Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

NCT00032227 | Completed

• 2 other identifiers: P60AR048093NIAMS-075
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Release; MR Nerve Imaging; Wrist MRI

Outcome Measures

Primary Outcomes (1)

• Carpal Tunnel Syndrome Assessment Questionnaire- function scale

  12 months

Secondary Outcomes (4)

• CTSAQ symptom scale

  12 months

• CTSAQ-function

  3 months

• CTSAQ-symptom

  3 months

• SF36

  12 months

Study Arms (2)

1

EXPERIMENTAL

Surgical release of CTS

Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS; Other: MR Nerve Imaging for CTS

2

ACTIVE COMPARATOR

Non-surgical treatment for CTS (splint, physical therapy, ultrasound)

Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS; Other: MR Nerve Imaging for CTS

Interventions

Early Carpal Tunnel Release for Mild or Moderate CTS PROCEDURE

Either open or endoscopic surgery

1; 2

MR Nerve Imaging for CTS OTHER

New diagnostic test for CTS to directly image the median nerve

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paresthesias involving 2 digits on hand diagram
• Willingness and ability to complete interviews

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (8)

• 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.

  PMID: 11525204 BACKGROUND

• 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. doi: 10.1002/mus.10013.

  PMID: 11870709 BACKGROUND

• 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. doi: 10.1227/01.neu.0000069534.43067.28.

  PMID: 12823890 BACKGROUND

• 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. doi: 10.1212/wnl.58.11.1597.

  PMID: 12058085 BACKGROUND

• 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. doi: 10.1016/j.nic.2004.02.002.

  PMID: 15177259 BACKGROUND

• 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. doi: 10.1186/1471-2474-6-2.

  PMID: 15656907 BACKGROUND

• 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. doi: 10.1016/j.apmr.2004.02.027.

  PMID: 15640981 BACKGROUND

• Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. 2009 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.

  PMID: 19782873 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Jeffrey G. Jarvik, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: March 12, 2002
• First Posted: March 13, 2002
• Study Start: August 1, 2002
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2008
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

US (1)