Ultra-Minimally Invasive Ultrasound-Guided Carpal Tunnel Release: A Randomized Clinical Trial.

Objectives: The purpose of this study was to compare the outcomes of 1-mm ultra-minimally invasive ultrasound-guided carpal tunnel release and 2-cm blind mini-open carpal tunnel release.

Methods: We conducted a single-center individual parallel-group controlled-superiority randomized control trial in an ambulatory office-based setting at a third-level referral hospital. Eligible participants had clinical signs of primary carpal tunnel syndrome and positive electrodiagnostic test results and were followed for 12 months. Independent outcome assessors were blinded. Patients were randomized by concealed allocation (1:1) by an independent blocked computer-generated list. The postoperative score on the Quick-Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire was the primary variable. Grip strength and time for discontinuation of oral analgesics, complete wrist flexion-extension, relief of paresthesia, and return to normal daily activities (including work) were assessed.

Results: Ninety-two of 128 eligible patients were randomly allocated and analyzed. QuickDASH scores were 2.2 to 3.3 times significantly lower in the ultra-minimally invasive group for the first 6 months: 23.6 [95% confidence interval (CI), 20.5, 27.4] versus 52.6 [95% CI, 49.4, 57.0] at the first week and 4.09 [95% CI, 1.5, 7.1] versus 13.0 [95% CI, 9.4, 18.9] at 6 months. Return to normal daily activities occurred significantly sooner in the ultra-minimally invasive group: 4.9 [95% CI, 3.2, 6.5] versus 25.4 [95% CI, 18.2, 32.6] days.

Conclusions: Ultra-minimally invasive carpal tunnel release provides earlier functional return and less postoperative morbidity with the same neurologic recovery as mini-open carpal tunnel release for patients with symptomatic primary carpal tunnel syndrome.