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 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.