Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Carpal Tunnel Syndrome Clinical Trial

Official title:

Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032227
• Other study ID #: P60AR048093
• Secondary ID: P60AR048093NIAMS
• Status: Completed
• Phase: N/A
• First received: March 12, 2002
• Last updated: May 4, 2013
• Start date: August 2002
• Est. completion date: April 2008

Study information

• Verified date: May 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: April 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;6:2. — View Citation

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. Erratum in: Arch Phys Med Rehabil. 2005 Apr;86(4):846. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carpal Tunnel Syndrome Assessment Questionnaire- function scale		12 months	No
Secondary	CTSAQ symptom scale		12 months	No
Secondary	CTSAQ-function		3 months	No
Secondary	CTSAQ-symptom		3 months	No
Secondary	SF36		12 months	No