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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00032227 |
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.
Condition | Intervention |
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Carpal Tunnel Syndrome |
Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS Other: MR Nerve Imaging for CTS |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Carpal Tunnel Syndrome: Diagnosis and Treatment Trial |
Enrollment: | 116 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Surgical release of CTS
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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
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2: Active Comparator
Non-surgical treatment for CTS (splint, physical therapy, ultrasound)
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
University of Washington Medical Center | |
Seattle, Washington, United States, 98104 |
Principal Investigator: | Jeffrey G. Jarvik, MD, MPH | University of Washington |
Responsible Party: | University of Washington ( Jeffrey G. Jarvik, MD MPH ) |
Study ID Numbers: | P60 AR48093, NIAMS-075 |
Study First Received: | March 12, 2002 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00032227 |
Health Authority: | United States: Federal Government |
Carpal Tunnel Release MR Nerve Imaging Wrist MRI |
Carpal Tunnel Syndrome Roussy Levy hereditary areflexic dystasia Charcot-Marie-Tooth Disease Wounds and Injuries Disorders of Environmental Origin Mononeuropathies Nerve Compression Syndromes |
Tomaculous neuropathy Neuromuscular Diseases Peripheral Nervous System Diseases Hereditary Motor and Sensory Neuropathies Charcot Marie Tooth disease Cumulative Trauma Disorders Sprains and Strains |
Median Neuropathy Pathologic Processes Disease Syndrome Nervous System Diseases |