Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Beijing University of Chinese Medicine, Beijing, China.
J Orthop Surg Res. 2023 Feb 6;18(1):89. doi: 10.1186/s13018-023-03570-6.
Hand osteoarthritis (OA) is a prevalent disorder in the general population. Patients with hand OA often report symptoms of pain, stiffness, and functional limitations, which cause clinical burden and impact on quality of daily life. However, the efficacy of current therapies for hand OA is limited. Other therapies with better effects and less adverse events are in urgent need. Acupuncture is well known for analgesia and has been proved effective in treating basal thumb joint arthritis. This study aims to clarify the efficacy and safety of acupuncture treatment for clinical symptomatic improvement of hand OA.
This will be a sham-controlled, randomized, multi-center clinical trial. A total of 340 participants will be recruited and randomly allocated to either traditional acupuncture group or sham acupuncture group. All participants will receive 12 treatment sessions over 4 weeks and 2 follow-up assessments in the following 3 months at week 8 and week 16. The primary outcome will be the proportion of responders at week 5. Secondary outcomes will include visual analog scale, Australian Canadian Osteoarthritis Hand Index, Functional Index for hand OA, the number of symptomatic joints, hand grip strength and pinch strength, global assessment, the World Health Organization Quality of Life abbreviated version and expectations. Safety will be evaluated during the whole process of the trial. All outcomes will be analyzed following the intention-to-treat principle.
This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of acupuncture treatment for hand OA. Results of this trial might contribute in offering a new option to clinical recommendations. Trial registration ClinicalTrials.gov Identifier: NCT05267093. Registered 23 February 2022.
手部骨关节炎（OA）是一种常见的多发病症，在普通人群中发病率较高。手部 OA 患者常伴有疼痛、僵硬和功能受限等症状，给患者带来了沉重的临床负担，影响了患者的日常生活质量。然而，目前针对手部 OA 的治疗效果有限，因此急需寻找疗效更好、不良反应更少的其他治疗方法。针刺以其良好的镇痛效果而闻名，并且已经被证实对治疗基础拇指指间关节炎有效。本研究旨在明确针刺治疗对手部 OA 患者临床症状改善的疗效和安全性。
这是一项假针刺对照、随机、多中心临床试验。共招募 340 名参与者，并随机分为传统针刺组或假针刺组。所有参与者将在 4 周内接受 12 次治疗，并在接下来的 3 个月内分别在第 8 周和第 16 周进行 2 次随访评估。主要结局指标为第 5 周的应答者比例。次要结局指标包括视觉模拟评分、澳大拉西亚手部关节炎指数、手部骨关节炎功能指数、症状关节数、手握力和捏力、总体评估、世界卫生组织生活质量简表和期望。在整个试验过程中评估安全性。所有结局指标均按照意向治疗原则进行分析。
这项前瞻性试验将为评估针刺治疗手部 OA 的疗效和安全性提供高质量的证据。该试验的结果可能为临床推荐提供新的选择。试验注册：ClinicalTrials.gov 标识符：NCT05267093。注册于 2022 年 2 月 23 日。
