Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

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.

Official Title
-----------------
Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS
* Other: MR Nerve Imaging for CTS


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Surgical release of CTS | Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS<br>* Either open or endoscopic surgery<br>Other: MR Nerve Imaging for CTS<br>* New diagnostic test for CTS to directly image the median nerve<br>|
| Active Comparator: 2<br>Non-surgical treatment for CTS (splint, physical therapy, ultrasound) | Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS<br>* Either open or endoscopic surgery<br>Other: MR Nerve Imaging for CTS<br>* New diagnostic test for CTS to directly image the median nerve<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carpal Tunnel Syndrome Assessment Questionnaire- function scale |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTSAQ symptom scale |  | 12 months | 
| CTSAQ-function |  | 3 months | 
| CTSAQ-symptom |  | 3 months | 
| SF36 |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carpal Tunnel Release, MR Nerve Imaging, Wrist MRI