OBJECTIVE: To compare the efficacy of surgical decompression vs local steroid injection in the treatment of idiopathic CTS. METHODS: This is an open, prospective, randomized clinical trial. We studied the effects of surgical decompression vs local steroid injection in 163 wrists with a clinical diagnosis and neurophysiological confirmation of CTS, with an extended follow-up of 2 years. The primary end point was the percentage of wrists that reached a ≥ 20% improvement in the visual analogue scale score for nocturnal paraesthesias. Statistical analysis was done by Student's t-test for continuous variables and by chi-square test for categorical variables. Analyses were performed on an intent-to-treat basis. P < 0.05 were considered statistically significant. RESULTS: Both treatment groups had comparable severity of CTS at baseline. Eighty wrists were randomly assigned to surgical decompression and 83 wrists to local steroid injection. Fifty-five wrists in the surgery group and 48 wrists in the injection group completed the 2-year follow-up. In the intent-to-treat analysis, at 2-year follow-up, 60% of the wrists in the injection group vs 69% in the surgery group reached a 20% response for nocturnal paraesthesias (P < 0.001). CONCLUSION: Our findings suggest that both local steroid injection and surgical decompression are effective treatments in alleviating symptoms in primary CTS at 2-year follow-up. Surgery has an additional benefit in the 2-year follow-up, although clinical relevance of those differences remains to be defined. TRIAL REGISTRATION: Current Controlled Trials, www.controlled-trials.com, ISRCTN26264638.
RCT Entities:
OBJECTIVE: To compare the efficacy of surgical decompression vs local steroid injection in the treatment of idiopathic CTS. METHODS: This is an open, prospective, randomized clinical trial. We studied the effects of surgical decompression vs local steroid injection in 163 wrists with a clinical diagnosis and neurophysiological confirmation of CTS, with an extended follow-up of 2 years. The primary end point was the percentage of wrists that reached a ≥ 20% improvement in the visual analogue scale score for nocturnal paraesthesias. Statistical analysis was done by Student's t-test for continuous variables and by chi-square test for categorical variables. Analyses were performed on an intent-to-treat basis. P < 0.05 were considered statistically significant. RESULTS: Both treatment groups had comparable severity of CTS at baseline. Eighty wrists were randomly assigned to surgical decompression and 83 wrists to local steroid injection. Fifty-five wrists in the surgery group and 48 wrists in the injection group completed the 2-year follow-up. In the intent-to-treat analysis, at 2-year follow-up, 60% of the wrists in the injection group vs 69% in the surgery group reached a 20% response for nocturnal paraesthesias (P < 0.001). CONCLUSION: Our findings suggest that both local steroid injection and surgical decompression are effective treatments in alleviating symptoms in primary CTS at 2-year follow-up. Surgery has an additional benefit in the 2-year follow-up, although clinical relevance of those differences remains to be defined. TRIAL REGISTRATION: Current Controlled Trials, www.controlled-trials.com, ISRCTN26264638.
Authors: Giselly Veríssimo de Miranda; Carlos Henrique Fernandes; Jorge Raduan; Lia Miyamoto Meirelles; João Baptista Gomes Dos Santos; Flávio Faloppa Journal: Acta Ortop Bras Date: 2015 Mar-Apr Impact factor: 0.513
Authors: Will Mason; Daniel Ryan; Asif Khan; Hui-Ling Kerr; David Beard; Jonathan Cook; Ines Rombach; Cushla Cooper Journal: Pilot Feasibility Stud Date: 2017-04-24