推拿疗法治疗臂丛神经损伤的疗效：一项随机临床试验方案

Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial.

作者信息

Xiao Bin, Zhao Lishu, Huang Yong, Ma Anqi, Pei Baoshun, Li Zhengyu, Gu Fei

机构信息

Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Shanghai Literature and Art Hospital, Shanghai, China.

出版信息

JMIR Res Protoc. 2023 May 29;12:e46054. doi: 10.2196/46054.

DOI:10.2196/46054

PMID:37247222

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10262027/

Abstract

BACKGROUND

Clinical rehabilitation for brachial plexus injury is difficult in terms of chronic pain and dysfunction. Physiotherapy is considered a routine intervention for rehabilitation. Common physical therapy may require a variety of instruments. One approach that does not need instruments, but belongs to the field of complementary and alternative medicine, is naprapathy. Naprapathy, also called Tuina in China, has been applied in rehabilitation after brachial plexus injury for a long time. Naprapathy can relieve chronic neuropathic pain, promote local blood circulation, and improve body edema. Naprapathy can passively help improve motor functions in patients with peripheral nerve injury. However, the efficacy of naprapathy in improving rehabilitation after brachial plexus injury is unclear.

OBJECTIVE

This study aims to evaluate the additional value of naprapathy when combined with conventional physical therapy for the treatment of brachial plexus injury.

METHODS

This will be a single-center randomized controlled trial. A total of 116 eligible patients with brachial plexus injury will be randomly divided into an experimental group (naprapathy plus physical therapy group) or a control group (physical therapy group). The participants will be followed up for 4 weeks of treatment. Observation outcomes will include the visual analog scale score, upper limb index, electromyography findings, and adverse reactions, among others. The measuring points for outcomes will be the baseline and the completion of treatment. In addition, a quality control group independent from the research team will be set up to control the quality of the trial. Finally, the data will be analyzed using SPSS software (version 21.0; IBM Corp).

RESULTS

The study is recruiting participants. The first participant was enrolled in September 2021. As of January 2023, a total of 100 participants have been enrolled. The trial is expected to be completed by September 2023. The study protocol was approved by the Ethics Review Committee of Yue Yang Hospital affiliated with the Shanghai University of Traditional Chinese Medicine (2021-012).

CONCLUSIONS

One limitation of this trial is that we will be unable to achieve strict double-blinding because of the features of naprapathy. The trial aims to contribute reliable evidence for decision-making in naprapathy for treating brachial plexus injury.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2100043515; http://www.chictr.org.cn/showproj.aspx?proj=122154.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46054.

摘要

背景

臂丛神经损伤的临床康复在慢性疼痛和功能障碍方面存在困难。物理治疗被认为是康复的常规干预措施。常见的物理治疗可能需要各种仪器。一种不需要仪器但属于补充和替代医学领域的方法是推拿疗法。推拿疗法在中国也被称为推拿，长期以来一直应用于臂丛神经损伤后的康复治疗。推拿疗法可以缓解慢性神经性疼痛，促进局部血液循环，改善身体水肿。推拿疗法可以被动地帮助改善周围神经损伤患者的运动功能。然而，推拿疗法在改善臂丛神经损伤后康复方面的疗效尚不清楚。

目的

本研究旨在评估推拿疗法与传统物理治疗相结合治疗臂丛神经损伤的附加价值。

方法

这将是一项单中心随机对照试验。总共116名符合条件的臂丛神经损伤患者将被随机分为实验组（推拿疗法加物理治疗组）或对照组（物理治疗组）。参与者将接受为期4周的治疗随访。观察结果将包括视觉模拟量表评分、上肢指数、肌电图检查结果和不良反应等。结果的测量点将是基线和治疗结束时。此外，将设立一个独立于研究团队的质量控制小组来控制试验质量。最后，将使用SPSS软件（版本21.0；IBM公司）对数据进行分析。