Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

University of Washington

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Other: MR Nerve Imaging for CTS; Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00032227

NIAMS-075

P60AR048093 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

1

Experimental group

Description:

Surgical release of CTS

Treatment:

Other: MR Nerve Imaging for CTS

Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS

2

Active Comparator group

Description:

Non-surgical treatment for CTS (splint, physical therapy, ultrasound)

Treatment:

Other: MR Nerve Imaging for CTS

Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS