart rate variability (HRV) biofeedback training for nine sessions with HRV presented visually. Two groups, formed by random assignment, were compared: The faded feedback group received concurrent visual HRV biofeedback in session 1, with the amount of biofeedback systematically reduced for ensuing sessions so that, by session 9, the participants were controlling HRV without external feedback. The full feedback group received visual HRV biofeedback continuously across all sessions. Outcome measures assessed at baseline, immediately after the program, and 3 mos after the program included pain intensity, fear-avoidance beliefs, and self-report physical functioning. Use of biofeedback skills was also assessed 3 mos after the program. Nominal variables were analyzed with χ. Continuous measures were analyzed with repeated-measures analyses of variance. The faded feedback schedule resulted in greater use of biofeedback skills at 3 mos and improved pain intensity and fear-avoidance beliefs after the program and at 3 mos. Physical functioning did not differ between groups. Systematically reducing the frequency of external visual feedback during HRV biofeedback training was associated with reduced reactivity to chronic pain. Results of this pilot study should be confirmed with a larger randomized study.

Perna canaliculus Lipid Complex PCSO-524™ Demonstrated Pain Relief for Osteoarthritis Patients Benchmarked against Fish Oil, a Randomized Trial, without Placebo Control

OpenAIRE

Zawadzki, Marek; Janosch, Claudia; Szechinski, Jacek

2013-01-01

Osteoarthritis (OA) typically generates pain, reduced mobility and reduced quality of life. Most conventional treatments for osteoarthritis, such as non-steroidal anti-inflammatory drugs (NSAIDs) and simple analgesics, have side effects. PCSO-524?, a non polar lipid extract from the New Zealand Green Lipped Mussel, is rich in omega-3 fatty acids and has been shown to reduce inflammation in both animal studies and patient trials. This OA trial examined pain relief changes in relation to qualit...

Manipulation Therapy Relieved Pain More Rapidly Than Acupuncture among Lateral Epicondylalgia (Tennis Elbow Patients: A Randomized Controlled Trial with 8-Week Follow-Up

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Chung-Yuan Hsu

2016-01-01

Full Text Available Radial bone adjustment manipulation treatment may be effective to reduce pain rapidly in lateral epicondylalgia patients and the pathological tension in the biceps brachii muscle is highly concerned. To prove this hypothesis, we conducted a randomized controlled trial and included 35 patients with lateral epicondylalgia for more than 2 months. Either manipulation treatment (n=16 or acupuncture (n=19 was given to these patients for 2 weeks and all patients’ symptoms were followed up for 8 weeks after treatment. Both groups demonstrated changes in pain VAS score, grip strength, and DASH questionnaire. Lateral epicondylalgia patients who received manipulation treatment felt pain relief sooner than those who had acupuncture treatments during the first few treatments. However, both acupuncture and manipulation are effective, while the difference has no significance at the 8-week follow-up. The trial was registered with Current Controlled Trials ISRCTN81308551 on 5 February 2016.

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.

Relaxation techniques for pain management in labour.

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Smith, Caroline A; Levett, Kate M; Collins, Carmel T; Armour, Mike; Dahlen, Hannah G; Suganuma, Machiko

2018-03-28

Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute to the popularity of complementary methods of pain management. This review examined currently available evidence on the use of relaxation therapies for pain management in labour. This is an update of a review first published in 2011. To examine the effects of mind-body relaxation techniques for pain management in labour on maternal and neonatal well-being during and after labour. We searched Cochrane Pregnancy and Childbirth's Trials Register (9 May 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 5 2017), MEDLINE (1966 to 24 May 2017), CINAHL (1980 to 24 May 2017), the Australian New Zealand Clinical Trials Registry (18 May 2017), ClinicalTrials.gov (18 May 2017), the ISRCTN Register (18 May 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (18 May 2017), and reference lists of retrieved studies. Randomised controlled trials (including quasi randomised and cluster trials) comparing relaxation methods with standard care, no treatment, other non-pharmacological forms of pain management in labour or placebo. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We attempted to contact study authors for additional information. We assessed evidence quality with GRADE methodology. This review update includes 19 studies (2519 women), 15 of which (1731 women) contribute data. Interventions examined included relaxation, yoga, music and mindfulness. Approximately half of the studies had a low risk of bias for random sequence generation and attrition bias. The majority of studies had a high risk of bias for performance and detection bias, and unclear risk of bias for, allocation concealment, reporting bias and other bias. We assessed the evidence from these studies as ranging from low to very low quality, and

Counselling low-back-pain patients in secondary healthcare: a randomised trial addressing experienced workplace barriers and physical activity.

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Jensen, Lone Donbæk; Maribo, Thomas; Schiøttz-Christensen, Berit; Madsen, Finn Hjorth; Gonge, Bigitte; Christensen, Michael; Frost, Poul

2012-01-01

To assess if counselling by an occupational physician (OP) addressing experienced workplace barriers and physical activity integrated as a part of low-back pain (LBP) outpatient treatment influences pain, function and sick leave. Randomised controlled trial in the secondary healthcare sector with 3 months' follow-up. The participants were LBP patients who, independently of sick-leave status, expressed concerns about the ability to maintain their current job. Patients referred for surgery were excluded. The intervention consisted of two counselling sessions conducted by an OP addressing both workplace barriers and leisure-time physical activity. A workplace visit was performed if required. Pain, function and duration of sick leave due to LBP were primary outcomes. A reduction in bodily pain and improvement in physical function both measured by the 36-item short-form health survey questionnaire in favour of the intervention group was found. The change in pain score was found to be clinically relevant. The risk of sick leave for at least 8 weeks due to LBP was significantly reduced in the intervention group. Two secondary outcomes, Fear Avoidance Beliefs about physical activity and maximum oxygen uptake, supported compliance and adherence to the part of the intervention focusing on enhanced physical activity. Two short counselling sessions by an OP combining advice on meeting workplace barriers and enhancing physical activity had a substantial effect on important prognostic factors for LBP patients with moderate to severe symptoms diagnosed in outpatient rheumatological clinics. Current Controlled Trials ISRCTN13071157.

Personalized pain medicine: the clinical value of psychophysical assessment of pain modulation profile.

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Granovsky, Yelena; Yarnitsky, David

2013-01-01

Experimental pain stimuli can be used to simulate patients' pain experience. We review recent developments in psychophysical pain testing, focusing on the application of the dynamic tests-conditioned pain modulation (CPM) and temporal summation (TS). Typically, patients with clinical pain of various types express either less efficient CPM or enhanced TS, or both. These tests can be used in prediction of incidence of acquiring pain and of its intensity, as well as in assisting the correct choice of analgesic agents for individual patients. This can help to shorten the commonly occurring long and frustrating process of adjusting analgesic agents to the individual patients. We propose that evaluating pain modulation can serve as a step forward in individualizing pain medicine.

Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial.

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McCormick, Zachary L; Hendrix, Andrew; Dayanim, David; Clay, Bryan; Kirsling, Amy; Harden, Norman

2018-03-08

We present a technical protocol for rigorous assessment of patient-reported outcomes and psychophysical testing relevant to lumbar sympathetic blocks for the treatment of postamputation pain (PAP). This description is intended to inform future prospective investigation. Series of four participants from a blinded randomized sham-controlled trial. Tertiary, urban, academic pain medicine center. Four participants with a single lower limb amputation and associated chronic PAP. Participants were randomized to receive a lumbar sympathetic block with 0.25% bupivacaine or sham needle placement. Patient-rated outcome measures included the numerical rating scale (NRS) for pain, the McGill Pain Questionnaire-Short Form, Center for Epidemiological Studies Depression Scale, Pain and Anxiety Symptoms Scale-short version, and Pain Disability Index (PDI). Psychophysical and biometric testing was also performed, which included vibration sensation testing, pinprick sensation testing, brush sensation testing, Von Frey repeated weighted pinprick sensation, and thermal quantitative sensory testing. In the four described cases, treatment of PAP with a single lumbar sympathetic block but not sham intervention resulted in reduction of both residual limb pain and phantom limb pain as well as perceived disability on the PDI at three-month follow-up. An appropriately powered randomized controlled study using this methodology may not only aid in determining the possible clinical efficacy of lumbar sympathetic block in PAP, but could also improve our understanding of underlying pathophysiologic mechanisms of PAP.

Patient training in cancer pain management using integrated print and video materials: a multisite randomized controlled trial.

Science.gov (United States)

Syrjala, Karen L; Abrams, Janet R; Polissar, Nayak L; Hansberry, Jennifer; Robison, Jeanne; DuPen, Stuart; Stillman, Mark; Fredrickson, Marvin; Rivkin, Saul; Feldman, Eric; Gralow, Julie; Rieke, John W; Raish, Robert J; Lee, Douglas J; Cleeland, Charles S; DuPen, Anna

2008-03-01

Standard guidelines for cancer pain treatment routinely recommend training patients to reduce barriers to pain relief, use medications appropriately, and communicate their pain-related needs. Methods are needed to reduce professional time required while achieving sustained intervention effectiveness. In a multisite, randomized controlled trial, this study tested a pain training method versus a nutrition control. At six oncology clinics, physicians (N=22) and nurses (N=23) enrolled patients (N=93) who were over 18 years of age, with cancer diagnoses, pain, and a life expectancy of at least 6 months. Pain training and control interventions were matched for materials and method. Patients watched a video followed by about 20 min of manual-standardized training with an oncology nurse focused on reviewing the printed material and adapted to individual concerns of patients. A follow-up phone call after 72 h addressed individualized treatment content and pain communication. Assessments at baseline, one, three, and 6 months included barriers, the Brief Pain Inventory, opioid use, and physician and nurse ratings of their patients' pain. Trained versus control patients reported reduced barriers to pain relief (P6 on a 0-10 scale) at 1-month outcomes (P=.03). Physician and nurse ratings were closer to patients' ratings of pain for trained versus nutrition groups (P=.04 and print materials, with brief individualized training, effectively improved pain management over time for cancer patients of varying diagnostic and demographic groups.

The effect of ultrapro or prolene mesh on postoperative pain and well-being following endoscopic Totally Extraperitoneal (TEP hernia repair (TULP: study protocol for a randomized controlled trial

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Schouten Nelleke

2012-06-01

Full Text Available Abstract Background The purpose of this study was to describe the rationale and design of a randomized controlled trial analyzing the effects of mesh type (Ultrapro versus Prolene mesh on postoperative pain and well-being following an endoscopic Totally Extraperitoneal (TEP repair for inguinal hernias (short: TULP trial. Methods and design The TULP trial is a prospective, two arm, double blind, randomized controlled trial to assess chronic postoperative pain and quality of life following implantation of a lightweight (Ultrapro and heavyweight (Prolene mesh in endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specializing in TEP hernia repair. All patients are operated on by one of four surgeons. Adult male patients (≥18 years of age with primary, reducible, unilateral inguinal hernias and no contraindications for TEP repair are eligible for inclusion in the study. The primary outcome is substantial chronic postoperative pain, defined as moderate to severe pain persisting ≥ 3 months postoperatively (Numerical Rating Scale, NRS 4–10. Secondary endpoints are the individual development of pain until three years after the TEP procedure, the quality of life (QoL, recurrence rate, patient satisfaction and complications. Discussion Large prospective randomized controlled studies with a long follow-up evaluating the incidence of chronic postoperative pain following implantation of lightweight and heavyweight mesh in endoscopic (TEP hernia repair are limited. By studying the presence of pain and quality of life, but also complications and recurrences in a large patient population, a complete efficiency and feasibility assessment of both mesh types in TEP hernia repair will be performed. Trial registration The TULP study is registered in the Dutch Trial Register (NTR2131

Hydrotherapy improves pain and function in older women with knee osteoarthritis: a randomized controlled trial.

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Dias, João Marcos; Cisneros, Lígia; Dias, Rosângela; Fritsch, Carolina; Gomes, Wellington; Pereira, Leani; Santos, Mary Luci; Ferreira, Paulo Henrique

Currently, there is poor evidence of the effect of hydrotherapy alone on patients with hip or knee osteoarthritis. The study aimed to assess the impact of hydrotherapy on pain, function, and muscle function in older women with knee osteoarthritis. A randomized controlled trial was conducted to evaluate the efficacy of hydrotherapy in women with knee osteoarthritis. Seventy-three women aged 65 and older were randomized to hydrotherapy (n=36) or a control group (n=37). The hydrotherapy group received the intervention program in a heated pool (twice per week for six weeks) and an educational protocol while the control group received an educational protocol only. Primary outcomes (before and post-treatment) were pain intensity (0-100) and function (0-100), assessed with the WOMAC questionnaire. Secondary outcomes (before and post-treatment) were knee extensor and knee flexor muscle performance (strength, power, and endurance), assessed by an isokinetic dynamometer. The magnitude of change between the groups for the outcomes was calculated using linear regression models adjusted by baseline outcome values. The hydrotherapy group had better outcomes for pain (adjusted mean difference=11 points, 95% CI: 3-18) and function (adjusted mean difference=12 points, 95% CI: 5-18). Patients receiving hydrotherapy had better performance for knee flexor and extensor strength, knee flexor power, and knee extensor endurance. Older women with knee osteoarthritis are likely to have benefits from a course of hydrotherapy exercises. Registry of clinical trials (Trial number RBR-8F57KR) - http://www.ensaiosclinicos.gov.br/rg/RBR-8f57kr/. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Pain scoring in endometriosis: entry criteria and outcome measures for clinical trials. Report from the Art and Science of Endometriosis meeting

OpenAIRE

Vincent, Katy; Kennedy, Stephen; Stratton, Pamela

2008-01-01

Standardized entry criteria and outcome measures for clinical trials in endometriosis-related pain would facilitate the comparison of trial results and the production of systematic reviews, improving evidence-based practice in this area. This report summarizes the recommendations from an international meeting for these criteria.

Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES trial

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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

Choice in the repeated-gambles experiment.

Science.gov (United States)

Silberberg, A; Murray, P; Christensen, J; Asano, T

1988-09-01

Humans chose 10 times between two roulette wheels projected on a monitor. During the first trial, the left wheel provided a hypothetical $100 with p = .94, and the right wheel provided $250 with p = .39. A titration procedure adjusted the probability of a $250 win across trials to permit estimation of an indifference point between alternatives. In Experiment 1, intertrial-interval duration (25 vs. 90 s) and whether sessions began with an intertrial interval or a trial were varied in a 2 x 2 design in this risky-choice procedure. Risk aversion (preference for the $100 wheel) increased with intertrial interval but was unaffected by whether sessions began with a trial or an intertrial interval. In Experiment 2, all sessions began with a trial, and subjects were informed that the experiment ended after 10 trials. Intertrial-interval duration had no effect on choice. In Experiment 3, intertrial-interval duration and whether subjects were given $10 or $10,000 before beginning were varied among four groups in a 2 x 2 design. In all other ways, the procedure was unchanged from Experiment 2. Intertrial interval had no effect on choice, but the $10,000 groups showed less risk aversion than the $10 groups. These results can be explained more readily in terms of Kahneman and Tversky's (1984) notion of "framing of the prospect" than in terms of Rachlin, Logue, Gibbon, and Frankel's (1986) behavioral account of risky choice.

Effectiveness of jyoti meditation for patients with chronic neck pain and psychological distress--a randomized controlled clinical trial.

Science.gov (United States)

Jeitler, Michael; Brunnhuber, Stefan; Meier, Larissa; Lüdtke, Rainer; Büssing, Arndt; Kessler, Christian; Michalsen, Andreas

2015-01-01

Chronic neck pain is a common medical complaint partly mediated by psychosocial distress and having a high socioeconomic impact. There is preliminary evidence that stress reduction by meditation might be beneficial in chronic pain syndromes. We aimed to evaluate the effectiveness of an 8-week meditation program (jyoti meditation) in patients with chronic neck pain by means of a randomized clinical trial. Eighty-nine patients (aged 49.7 ± 10.5 years, 73 female) with chronic neck pain who scored >40 mm on a 100-mm visual analog scale and had concomitant increased perceived stress were randomized to an 8-week meditation program (jyoti meditation) with weekly 90-minute classes (n = 45) or to a home-based exercise program (n = 44) with a wait list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed at baseline and after 8 weeks. Primary outcome measure was change of mean pain at rest (visual analog scale score) from baseline to week 8. Secondary outcomes included pain at motion, functional disability, pain-related bothersomeness, perceived stress, quality of life, and psychological outcomes. Patients had neck pain for a mean of 11 years. Eighteen patients in the meditation group and 16 patients in the exercise group were lost to follow-up. Meditation training significantly reduced pain when compared to the exercise group after 8 weeks (reduction of 45.5 ± 23.3 mm to 21.6 ± 17.2 mm in the meditation group, and 43.8 ± 22.0 mm to 37.7 ± 21.5 mm in the exercise group; mean difference: 13.2 mm [95% confidence interval: 2.1, 24.4; P = .02]). Pain-related bothersomeness decreased more in the meditation group (group difference 11.0 mm [95% confidence interval: 1.0, 21.0; P = .03]). No significant treatment effects were found for pain at motion, psychological scores, and quality of life, although the meditation group showed nonsignificant greater improvements compared to the exercise group. In conclusion

Effects of internet-based pain coping skills training prior to home exercise for individuals with hip osteoarthritis (HOPE trial): a randomised controlled trial.

Science.gov (United States)

Bennell, Kim L; Nelligan, Rachel K; Rini, Christine; Keefe, Francis J; Kasza, Jessica; French, Simon; Forbes, Andrew; Dobson, Fiona; Abbott, J Haxby; Dalwood, Andrew; Harris, Anthony; Vicenzino, Bill; Hodges, Paul W; Hinman, Rana S

2018-05-22

This assessor-, therapist- and participant-blinded randomised controlled trial evaluated the effects of an automated internet-based pain coping skills training (PCST) program prior to home exercise for people with clinically-diagnosed hip osteoarthritis (OA). 144 people were randomised to either the PCST group or the comparator group. In the first 8 weeks, the PCST group received online education and PCST while the comparison group received online education only. From weeks 8-24, both groups visited a physiotherapist 5 times for home exercise prescription. Assessments were performed at baseline, 8, 24 and 52 weeks. Primary outcomes were hip pain on walking (11-point numerical rating scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) at 24 weeks. Secondary outcomes were other measures of pain, quality-of-life, global change, self-efficacy, pain coping, pain catastrophizing, depression, anxiety, stress, physical activity and adverse events. Primary outcomes were completed by 137 (95%), 131 (91%) and 127 (88%) participants at 8, 24 and 52 weeks, respectively. There were no significant between-group differences in primary outcomes at week 24 (change in: walking pain (mean difference 0.5 units; 95%CI, -0.3 to 1.3) and function (-0.9 units; 95%CI, -4.8 to 2.9)), with both groups showing clinically-relevant improvements. At week 8, the PCST group had greater improvements in function, pain coping and global improvement than comparison. Greater pain coping improvements persisted at 24 and 52 weeks. In summary, online PCST immediately improved pain coping and function but did not confer additional benefits to a subsequent exercise program, despite sustained pain coping improvements.

Interventions to address deficits of pharmacological pain management in nursing home residents--A cluster-randomized trial.

Science.gov (United States)

Könner, F; Budnick, A; Kuhnert, R; Wulff, I; Kalinowski, S; Martus, P; Dräger, D; Kreutz, R

2015-10-01

To evaluate the effect of interventions for general practitioners and nursing home staff to improve pain severity and appropriateness of pain medication in nursing home residents (NHR). This cluster-randomized controlled trial was conducted in six nursing homes in the intervention and control group, respectively. Pain management was analysed before (T0) and after (T1, T2) an educational intervention in 239 NHR, aged ≥65 years, without moderate or severe cognitive impairment. Primary and secondary outcomes were average pain severity and appropriateness of pain medication as determined with the Numeric Rating Scale and Pain Medication Appropriateness Scale (PMASD ), respectively. At T0, 72.2% and 73.7% of NHR (mean age 83 years) reported pain (average pain severity 2.4) in the intervention and control group, respectively. The PMASD at T0 was 53.9 in the intervention group and 60.8 in the control group (p = 0.12), while 20.6% compared to 6.9% (p = 0.009) received no pain medication in the two groups. At T2, non-significant improvements in the average pain severity (1.59) and PMASD (61.07) were observed in the intervention group. Moreover, the mean individual PMASD increased by 8.09 (p = 0.03) and the proportion of NHR without pain medication decreased by 50% (p = 0.03) in the intervention group. No appreciable changes were found in the control group at T2. NHR exhibited a high prevalence of pain with overall low severity, while a high proportion of individuals received inappropriate pain medications. Both findings were not significantly improved by the intervention, although some aspects of drug treatment were meaningful improved. © 2015 European Pain Federation - EFIC®

A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol [version 1; referees: 2 approved

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Rebeccah Slater

2016-11-01

Full Text Available Infant pain has both immediate and long-term negative consequences, yet in clinical practice it is often undertreated. To date, few pain-relieving drugs have been tested in infants. Morphine is a potent analgesic that provides effective pain relief in adults, but there is inconclusive evidence for its effectiveness in infants. The purpose of this study is to establish whether oral morphine provides effective analgesia for procedural pain in infants.   A blinded, placebo-controlled, parallel-group randomized, phase II, clinical trial will be undertaken to determine whether morphine sulphate administered orally prior to clinically-required retinopathy of prematurity (ROP screening and heel lancing provides effective analgesia. 
156 infants between 34 and 42 weeks’ gestational age who require a clinical heel lance and ROP screening on the same test occasion will be included in the trial. Infants will be randomised to receive either a single dose of morphine sulphate (100 μg/kg or placebo. Each infant will be monitored for 48 hours and safety data will be collected during the 24 hours following drug administration.   The primary outcome will be the Premature Infant Pain Profile–revised (PIPP-R score 30 seconds after ROP screening. The co-primary outcome will be the magnitude of nociceptive-specific brain activity evoked by a clinically-required heel lance. Infant clinical stability will be assessed by comparing the number of episodes of bradycardia, tachycardia, desaturation and apnoea, and changes in respiratory support requirements in the 24-hour periods before and after the clinical intervention. In addition, drug safety will be assessed by considering the occurrence of apnoeic and hypotensive episodes requiring intervention in the 24-hour period following drug administration. This study has been published as an Accepted Protocol Summary by The Lancet.

Evaluation of the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain: study protocol for a randomized controlled trial.

Science.gov (United States)

Calamita, Simone Aparecida Penimpedo; Biasotto-Gonzalez, Daniela Aparecida; De Melo, Nivea Cristina; dos Santos, Douglas Meira; de Lassa, Roberta; de Mendonça, Fabiana Sarilho; Oliveira, Claudia Santos; Amorim, César Ferreira; Gonzalez, Tabajara Oliveira; Fumagalli, Marco Antônio; de Gomes, Cid André Fidelis Paula; Politti, Fabiano

2015-03-19

Nonspecific neck pain can cause considerable suffering, possible disability and reductions in quality of life and productivity. The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain. A total of 12 patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized, single-blind crossover study. Each subject will receive two forms of treatment in random order: a single session of traditional acupuncture (acupoints: triple energizer 5, 'Wai-guan' and large intestine 11, 'Qu-chi') and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine motor control in the upper trapezius muscle before and after treatment. The outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0 (no pain) to 10 (maximum pain)), documentation of the pain area on a body chart and cervical range of motion. Comparisons before and after acupuncture treatment will demonstrate whether acupoints affect the activity of the upper trapezius muscle, pain and cervical range of motion. The purpose of this randomized clinical trial is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain. Data will be published after the study is completed. The study will support the practice of evidence-based physical therapy for individuals with nonspecific neck pain. This trial was registered with Clinicaltrials.gov (identifier: NCT0984021 ) on 7 November 2013 ( https://clinicaltrials.gov/ct2/show/NCT01984021 ).

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

Science.gov (United States)

2014-01-01

Background Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. Methods/Design This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using

PAIN RELIEF IN POLYTRAUMA PATIENTS

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M. C. Rajesh

2016-09-01

Full Text Available BACKGROUND Pain management in Polytrauma is a poorly-addressed concern at the time of active resuscitation. But, very often, pain assessment is also a challenge! Opioids belong to conventional analgesics of choice in any acute pain conditions. But, recently application of regional anaesthesia techniques and subanaesthetic doses of ketamine are satisfactorily employed. A clear understanding of neuropathic element of pain must be made as they require specific therapy. It must be emphasised that effective pain therapy is a multidisciplinary team work with active involvement of pain psychologist.

Decoupled choice-driven and stimulus-related activity in parietal neurons may be misrepresented by choice probabilities.

Science.gov (United States)

Zaidel, Adam; DeAngelis, Gregory C; Angelaki, Dora E

2017-09-28

Trial-by-trial correlations between neural responses and choices (choice probabilities) are often interpreted to reflect a causal contribution of neurons to task performance. However, choice probabilities may arise from top-down, rather than bottom-up, signals. We isolated distinct sensory and decision contributions to single-unit activity recorded from the dorsal medial superior temporal (MSTd) and ventral intraparietal (VIP) areas of monkeys during perception of self-motion. Superficially, neurons in both areas show similar tuning curves during task performance. However, tuning in MSTd neurons primarily reflects sensory inputs, whereas choice-related signals dominate tuning in VIP neurons. Importantly, the choice-related activity of VIP neurons is not predictable from their stimulus tuning, and these factors are often confounded in choice probability measurements. This finding was confirmed in a subset of neurons for which stimulus tuning was measured during passive fixation. Our findings reveal decoupled stimulus and choice signals in the VIP area, and challenge our understanding of choice signals in the brain.Choice-related signals in neuronal activity may reflect bottom-up sensory processes, top-down decision-related influences, or a combination of the two. Here the authors report that choice-related activity in VIP neurons is not predictable from their stimulus tuning, and that dominant choice signals can bias the standard metric of choice preference (choice probability).

The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

Science.gov (United States)

Darlow, Ben; Stanley, James; Dean, Sarah; Abbott, J Haxby; Garrett, Sue; Mathieson, Fiona; Dowell, Anthony

2017-10-17

Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care. This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care

Randomized controlled trial of the combined monoaminergic and opioid investigational compound GRT9906 in painful polyneuropathy

DEFF Research Database (Denmark)

Sindrup, Søren Hein; Konder, R; Lehmann, R

2012-01-01

with tramadol. During 4-week treatment periods, daily oral doses of either GRT9906 120-240 mg, or placebo, or tramadol 200-400 mg were given. These were separated by 1-week washout periods. The primary endpoint was the average pain intensity (average of daily current pain intensity over the last 3 days of each......GRT9906 is an investigational novel compound with μ-opioid receptor agonism and inhibition of noradrenalin/serotonin re-uptake. In this randomized, double-blind, placebo-controlled, three-way cross-over trial in painful polyneuropathy, the efficacy and safety of GRT9906 was assessed and compared...... treatment period rated on a 0 to 10-point numeric rating scale). One hundred seventeen patients were enrolled and 64 were randomized to one of six treatment sequences. Forty-seven patients qualified for the per protocol analysis. GRT9906 reduced average pain intensity by 2.1 points compared with a reduction...

Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

International Nuclear Information System (INIS)

Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R.

2012-01-01

Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 ± 23.7 and 53.2 ± 21.8 (p = 0.158), 38.2 ± 26.1 and 34.0 ± 24.5 (p = 0.189), and 33.0 ± 27.2 and 23.7 ± 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 ± 3.0 and 9.5 ± 2.7 (p = 0.309), 6.1 ± 3.6 and 5.4 ± 3.6 (p = 0.096), 5.3 ± 3.7 and 4.1 ± 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations

Science.gov (United States)

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin; Buckenmaier, Chester; Buckenmaier, Pamela; Cambron, Jerrilyn; Deery, Christopher; Schwartz, Jan; Werner, Ruth; Whitridge, Pete

2016-01-01

Abstract Objective Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy’s efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Methods Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Results Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = −0.79] and anxiety (SMD = −0.57) compared to active comparators. Conclusion Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. PMID:27165970

Beyond pain: modeling decision-making deficits in chronic pain

Science.gov (United States)

Hess, Leonardo Emanuel; Haimovici, Ariel; Muñoz, Miguel Angel; Montoya, Pedro

2014-01-01

Risky decision-making seems to be markedly disrupted in patients with chronic pain, probably due to the high cost that impose pain and negative mood on executive control functions. Patients’ behavioral performance on decision-making tasks such as the Iowa Gambling Task (IGT) is characterized by selecting cards more frequently from disadvantageous than from advantageous decks, and by switching often between competing responses in comparison with healthy controls (HCs). In the present study, we developed a simple heuristic model to simulate individuals’ choice behavior by varying the level of decision randomness and the importance given to gains and losses. The findings revealed that the model was able to differentiate the behavioral performance of patients with chronic pain and HCs at the group, as well as at the individual level. The best fit of the model in patients with chronic pain was yielded when decisions were not based on previous choices and when gains were considered more relevant than losses. By contrast, the best account of the available data in HCs was obtained when decisions were based on previous experiences and losses loomed larger than gains. In conclusion, our model seems to provide useful information to measure each individual participant extensively, and to deal with the data on a participant-by-participant basis. PMID:25136301

Beyond pain: modeling decision-making deficits in chronic pain.

Science.gov (United States)

Hess, Leonardo Emanuel; Haimovici, Ariel; Muñoz, Miguel Angel; Montoya, Pedro

2014-01-01

Risky decision-making seems to be markedly disrupted in patients with chronic pain, probably due to the high cost that impose pain and negative mood on executive control functions. Patients' behavioral performance on decision-making tasks such as the Iowa Gambling Task (IGT) is characterized by selecting cards more frequently from disadvantageous than from advantageous decks, and by switching often between competing responses in comparison with healthy controls (HCs). In the present study, we developed a simple heuristic model to simulate individuals' choice behavior by varying the level of decision randomness and the importance given to gains and losses. The findings revealed that the model was able to differentiate the behavioral performance of patients with chronic pain and HCs at the group, as well as at the individual level. The best fit of the model in patients with chronic pain was yielded when decisions were not based on previous choices and when gains were considered more relevant than losses. By contrast, the best account of the available data in HCs was obtained when decisions were based on previous experiences and losses loomed larger than gains. In conclusion, our model seems to provide useful information to measure each individual participant extensively, and to deal with the data on a participant-by-participant basis.

Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial.

Science.gov (United States)

Chester, Stephen J; Stockton, Kellie; De Young, Alexandra; Kipping, Belinda; Tyack, Zephanie; Griffin, Bronwyn; Chester, Ralph L; Kimble, Roy M

2016-04-29

Burns and the associated wound care procedures can be extremely painful and anxiety-provoking for children. Burn injured children and adolescents are therefore at greater risk of experiencing a range of psychological reactions, in particular posttraumatic stress disorder, which can persist for months to years after the injury. Non-pharmacological intervention is critical for comprehensive pain and anxiety management and is used alongside pharmacological analgesia and anxiolysis. However, effective non-pharmacological pain and anxiety management during pediatric burn procedures is an area still needing improvement. Medical hypnosis has received support as a technique for effectively decreasing pain and anxiety levels in adults undergoing burn wound care and in children during a variety of painful medical procedures (e.g., bone marrow aspirations, lumbar punctures, voiding cystourethrograms, and post-surgical pain). Pain reduction during burn wound care procedures is linked with improved wound healing rates. To date, no randomized controlled trials have investigated the use of medical hypnosis in pediatric burn populations. Therefore this study aims to determine if medical hypnosis decreases pain, anxiety, and biological stress markers during wound care procedures; improves wound healing times; and decreases rates of traumatic stress reactions in pediatric burn patients. This is a single-center, superiority, parallel-group, prospective randomized controlled trial. Children (4 to 16 years, inclusive) with acute burn injuries presenting for their first dressing application or change are randomly assigned to either the (1) intervention group (medical hypnosis) or (2) control group (standard care). A minimum of 33 participants are recruited for each treatment group. Repeated measures of pain, anxiety, stress, and wound healing are taken at every dressing change until ≥95 % wound re-epithelialization. Further data collection assesses impact on posttraumatic stress

Systematic review of dexketoprofen in acute and chronic pain.

Science.gov (United States)

Moore, R Andrew; Barden, Jodie

2008-10-31

Dexketoprofen, an NSAID used in the management of acute and chronic pains, is licensed in several countries but has not previously been the subjected of a systematic review. We used published and unpublished information from randomised clinical trials (RCTs) of dexketoprofen in painful conditions to assess evidence on efficacy and harm. PubMed and Cochrane Central were searched for RCTs of dexketoprofen for pain of any aetiology. Reference lists of retrieved articles and reviews were also searched. Menarini Group produced copies of published and unpublished studies (clinical trial reports). Data were abstracted into a standard form. For studies reporting results of single dose administration, the number of patients with at least 50% pain relief was derived and used to calculate the relative benefit (RB) and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief compared with placebo. Thirty-five trials were found in acute pain and chronic pain; 6,380 patients were included, 3,381 receiving dexketoprofen. Information from 16 trials (almost half the total patients) was obtained from clinical trial reports from previously unpublished trials or abstracts. Almost all of the trials were of short duration in acute conditions or recent onset pain.All 12 randomised trials that compared dexketoprofen (any dose) with placebo found dexketoprofen to be statistically superior. Five trials in postoperative pain yielded NNTs for 12.5 mg dexketoprofen of 3.5 (2.7 to 4.9), 25 mg dexketoprofen of 3.0 (2.4 to 3.9), and 50 mg dexketoprofen of 2.1 (1.5 to 3.5). In 29/30 active comparator trials, dexketoprofen at the dose used was at least equivalent in efficacy to comparator drugs. Adverse event withdrawal rates were low in postoperative pain and somewhat higher in trials of longer duration; no serious adverse events were reported. Dexketoprofen was at least as effective as other NSAIDs and paracetamol/opioid combinations. While adverse event withdrawal was not

Once-Yearly Zoledronic Acid and Days of Disability, Bed Rest, and Back Pain: Randomized, Controlled HORIZON Pivotal Fracture Trial

Science.gov (United States)

Cauley, Jane A.; Black, Dennis; Boonen, Steven; Cummings, Steven R.; Mesenbrink, Peter; Palermo, Lisa; Man, Zulema; Hadji, Peyman; Reid, Ian R.

2016-01-01

The objective of this study was to determine the effect of once-yearly zoledronic acid on the number of days of back pain and the number of days of disability (ie, limited activity and bed rest) owing to back pain or fracture in postmenopausal women with osteoporosis. This was a multicenter, randomized, double-blind, placebo-controlled trial in 240 clinical centers in 27 countries. Participants included 7736 postmenopausal women with osteoporosis. Patients were randomized to receive either a single 15-minute intravenous infusion of zoledronic acid (5 mg) or placebo at baseline, 12 months, and 24 months. The main outcome measures were self-reported number of days with back pain and the number of days of limited activity and bed rest owing to back pain or a fracture, and this was assessed every 3 months over a 3-year period. Our results show that although the incidence of back pain was high in both randomized groups, women randomized to zoledronic acid experienced, on average, 18 fewer days of back pain compared with placebo over the course of the trial (p = .0092). The back pain among women randomized to zoledronic acid versus placebo resulted in 11 fewer days of limited activity (p = .0017). In Cox proportional-hazards models, women randomized to zoledronic acid were about 6% less likely to experience 7 or more days of back pain [relative risk (RR) = 0.94, 95% confidence interval (CI) 0.90–0.99] or limited activity owing to back pain (RR = 0.94, 95% CI 0.87–1.00). Women randomized to zoledronic acid were significantly less likely to experience 7 or more bed-rest days owing to a fracture (RR = 0.58, 95% CI 0.47–0.72) and 7 or more limited-activity days owing to a fracture (RR = 0.67, 95% CI 0.58–0.78). Reductions in back pain with zoledronic acid were independent of incident fracture. Our conclusion is that in women with postmenopausal osteoporosis, a once-yearly infusion with zoledronic acid over a 3-year period significantly reduced the number of days that

The CUPCIG (CAM-Use in Primary Care in Germany) Study:Part I-Pain. Study Protocol of a Pilot-trial to Assess Feasibility, Acceptability and Perceived Effectiveness of CAM in Pain Disorders in Primary Care.

Science.gov (United States)

Schencking, Martin; Sönnichsen, Andreas; Bassüner, Susanne; Redaelli, Marcus

2015-01-01

There is limited valid data available on CAM procedures for chronic joint and neuropathic pain in primary care in Germany. Indiviual CAM qualifications of the general practitioners (GPs) and the potential of cost reduction through CAM treatment are almost unknown. The aim of this pilot trial preceding the main study is to examine the survey mode, to estimate the response rate by GPs with or without an additional qualification for CAM, and to identify the status quo in therapeutic approaches for chronic pain disorders in primary care. This is a cross-sectional study with an ex post facto design among German GPs consisting of 2 parts: In a first step, a pilot trial precedes the main study targeting 200 GPs with and 200 GPs without additional qualification in CAM in a selected region. The results of the CUPCIG study comprise the distribution of pain types treated in primary care practices, the GPs' attitude toward complementary pain therapy, pharmacological or CAM treatment, the estimate of cost reduction through CAM treatment of pain, the application of diverse CAM procedures, and biographical data. The CUPCIG study serves to compile pain therapy approaches in primary care in Germany with respect to the individual CAM expertise of the GPs. © 2015 S. Karger GmbH, Freiburg.

Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial.

Science.gov (United States)

Bertrand, Helene; Kyriazis, Marylene; Reeves, K Dean; Lyftogt, John; Rabago, David

2015-11-01

Capsaicin specifically activates, and then gradually exhausts, the transient receptor potential vanilloid type 1 (TRPV1) receptor, a key receptor in neuropathic pain. Activation of the TRPV-1 receptor is accompanied by burning pain. A natural substance or medication that can reduce the burning pain resulting from capsaicin application may have therapeutic potential in neuropathic pain. To assess the pain-relieving effects of a mannitol-containing cream in a capsaicin-based pain model. Randomized, placebo-controlled, double-blind clinical trial. Outpatient pain clinic. Twenty-five adults with pain-free lips. Capsaicin .075% cream was applied to both halves of each participant's upper lip, inducing pain via stimulation of the transient receptor potential vanilloid 1 (TRPV1, capsaicin) receptor, then removed after 5 minutes or when participants reported a burning pain of 8/10, whichever came first. A cream containing mannitol and the same cream without mannitol (control) were then immediately applied, 1 on each side of the lip, in an allocation-masked manner. Participants self-recorded a numeric rating scale (NRS, 0-10) pain score for each side of the lip per minute for 10 minutes. A t-test was performed to evaluate the pain score change from baseline between each side of the lip at each recording. Area under the curve (AUC) analysis was used to determine the overall difference between groups. Participants reached a capsaicin-induced pain level of 7.8 ± 1.0 points in 3.3 ± 1.6 minutes that was equal on both sides of the lip. Both groups reported progressive diminution of pain over the 10-minute study period. However, participants reported significantly reduced pain scores on the mannitol cream half-lip compared to control at 3 through 10 minutes (P < .05) and in AUC analysis (P < .001). Mannitol cream reduced self-reported pain scores in a capsaicin pain model more rapidly than a control cream, potentially via a TRPV1 receptor effect. Copyright © 2015 American

Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial

DEFF Research Database (Denmark)

Eklund, Andreas; Axén, Iben; Kongsted, Alice

2014-01-01

is the number of days with bothersome pain over 12 months. Secondary measures are self-rated health (EQ-5D), function (the Roland Morris Disability Questionnaire), psychological profile (the Multidimensional Pain Inventory), pain intensity (the Numeric Rating Scale), and work absence.The primary utility measure...... of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms: 1) Symptom-guided treatment (patient controlled), receiving care when patients feel a need....... Strict inclusion criteria should ensure a suitable target group and the use of frequent data collection should provide an accurate outcome measurement. The study utilizes normal clinical procedures, which should aid the transferability of the results.Trial registration: Clinical trials.gov; NCT01539863...

Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial

OpenAIRE

van der Roer, Nicole; van Tulder, Maurits; Barendse, Johanna; Knol, Dirk; van Mechelen, Willem; de Vet, Henrica

2008-01-01

Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapist...

Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life

OpenAIRE

Lambeek, L.C.; van Mechelen, W.; Knol, D.L.; Loisel, P.; Anema, J.R.

2010-01-01

Objective To evaluate the effectiveness of an integrated care programme, combining a patient directed and a workplace directed intervention, for patients with chronic low back pain. Design Population based randomised controlled trial. Setting Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals). Participants 134 adults aged 18-65 sick listed for at least 12 weeks owing to low back pain. Intervention P...

Massage Therapy for Pain and Function in Patients With Arthritis: A Systematic Review of Randomized Controlled Trials.

Science.gov (United States)

Nelson, Nicole L; Churilla, James R

2017-09-01

Massage therapy is gaining interest as a therapeutic approach to managing osteoarthritis and rheumatoid arthritis symptoms. To date, there have been no systematic reviews investigating the effects of massage therapy on these conditions. Systematic review was used. The primary aim of this review was to critically appraise and synthesize the current evidence regarding the effects of massage therapy as a stand-alone treatment on pain and functional outcomes among those with osteoarthritis or rheumatoid arthritis. Relevant randomized controlled trials were searched using the electronic databases Google Scholar, MEDLINE, and PEDro. The PEDro scale was used to assess risk of bias, and the quality of evidence was assessed with the GRADE approach. This review found seven randomized controlled trials representing 352 participants who satisfied the inclusion criteria. Risk of bias ranged from four to seven. Our results found low- to moderate-quality evidence that massage therapy is superior to nonactive therapies in reducing pain and improving certain functional outcomes. It is unclear whether massage therapy is more effective than other forms of treatment. There is a need for large, methodologically rigorous randomized controlled trials investigating the effectiveness of massage therapy as an intervention for individuals with arthritis.

Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain.

Science.gov (United States)

Moore, R Andrew; Gay-Escoda, C; Figueiredo, R; Tóth-Bagi, Z; Dietrich, T; Milleri, S; Torres-Lagares, D; Hill, C M; García-García, A; Coulthard, P; Wojtowicz, A; Matenko, D; Peñarrocha-Diago, M; Cuadripani, S; Pizà-Vallespir, B; Guerrero-Bayón, C; Bertolotti, M; Contini, M P; Scartoni, S; Nizzardo, A; Capriati, A; Maggi, C A

2015-01-01

Combination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective. This was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo. The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours. 606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders (72%) was achieved in the dexketoprofen trometamol 25 mg plus tramadol hydrochloride 75 mg group (NNT 1.6, 95% confidence interval 1.3 to 2.1). Addition of tramadol to dexketoprofen resulted in greater peak pain relief and greater pain relief over the longer term, particularly at times longer than six hours (median duration of 8.1 h). Adverse events were unremarkable. Dexketoprofen trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain. The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae. EudraCT (2010-022798-32); Clinicaltrials.gov (NCT01307020).

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

Science.gov (United States)

Saper, Robert B; Sherman, Karen J; Delitto, Anthony; Herman, Patricia M; Stevans, Joel; Paris, Ruth; Keosaian, Julia E; Cerrada, Christian J; Lemaster, Chelsey M; Faulkner, Carol; Breuer, Maya; Weinberg, Janice

2014-02-26

Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic

Personalized Pain Medicine: The Clinical Value of Psychophysical Assessment of Pain Modulation Profile

Directory of Open Access Journals (Sweden)

Yelena Granovsky

2013-10-01

Full Text Available Experimental pain stimuli can be used to simulate patients’ pain experience. We review recent developments in psychophysical pain testing, focusing on the application of the dynamic tests—conditioned pain modulation (CPM and temporal summation (TS. Typically, patients with clinical pain of various types express either less efficient CPM or enhanced TS, or both. These tests can be used in prediction of incidence of acquiring pain and of its intensity, as well as in assisting the correct choice of analgesic agents for individual patients. This can help to shorten the commonly occurring long and frustrating process of adjusting analgesic agents to the individual patients. We propose that evaluating pain modulation can serve as a step forward in individualizing pain medicine.

The efficacy of adhesiolysis on chronic abdominal pain

DEFF Research Database (Denmark)

Gerner-Rasmussen, Jonas; Burcharth, Jakob; Gögenur, Ismail

2015-01-01

INTRODUCTION: Abdominal adhesions are a frequent reason for chronic abdominal pain. The purpose of this systematic review was to investigate the evidence of performing laparoscopic adhesiolysis as a treatment for patients with chronic abdominal pain. METHODS: Medline, Embase, and The Cochrane Cen...... Central Register of Controlled Trials were searched for trials performing lysis of adhesions on patients suffering from chronic abdominal pain. Clinical studies on patients being treated for chronic abdominal pain with surgical adhesiolysis were included. The main outcome of the study...... chronic abdominal pain. A total of 22 trials were identified as case-series and included no control group. Three studies were identified as randomized controlled trials (RCT). A benefit of the intervention varied from 16 to 88 % in the non-randomized studies, with the majority reporting pain relief...... no difference between the intervention and control group. CONCLUSION: The identified studies showed promising but preliminary results of laparoscopic adhesiolysis as a treatment of chronic abdominal pain. The evidence for laparoscopic adhesiolysis is not sufficient to make definitive conclusions....