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

ABSTRACT: 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).

SUBMITTER: Yang M

PROVIDER: S-EPMC4228121 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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

Yang Mingxiao M Feng Yue Y Pei Hong H Deng Shufang S Wang Minyu M Xiao Xianjun X Zheng Hui H Lai Zhenhong Z Chen Jiao J Li Xiang X He Xiaoguo X Liang Fanrong F

Trials 20141029

<h4>Background</h4>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 ...[more]

PMID: 25352050

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Project description:IntroductionChronic low back pain disorders (CLBDs) present a substantial societal burden; however, optimal treatment remains debated. To date, pairwise and network meta-analyses have evaluated individual treatment modes, yet a comparison of a wide range of common treatments is required to evaluate their relative effectiveness. Using network meta-analysis, we aim to evaluate the effectiveness of treatments (acupuncture, education or advice, electrophysical agents, exercise, manual therapies/manipulation, massage, the McKenzie method, pharmacotherapy, psychological therapies, surgery, epidural injections, percutaneous treatments, traction, physical therapy, multidisciplinary pain management, placebo, 'usual care' and/or no treatment) on pain intensity, disability and/or mental health in patients with CLBDs.Methods and analysisSix electronic databases and reference lists of 285 prior systematic reviews were searched. Eligible studies will be randomised controlled/clinical trials (including cross-over and cluster designs) that examine individual treatments or treatment combinations in adult patients with CLBDs. Studies must be published in English, German or Chinese as a full-journal publication in a peer-reviewed journal. A narrative approach will be used to synthesise and report qualitative and quantitative data, and, where feasible, network meta-analyses will be performed. Reporting of the review will be informed by Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidance, including the network meta-analysis extension (PRISMA-NMA). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach for network meta-analysis will be implemented for assessing the quality of the findings.Ethics and disseminationEthical approval is not required for this systematic review of the published data. Findings will be disseminated via peer-reviewed publication.Prospero registration numberPROSPERO registration number CRD42020182039.

Project description:Chronic low back pain (LBP) and neck pain (NP) are highly prevalent conditions resulting in high economic costs. Treatment guidelines recommend relaxation techniques, such as progressive muscle relaxation, as adjuvant therapies. Self-care interventions could have the potential to reduce costs in the health care system, but their effectiveness, especially in a usual care setting, is unclear. The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone.Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic (>12 weeks) LBP or NP and an average pain intensity of???4 on a numeric rating scale (NRS) in the 7 days before recruitment. The participants will be randomized into an intervention and a usual care group. The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization: autogenic training, mindfulness meditation, or guided imagery. Instructions and exercises will be provided using a smartphone app, baseline information will be collected using paper and pencil. Follow-up information (daily, weekly, and after 3 and 6 months) will be collected using electronic diaries and questionnaires included in the app. The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS (0?=?no pain, 10?=?worst possible pain). The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements, the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months, pain acceptance, 'LBP- and NP-related' stress, sick leave days, pain medication intake, adherence, suspected adverse reaction, and serious adverse events.The designed studies reflect a usual self-care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals.ClinicalTrials.gov identifier Relaxback NCT02019498, Relaxneck NCT02019134 registered on 18 December 2013.

Project description:BACKGROUND:Chronic low back pain (CLBP) is a highly prevalent condition that has substantial impact on patients, the healthcare system and society. Pain management services (PMS), which aim to address the complex nature of back pain, are recommended in clinical practice guidelines to manage CLBP. Although the effectiveness of such services has been widely investigated in relation to CLBP, the quality of evidence underpinning the use of these services remains moderate. Therefore the aim is to summarize and critically appraise the current evidence for the cost effectiveness of pain management services for managing chronic back pain. METHODS:Electronic searches were conducted in MEDLINE, EMBASE and PsycINFO from their inception to February 2019. Full economic evaluations undertaken from any perspective conducted alongside randomized clinical trials (RCTs) or based on decision analysis models were included. Cochrane Back Review Group (CBRG) risk assessment and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist were used to assess the methodological quality of eligible studies. RESULTS:Five studies fulfilled eligibility criteria. The interventions varied significantly between studies in terms of the number and types of treatment modalities, intensity and the duration of the program. Interventions were compared with either standard care, which varied according to the country and the setting; or to surgical interventions. Three studies showed that pain management services are cost effective, while two studies showed that these services are not cost effective. In this review, three out of five studies had a high risk of bias based on the design of the randomised controlled trials (RCTs). In addition, there were limitations in the statistical and sensitivity analyses in the economic evaluations. Therefore, the results from these studies need to be interpreted with caution. CONCLUSION:Pain management services may be cost effective for the management of low back pain. However, this systematic review highlights the variability of evidence supporting pain management services for patients with back pain. This is due to the quality of the published studies and the variability of the setting, interventions, comparators and outcomes.

Project description:Background Extensive studies have been conducted to evaluate the pain relief effect of traditional Chinese medicine (TCM) interventions on patients with low back pain, including in China. However, there is a dearth in the literature documenting the diverse goals of TCM interventions, let alone the overall effect of such interventions. In this study, the goal attainment scaling (GAS) method was adopted to evaluate individualised TCM interventions on chronic low back pain. Methods A pre-post intervention study was conducted on patients with chronic low back pain who received individualised TCM interventions in community health services. The study was undertaken in three community health centres in Hangzhou of China. A total of 165 eligible patients were invited, and 150 participated in the study, including 136 who completed both pre- and postintervention surveys. Each participant was asked to identify three to five intended goals from a pool of 26 outcome indicators and their corresponding expectations of these goals prior to the TCM interventions. Their conditions were rated against the selected indicators on a self-report five-point Likert scale before and after the TCM interventions, respectively. Gaps between the actual conditions and the expected goals were summed up for each participant and converted into a standardised GAS score, with a higher score indicating higher achievements, and 50 indicting patient expectations were met. Linear regression models were established to determine the factors associated with the pre-post GAS changes after adjustment for variations in other variables. Results On average, an increase of 14.99 (SD?=?9.81) in the GAS scores was achieved. This resulted in a mean GAS score of 48.33 (SD?=?9.74) after the TCM interventions, falling slightly short (<2) of patient expectations. The multivariate linear regression models revealed that local residents, the retired, and those who perceived lower professional competency of their attending doctors had a smaller increase in the GAS scores after adjustment for variations in other variables. Conclusion The individualised TCM interventions can help patients with low back pain to achieve their expected goals as measured by the GAS. Further studies are needed to better understand how patients set up their goals and the professional competency requirements to meet patient expectations.

Dataset Information

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

Publications

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

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