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...
Brief Summary
Official Title: “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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: April 2007
Detailed Clinical Trial Description
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.
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Surgical release of CTS
- Active Comparator: 2
- Non-surgical treatment for CTS (splint, physical therapy, ultrasound)
Outcome Measures for this Clinical Trial
Primary Measures
- Carpal Tunnel Syndrome Assessment Questionnaire- function scale
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
Secondary Measures
- CTSAQ symptom scale
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
- CTSAQ-function
- Time Frame: 3 months
Safety Issue?: No
- Time Frame: 3 months
- CTSAQ-symptom
- Time Frame: 3 months
Safety Issue?: No
- Time Frame: 3 months
- SF36
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) NIH
Overall Clinical Trial Officials and Contacts
Jeffrey G. Jarvik, MD, MPH Principal Investigator University of Washington
Related Publications
References
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.
Martin BI, Levenson LM, Hollingworth W, Kliot M, Heagerty PJ, Turner JA, Jarvik JG. Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481]. BMC Musculoskelet Disord. 2005 Jan 18;6(1):2.
Storm S, Beaver SK, Giardino N, Kliot M, Franklin GM, Jarvik JG, Chan L. Compliance with electrodiagnostic guidelines for patients undergoing carpal tunnel release. Arch Phys Med Rehabil. 2005 Jan;86(1):8-11; quiz 180.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00032227
Study ID Number: P60 AR48093
ClinicalTrials.gov Identifier: NCT00032227
Health Authority: United States: Federal Government
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00032227
