Carpal Tunnel Syndrome: Diagnosis and Treatment Trial - Full Text View

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)
ClinicalTrials.gov Identifier:	NCT00032227

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome Surgery

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Carpal Tunnel Syndrome Assessment Questionnaire- function scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CTSAQ symptom scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
CTSAQ-function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
CTSAQ-symptom [ Time Frame: 3 months ] [ Designated as safety issue: No ]
SF36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	116
Study Start Date:	August 2002
Study Completion Date:	April 2008
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Surgical release of CTS	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
2: Active Comparator Non-surgical treatment for CTS (splint, physical therapy, ultrasound)	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

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032227

Locations

United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98104

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator:

Jeffrey G. Jarvik, MD, MPH

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.

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.

Responsible Party:	University of Washington ( Jeffrey G. Jarvik, MD MPH )
Study ID Numbers:	P60 AR48093, NIAMS-075
Study First Received:	March 12, 2002
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00032227 History of Changes
Health Authority:	United States: Federal Government

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

Carpal Tunnel Release
MR Nerve Imaging
Wrist MRI

Study placed in the following topic categories:

Roussy Levy Hereditary Areflexic Dystasia
Carpal Tunnel Syndrome
Charcot Marie Tooth Disease
Charcot-Marie-Tooth Disease
Wounds and Injuries
Disorders of Environmental Origin
Tomaculous Neuropathy

Mononeuropathies
Nerve Compression Syndromes
Neuromuscular Diseases
Peripheral Nervous System Diseases
Hereditary Motor and Sensory Neuropathies
Cumulative Trauma Disorders
Sprains and Strains

Additional relevant MeSH terms:

Median Neuropathy
Carpal Tunnel Syndrome
Disease
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Mononeuropathies

Nerve Compression Syndromes
Pathologic Processes
Neuromuscular Diseases
Syndrome
Peripheral Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains

ClinicalTrials.gov processed this record on July 02, 2009