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Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey G. Jarvik, MD, MPH, University of Washington
ClinicalTrials.gov Identifier:
NCT00032227
First received: March 12, 2002
Last updated: May 4, 2013
Last verified: May 2013

March 12, 2002
May 4, 2013
August 2002
April 2007   (final data collection date for primary outcome measure)
Carpal Tunnel Syndrome Assessment Questionnaire- function scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00032227 on ClinicalTrials.gov Archive Site
  • CTSAQ symptom scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • CTSAQ-function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • CTSAQ-symptom [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • SF36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carpal Tunnel Syndrome
  • Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS
    Either open or endoscopic surgery
  • Other: MR Nerve Imaging for CTS
    New diagnostic test for CTS to directly image the median nerve
  • Experimental: 1
    Surgical release of CTS
    Interventions:
    • Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS
    • Other: MR Nerve Imaging for CTS
  • Active Comparator: 2
    Non-surgical treatment for CTS (splint, physical therapy, ultrasound)
    Interventions:
    • Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS
    • Other: MR Nerve Imaging for CTS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
April 2008
April 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032227
P60 AR48093, P60AR048093, NIAMS-075
Not Provided
Jeffrey G. Jarvik, MD, MPH, University of Washington
University of Washington
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Jeffrey G. Jarvik, MD, MPH University of Washington
University of Washington
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP