RESUMO
OBJECTIVE: This study aimed to determine the effectiveness of pregabalin for the control of symptoms in mild to moderate idiopathic Carpal tunnel syndrome (CTS). METHODS: In this randomized, placebo-controlled trial, 146 mild to moderate idiopathic CTS patients were randomized into pregabalin (n=74) and placebo groups (n=72). Per protocol, analysis was conducted with 131 patients; pregabalin (n=65) and placebo (n=66). The drug titration dose was 50 mg once daily for the first week, twice daily for the second week and thrice daily for the next 6 weeks. The primary outcome included a change in the Symptom Severity Scale and Functional Status Scale (FSS) of the Boston Carpal Tunnel Questionnaire after the eighth week. The secondary outcome was the change in clinical and electrophysiological grading after 8 weeks of therapy. RESULTS: There was a statistically significant improvement in the mean Symptom Severity Scale (14.92±3.72 vs. 16.55±4.45; P =0.025) and FSS (10.77±2.64 vs. 12.0±2.55; P =0.007) in the pregabalin group after 8 weeks. Mean clinical and electrophysiological grading changed significantly from 2.3±0.7 to 2.1±0.8 ( P =0.001) and 1.9±0.7 to 1.8±0.8 ( P =0.020), respectively in the pregabalin group but not in the placebo group. DISCUSSION: The results of this study demonstrates that pregabalin is effective in ameliorating symptoms and improving functional outcomes in mild to moderate idiopathic CTS.