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Abstract：
BACKGROUND: Knee osteoarthritis (KOA) is one of the most common osteoarthritis, imposing substantial economic and medical burdens on both individuals and society. In China, Tuina has been selected as a complementary and alternative therapy to relieve knee pain and dysfunction symptoms. However, the current evidence is insufficient to support the efficacy of Tuina therapy in addressing knee pain and improving physical function. The trial aims to compare the effectiveness of Tuina with celecoxib, which is considered as the standard treatment, and to assess its potential as an alternative therapy through changes in outcome measures.
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.
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.
摘要：
背景：膝骨关节炎（KOA）是最常见的骨关节炎之一，给个人和社会带来巨大的经济和医疗负担。在中国,推拿已被选为补充和替代疗法，以缓解膝关节疼痛和功能障碍症状。然而,目前的证据不足以支持推拿疗法在治疗膝关节疼痛和改善身体功能方面的疗效.该试验旨在比较推拿与塞来昔布的有效性，这被认为是标准治疗，并通过结果测量的变化来评估其作为替代疗法的潜力。
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。
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。
