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Clinical Trials/NCT00032227
NCT00032227CompletedNot Applicable

Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

University of Washington2 sites in 1 country116 target enrollmentStarted: August 2002Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
116
Locations
2
Primary Endpoint
Carpal Tunnel Syndrome Assessment Questionnaire- function scale

Study Overview

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 Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Paresthesias involving 2 digits on hand diagram
  • Willingness and ability to complete interviews

Exclusion Criteria

  • Evidence of denervation on EDS
  • Abnormal 2-pt discrimination or thenar atrophy
  • Prior wrist surgery or acute external trauma
  • MRI contraindications
  • Metallic hardware in wrists

Outcomes

Primary Outcomes

Carpal Tunnel Syndrome Assessment Questionnaire- function scale

Time Frame: 12 months

Secondary Outcomes

  • CTSAQ-function(3 months)
  • CTSAQ-symptom(3 months)
  • SF36(12 months)
  • CTSAQ symptom scale(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeffrey G. Jarvik, MD, MPH

Study Principal Investigator

University of Washington

Study Sites (2)

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