The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
The First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
Trials. 2021 Apr 20;22(1):295. doi: 10.1186/s13063-021-05247-z.
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.
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.
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.
Chinese Clinical Trial Registry ChiCTR2000033047 . Registered on 18 May 2020.
在中国，膝关节骨性关节炎（KOA）的症状较为常见。由于安全性问题，药物治疗并非首先推荐的方法。对于 KOA，强烈推荐非药物治疗，如生活方式调整、减肥、肌肉强化和有氧运动计划。然而，由于患者依从性差，这些方法可能会失败。针刀治疗 KOA 的高质量随机对照试验较少。本研究旨在探讨针刀治疗 KOA 的疗效。
共有 136 名患者将在广州中医药大学第一附属医院就诊，并根据区组随机化方案分为针刀组或假针刀组。针刀组患者将接受 2 次针刀治疗，2 周为 1 个疗程（每周 1 次）。假针刀组患者将接受 2 次假刺激治疗，2 周为 1 个疗程（每周 1 次）。所有患者均外用吲哚美辛乳膏。主要结局指标为西安大略和麦克马斯特大学骨关节炎指数（WOMAC），次要结局指标为视觉模拟评分（VAS）评分、足底压力分布测试结果、X 线检查结果、肌骨超声检查结果、最大膝关节周长、关节活动度和生活质量。在基线、治疗结束后 1 周以及 3 个月和 6 个月随访时进行测量。
据我们所知，这将是首次对针刀进行单盲、假对照研究。结果评估者也将被蒙蔽。这项工作的目的是证明针刀治疗 KOA 的疗效。
中国临床试验注册中心 ChiCTR2000033047 。注册于 2020 年 5 月 18 日。
