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太极拳与物理治疗对慢性下腰痛老年人疼痛及认知表现的影响:一项随机对照试验的研究方案

Tai Chi Quan Versus Physical Therapy on Pain and Cognitive Performance for Elderly People With Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial.

作者信息

Wang Rui, Zhu Dong, Wang Lin, Liu Jing, Zou Jun, Sun Yang, Jiang Yan, Hu Hao-Yu, Deng Zhi-Wei, Weng Lin-Man, Zheng Kang-Yong, Kiartivich Suparata, Wang Xue-Qiang

机构信息

Department of Sport Rehabilitation, Shanghai University of Sport, Shanghai, China.

School of International Education, Shanghai University of Sport, Shanghai, China.

出版信息

Front Aging Neurosci. 2022 Jun 16;14:900430. doi: 10.3389/fnagi.2022.900430. eCollection 2022.

Abstract

OBJECTIVES

Chronic low back pain has become a major cause of global disability and caused a huge economic burden to society. Physical therapy is a vital strategy for rehabilitation of chronic low back pain. Although several trials have shown that Tai Chi Quan is a beneficial treatment, the comparative effectiveness of Tai Chi Quan versus physical therapy is unknown. We are conducting a randomized controlled trial to assess the effectiveness of Tai Chi Quan versus that of physical therapy in treating chronic low back pain.

METHODS

We will perform a single-blind randomized controlled trial on elderly people with chronic low back pain. 138 participants will be randomly assigned to the Tai Chi Quan group (60-min classes, three times per week for 12 weeks) or physical therapy group (10 min of evaluation and warm-up, 40 min of therapist-directed exercise therapy, and 10 min of relaxation, three times per week for 12 weeks) with an allocation of 1:1. The participants will be followed up for 40 weeks for the study of long-term effects. The primary outcomes include pain intensity and back-related function at 12 weeks. Secondary outcomes include lumbar quantitative sensory testing, balance, cognitive function, psychosocial function, cost-effectiveness, compliance and adverse events. We will perform the intention-to-treat analysis for withdrawal and missing data.

DISCUSSION

The study will be the first randomized trial with comparative-effectiveness of Tai Chi Quan and physical therapy for chronic low back pain. Standardized protocol, large sample size, and comprehensive outcomes are important features in this trial. This study aims to determine the feasibility and effectiveness of Tai Chi Quan for low back pain. The results of this study will be beneficial for elderly people with low back pain and medical rehabilitation personnel.

CLINICAL TRIAL REGISTRATION

www.chictr.org.cn, identifier ChiCTR2000029723.

摘要

目的

慢性下腰痛已成为全球残疾的主要原因,并给社会带来了巨大的经济负担。物理治疗是慢性下腰痛康复的重要策略。尽管多项试验表明太极拳是一种有益的治疗方法,但太极拳与物理治疗的相对疗效尚不清楚。我们正在进行一项随机对照试验,以评估太极拳与物理治疗在治疗慢性下腰痛方面的效果。

方法

我们将对患有慢性下腰痛的老年人进行单盲随机对照试验。138名参与者将被随机分配到太极拳组(60分钟课程,每周三次,共12周)或物理治疗组(10分钟评估和热身,40分钟治疗师指导的运动治疗,以及10分钟放松,每周三次,共12周),分配比例为1:1。参与者将被随访40周以研究长期效果。主要结局包括12周时的疼痛强度和与背部相关的功能。次要结局包括腰椎定量感觉测试、平衡、认知功能、心理社会功能、成本效益、依从性和不良事件。我们将对退出和缺失数据进行意向性分析。

讨论

该研究将是第一项比较太极拳和物理治疗对慢性下腰痛疗效的随机试验。标准化方案、大样本量和综合结局是该试验的重要特征。本研究旨在确定太极拳治疗下腰痛的可行性和有效性。本研究结果将对患有下腰痛的老年人和医学康复人员有益。

临床试验注册

www.chictr.org.cn,标识符ChiCTR2000029723。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a56/9243751/68fcf03eaa16/fnagi-14-900430-g001.jpg

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