Skip to content

Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00032227
Enrollment
116
Registered
2002-03-13
Start date
2002-08-31
Completion date
2008-04-30
Last updated
2013-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Release, MR Nerve Imaging, Wrist MRI

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.

Interventions

PROCEDUREEarly Carpal Tunnel Release for Mild or Moderate CTS

Either open or endoscopic surgery

OTHERMR Nerve Imaging for CTS

New diagnostic test for CTS to directly image the median nerve

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Carpal Tunnel Syndrome Assessment Questionnaire- function scale12 months

Secondary

MeasureTime frame
CTSAQ symptom scale12 months
CTSAQ-function3 months
CTSAQ-symptom3 months
SF3612 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026