Palmbergen Wijnand A C, Beekman Roy, Heeren A Marijne, van Nuenen Bart F L, Alleman Tim W H, Verstraete Esther, Jellema Korné, Verhagen Wim I M, Visser Leo H, de Ruiter Godard C W, van de Beek Diederik, de Borgie Corianne A J M, Bogaards Johannes A, de Bie Rob M A, Verhamme Camiel
Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands; Department of Neurology, BovenIJ Hospital, Amsterdam, Netherlands.
Department of Neurology, Zuyderland Medical Center, Heerlen, Netherlands.
Lancet. 2025 Jun 14;405(10495):2153-2163. doi: 10.1016/S0140-6736(25)00368-X.
Surgery and corticosteroid injections are established treatments for carpal tunnel syndrome, but the optimal treatment strategy remains unclear. This study aimed to compare starting treatment with surgery versus starting with a corticosteroid injection.
We conducted an open-label, randomised controlled trial across 31 hospitals in the Netherlands. Eligible patients, diagnosed with carpal tunnel syndrome for at least 6 weeks and confirmed by electrophysiological or sonographic testing, were randomly assigned (1:1) to start treatment with either surgery or an injection via a web-based system. Randomisation was stratified by unilateral or bilateral symptoms, carpal tunnel syndrome with or without concomitant disease as risk factor, and previous ipsilateral injections. If needed, additional treatments were allowed, such as additional injections or surgery. The primary outcome, assessed in the intention-to-treat population, was the proportion of patients who were recovered (defined as a score of less than eight points on the six-item carpal tunnel syndrome scale) at 18 months. The trial was preregistered with the ISRCTN Registry (ISRCTN13164336) and is now completed.
From Nov 7, 2017, to Nov 4, 2021, 934 participants (545 female and 389 male participants) were included. 468 were randomised to the surgery group and 466 to the injection group. At 18 months, 805 (86%) of 934 participants had primary outcome data. In the surgery group, 243 (61%) of 401 participants had recovered, significantly higher than the 180 (45%) of 404 participants recovered in the injection group (relative risk 1·36; 95% CI 1·19-1·56; p<0·0001). One or more adverse event occurred in 376 (86%) of 436 participants in the surgery group and in 384 (85%) of 453 participants in the injection group. One participant in the surgery group was hospitalised due to complications. No treatment-related deaths were reported.
In patients with carpal tunnel syndrome, initiating treatment with surgery offers a higher chance of recovery after 18 months compared with starting with a corticosteroid injection, even with the possibility of additional interventions.
The Netherlands Organization for Health Research and Development and Zorgverzekeraars Nederland.
手术和皮质类固醇注射是腕管综合征的既定治疗方法，但最佳治疗策略仍不明确。本研究旨在比较手术起始治疗与皮质类固醇注射起始治疗。
我们在荷兰的31家医院进行了一项开放标签的随机对照试验。符合条件的患者，经诊断患有腕管综合征至少6周，并通过电生理或超声检查确诊，通过基于网络的系统随机分配（1:1）开始手术治疗或注射治疗。随机分组按单侧或双侧症状、有或无合并疾病作为危险因素的腕管综合征以及既往同侧注射情况进行分层。如有需要，允许进行额外治疗，如额外注射或手术。在意向性治疗人群中评估的主要结局是18个月时康复的患者比例（定义为六项腕管综合征量表得分低于8分）。该试验已在国际标准随机对照试验编号注册库（ISRCTN13164336）进行预注册，现已完成。
从2017年11月7日至2021年11月4日，纳入了934名参与者（545名女性和389名男性参与者）。468人被随机分配到手术组，466人被随机分配到注射组。18个月时，934名参与者中有805人（86%）有主要结局数据。手术组401名参与者中有243人（61%）康复，显著高于注射组404名参与者中的180人（45%）康复（相对风险1.36；95%置信区间1.19 - 1.56；p<0.0001）。手术组436名参与者中有376人（86%）发生了一个或多个不良事件，注射组453名参与者中有384人（85%）发生了不良事件。手术组有一名参与者因并发症住院。未报告与治疗相关的死亡病例。
在腕管综合征患者中，与皮质类固醇注射起始治疗相比，手术起始治疗在18个月后康复的机会更高，即使可能需要额外干预。
荷兰卫生研究与发展组织和荷兰医疗保险公司。
