The superiority trial of Baduanjin training on patients chronic low back pain: a study protocol for a randomized controlled trial.

IF 4.3 3区 材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2024-11-06 DOI:10.1186/s12906-024-04649-1
Tian-Yang Tan, Bing-Yan Cao, Wen-Ming Liang, Shuang Lou, Zheng Han, Yu-Xuan Ji, Jing Xiao
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Abstract

Background: CNSLBP accounts for 85% of all LBP cases and impairs physical health, quality of life, and work productivity, posing a significant health and economic burden. Baduanjin (BDJ) exercises are traditional Chinese Qi Gong mind-body exercises that have been practiced for over 1,000 years. However, the standard BDJ protocol established by the State Sports General Administration does not stimulate core muscles, limiting the effectiveness of low back pain rehabilitation. Therefore, it is necessary to improve the original BDJ protocol.

Methods: This 24-week single-center, single-blind, parallel-group randomized control superiority trial will allocate 100 patients into two groups (control and intervention) at a 1:1 ratio. The patients in the control group will perform the standard BDJ protocol established by the State Sports General Administration. The patients in the patients in the control group will perform the standard BDJ protocol established by the State Sports General Administration. The intervention group will perform intervention. The primary outcomes will be Quebec back pain disability scale. Secondary outcomes will include visual analog scale pain scores, Surface electromyography. The assessments of the tests will be performed at four time points. Adverse events will be recorded faithfully during the study.

Discussion: This randomized control trial is the first to compare a standard BDJ protocol and an optimized protocol in patients with CNSLBP. This study can help guide rehabilitation programs.

Trial registration: Chinese Clinical Trial Registry, ChiCTR2200065618, Registered on 10 Nov. 2022. This protocol is the first version 1, which was approved on 26 Aug 2022.

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八段锦训练对慢性腰背痛患者的优越性试验:随机对照试验研究方案。
背景:中枢神经系统腰痛占所有腰痛病例的 85%,会损害身体健康、生活质量和工作效率,对健康和经济造成重大负担。八段锦(BDJ)是中国传统的气功身心锻炼方法,已有一千多年的历史。然而,国家体育总局制定的标准八段锦方案不能刺激核心肌肉,限制了腰背痛康复的效果。因此,有必要对原有的 BDJ 方案进行改进:这项为期 24 周的单中心、单盲、平行组随机对照优效试验将把 100 名患者按 1:1 的比例分为两组(对照组和干预组)。对照组患者将执行国家体育总局制定的标准 BDJ 方案。对照组患者将执行国家体育总局制定的标准北斗七星方案。干预组将进行干预。主要结果为魁北克背痛残疾量表。次要结果将包括视觉模拟量表疼痛评分和表面肌电图。测试评估将在四个时间点进行。研究期间将如实记录不良事件:这项随机对照试验首次比较了标准 BDJ 方案和 CNSLBP 患者的优化方案。该研究有助于指导康复计划:试验注册:中国临床试验注册中心,ChiCTR2200065618,注册日期:2022年11月10日。本方案为第一版,已于2022年8月26日获得批准。
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7.20
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4.30%
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567
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