Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481]
1 Department of Medicine, Division of General Internal Medicine, Multidisciplinary Clinical Research Center, Box 359736, 325 Ninth Ave. Seattle, Washington, 98104, USA
2 Department Psychiatry and Behavioral Sciences, University of Washington, Box 356560, 1959 NE Pacific Street, Seattle, Washington, 98195 USA
3 Department of Radiology, University of Washington, Box 357115, 1959 NE Pacific Street, Seattle, Washington, 98195, USA
4 Department Neurological Surgery, Harborview Medical Center, Box 359766, 325 Ninth Ave., Seattle, WA 98104, USA
5 Department of Biostatistics, University of Washington, Box 357232, 1959 NE Pacific Street, Seattle, Washington, 98195, USA
BMC Musculoskeletal Disorders 2005, 6:2 doi:10.1186/1471-2474-6-2Published: 18 January 2005
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. 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 design
Two 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.
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 MRI to predict patient outcomes.