Study protocol

Splinting or surgery for carpal tunnel syndrome? Design of a randomized controlled trial [ISRCTN18853827]

Annette AM Gerritsen ¹ , Rob JPM Scholten ² , Willem JJ Assendelft ³ , Herman Kuiper ⁴ , Henrica CW de Vet ⁵ and Lex M Bouter ⁶

¹Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands

²Dutch Cochrane Center/Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

³Dutch College of General Practitioners, Utrecht

⁴Department of Neurology, Flevoziekenhuis, Almere, The Netherlands

⁵Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands

⁶Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands

author email corresponding author email

BMC Neurology 2001, 1:8doi:10.1186/1471-2377-1-8

Published:	18 December 2001

Abstract

Background

Carpal tunnel syndrome is a common disorder, which can be treated with surgery or conservative options. However, there is insufficient evidence and no consensus among physicians with regard to the preferred treatment for carpal tunnel syndrome. Therefore, a randomized controlled trial is conducted to compare the short- and long-term efficacy of surgery and splinting in patients with carpal tunnel syndrome. An attempt is also made to avoid the (methodological) limitations encountered in earlier trials on the efficacy of various treatment options for carpal tunnel syndrome.

Methods

Patients of 18 years and older, with clinically and electrophysiologically confirmed idiopathic carpal tunnel syndrome, are recruited by neurologists in 13 hospitals. Patients included in the study are randomly allocated to either open carpal tunnel release or wrist splinting during the night for at least 6 weeks. The primary outcomes are general improvement, waking up at night and severity of symptoms (main complaint, night and daytime pain, paraesthesia and hypoesthesia). Outcomes are assessed up to 18 months after randomization.