推拿治疗慢性颈部疼痛患者的疗效：一项随机对照试验的研究方案

Efficacy of tuina in patients with chronic neck pain: study protocol for a randomized controlled trial.

作者信息

Wu Zhiwei, Kong Lingjun, Zhu Qingguang, Song Pengfei, Fang Min, Sun Wuquan, Zhang Hao, Cheng Yanbin, Xu Shanda, Guo Guangxin, Zhou Xin, Lv Zhizhen

机构信息

Tuina Department, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.

Institute of Tuina, Shanghai Institute of Traditional Chinese Medicine, Shanghai, 200437, China.

出版信息

Trials. 2019 Jan 17;20(1):59. doi: 10.1186/s13063-018-3096-3.

DOI:10.1186/s13063-018-3096-3

PMID:30654844

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6337769/

Abstract

BACKGROUND

Chronic 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/DESIGN: This 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.

DISCUSSION

The 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 REGISTRATION

Chinese Clinical Trial Registry, ChiCTR-INR-17013763 . Registered 8 December 2017.

摘要

背景

慢性颈部疼痛（CNP）在发展中国家和发达国家都是一种常见且致残的肌肉骨骼疾病。先前的研究表明，推拿和传统中医按摩对CNP患者是有效的治疗方法。然而，几乎没有证据支持使用一种干预措施优于另一种。本研究的目的是比较推拿和传统中医按摩对CNP患者疼痛和残疾的治疗效果。

方法/设计：这是一项多中心、评估者和分析者双盲、随机对照试验，有两个平行组：推拿组和传统中医按摩组。总共356名符合条件的CNP患者将按1:1的比例随机分配到各组。推拿组的干预包括结构性按摩和放松按摩，而传统中医按摩组仅接受放松按摩。两组的干预时间均为15分钟，每周进行三次，为期4周。主要结局将是诺斯威克公园颈部疼痛问卷的变化。次要结局将通过视觉模拟量表（VAS）、颈部残疾指数（NDI）和36项简短健康调查问卷（SF-36）进行测量。数据将在基线、干预结束时以及随访的3个月期间通过重复测量方差分析进行分析。显著性水平为5%。每次治疗后将评估推拿和传统中医按摩的安全性。本试验的结果将有助于阐明推拿和传统中医按摩作为CNP治疗方法的价值，并突出治疗效果的任何差异。