College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.
Rehabilitation Medicine Center, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510655, China.
Trials. 2022 Nov 22;23(1):951. doi: 10.1186/s13063-022-06909-2.
BACKGROUND: Tai Chi (TC), as one of mild to moderate exercise therapies specifically recommended by clinical practice guideline from the American College of Physician, is a viable option for chronic non-specific low back pain (CNLBP) treatment. Nevertheless, limited studies focused on the effect of different weekly frequencies of TC in elders with CNLBP. This superiority study aims to compare the differences of TC with different weekly frequencies in elders with CNLBP on the premise of proving its effectiveness, and identifying whether mindfulness mediates the effect of TC on treatment outcomes. METHODS: In total, 284 senior citizens with CNLBP will be recruited in this single-centre, randomised, single-blinded (outcome assessors, data managers and the statistician), parallel controlled trial. Participants will be randomly divided into either one of three TC groups (1, 3, or 5 sessions/week, on the basis of weekly health educational lectures) or weekly health educational lectures, sustaining for 12 weeks, followed by 12 weeks of follow-up after the end of intervention. The primary outcome (the changes of LBP intensity at rest) will be measured at baseline before randomisation and immediately after the completion of weeks 4, 8 and 12 of the intervention, and the end of follow-up (week 24) using the visual analogue scale (VAS, 0-10 cm) to put a mark on the VAS scale to show how severities of their average low back pain have been over the past 24 h. Secondary outcomes, including Beck Depression Inventory-II, Pain Catastrophising Scale and Five Facet Mindfulness Questionnaire, Oswestry Disability Index and Short Form-36, will be measured at baseline and immediately after the completion of week 12 of the intervention and end of follow-up. The intention-to-treat and per-protocol principles will be used to analyse outcomes with a setting at α = 0.05 as statistical significance. DISCUSSION: This comprehensive and detailed protocol will be the first trial to compare the effectiveness of different weekly frequencies of TC in elders with CNLBP. The outcomes may provide valuable data about the choice of the ideal number of sessions to further normalise the application of exercise for clinicians. TRIAL REGISTRATION: Chinese clinical trial registry ChiCTR2200058190 . Registered on 1 April 2022.
背景:太极(TC)作为美国医师学院临床实践指南特别推荐的一种温和到中度的运动疗法,是慢性非特异性下腰痛(CNLBP)治疗的一种可行选择。然而,有限的研究集中在 CNLBP 老年人中不同每周 TC 频率的效果。这项优势研究旨在在证明其有效性的前提下,比较不同每周 TC 频率对 CNLBP 老年人的影响,并确定正念是否介导 TC 对治疗结果的影响。 方法:本单中心、随机、单盲(结局评估者、数据管理者和统计学家)、平行对照试验将招募 284 名患有 CNLBP 的老年人。参与者将随机分为三组 TC 组(每周 1、3 或 5 次,基于每周健康教育讲座)或每周健康教育讲座,持续 12 周,干预结束后进行 12 周随访。主要结局(休息时腰痛强度的变化)将在随机分组前的基线时、干预第 4、8 和 12 周结束时以及随访结束时(第 24 周)使用视觉模拟量表(VAS,0-10cm)进行测量,在 VAS 量表上标记以显示过去 24 小时内他们平均腰痛的严重程度。次要结局包括贝克抑郁量表二、疼痛灾难化量表和五因素正念问卷、Oswestry 残疾指数和简化 36 项健康调查,将在基线时和干预第 12 周结束时以及随访结束时进行测量。将采用意向治疗和方案治疗原则进行分析,以设置α=0.05 为统计学意义。 讨论:这是一项比较 CNLBP 老年人不同每周 TC 频率效果的首次试验。这些结果可能为进一步规范运动疗法的应用,为临床医生提供选择理想次数的有价值数据。 试验注册:中国临床试验注册中心 ChiCTR2200058190。注册于 2022 年 4 月 1 日。
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