马王堆导引功法治疗慢性非特异性下腰痛患者：一项随机对照试验的研究方案
Mawangdui-Guidance Qigong Exercise for patients with chronic non-specific low back pain: Study protocol of a randomized controlled trial.
作者信息
Zhang Guilong, Gao Liang, Zhang Di, Li Hongjian, Shen Yuquan, Zhang Zhengsong, Huang Yong
机构信息
Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Beijing Bo'ai Hospital China Rehabilitation Research Center, School of Rehabilitation, Capital Medical University, Beijing, China.
出版信息
Front Neurosci. 2023 Mar 13;17:1090138. doi: 10.3389/fnins.2023.1090138. eCollection 2023.
INTRODUCTION
Worldwide, there is a high frequency of chronic non-specific low back pain (CNLBP), which is a significant public health concern. The etiology is complicated and diverse, and it includes a number of risk factors such as diminished stability and weak core muscles. Mawangdui-Guidance Qigong has been employed extensively to bolster the body in China for countless years. However, the effectiveness of treating CNLBP has not been assessed by a randomized controlled trial (RCT). In order to verify the results of the Mawangdui-Guidance Qigong Exercise and examine its biomechanical mechanism, we intend to perform a randomized controlled trial.
METHODS AND ANALYSIS
Over the course of 4 weeks, 84 individuals with CNLBP will be randomly assigned to receive either Mawangdui-Guidance Qigong Exercise, motor control exercise, or medication (celecoxib). Electromyographic data, including muscle activation time, iEMGs, root mean square value (RMS) and median frequency (MF), will be the main outcomes. The Japanese Orthopedic Association (JOA) Score, the Mcgill Pain Questionnaire (MPQ), beta-endorphin, and substance P are examples of secondary outcomes. At the start of treatment and 4 weeks later, all outcomes will be evaluated. SPSS version 20.0 (SPSS Inc., Chicago, IL, USA) will be used for all of the analysis.
DISCUSSION
The prospective findings are anticipated to offer an alternative treatment for CNLBP and provide a possible explanation of the mechanism of Mawangdui-Guidance Qigong Exercise on CNLBP.
ETHICS AND DISSEMINATION
The Sichuan Regional Ethics Review Committee on Traditional Chinese Medicine has given the study approval (Approval No. 2020KL-067). It has also registered at the website of China Clinical Trial Center Registration. The application adheres to the Declaration of Helsinki's tenets (Version Edinburgh 2000). Peer-reviewed papers will be used to publicize the trial's findings.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov, identifier ChiCTR2000041080.
引言
在全球范围内，慢性非特异性下腰痛（CNLBP）的发病率很高，这是一个重大的公共卫生问题。其病因复杂多样，包括一些风险因素，如稳定性下降和核心肌肉无力。多年来，马王堆导引术在中国被广泛用于强身健体。然而，其治疗CNLBP的有效性尚未通过随机对照试验（RCT）进行评估。为了验证马王堆导引术锻炼的效果并研究其生物力学机制，我们打算进行一项随机对照试验。
方法与分析
在4周的时间里，84名CNLBP患者将被随机分配接受马王堆导引术锻炼、运动控制锻炼或药物治疗（塞来昔布）。肌电图数据，包括肌肉激活时间、积分肌电图（iEMGs）、均方根值（RMS）和中位频率（MF），将作为主要观察指标。日本骨科协会（JOA）评分、麦吉尔疼痛问卷（MPQ）、β-内啡肽和P物质等为次要观察指标。在治疗开始时和4周后，将对所有观察指标进行评估。所有分析将使用SPSS 20.0版本（SPSS公司，美国伊利诺伊州芝加哥）。
讨论
预期的前瞻性研究结果将为CNLBP提供一种替代治疗方法，并为马王堆导引术锻炼对CNLBP的作用机制提供一种可能的解释。
伦理与传播
四川省中医药区域伦理审查委员会已批准该研究（批准号：2020KL-067）。该研究也已在中国临床试验中心注册网站上注册。该申请遵循《赫尔辛基宣言》的原则（2000年爱丁堡版本）。将通过同行评审论文来公布试验结果。
试验注册号
ClinicalTrials.gov，标识符ChiCTR2000041080。
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