Study protocol
Splinting or surgery for carpal tunnel syndrome? Design of a randomized controlled trial [ISRCTN18853827]
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* Corresponding author: Annette AM Gerritsen aam.gerritsen.emgo@med.vu.nl
1 Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands
2 Dutch Cochrane Center/Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
3 Dutch College of General Practitioners, Utrecht
4 Department of Neurology, Flevoziekenhuis, Almere, The Netherlands
5 Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands
6 Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands
BMC Neurology 2001, 1:8 doi:10.1186/1471-2377-1-8
Published: 18 December 2001Abstract
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.