BMC complementary medicine and therapies · 2024
The superiority trial of Baduanjin training on patients chronic low back pain: a study protocol for a randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Tan Tian-Yang, Cao Bing-Yan, Liang Wen-Ming, Lou Shuang, Han Zheng, Ji Yu-Xuan, Xiao Jing
Аннотация
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.
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.