Wang Xue-Qiang, Huang Ling-Yan, Liu Yu, Li Jing-Xian, Wu Xie, Li Hai-Peng, Wang Lin
Key Laboratory of Exercise and Health Sciences, Ministry of Education, Shanghai University of Sport, Shanghai 200438, China.
Trials. 2013 Nov 7;14:375. doi: 10.1186/1745-6215-14-375.
Knee osteoarthritis (OA) is a major cause of disability as well as a burden on healthcare resources. Tai chi has been proposed as an alternative and complementary treatment for the management of knee osteoarthritis, but there appears to be no consensus on its usefulness. This study aims to develop an innovative tai chi rehabilitation program (ITCRP) for patients with knee OA, and to investigate the effect of ITCRP intervention on a range of outcomes including pain, function, balance, neuromuscular response, and biomechanics in knee OA.
METHODS/DESIGN: We will conduct a prospective, single-blind, randomized controlled trial of 140 individuals with symptomatic knee OA. Patients will be randomly assigned into either an ITCRP group or a control group. The ITCRP group will participate in tai chi two or three times a week for 6 months. The control group will receive health education. After the 6-month intervention period, there will be a 6-month follow-up period with no active intervention in either group. The primary and secondary outcomes will be assessed at baseline, 6 months, and 12 months. Primary outcome measures will be a visual analog scale for pain, the Western Ontario and McMaster Universities Osteoarthritis Index,and the Lequesne Knee Score. The secondary outcome measures will include the Berg balance scale, knee and ankle proprioception, neuromuscular response, and 3D functional biomechanics. Furthermore, adverse events will be recorded and analyzed. If any participants withdraw from the trial, intention-to-treat analysiswill be performed.
Important features of this trial include the randomization procedures, large sample size, and a standardized protocol for ITCRP for knee OA. This study aims to determine the feasibility of ITCRP for knee OA and provide data on the effects of ITCRP. Hence, our results will be useful for patients with knee OA as well as for medical staff and healthcare decision makers.
Chinese Clinical Trial Registry: ChiCTR-TRC-13003264.
膝关节骨关节炎(OA)是导致残疾的主要原因,也是医疗资源的负担。太极拳已被提议作为膝关节骨关节炎管理的替代和补充治疗方法,但关于其有效性似乎尚未达成共识。本研究旨在为膝关节OA患者开发一种创新的太极拳康复计划(ITCRP),并研究ITCRP干预对一系列结局的影响,包括膝关节OA患者的疼痛、功能、平衡、神经肌肉反应和生物力学。
方法/设计:我们将对140例有症状的膝关节OA患者进行一项前瞻性、单盲、随机对照试验。患者将被随机分为ITCRP组或对照组。ITCRP组将每周参加两次或三次太极拳练习,为期6个月。对照组将接受健康教育。在6个月的干预期后,将有一个6个月的随访期,两组均不进行积极干预。主要和次要结局将在基线、6个月和12个月时进行评估。主要结局指标将是疼痛视觉模拟量表、西安大略和麦克马斯特大学骨关节炎指数以及Lequesne膝关节评分。次要结局指标将包括伯格平衡量表、膝关节和踝关节本体感觉、神经肌肉反应以及3D功能生物力学。此外,将记录和分析不良事件。如果有任何参与者退出试验,将进行意向性分析。
该试验的重要特征包括随机化程序、大样本量以及针对膝关节OA的ITCRP标准化方案。本研究旨在确定ITCRP对膝关节OA的可行性,并提供有关ITCRP效果的数据。因此,我们的结果将对膝关节OA患者以及医务人员和医疗保健决策者有用。
中国临床试验注册中心:ChiCTR-TRC-13003264