Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481

Brook I Martin,William Hollingworth,Michel Kliot,Linda M Levenson,Patrick J Heagerty,Judith A Turner,Jeffrey G Jarvik

doi:10.1186/1471-2474-6-2

Abstract

BackgroundConservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options. There is an increasing interest in the usefulness of wrist magnetic resonance imaging could play in predicting who will benefit for various treatments.Method and designTwo hundred patients with mild to moderate symptoms will be recruited over 3 1/2 years from neurological surgery, primary care, electrodiagnostic clinics. We will exclude patients with clinical or electrodiagnostic evidence of denervation or thenar muscle atrophy.We will randomly assign patients to either a well-defined conservative care protocol or surgery. The conservative care treatment will include visits with a hand therapist, exercises, a self-care booklet, work modification/ activity restriction, B6 therapy, ultrasound and possible steroid injections. The surgical care would be left up to the surgeon (endoscopic vs. open) with usual and customary follow-up. All patients will receive a wrist MRI at baseline.Patients will be contacted at 3, 6, 9 and 12 months after randomization to complete the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ). In addition, we will compare disability (activity and work days lost) and general well being as measured by the SF-36 version II. We will control for demographics and use psychological measures (SCL-90 somatization and depression scales) as well as EDS and MRI predictors of outcomes.DiscussionWe have designed a randomized controlled trial which will assess the effectiveness of surgery for patients with mild to moderate carpal tunnel syndrome. An important secondary goal is to study the ability of MRI to predict patient outcomes.

Highlights

Conservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options
We have designed a randomized controlled trial which will assess the effectiveness of surgery for patients with mild to moderate carpal tunnel syndrome
An important secondary goal is to study the ability of magnetic resonance imaging (MRI) to predict patient outcomes

Summary

Introduction

Conservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options. Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment syndrome, with an annual incidence of 50–150 cases/100,000. It is an important cause of workplace morbidity [1] with approximately 30,000 cases of CTS resulting in days lost from work in 1996 (BLS US Department of Labor 1998; [2]). This study demonstrated significant clinical improvement in electromyography and symptoms reported at 1 year for surgical release over splinting with a cohort of 22 women. Gerritsen et al, published a second randomized study of surgical release versus splinting in 176 patients with moderate carpal tunnel syndrome, defined by clinical and electrophysiological testing [8,9]. The evidence is less clear for patients with a shorter duration of symptoms or the use of conservative therapies other than splinting, such as physical therapy and ultrasound [9,10]

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