Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Physical Education Institute, Jimei University, Xiamen, China.
BMC Complement Med Ther. 2024 Nov 6;24(1):383. doi: 10.1186/s12906-024-04649-1.
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.
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.
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.
Chinese Clinical Trial Registry, ChiCTR2200065618, Registered on 10 Nov. 2022. This protocol is the first version 1, which was approved on 26 Aug 2022.
CNSLBP 占所有 LBP 病例的 85%,会损害身体健康、生活质量和工作生产力,造成重大的健康和经济负担。八段锦(BDJ)是一种传统的中国气功身心锻炼方法,已经练习了 1000 多年。然而,国家体育总局制定的标准 BDJ 方案并没有刺激核心肌肉,限制了对下腰痛康复的效果。因此,有必要改进原始 BDJ 方案。
这是一项为期 24 周的单中心、单盲、平行组随机对照优效性试验,将以 1:1 的比例将 100 名患者分为两组(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。干预组患者将执行干预方案。主要结局将是魁北克腰痛残疾量表。次要结局将包括视觉模拟评分、表面肌电图。测试评估将在四个时间点进行。在研究期间,将忠实地记录不良事件。
这是第一项比较 CNSLBP 患者标准 BDJ 方案和优化方案的随机对照试验。本研究可以帮助指导康复计划。
中国临床试验注册中心,ChiCTR2200065618,于 2022 年 11 月 10 日注册。本方案是第一版 1,于 2022 年 8 月 26 日批准。