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

Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial.
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中医按摩疗法(推拿)对慢性腰痛的有效性:随机对照试验的研究方案

DOI:
10.1186/1745-6215-15-418
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发表时间:
2014-10-29
期刊:
影响因子:
2.5
通讯作者:
Liang F
Liang F
中科院分区:
医学4区
文献类型:
--
作者:
Yang M;Feng Y;Pei H;Deng S;Wang M;Xiao X;Zheng H;Lai Z;Chen J;Li X;He X;Liang F

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腰痛是一种常见的,致残性肌肉骨骼疾病在发展中国家和发达国家。尽管经常被推荐,但由于样本量不足、方法学质量低以及迄今为止的亚临床给药方案,按摩疗法(尤其是中医推拿)缓解慢性腰痛(CLBP)的潜在疗效尚未完全确立。因此,本随机对照试验(RCT)的目的是评估推拿按摩疗法与传统镇痛药治疗CLBP的比较有效性。本研究是一项单中心、两组、开放标签RCT。将符合条件的150例慢性腰痛患者按1:1的比例随机分为推拿治疗组和常规药物对照组。推拿组的患者接受20分钟,4步治疗方案,其中包括结构和放松按摩,在4周内的20个疗程中进行。常规药物对照组的患者被指示服用特定日剂量的布洛芬。主要结果测量是在两个月时通过Roland-Morris残疾问卷测量的基线背痛和功能的变化。次要结局指标包括视觉模拟量表、日本骨科协会评分(JOAS)和麦吉尔疼痛问卷。本试验的设计和方法学的严谨性将允许收集有价值的数据,以评估特定推拿治疗CLBP的疗效。因此,这项试验将有助于为CLBP的临床治疗以及未来的按摩治疗研究提供坚实的基础。该试验于2013年10月22日在国家卫生研究院的ClinicalTrials.gov上注册(http://NCT 01973010)。
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).
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