Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol
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STUDY PROTOCOL
Open Access
Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial Yuanjie Gao1† , Lu Liu1,2†, Bin Li1, Jing Guo1, Huilin Liu1, Shaosong Wang1, Fan Zhang1, Xu Ji1, Yuanbo Fu1, Yizhan Wang1, Jingqing Sun1* and Fang Yuan1*
Abstract 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
* Correspondence: [email protected]; [email protected] † Yuanjie Gao and Lu Liu contributed equally to this work. 1 Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This 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
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