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A Randomized Controlled Trial

Annette A. M. Gerritsen, PhD; Henrica C. W. de Vet, PhD; Rob J. P. M. Scholten, MD, PhD; Frits W. Bertelsmann, MD, PhD; Marc C. T. F. M. de Krom, MD, PhD; Lex M. Bouter, PhD

JAMA. 2002;288:1245-1251.

Context  Carpal tunnel syndrome (CTS) can be treated with nonsurgical or surgical options. However, there is no consensus on the most effective method of treatment.

Objective  To compare the short-term and long-term efficacy of splinting and surgery for relieving the symptoms of CTS.

Design, Setting, and Patients  A randomized controlled trial conducted from October 1998 to April 2000 at 13 neurological outpatient clinics in the Netherlands. A total of 176 patients with clinically and electrophysiologically confirmed idiopathic CTS were assigned to wrist splinting during the night for at least 6 weeks (89 patients) or open carpal tunnel release (87 patients); 147 patients (84%) completed the final follow-up assessment 18 months after randomization.

Main Outcome Measures  General improvement, number of nights waking up due to symptoms, and severity of symptoms.

Results  In the intention-to-treat analyses, surgery was more effective than splinting on all outcome measures. The success rates (based on general improvement) after 3 months were 80% for the surgery group (62/78 patients) vs 54% for the splinting group (46/86 patients), which is a difference of 26% (95% confidence interval [CI], 12%-40%; P<.001). After 18 months, the success rates increased to 90% for the surgery group (61/68 patients) vs 75% for the splinting group (59/79 patients), which is a difference of 15% (95% CI, 3%-27%; P = .02). However, by that time 41% of patients (32/79) in the splint group had also received the surgery treatment.

Conclusion  Treatment with open carpal tunnel release surgery resulted in better outcomes than treatment with wrist splinting for patients with CTS.

Author Affiliations: Institute for Research in Extramural Medicine, Vrije Universiteit Medical Center, Amsterdam, the Netherlands (Drs Gerritsen, de Vet, and Bouter); Dutch Cochrane Center/Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (Dr Scholten); Department of Neurology, Amstelveen Hospital, Amstelveen, the Netherlands (Dr Bertelsmann); and Department of Neurology, Maastricht University Hospital, Maastricht, the Netherlands (Dr de Krom).

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