School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China.
Department of Traditional Chinese Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, China.
J Orthop Surg Res. 2022 Dec 1;17(1):517. doi: 10.1186/s13018-022-03415-8.
Manual reduction and surgical treatment are common methods for distal radius fractures (DRFs). The existing literature suggests that postoperative combined rehabilitation treatment and medication are effective for the healing of DRFs. However, the side effects of these treatments remain to be solved. Previous studies have shown that electroacupuncture (EA) can effectively relieve wrist swelling and improve the joint function in patients with DRFs, but more evidence is needed to prove the effectiveness of EA. This trial aims to explore the efficiency and feasibility of combined EA treatment in postoperative treatment of DRFs compared with routine treatment.
This is a parallel randomized controlled trial. A total of 222 patients diagnosed with moderate DRFs will be recruited and randomly assigned to an EA group or a routine treatment group at a ratio of 1:1. Routine treatment group will receive medication and rehabilitation. Yangxi (LI 5), Yangchi (TE 4), Yanggu (SI 5), Hegu (LI 4), and Taiyuan (LU 9) will be selected in the EA group for intervention three times a week on the basis of routine treatment. Both groups will receive 8 weeks of treatment and 4 weeks of follow-up. The primary outcome will be ulnar positive variance. The secondary outcomes will include radiographic healing rate, bone strength, hemorheological indices, serum biochemical indicators and inflammatory factors, grip strength, wrist swelling score, patient-rated wrist evaluation, disabilities of arm, shoulder and hand, and visual analogue scale. Outcomes will be evaluated at baseline, postoperative 3rd day, 2nd, 4th, 6th, 8th, and 12th weeks.
The results of this study will help establish a more optimized scheme to treat patients with DRFs. Trial registration Chinese Clinical Trial Registry ChiCTR2200062857. Registered on 21 August 2022, www.chictr.org.cn/com/25/showproj.aspx?proj=175567 .
手法复位和手术治疗是桡骨远端骨折（DRF）的常见方法。现有文献表明，术后联合康复治疗和药物治疗对 DRF 的愈合有效。然而，这些治疗方法的副作用仍有待解决。既往研究表明，电针（EA）可有效缓解腕部肿胀，改善 DRF 患者的关节功能，但需要更多证据证明 EA 的有效性。本试验旨在探讨与常规治疗相比，术后联合 EA 治疗 DRF 的效率和可行性。
这是一项平行随机对照试验。共纳入 222 例中度 DRF 患者，按 1:1 比例随机分为 EA 组和常规治疗组。常规治疗组接受药物和康复治疗。在常规治疗的基础上，EA 组每周选择阳溪（LI5）、阳池（TE4）、阳谷（SI5）、合谷（LI4）和太渊（LU9）进行 3 次干预。两组均接受 8 周治疗和 4 周随访。主要结局指标为尺偏阳性方差。次要结局指标包括影像学愈合率、骨强度、血液流变学指标、血清生化指标和炎症因子、握力、腕部肿胀评分、患者腕部评价、上肢肩手残疾、视觉模拟评分。在基线、术后第 3 天、第 2、4、6、8 和 12 周进行评估。
本研究结果将有助于建立更优化的方案来治疗 DRF 患者。
中国临床试验注册中心 ChiCTR2200062857。注册于 2022 年 8 月 21 日，www.chictr.org.cn/com/25/showproj.aspx?proj=175567。
