Clinical Trial: Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Brief Summary: 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.

Detailed Summary: 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 wrist MRI might be a better predictor of outcome than EDS. Thus, wrist MRI 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 wrist MRI accurately identifies those patients more likely to benefit from surgery. We will perform a randomized, controlled treatment trial nested within a prospective cohort as our study design.
Sponsor: University of Washington

Current Primary Outcome: Carpal Tunnel Syndrome Assessment Questionnaire- function scale [ Time Frame: 12 months ]

Original Primary Outcome:

Current Secondary Outcome:

  • CTSAQ symptom scale [ Time Frame: 12 months ]
  • CTSAQ-function [ Time Frame: 3 months ]
  • CTSAQ-symptom [ Time Frame: 3 months ]
  • SF36 [ Time Frame: 12 months ]


Original Secondary Outcome:

Information By: University of Washington

Dates:
Date Received: March 12, 2002
Date Started: August 2002
Date Completion:
Last Updated: May 4, 2013
Last Verified: May 2013