Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial

Trials

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[1] 0000 0001 2372 7462, grid.412540.6, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, 200032, Shanghai, China;0000 0001 2372 7462, grid.412540.6, Spine Disease Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, 200032, Shanghai, China;0000 0004 0369 1660, grid.73113.37, Department of Orthopaedic, Shanghai Pudong Gongli Hospital, Second Military Medical University, 219 Miaopu Road, 200013, Shanghai, China;0000 0001 2372 7462, grid.412540.6, Spine Disease Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, 200032, Shanghai, China;0000 0004 0369 313X, grid.419897.a, Key Laboratory of Theory and Therapy of Muscles and Bones, Ministry of Education (Shanghai University of Traditional Chinese Medicine), 725 South Wanping Road, 200032, Shanghai, China;0000 0001 2372 7462, grid.412540.6, Spine Disease Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, 200032, Shanghai, China;Gansu Provincial Hospital of Traditional Chinese Medicine, 418 Guazhou Road, Qi lihe District, 730050, Gansu, Lanzhou, China;0000 0001 2372 7462, grid.412540.6, Spine Disease Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, 200032, Shanghai, China;Lu’an Hospital of Traditional Chinese Medicine, 76 Renmin Road, 237000, Anhui, Lu’an, China;0000 0001 2372 7462, grid.412540.6, Spine Disease Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, 200032, Shanghai, China;Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, 540 Xinhua Road, 200052, Shanghai, China;Ehu Branch of Xishan People’s Hospital, No. 1 Xuehai East Road, Xishan District, 214116, Wuxi, Jiangsu, China;

关键词: Clinical trials;    Knee osteoarthritis;    Tong-luo Qu-tong plaster;    Randomized;    Protocol;   

DOI  :  10.1186/s13063-019-3481-6

来源: publisher

【 摘 要 】

BackgroundKnee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affects quality of life. Patients with KOA frequently develop one or more of the following typical symptoms: joint pain, stiffness, joint friction noise and impaired functionality. Traditional Chinese medicine (TCM) has been shown to have a superior effect and a particular advantage in the treatment of KOA; among TCM, the Tong-luo Qu-tong plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high-quality clinical evidences to support the therapeutic effect that Chinese adhesive plaster can have in relieving pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-tong plaster in patients with KOA.Methods/designThis study will be a randomized, double-blind, parallel positive controlled, multi-center clinical trial, a non-inferiority trial design was adopted. A total of 2000 participants older than 40 years, with KOA, will be randomly allocated into an experimental group (n = 1500) and a control group (n = 500). All participants will receive a conventional conservative treatment lasting for 14 days as two courses, once daily. Tong-luo Qu-tong plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score and visual analog scale scores will be measured during the assessment visits (baseline and 1-week and 2-week follow up). In addition, adverse events related to clinical symptoms and signs and results of laboratory tests will be documented during the clinical trials.DiscussionThis study will provide reliable evidence of the effectiveness and safety of Tong-luo Qutong plaster in patients with KOA. If the results are favorable, it is expected that the patients with KOA will benefit from this study, many patients may have a good alternative treatment for KOA.Trial registrationClinicalTrials.gov, ID: NCT03309501. Registered on 8 November 2017.

【 授权许可】

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