Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.
Department of Diagnostics, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.
Medicine (Baltimore). 2022 Aug 5;101(31):e29306. doi: 10.1097/MD.0000000000029306.
Thread embedding acupuncture (TEA) is a widely used clinical procedure for the treatment of musculoskeletal pain. However, few clinical studies have been conducted on the efficacy and safety of TEA for knee osteoarthritis (KOA), and data from randomized controlled trials are lacking. This randomized controlled pilot study aimed to assess the feasibility of conducting large-scale studies on the efficacy and safety of TEA for KOA.
Forty participants were included in the study and randomly divided into 2 groups (TEA and acupuncture) of 20 each. The intervention period was 6 weeks. The experimental group received TEA once a week (total of 6 sessions) on 14 defined knee areas, and the control group received acupuncture twice a week (total of 12 sessions) on 9 defined acupuncture points. The primary outcome measure was the visual analogue scale score, and the secondary outcome measures were the short-form McGill pain questionnaire, and Western Ontario and McMaster Universities Osteoarthritis Index scores. Participants were assessed prior to the intervention (baseline) and at 3, 6, and 10 weeks (4 weeks after the end of intervention). The adverse effects of TEA and acupuncture were documented. Hematological examination and biochemical tests were performed at the screening and at 6 weeks.
Of the 40 participants, 37 completed the study and 3 participants dropped out. Both the TEA and acupuncture groups showed a significant improvement in the visual analogue scale, short-form McGill Pain Questionnaire, and Western Ontario and McMaster Universities Osteoarthritis Index scores in a time-dependent manner. However, there was no significant interaction between group and time. No serious adverse events were reported in the groups, and no clinically significant changes were observed in the hematological and biochemical parameters.
This pilot study suggests that TEA is a safe and effective procedure for relieving pain in patients with KOA. The results of this study provide basic data and indicate the feasibility of large-scale clinical studies to evaluate the efficacy and safety of TEA for KOA.
线嵌入针法（TEA）是一种广泛应用于治疗肌肉骨骼疼痛的临床操作。然而，关于 TEA 治疗膝骨关节炎（KOA）的疗效和安全性的临床研究较少，且缺乏随机对照试验的数据。本随机对照初步研究旨在评估关于 TEA 治疗 KOA 的疗效和安全性进行大规模研究的可行性。
本研究纳入了 40 名参与者，并将其随机分为 TEA 组和针刺组，每组各 20 名。干预期为 6 周。实验组每周接受 TEA 治疗一次（共 6 次），治疗 14 个定义明确的膝关节区域；对照组每周接受针刺治疗两次（共 12 次），治疗 9 个定义明确的穴位。主要结局指标为视觉模拟评分，次要结局指标为简明 McGill 疼痛问卷和西部安大略省和麦克马斯特大学骨关节炎指数评分。参与者在干预前（基线）以及 3、6 和 10 周（干预结束后 4 周）进行评估。记录 TEA 和针刺的不良反应。在筛选和 6 周时进行血液检查和生化检查。
在 40 名参与者中，有 37 名完成了研究，3 名参与者退出了研究。TEA 组和针刺组的视觉模拟评分、简明 McGill 疼痛问卷和西部安大略省和麦克马斯特大学骨关节炎指数评分均呈时间依赖性显著改善，但组间和时间间无显著交互作用。两组均未报告严重不良事件，血液学和生化参数也未观察到有临床意义的变化。
本初步研究表明 TEA 是缓解 KOA 患者疼痛的一种安全有效的方法。本研究结果提供了基本数据，并表明了进行大规模临床研究评估 TEA 治疗 KOA 的疗效和安全性的可行性。
