Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, 274 Zhijiangzhong Road, Shanghai, 200071, China.
LongHua Hospital Shanghai University of Traditional Chinese Medicine, 725 Wanpingnan Road, Shanghai, 200032, China.
Trials. 2023 Aug 7;24(1):498. doi: 10.1186/s13063-023-07540-5.
Rotator cuff-related shoulder pain (RCRSP) is the most common cause of shoulder disorders. In China, manipulation has been used extensively for the treatment of patients with RCRSP. However, high-quality clinical evidence to support the therapeutic effect of manipulation is still limited.
A multicenter, participant-, outcome assessor-, and data analyst-blinded, randomized, placebo-controlled trial will be conducted. A total of 280 participants with RCRSP will be recruited from three hospitals and randomly assigned to a five-step shoulder manipulation (FSM) group or a sham manipulation (SM) group. Each group will receive four weekly treatment sessions, with all participants performing exercises at home for 12 weeks. Assessments, namely the Constant-Murley score, visual analog scale, range of motion, and 36-Item Short Form Survey, will be made at baseline, 4, 12, 18, and 24 weeks. Adverse events during the study will also be recorded.
This is a pragmatic clinical trial to evaluate the efficacy and safety of FSM in patients with RCRSP. The findings of this study will provide worthy clinical evidence for manual therapy for RCRSP.
China Registered Clinical Trial Registration Center ChiCTR2000037577. Registered on 29 August 2020.
肩袖相关肩痛（RCRSP）是肩部疾病最常见的原因。在中国，推拿广泛用于治疗 RCRSP 患者。然而，支持推拿治疗效果的高质量临床证据仍然有限。
将进行一项多中心、参与者、结局评估者和数据分析师设盲、随机、安慰剂对照试验。将从三所医院招募 280 名 RCRSP 患者，并随机分为五步肩部推拿（FSM）组或假推拿（SM）组。每组将接受每周 4 次治疗，所有参与者在 12 周内在家中进行锻炼。在基线、4、12、18 和 24 周时进行评估，即 Constant-Murley 评分、视觉模拟评分、运动范围和 36 项简短健康调查。还将记录研究期间的不良事件。
这是一项评估 FSM 治疗 RCRSP 患者疗效和安全性的实用性临床试验。该研究的结果将为 RCRSP 的手法治疗提供有价值的临床证据。
中国临床试验注册中心 ChiCTR2000037577。于 2020 年 8 月 29 日注册。
