Li Ruiyang, Sun Pingping, Zhan Yu, Xie Xuetao, Yan Weibing, Luo Congfeng
Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.
Trials. 2022 Apr 18;23(1):323. doi: 10.1186/s13063-022-06282-0.
BACKGROUND: Knee osteoarthritis (OA) is a leading cause of global disability. According to current guidelines, exercise is the most recommended and important non-surgical treatment for knee OA. However, the best type of exercise for this condition remains unclear. Evidence has shown that traditional Chinese exercises may be more effective. Therefore, the current prospective, two-armed, single-center randomized controlled trial (RCT) aimed to identify an effective physiotherapy for knee OA. METHODS/DESIGN: In total, 114 patients with painful knee OA will be recruited from the orthopedic outpatient department of Shanghai Jiao Tong University Affiliated Sixth People's Hospital. To compare the therapeutic effect of two different home-based exercise programs, the participants will be randomly assigned into the experimental group (leg swing exercise) or the control group (quadriceps strengthening exercise). Each participant in both groups will be required to attend five individual sessions with a physiotherapist who will teach the exercise program and monitor progress. Participants will be instructed to perform the exercises at home every day for 12 weeks. Clinical outcomes will be assessed at baseline and 12 and 24 weeks after starting the intervention. The primary outcomes are average overall knee pain and physical function in daily life. The secondary outcomes include other measures of knee pain, physical function, patient-perceived satisfactory improvement, health-related quality of life, physical activity and performance, muscle strength of the lower limb, and adherence. DISCUSSION: This study will provide more evidence on the effects of traditional Chinese exercise on improving physical function and relieving joint pain among patients with knee OA. If proven effective, leg swing exercise can be used as a non-surgical treatment for knee OA in the future. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000039005 . Registered on 13 October 2020.
背景:膝关节骨关节炎(OA)是全球致残的主要原因。根据现行指南,运动是膝关节OA最推荐且重要的非手术治疗方法。然而,针对这种疾病的最佳运动类型仍不明确。有证据表明,传统中式运动可能更有效。因此,当前这项前瞻性、双臂、单中心随机对照试验(RCT)旨在确定一种有效的膝关节OA物理治疗方法。 方法/设计:总共将从上海交通大学附属第六人民医院骨科门诊招募114名膝关节疼痛的OA患者。为比较两种不同的居家运动方案的治疗效果,参与者将被随机分配到实验组(摆腿运动)或对照组(股四头肌强化运动)。两组中的每位参与者都需要参加五次与物理治疗师的单独课程,物理治疗师将教授运动方案并监测进展。将指导参与者每天在家中进行运动,持续12周。将在基线以及开始干预后的12周和24周评估临床结果。主要结果是膝关节平均总体疼痛和日常生活中的身体功能。次要结果包括膝关节疼痛、身体功能、患者感知的满意改善、健康相关生活质量、身体活动和表现、下肢肌肉力量以及依从性的其他测量指标。 讨论:本研究将为传统中式运动对改善膝关节OA患者身体功能和缓解关节疼痛的效果提供更多证据。如果被证明有效,摆腿运动未来可作为膝关节OA的非手术治疗方法。 试验注册:中国临床试验注册中心ChiCTR2000039005。于2020年10月13日注册。
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