60 patients with carpal tunnel syndrome were randomized to receive either high-intensity laser therapy by ultrasonography (HILT; n=30) or sham laser (n=30). The primary outcome of interest was pain on a Visual Analog Scale (VAS). Secondary outcomes included grip strength, cross-sectional area of the median nerve, and the Boston Carpal Tunnel Syndrome Questionnaire (BCTS) symptom severity (SSS) and functional status (FSS). All outcomes were assessed after treatment (2 weeks) and at 3 months. Pain, functional status, and median nerve cross-sectional area were similar between the two groups at 2 weeks and 3 months. Hand-grip strength was significantly better in the HILT group at 2 weeks but similar between the two treatments at 3 months. Significant decreases in VAS pain scores were observed within both groups when comparing pre- and post-treatment values. Similarly, FSS and SSS scores also showed significant improvements over time in both groups, whereas hand-grip strength and cross-sectional area of the medial nerve significantly improved from baseline in the HILT group.