Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique.

Background: Comparative studies of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open CTR (mOCTR) are limited, prompting development of this randomized trial to compare efficacy and safety of these techniques.

Research Design And Methods: Patients were randomized (2:1) to CTR-US or mOCTR, treated by experienced hand surgeons (median previous cases: 12 CTR-US; 1000 mOCTR), and followed for 3 months.

Results: Among 149 randomized patients, 122 received CTR-US ( = 94) or mOCTR ( = 28). Mean incision length was 6 ± 2 mm in the wrist (CTR-US) vs. 22 ± 7 mm in the palm (mOCTR) ( < 0.001). Median time to return to daily activities (2 vs. 2 days;  = 0.81) and work (3 vs. 4 days;  = 0.61) were similar. Both groups reported statistically significant and clinically important improvements in Boston Carpal Tunnel Questionnaire Symptom Severity and Functional Status Scales, Numeric Pain Scale, and EuroQoL-5 Dimension 5-Level, with no statistical differences between groups. Freedom from wound sensitivity and pain favored CTR-US (61.1% vs. 17.9%;  < 0.001). Adverse event rates were low in each group (2.1% vs. 3.6%;  = 0.55).

Conclusions: The efficacy and safety of CTR-US were comparable to mOCTR despite less previous surgical experience with CTR-US. The choice of CTR technique should be determined by shared decision-making between patient and physician.

Clinical Trial Registration: www.clinicaltrials.gov identifier is NCT05405218.