Fu’s subcutaneous needling approach versus electroacupuncture for knee osteoarthritis: protocol for comparative effectiveness and safety randomized controlled trial

Introduction With the aging of the population, knee osteoarthritis (KOA) is a common chronic osteoarthritic disorder among middle-aged and elderly people. Fu’s subcutaneous needling (FSN) and electroacupuncture (EA) are both effective means of treating KOA. FSN, with characterized by simple operation, quick effect, safety and green,is a modern acupuncture that integrates modern medicine with traditional acupuncture theory. Our team has demonstrated through clinical trials that FSN can effectively relieve pain and improve walking ability in patients with KOA. However, studies on the difference in clinical efficacy of FSN in treating KOA still lack clinical validation with large samples. The purpose of this study was to provide high-level clinical evidence for the clinical management of KOA by comparing the multicenter differences between FSN and EA in the treatment of this disease. Methods and analysis This study is a prospective, multicenter, randomized controlled trial to compare the efficacy and safety of FSN with EA in the treatment of KOA. This study intends to recruit 300 patients with osteoarthritis of the knee in 6 tertiary hospitals in China, including Shandong Provincial Third Hospital, Shandong University, etc. The group was randomly divided into FSN group and EA group according to 1: 1 ratio. The intervention time is 30 min, and the treatment was carried out three times a week for 4 weeks, and the long-term follow-up was carried out one month after the treatment. The primary outcome index was the response rate of knee symptom relief, and the secondary outcome indexes were the numerical assessment of knee pain (NRS), WOMAC osteoarthritis index, quality of life evaluation (SF-12), 6-min walk test and safety evaluation. Clinical trial registration ClinicalTrials.gov , ChiCTR2400080196.