Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.
Trials. 2020 Nov 4;21(1):911. doi: 10.1186/s13063-020-04827-9.
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.
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.
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.
Chinese Clinical Trial Registry ChiCTR1800019579 . Registered on November 18, 2018.
膝骨关节炎是一种常见的临床慢性退行性疾病，发病率高，长期致残。既往研究已证实针刺治疗膝骨关节炎有效。火针是一种热针与针刺相结合的方法，可能比常用的毫针针刺更有效。本研究设计为一项随机对照试验，旨在评估火针对膝骨关节炎患者的疗效和安全性。
这是一项前瞻性随机对照优效性临床试验，旨在评估火针对膝骨关节炎的疗效和安全性。共纳入 100 名参与者，随机分为两组。火针组接受火针治疗，毫针组在火针组相同穴位接受毫针治疗。所有参与者均接受 6 周治疗（每周 2 次）。主要结局是 Western Ontario and McMaster Universities Osteoarthritis Index 的变化，次要结局包括从基线到终点视觉模拟量表和 12 项简短健康调查问卷的变化。
本研究已获得首都医科大学附属北京中医医院研究伦理委员会的批准（2018SB-066）。将从所有参与者处获得书面知情同意。试验结果将通过同行评审的出版物传播。
中国临床试验注册中心 ChiCTR1800019579 ，于 2018 年 11 月 18 日注册。
