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Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial

BACKGROUND: Knee osteoarthritis is a common clinical chronic degenerative disease associated with high morbidity and long-term disability. Previous studies have confirmed the efficacy of acupuncture on knee osteoarthritis. Fire needle acupuncture is a combination of heat and acupuncture, which may b...

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Autores principales: Gao, Yuanjie, Liu, Lu, Li, Bin, Guo, Jing, Liu, Huilin, Wang, Shaosong, Zhang, Fan, Ji, Xu, Fu, Yuanbo, Wang, Yizhan, Sun, Jingqing, Yuan, Fang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640691/
https://www.ncbi.nlm.nih.gov/pubmed/33148299
http://dx.doi.org/10.1186/s13063-020-04827-9
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author Gao, Yuanjie
Liu, Lu
Li, Bin
Guo, Jing
Liu, Huilin
Wang, Shaosong
Zhang, Fan
Ji, Xu
Fu, Yuanbo
Wang, Yizhan
Sun, Jingqing
Yuan, Fang
author_facet Gao, Yuanjie
Liu, Lu
Li, Bin
Guo, Jing
Liu, Huilin
Wang, Shaosong
Zhang, Fan
Ji, Xu
Fu, Yuanbo
Wang, Yizhan
Sun, Jingqing
Yuan, Fang
author_sort Gao, Yuanjie
collection PubMed
description BACKGROUND: Knee osteoarthritis is a common clinical chronic degenerative disease associated with high morbidity and long-term disability. Previous studies have confirmed the efficacy of acupuncture on knee osteoarthritis. Fire needle acupuncture is a combination of heat and acupuncture, which may be more effective than the commonly used filiform needle acupuncture. This study is designed as a randomized controlled trial to evaluate the efficacy and safety of fire needle acupuncture compared to filiform needle acupuncture in knee osteoarthritis patients. METHODS AND ANALYSIS: This is a prospective randomized controlled superiority clinical trial to evaluate the efficacy and safety of fire needle acupuncture compared to filiform needle acupuncture for knee osteoarthritis. A total of 100 participants will be randomly assigned to two different groups. Participants will receive fire needle acupuncture treatment in the fire needle group, while participants in the filiform needle group will be treated with a filiform needle at the same acupuncture points as the fire needle group. All participants will receive 6 weeks of treatment (2 times per week). The primary outcome is the change of the Western Ontario and McMaster Universities Osteoarthritis Index, and the secondary outcomes include the change of the visual analog scale and 12-item Short Form Health Survey from baseline to endpoint. ETHICS AND DISSEMINATION: Ethical approval of this study was granted by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (2018SB-066). Written informed consent will be obtained from all participants. Outcomes of the trial will be disseminated through peer-reviewed publications. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800019579. Registered on November 18, 2018
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spelling pubmed-76406912020-11-05 Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial Gao, Yuanjie Liu, Lu Li, Bin Guo, Jing Liu, Huilin Wang, Shaosong Zhang, Fan Ji, Xu Fu, Yuanbo Wang, Yizhan Sun, Jingqing Yuan, Fang Trials Study Protocol BACKGROUND: Knee osteoarthritis is a common clinical chronic degenerative disease associated with high morbidity and long-term disability. Previous studies have confirmed the efficacy of acupuncture on knee osteoarthritis. Fire needle acupuncture is a combination of heat and acupuncture, which may be more effective than the commonly used filiform needle acupuncture. This study is designed as a randomized controlled trial to evaluate the efficacy and safety of fire needle acupuncture compared to filiform needle acupuncture in knee osteoarthritis patients. METHODS AND ANALYSIS: This is a prospective randomized controlled superiority clinical trial to evaluate the efficacy and safety of fire needle acupuncture compared to filiform needle acupuncture for knee osteoarthritis. A total of 100 participants will be randomly assigned to two different groups. Participants will receive fire needle acupuncture treatment in the fire needle group, while participants in the filiform needle group will be treated with a filiform needle at the same acupuncture points as the fire needle group. All participants will receive 6 weeks of treatment (2 times per week). The primary outcome is the change of the Western Ontario and McMaster Universities Osteoarthritis Index, and the secondary outcomes include the change of the visual analog scale and 12-item Short Form Health Survey from baseline to endpoint. ETHICS AND DISSEMINATION: Ethical approval of this study was granted by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (2018SB-066). Written informed consent will be obtained from all participants. Outcomes of the trial will be disseminated through peer-reviewed publications. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800019579. Registered on November 18, 2018 BioMed Central 2020-11-04 /pmc/articles/PMC7640691/ /pubmed/33148299 http://dx.doi.org/10.1186/s13063-020-04827-9 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Gao, Yuanjie
Liu, Lu
Li, Bin
Guo, Jing
Liu, Huilin
Wang, Shaosong
Zhang, Fan
Ji, Xu
Fu, Yuanbo
Wang, Yizhan
Sun, Jingqing
Yuan, Fang
Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial
title Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial
title_full Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial
title_fullStr Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial
title_full_unstemmed Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial
title_short Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial
title_sort evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640691/
https://www.ncbi.nlm.nih.gov/pubmed/33148299
http://dx.doi.org/10.1186/s13063-020-04827-9
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