The primary objective of the present clinical trial was to evaluate efficacy and safety of tramadol versus prednisone in Chinese patients with carpal tunnel syndrome (CTS) diagnosed by ultrasonography. A total of 60 patients' diagnosed with moderate CTS based on a clinical and electrophysiological parameters were enrolled in this clinical trial. The patients were randomly assigned to one of two groups in allocation ratio of 1:1. Test group was given controlled release Tramadol (100 mg every 12 hours) and Reference Group received Prednisone 20 mg once daily for 2 weeks (14 days). Ultrasound therapy (UT) was given as adjuvant therapy in both the group. CTS were evaluated before and after treatment through clinical findings, Boston Carpal Tunnel Questionnaire, visual analog scale (VAS) and electrophysiological data. The results were evaluated with Student's t test and chi-squared. A statistically significant difference was observed between both the treatment group regarding Durkan's test, Phalen's test, VAS and electrophysiological data after treatment. Improvement in patients treated with tramadol was significantly higher compared to prednisone group in all clinical and electrophysiological parameters. The Boston Questionnaire showed better results in tramadol groups, with a significant improvement in the symptom severity scale (SSS; p<0.005) and functional status scale (FSS; p<0.005). The results of this clinical trial suggest that treatment of CTS with tramadol along with UT as adjuvant therapy was associated with a significant improvement of clinical and electrophysiological parameters compared to Prednisone.
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