Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial

Trials

Ren Guo¹  Ming-Zhe Yan¹  Shu-Ming Li¹  Wei-Shuai Du¹  Ping Chen¹  Wu-Zhong Cheng²  Tian-Li Li³  Si-Bo Kang⁴ 

[1] Department of Pain, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Dongcheng District, Beijing, China;Department of Tuina, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Dongcheng District, Beijing, China;Dongzhimen Hospital, Beijing University of Chinese Medicine, Dongcheng District, Beijing, China;School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, Beijing, China;

关键词: Knee osteoarthritis;    Acupotomy;    NSAIDs;    Randomized controlled trial;   

DOI  :  10.1186/s13063-021-05786-5

来源: Springer

【 摘 要 】

BackgroundKnee osteoarthritis (KOA) is one of the most common musculoskeletal disorders. Acupotomy may be effective for KOA, but the evidence is limited. This trial aims to determine the effectiveness and safety of acupotomy for KOA.Methods/designThis is a parallel-group, assessor-blinded randomized controlled trial. Two hundred patients with KOA will be recruited and randomly assigned to two groups (group A or group D) in a 1:1 ratio. Patients in group A will receive acupotomy and topical diclofenac diethylamine for 4 weeks, while patients in group D will receive topical diclofenac diethylamine alone for 4 weeks. The primary outcome will be the response rate—the proportion of patients who achieve the minimal clinically important improvement in pain and function at week 4 compared with baseline. Secondary outcomes will include pain, function, quality of life, the use of rescue medicine (loxoprofen sodium), and adverse events at weeks 4, 8, and 24 after randomization. Besides, joint fluid and serum will be collected to assess the level of inflammatory cytokines, like TNF-α, IL-1β, and MMP-3.DiscussionThis study will contribute to a better understanding of the effectiveness and safety of acupotomy in combination with topical nonsteroidal anti-inflammatory drugs. If the hypothesis is confirmed, acupotomy may be recommended as adjunctive therapy for patients with KOA. Results of the study will be of great importance for the guidelines of clinical therapy.Trial registrationChinese Clinical Trial Registry ChiCTR2100043005 Registered on 4 February 2021.

【 授权许可】

CC BY