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Carpal Tunnel Syndrome: Diagnosis and Treatment Trial - Article


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Cri-du-chat syndrome

5p Deletion Syndrome; 5p- Syndrome; Cat cry syndrome


Clinical Trial: Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

This study is currently recruiting patients.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

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 Treatment or Intervention
Carpal Tunnel Syndrome
 Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS
 Procedure: MR Neurographic Imaging for CTS

MedlinePlus related topics:  Carpal Tunnel Syndrome

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  500

Study start: August 2002;  Expected completion: March 2007

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Parethesias involving 2 digits on hand diagram
  • Willingness and ability to complete interviews
  • Live in Washington State

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

Location and Contact Information

Brook I. Martin, MPH      (206) 616-0982    bim@u.washington.edu

Washington
      University of Washington Medical Center, Seattle,  Washington,  98104,  United States; Recruiting
Brook I. Martin, MPH  206-744-1803    bim@u.washington.edu 
Jeffrey G. Jarvik, MD, MPH  206-543-3617    jarvikj@u.washington.edu 
Jeffrey G. Jarvik, MD, MPH,  Principal Investigator
Michel Kliot, MD,  Sub-Investigator
Leighton Chan, MD, MPH,  Sub-Investigator
Thomas Trumble, MD,  Sub-Investigator
Judith A. Turner, PhD,  Sub-Investigator
Lawrence R. Robinson, MD,  Sub-Investigator
Patrick J. Heagerty, PhD,  Sub-Investigator
Gary M. Franklin, MD,  Sub-Investigator
Kenneth R. Maravilla, MD,  Sub-Investigator
Branko Kopjar, MD,  Sub-Investigator
Gavin W. Britz, MD,  Sub-Investigator

Study chairs or principal investigators

Jeffrey G. Jarvik, MD, MPH,  Principal Investigator,  University of Washington   

More Information

Publications

Jarvik JG, Yuen E. Diagnosis of carpal tunnel syndrome: electrodiagnostic and magnetic resonance imaging evaluation. Neurosurg Clin N Am. 2001 Apr;12(2):241-53.

Grant GA, Britz GW, Goodkin R, Jarvik JG, Maravilla K, Kliot M. The utility of magnetic resonance imaging in evaluating peripheral nerve disorders. Muscle Nerve. 2002 Mar;25(3):314-31. Review.

Aagaard BD, Lazar DA, Lankerovich L, Andrus K, Hayes CE, Maravilla K, Kliot M. High-resolution magnetic resonance imaging is a noninvasive method of observing injury and recovery in the peripheral nervous system. Neurosurgery. 2003 Jul;53(1):199-203; discussion 203-4.

Jarvik JG, Yuen E, Haynor DR, Bradley CM, Fulton-Kehoe D, Smith-Weller T, Wu R, Kliot M, Kraft G, Wang L, Erlich V, Heagerty PJ, Franklin GM. MR nerve imaging in a prospective cohort of patients with suspected carpal tunnel syndrome. Neurology. 2002 Jun 11;58(11):1597-602.

Jarvik JG, Yuen E, Kliot M. Diagnosis of carpal tunnel syndrome: electrodiagnostic and MR imaging evaluation. Neuroimaging Clin N Am. 2004 Feb;14(1):93-102, viii. Review.

Study ID Numbers:  NIAMS-075; P60 AR48093
Record last reviewed:  September 2004
Last Updated:  April 7, 2005
Record first received:  March 12, 2002
ClinicalTrials.gov Identifier:  NCT00032227
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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September 5, 2008



Page Updated: September 6, 2005
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