METHODS: A total of 360 KOA patients aged between 40 and 70 years and classified as Kellgren and Lawrence grades I-II will be recruited from eight subcentral hospitals. The participants will be randomly assigned to either the treatment group (Tuina, Biw) or the control group (celecoxib, Qd), with both groups undergoing a 4-week intervention phase followed by an 8-week follow-up phase. The primary outcome is the change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale at week 4 compared with baseline. Secondary outcomes including WOMAC stiffness and function subscales, WOMAC total score, 36-item Short-Form Health Survey, Timed Up and Go test, Short Physical Performance Battery, gait analysis parameters and pain medication records will be assessed at weeks 4, 8 and 12. Any adverse events that occur during the trial will be promptly recorded.
BACKGROUND: This study has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2023SHL-KY-16-01, 2023SHL-KY-16-02). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and conference presentations.
BACKGROUND: ChiCTR2300069416.
方法:将从8家亚中心医院招募360名年龄在40至70岁之间,分为Kellgren和LawrenceI-II级的KOA患者。参与者将被随机分配到治疗组(Tuina,Biw)或对照组(塞来昔布,Qd),两组均接受为期4周的干预阶段,然后进行为期8周的随访阶段。主要结果是与基线相比,第4周西安大略省和麦克马斯特大学骨关节炎指数(WOMAC)疼痛分量表的变化。次要结果包括WOMAC刚度和功能分量表,WOMAC总分,36项简式健康调查,计时和测试,短物理性能电池,步态分析参数和疼痛药物记录将在第4、8和12周进行评估。在试验期间发生的任何不良事件将被及时记录。
背景:本研究已获得上海市中医医院伦理委员会批准(2023SHL-KY-16-01,2023SHL-KY-16-02)。将获得所有参与者的书面知情同意书。研究结果将通过同行评审的期刊和会议演讲进行传播。
背景:ChiCTR2300069416。