Background Symptomatic knee osteoarthritis (KOA) is common in China. Pharmacological therapy is not the first recommendation because of its safety issues. Nonpharmacological therapy, such as lifestyle adjustments, weight loss, muscle strengthening, and aerobic exercise programs, is strongly recommended for KOA. However, these approaches may fail due to poor patient compliance. There is a lack of high-quality randomized controlled trials of acupotomy, an effective treatment for KOA. This study was designed to investigate the efficacy of acupotomy in patients with KOA. Methods A total of 136 patients will be enrolled at the First Affiliated Hospital of Guangzhou University of Chinese Medicine and assigned to the acupotomy group or sham acupotomy group according to the block randomization scheme. Patients in the acupotomy group will receive 2 sessions of acupotomy for 2 weeks (once a week). Patients in the sham group will receive 2 sessions of sham stimulation for 2 weeks (once a week). All patients will use indomethacin cream externally. The primary outcome will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the secondary outcomes will be the visual analog scale (VAS) score, plantar pressure distribution test result, X-ray examination findings, musculoskeletal ultrasound findings, maximum knee circumference, joint mobility, and quality of life. Measurements will be taken at baseline, 1 week after the end of treatment, and at the 3- and 6-month follow-ups. Discussion To the best of our knowledge, this will be the first single-blind, sham-controlled study of acupotomy. The outcome assessors will also be blinded. The aim of this work is to demonstrate the efficacy of acupotomy in treating KOA. Trial registration Chinese Clinical Trial Registry ChiCTR2000033047. Registered on 18 May 2020.
BackgroundSymptomatic knee osteoarthritis patients are common in China. Pharmacologic therapy is not the first recommendation because of its safety issues. Non-pharmacologic therapy, such as lifestyle adjustments, weight loss, and proper exercise is strongly recommended to use in knee osteoarthritis. But the adherance rate is very poor. Acupotomy therapy, as an effective treatment for knee osteoarthritis, is lack of high quality randomized controlled trials. This study set out to investigate the efficacy of acupotomy in patients with knee osteoarthritis.Methods136 patients will be enrolled in the First Affiliated Hospital of Guangzhou University of Chinese Medicine, and assigned into acupotomy group or sham acupotomy group according to the block randomization number. The acupotomy group will receive 2 sessions of acupotomy for 2 weeks(once a week). The sham group will receive 2 sessions of sham stimulation for 2 weeks༈once 2 week. All the patients will use indomethacin cream externally. The primary outcome is the WOMAC index and the secondary outcomes are VAS, plantar pressure distribution test, X-ray examination, musculoskeletal ultrasound, maximum knee circumference, and joint mobility. We will measure them at baseline, one week after the end of treatments, the third month and sixth month follow up.DiscussionAs we know, this is the first single-blinding and sham controlled design in acupotomy research. We aim to prove the efficacy of acupotomy in treating knee osteoarthritis.Trial registrationChinese Clinical Trial Registry: ChiCTR2000033047(2020-5-18).
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