Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS; Other: MR Nerve Imaging for CTS

• Registration Number: NCT00032227
• Lead Sponsor: University of Washington

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 Timeline

• Study First Submitted: 2002-03-12
• Study First Submitted QC: 2002-03-12
• Study First Posted: 2002-03-13
• Study Start: 2002-08
• Primary Completion: 2007-04
• Study Completion: 2008-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-04
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Early Carpal Tunnel Release for Mild or Moderate CTS	Surgical release of CTS
1	MR Nerve Imaging for CTS	Surgical release of CTS
2	Early Carpal Tunnel Release for Mild or Moderate CTS	Non-surgical treatment for CTS (splint, physical therapy, ultrasound)
2	MR Nerve Imaging for CTS	Non-surgical treatment for CTS (splint, physical therapy, ultrasound)

Primary Outcome Measures

Name	Time	Method
Carpal Tunnel Syndrome Assessment Questionnaire- function scale	12 months

Secondary Outcome Measures

Name	Time	Method
CTSAQ-function	3 months
CTSAQ-symptom	3 months
SF36	12 months
CTSAQ symptom scale	12 months

Trial Locations

Locations (1)

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States