Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

China Registered Clinical Trial Registration Center ChiCTR2000037577. Registered on 29 August 2020.

Details

Title
Efficacy of five-step shoulder manipulation for rotator cuff-related shoulder pain: protocol for a multicenter randomized controlled trial
Author
Liu, Shuang 1 ; Liu, Jin-Tao 2 ; Chen, Lin 3 ; Fan, Tian-You 3 ; Cui, Xue-Jun 4 ; Cheng, Shao-Dan 5 ; Chen, Yan-Jiao 6 ; Shi, Qi 7 ; Xue, Chun-Chun 3   VIAFID ORCID Logo  ; Li, Xiao-Feng 8 

1  Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China (GRID:grid.412540.6) (ISNI:0000 0001 2372 7462); LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China (GRID:grid.411480.8) (ISNI:0000 0004 1799 1816) 
2  Suzhou Hospital of Traditional Chinese Medicine, Suzhou, China (GRID:grid.477943.a) 
3  Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China (GRID:grid.412540.6) (ISNI:0000 0001 2372 7462) 
4  LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China (GRID:grid.411480.8) (ISNI:0000 0004 1799 1816) 
5  Shanghai GuangHua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China (GRID:grid.440158.c) (ISNI:0000 0004 8516 2657) 
6  Shanghai Research Institute of Acupuncture and Meridian, YueYang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China (GRID:grid.440271.4) 
7  LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China (GRID:grid.411480.8) (ISNI:0000 0004 1799 1816); Qi Shi’s Studio of Famous Chinese Medicine Physician, Shanghai, China (GRID:grid.411480.8) 
8  Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China (GRID:grid.412540.6) (ISNI:0000 0001 2372 7462); Qi Shi’s Studio of Famous Chinese Medicine Physician, Shanghai, China (GRID:grid.412540.6) 
Pages
498
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-023-07540-5
ProQuest document ID
2847154906
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.