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Carpal Tunnel Syndrome: Diagnosis and Treatment Trial



Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

For Condition: Carpal Tunnel Syndrome
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a randomized trial comparing surgical and nonsurgical treatments for patients with early, mild to moderate carpal tunnel syndrome. In addition the study will evaluate the ability of a new magnetic resonance (MR) technique at predicting who will likely benefit from carpal tunnel syndrome (CTS) surgery.
Details: While there is good evidence that patients with severe CTS benefit from surgery, there is less evidence of a benefit for patients with mild to moderate disease. However, mild to moderate disease still accounts for important disability. Electrodiagnostic studies (EDS) have not been shown to accurately predict outcomes for patients with CTS. Recent advances in MR permit high-resolution neurographic imaging of the median nerve, and pilot data suggest that MR neurographic imaging (MRNI) might be a better predictor of outcome than EDS. Thus, MRNI has the potential for playing a major role in the treatment of patients with CTS. We will test two main hypotheses: 1) that select patients with early, mild or moderate CTS benefit more from early surgery than with conservative therapy; and, 2) that MRNI accurately identifies those patients more likely to benefit from early surgery. We will perform a randomized, controlled treatment trial nested within a prospective cohort as our study design.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Parathesias involving 2 digits on hand diagram - No evidence of denervation on EDS - No abnormal 2-pt discrimination or thenar atrophy - No prior wrist surgery or acute external trauma - No MRI contraindications - No metallic hardware in wrists - Willingness and ability to complete interviews - Live in Washington State
Total Enrollment: 500

Location and Contact Information:

University of Washington Medical Center *Recruiting*
Seattle,  Washington,  98103
United States
Recruiting Brook  Martin 206-616-0982


Additional Information:
Study ID Numbers:  NIAMS-075;  P60 AR48093
Study Start Date: August 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032227

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