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Completed

NCT Number: NCT00032227

Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Medical Center

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Carpal Tunnel Release for Mild or Moderate CTS

Procedure

Either open or endoscopic surgery

MR Nerve Imaging for CTS

Other

New diagnostic test for CTS to directly image the median nerve

Primary outcomes

  1. Carpal Tunnel Syndrome Assessment Questionnaire- function scale

    Time frame: 12 months

Secondary outcomes

  1. CTSAQ symptom scale

    Time frame: 12 months

  2. CTSAQ-function

    Time frame: 3 months

  3. CTSAQ-symptom

    Time frame: 3 months

  4. SF36

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2002
Primary completion
2007
Study completion
2008
First posted
Mar 13, 2002
Registry last updated
May 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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