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Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial

PURPOSE: Knee osteoarthritis (KOA) is regarded as one of the leading musculoskeletal diseases. Although the efficacy is under exploration, fire needling therapy is considered an effective alternative for KOA. This trial aims to investigate the effectiveness of different frequencies of fire needling...

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Autores principales: Wang, Mina, Xu, Xiaobai, Zhao, Bingcong, Liu, Lu, Zhao, Luopeng, Zhang, Fan, Ji, Xu, Yuan, Fang, Xia, Qiuyu, Wang, Shaosong, Tian, Wei, Wang, Linpeng, Li, Bin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10147561/
https://www.ncbi.nlm.nih.gov/pubmed/37128272
http://dx.doi.org/10.2147/JPR.S408084
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author Wang, Mina
Xu, Xiaobai
Zhao, Bingcong
Liu, Lu
Zhao, Luopeng
Zhang, Fan
Ji, Xu
Yuan, Fang
Xia, Qiuyu
Wang, Shaosong
Tian, Wei
Wang, Linpeng
Li, Bin
author_facet Wang, Mina
Xu, Xiaobai
Zhao, Bingcong
Liu, Lu
Zhao, Luopeng
Zhang, Fan
Ji, Xu
Yuan, Fang
Xia, Qiuyu
Wang, Shaosong
Tian, Wei
Wang, Linpeng
Li, Bin
author_sort Wang, Mina
collection PubMed
description PURPOSE: Knee osteoarthritis (KOA) is regarded as one of the leading musculoskeletal diseases. Although the efficacy is under exploration, fire needling therapy is considered an effective alternative for KOA. This trial aims to investigate the effectiveness of different frequencies of fire needling therapy in attenuating pain and promoting function in KOA patients. METHODS: This is a study protocol for a pilot, three-arm, single-center, randomized controlled trial. A total of 90 participants with KOA will be recruited and randomly assigned to the high-frequency fire needling group (3 sessions per week, for 6 weeks), the low-frequency fire needling group (1 session per week, for 6 weeks) or the positive control group (Diclofenac Diethylamine Emulgel, 3 times per day, for 6 weeks) in a 1:1:1 ratio. Participants will accomplish the trial at Week 14 after a follow-up evaluation. The response rate will be set as the primary outcome that the proportion of participants obtaining a minimal clinically important difference, which is identified as ≥2 units on the numerical rating scale (NRS) and ≥6 units on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at Week 6 compared with Week 0. Secondary outcomes are NRS, WOMAC, Brief Pain Inventory, Short-Form Health Survey-12, Timed Up and Go Test, and pain threshold. DISCUSSION: This is the first standardized protocol comparing fire needling therapy and positive control drugs. This trial may provide reliable evidence for the effectiveness of fire needling therapy and dose–effect property of it in KOA. Trial registration: The trial has been registered on Chinese Clinical Trial Registry (Registered number: ChiCTR2100043041), registered on 4 February 2021.
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spelling pubmed-101475612023-04-30 Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial Wang, Mina Xu, Xiaobai Zhao, Bingcong Liu, Lu Zhao, Luopeng Zhang, Fan Ji, Xu Yuan, Fang Xia, Qiuyu Wang, Shaosong Tian, Wei Wang, Linpeng Li, Bin J Pain Res Study Protocol PURPOSE: Knee osteoarthritis (KOA) is regarded as one of the leading musculoskeletal diseases. Although the efficacy is under exploration, fire needling therapy is considered an effective alternative for KOA. This trial aims to investigate the effectiveness of different frequencies of fire needling therapy in attenuating pain and promoting function in KOA patients. METHODS: This is a study protocol for a pilot, three-arm, single-center, randomized controlled trial. A total of 90 participants with KOA will be recruited and randomly assigned to the high-frequency fire needling group (3 sessions per week, for 6 weeks), the low-frequency fire needling group (1 session per week, for 6 weeks) or the positive control group (Diclofenac Diethylamine Emulgel, 3 times per day, for 6 weeks) in a 1:1:1 ratio. Participants will accomplish the trial at Week 14 after a follow-up evaluation. The response rate will be set as the primary outcome that the proportion of participants obtaining a minimal clinically important difference, which is identified as ≥2 units on the numerical rating scale (NRS) and ≥6 units on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at Week 6 compared with Week 0. Secondary outcomes are NRS, WOMAC, Brief Pain Inventory, Short-Form Health Survey-12, Timed Up and Go Test, and pain threshold. DISCUSSION: This is the first standardized protocol comparing fire needling therapy and positive control drugs. This trial may provide reliable evidence for the effectiveness of fire needling therapy and dose–effect property of it in KOA. Trial registration: The trial has been registered on Chinese Clinical Trial Registry (Registered number: ChiCTR2100043041), registered on 4 February 2021. Dove 2023-04-24 /pmc/articles/PMC10147561/ /pubmed/37128272 http://dx.doi.org/10.2147/JPR.S408084 Text en © 2023 Wang et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Study Protocol
Wang, Mina
Xu, Xiaobai
Zhao, Bingcong
Liu, Lu
Zhao, Luopeng
Zhang, Fan
Ji, Xu
Yuan, Fang
Xia, Qiuyu
Wang, Shaosong
Tian, Wei
Wang, Linpeng
Li, Bin
Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial
title Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial
title_full Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial
title_fullStr Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial
title_full_unstemmed Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial
title_short Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial
title_sort fire needling therapy of different frequencies versus external diclofenac diethylamine emulgel for knee osteoarthritis: study protocol for a pilot randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10147561/
https://www.ncbi.nlm.nih.gov/pubmed/37128272
http://dx.doi.org/10.2147/JPR.S408084
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