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Effects of tai chi program on neuromuscular function for patients with knee osteoarthritis: study protocol for a randomized controlled trial

机译:太极拳对膝骨性关节炎患者神经肌肉功能的影响:一项随机对照试验的研究方案

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Background 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. Discussion 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. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-13003264 .
机译:背景技术膝骨关节炎(OA)是致残的主要原因,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治疗的替代和补充疗法,但在其用途方面似乎尚未达成共识。这项研究旨在为膝骨关节炎患者开发创新的太极拳康复计划(ITCRP),并研究ITCRP干预对膝骨关节炎疼痛,功能,平衡,神经肌肉反应和生物力学等一系列结局的影响。方法/设计我们将对140例有症状膝骨关节炎的个体进行前瞻性,单盲,随机对照试验。将患者随机分为ITCRP组或对照组。 ITCRP小组每周参加两次或三次太极拳,为期6个月。对照组将接受健康教育。经过6个月的干预期后,将进行6个月的随访期,两组均无积极干预。主要和次要结局将在基线,6个月和12个月时评估。主要结果指标将是疼痛的视觉模拟量表,西安大略省和麦克马斯特大学的骨关节炎指数以及莱克森膝盖得分。次要结果指标将包括Berg平衡量表,膝盖和脚踝本体感受,神经肌肉反应和3D功能生物力学。此外,不良事件将被记录和分析。如果有任何参与者退出试验,将进行意向性治疗分析。讨论该试验的重要特征包括随机程序,大样本量以及用于膝骨关节炎的ITCRP的标准化方案。这项研究旨在确定ITCRP用于膝骨关节炎的可行性,并提供有关ITCRP影响的数据。因此,我们的结果将对膝骨关节炎患者以及医务人员和医疗保健决策者有用。试验注册中国临床试验注册:ChiCTR-TRC-13003264。

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