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

ABSTRACT: Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low "doses" of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment.In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks.A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued.This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836

SUBMITTER: Sherman KJ

PROVIDER: S-EPMC3546891 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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

Sherman Karen J KJ Cook Andrea J AJ Kahn Janet R JR Hawkes Rene J RJ Wellman Robert D RD Cherkin Daniel C DC

BMC complementary and alternative medicine 20120918

<h4>Background</h4>Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low "doses" of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to ad ...[more]

PMID: 22985134

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Project description:This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments.The aim was to determine the optimal dose of massage for neck pain.Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage.A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included.Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline.Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs.There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups."Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain.

Project description:BACKGROUND:Neck pain is a highly prevalent medical condition that incurs substantial social burden. Although manual therapy is widely used for treatment of neck pain, the body of evidence supporting its effectiveness and safety is not conclusive. The aim of this study is to examine the effect, safety, and cost-effectiveness of Chuna manual therapy, a traditional Korean manual therapy for treatment of various musculoskeletal complaints. METHODS/DESIGN:This study is the protocol for a two-armed parallel, assessor-blinded, multicenter, randomized controlled trial. A total 108 patients with chronic neck pain (time to onset ??3 months, numeric rating scale [NRS] of neck pain ??5) will be recruited at five Korean medicine hospital sites. Participants will be allotted to one of two groups (n =?54, respectively): the Chuna manual therapy group, and the usual care (conventional physical therapy and medication treatment) group. Ten sessions of Chuna manual therapy or usual care will be administered twice a week for five weeks. Since the study design does not permit patient or physician blinding, the outcome assessor and statistician will be blinded. The primary outcome will be the visual analogue scale (VAS) of neck pain at 5 weeks after randomization. Secondary outcomes include the VAS of radiating arm pain, NRS of neck pain and radiating arm pain, Vernon-Mior neck disability index (NDI), Northwick Park neck pain questionnaire (NPQ), EuroQol-5 Dimension (EQ-5D), EQ-VAS, patient global impression of change (PGIC), economic evaluation, adverse effects, and drug consumption. Follow-up outcome assessments will be conducted at 3, 6, 9, and 12 months after randomization. DISCUSSION:This study will evaluate the comparative effectiveness of Chuna manual therapy and usual care on chronic neck pain. Adverse events, and costs and effectiveness (utility) data will be evaluated to assess safety and exploratory cost-effectiveness (economic evaluation). This study aims to provide evidence on the effectiveness, safety, and cost-effectiveness of Chuna manual therapy. TRIAL REGISTRATION:Clinical Research Information Service (CRIS), KCT0002732 . Registered on 13 March 2018. ClinicalTrials.gov, NCT03294785 . Registered on 27 September 2017.

Project description:INTRODUCTION:Chronic pain is prevalent, and approximately half of patients with chronic pain experience sleep disturbance. Exogenous melatonin is licensed to treat primary insomnia and there is some evidence for analgesic effects of melatonin.The aim of this study is to investigate the effects of oral melatonin (as Circadin) 2 mg at night in adults with severe non-malignant pain of at least 3 months' duration. METHODS AND ANALYSIS:We will conduct a randomised double-blind placebo-controlled cross-over study. The primary outcome is sleep disturbance. Secondary outcomes are pain intensity, actigraphy, fatigue, reaction time testing, serum melatonin and endogenous opioid peptide levels along with patient views about study participation.We aim to recruit 60 patients with severe chronic pain (average pain intensity ?7 on the Brief Pain Inventory (BPI)) from a tertiary referral pain clinic in Northeast Scotland. Participants will be randomised to receive melatonin (as modified release Circadin) 2?mg daily for 6?weeks or placebo, followed by a 4-week washout period, then 6?weeks treatment with the treatment they did not receive. Participants will complete the Verran Snyder-Halpern Sleep Scale, Pittsburgh Sleep Quality Index, Pain and Sleep Questionnaire 3-item index, BPI and psychomotor vigilance reaction time testing at 6 points over 20 weeks. Actigraphy watches will be used to provide objective measures of sleep duration and latency and other sleep measures and will prompt patients to report contemporaneous pain and fatigue scores daily.Cross-over analyses will include tests for effects of treatment, period, treatment-period interaction (carryover effect) and sequence. Within-patient effects and longitudinal data will be analysed using mixed linear models, accounting for potential confounders. ETHICS AND DISSEMINATION:Approved by Office for Research Ethics Committees Northern Ireland, reference 19/NI/0007. Results will be published in peer-reviewed journals and will be presented at national and international conferences. TRIAL REGISTRATION NUMBER:ISRCTN12861060.

Project description:Background:Musculoskeletal disorders are highly prevalent among office workers, with strong evidence suggesting that workplace-based resistance training programs can prevent several upper extremity musculoskeletal disorders. The aim of the present study was to examine the dose-response relationship between resistance training frequency and pain relief among office workers with neck- and shoulder pain. Methods:Thirty participants with mild to moderate neck- and shoulder pain attended a 16-week intervention starting with an eight-week control period followed by an eight-week training period. After the control period, the participants were randomized into either a 10?min (TG10) or 2?×?10?min (TG2) workplace-based, high-intensity neck- and shoulder specific resistance training program that was executed 5 days per week and consisting of four exercises. The participants were tested pre and post each period for mean and worst pain using the 0-100?mm visual analog scale (VAS), 0-100?mm health-related quality of life and isometric strength of the neck-and shoulder region. The analysis of variance (ANOVA) and Friedman with Bonferroni post hoc corrections were used to assess differences in between and within groups for the three testing times pre, mid and post intervention. Results:No differences were observed between the groups in any of the variables in the control period (p?=?0.27-0.97) or training period (p?=?0.37-0.68). When merging the two groups, the mean and worst pain was reduced by 25 and 43% (p?=?0.05 and?<?0.01, ES?=?0.41 and 0.55) in the training period in addition to 10.6% increase in health-related quality of life (p?=?0.01, ES?=?0.52). No difference in strength was observed (p?=?0.29-0.85). Conclusion:Daily bouts of specific high-intensity resistance training of the shoulder and neck region at the workplace reduced neck- and shoulder pain and improved quality of life of office workers. However, 10?min bouts were equally effective as 2?×?10?min bouts per day. The authors recommend office workers to perform daily neck- and shoulder resistance training to possibly prevent and/or decrease pain in the neck- and shoulder area. Trial registration:ISRCTN69968888, retrospectively registered (24/09/2019).

Project description:BackgroundChronic neck pain (CNP) is a common and disabling musculoskeletal disorder in developing and developed countries. Previous studies have shown that tuina and traditional Chinese massage are effective treatments for patients with CNP. However, there is little evidence to support the use of one intervention over the other. The aim of this study is to compare the effects of tuina and traditional Chinese massage in the treatment of pain and disability in patients with CNP.Methods/designThis is a multicenter, assessor- and analyst-blinded, randomized controlled trial with two parallel arms: a tuina group and a traditional Chinese massage group. A total of 356 eligible CNP patients will be randomly assigned to the groups in a 1:1 ratio. The intervention in the tuina group includes both structural and relaxation massage, while the traditional Chinese massage group will receive relaxation massage only. The interventions for both groups will last for 15?min and will be carried out three times a week for a period of 4?weeks. The primary outcome will be changes in the Northwick Park Neck Pain Questionnaire. Secondary outcomes will be measured by a visual analogue scale (VAS), the Neck Disability Index (NDI), and the 36-item Short-Form Health Survey (SF-36). The data will be analyzed at the baseline, at the end of the intervention, and during the 3?months of follow-up by repeated measures analysis of variance. The significance level is 5%. The safety of tuina and traditional Chinese massage will be evaluated after each treatment session. The results of this trial will help clarify the value of tuina and traditional Chinese massage as treatments for CNP and will highlight any differences in the efficacy of the treatments.DiscussionThe purpose of this trial is to determine whether tuina is more effective than traditional Chinese massage in adults with CNP. This trial will, therefore, contribute to providing a solid foundation for clinical treatment of CNP, as well as future research in massage therapy.Trial registrationChinese Clinical Trial Registry, ChiCTR-INR-17013763 . Registered 8 December 2017.

Project description:IntroductionChronic neck pain is a challenging condition to treat in clinical practice and has a considerable impact on quality of life and disability. According to the theory of traditional Chinese medicine, acupoints and tender points may become sensitised when the body is in a diseased state. Stimulation of such sensitive points may lead to disease improvement and improved clinical efficacy. This study aims to evaluate the efficacy and safety of needling at sensitive acupoints in providing pain relief, improvement of cervical vertebral function and quality of life in patients with chronic neck pain.Methods and analysisThis multicentre, randomised controlled, explanatory and parallel clinical trial will include 716 patients with chronic neck pain. Study participants will be randomly assigned in a 1:1:1:1 ratio to four treatment groups: the highly sensitive acupoints group, low/non-sensitive acupoints group, sham acupuncture group and waiting-list control group. The primary outcome will be the change in the visual analogue scale score for neck pain from baseline to 4 weeks. Secondary outcomes will be the Northwick Park Neck Pain Questionnaire and McGill pain questionnaire, 12-item Short-Form health survey, Neck Disability Index, changes in the pressure pain threshold, range of cervical motion, Self-Rating Anxiety Scale, Self-Rating Depression Scale and adverse events before treatment, post-treatment, and at 4, 8, 12, 16 and 20 weeks post-treatment. The intention-to-treat approach will be used in the statistical analysis. Group comparisons will be undertaken using χ2 tests for categorical characteristics, and analysis of variance for continuous variables to analyse whether acupuncture in the highly sensitive acupoints group achieves better treatment outcomes than in each of the other three groups.Ethics and disseminationEthical approval of this study has been granted by the local Institutional Review Board (ID: 2017 KL-038). The outcomes of the trial will be disseminated through peer-reviewed publications.Trial registration numberChiCTR1800016371; Pre-results.

Dataset Information

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

Publications

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

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