Background: 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.

Methods: 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.

Findings: 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.

Interpretation: 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.

Funding: The Netherlands Organization for Health Research and Development and Zorgverzekeraars Nederland.

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背景：

手术和皮质类固醇注射是治疗腕管综合征的常规治疗方法，但最佳治疗策略仍不清楚。本研究旨在比较从手术开始治疗与从皮质类固醇注射开始治疗的效果。

方法：

我们在荷兰的31家医院进行了一项开放标签、随机对照试验。诊断为腕管综合征至少6周并经电生理学或超声检查确认符合条件的患者，通过网络系统以1:1的比例被随机分配到手术组或注射组。根据单侧或双侧症状、是否伴有作为风险因素的腕管综合征以及之前是否有同侧注射进行分层随机化。如有必要，允许额外治疗，如再次注射或手术。主要结果是在意向性治疗人群中，在18个月时患者恢复的比例（定义为六项腕管综合征量表得分低于8分）。该试验已在ISRCTN注册库（ISRCTN13164336）预先注册，并已结束。

发现：

从2017年11月7日至2021年11月4日，共有934名参与者（545名为女性，389名为男性）被纳入研究。其中468人随机分配到手术组，466人随机分配到注射组。在18个月时，934名参与者的805人（86%）具有主要结果数据。在手术组中，401名参与者中的243人（61%）恢复了健康，显著高于注射组中404名参与者中的180人（45%）（相对风险 1·36；95% CI 1·19-1·56；p

解释：

对于腕管综合征患者，与从皮质类固醇注射开始治疗相比，即使存在额外干预的可能性，从手术开始治疗在18个月后恢复的几率更高。

资金来源：

荷兰卫生研究与发展组织和Zorgverzekeraars Nederland。