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.
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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
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
Washington
University of Washington Medical Center, Seattle, Washington, 98104, United States; Recruiting
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
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.
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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