Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Surgical release of CTS

Group Type EXPERIMENTAL

Early Carpal Tunnel Release for Mild or Moderate CTS

Intervention Type PROCEDURE

Either open or endoscopic surgery

MR Nerve Imaging for CTS

Intervention Type OTHER

New diagnostic test for CTS to directly image the median nerve

2

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

Group Type ACTIVE_COMPARATOR

Early Carpal Tunnel Release for Mild or Moderate CTS

Intervention Type PROCEDURE

Either open or endoscopic surgery

MR Nerve Imaging for CTS

Intervention Type OTHER

New diagnostic test for CTS to directly image the median nerve

Interventions

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Early Carpal Tunnel Release for Mild or Moderate CTS

Either open or endoscopic surgery

Intervention Type PROCEDURE

MR Nerve Imaging for CTS

New diagnostic test for CTS to directly image the median nerve

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No