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 Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS; Other: MR Nerve Imaging for CTS

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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
Active Comparator: 2; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Carpal Tunnel Syndrome Assessment Questionnaire- function scale	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
CTSAQ symptom scale	12 months
CTSAQ-function	3 months
CTSAQ-symptom	3 months
SF36	12 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Jeffrey G. Jarvik, MD, MPH, University of Washington

Publications and helpful links

General 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. doi: 10.1002/mus.10013.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Arch Phys Med Rehabil. 2005 Apr;86(4):846.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: March 12, 2002
• First Submitted That Met QC Criteria: March 12, 2002
• First Posted (Estimate): March 13, 2002

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 4, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Carpal Tunnel Release; MR Nerve Imaging; Wrist MRI
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: P60AR048093 (U.S. NIH Grant/Contract); NIAMS-075