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

Abstract Background Knee 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/design This is a parallel-group, assessor-blinde...

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Autores principales:	Shu-Ming Li, Tian-Li Li, Ren Guo, Ping Chen, Wei-Shuai Du, Si-Bo Kang, Ming-Zhe Yan, Wu-Zhong Cheng
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Knee osteoarthritis Acupotomy NSAIDs Randomized controlled trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/f37219bddb714251b13d14cce41bf326
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spelling	oai:doaj.org-article:f37219bddb714251b13d14cce41bf3262021-11-21T12:31:26ZEffectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial10.1186/s13063-021-05786-51745-6215https://doaj.org/article/f37219bddb714251b13d14cce41bf3262021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05786-5https://doaj.org/toc/1745-6215Abstract Background Knee 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/design This 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. Discussion This 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 registration Chinese Clinical Trial Registry ChiCTR2100043005 Registered on 4 February 2021.Shu-Ming LiTian-Li LiRen GuoPing ChenWei-Shuai DuSi-Bo KangMing-Zhe YanWu-Zhong ChengBMCarticleKnee osteoarthritisAcupotomyNSAIDsRandomized controlled trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Knee osteoarthritis Acupotomy NSAIDs Randomized controlled trial Medicine (General) R5-920
spellingShingle	Knee osteoarthritis Acupotomy NSAIDs Randomized controlled trial Medicine (General) R5-920 Shu-Ming Li Tian-Li Li Ren Guo Ping Chen Wei-Shuai Du Si-Bo Kang Ming-Zhe Yan Wu-Zhong Cheng Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial
description	Abstract Background Knee 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/design This 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. Discussion This 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 registration Chinese Clinical Trial Registry ChiCTR2100043005 Registered on 4 February 2021.
format	article
author	Shu-Ming Li Tian-Li Li Ren Guo Ping Chen Wei-Shuai Du Si-Bo Kang Ming-Zhe Yan Wu-Zhong Cheng
author_facet	Shu-Ming Li Tian-Li Li Ren Guo Ping Chen Wei-Shuai Du Si-Bo Kang Ming-Zhe Yan Wu-Zhong Cheng
author_sort	Shu-Ming Li
title	Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial
title_short	Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial
title_full	Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial
title_fullStr	Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial
title_full_unstemmed	Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial
title_sort	effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/f37219bddb714251b13d14cce41bf326
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Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial

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