Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Carpal Tunnel Release for Mild or Moderate CTS
MR Nerve Imaging for CTS
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Release, MR Nerve Imaging, Wrist MRI
Eligibility 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
Sites / Locations
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Surgical release of CTS
Non-surgical treatment for CTS (splint, physical therapy, ultrasound)
Outcomes
Primary Outcome Measures
Carpal Tunnel Syndrome Assessment Questionnaire- function scale
Secondary Outcome Measures
CTSAQ symptom scale
CTSAQ-function
CTSAQ-symptom
SF36
Full Information
NCT ID
NCT00032227
First Posted
March 12, 2002
Last Updated
May 4, 2013
Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00032227
Brief Title
Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
Official Title
Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Release, MR Nerve Imaging, Wrist MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Surgical release of CTS
Arm Title
2
Arm Type
Active Comparator
Arm Description
Non-surgical treatment for CTS (splint, physical therapy, ultrasound)
Intervention Type
Procedure
Intervention Name(s)
Early Carpal Tunnel Release for Mild or Moderate CTS
Intervention Description
Either open or endoscopic surgery
Intervention Type
Other
Intervention Name(s)
MR Nerve Imaging for CTS
Intervention Description
New diagnostic test for CTS to directly image the median nerve
Primary Outcome Measure Information:
Title
Carpal Tunnel Syndrome Assessment Questionnaire- function scale
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CTSAQ symptom scale
Time Frame
12 months
Title
CTSAQ-function
Time Frame
3 months
Title
CTSAQ-symptom
Time Frame
3 months
Title
SF36
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey G. Jarvik, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11525204
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.
Results Reference
background
PubMed Identifier
11870709
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. doi: 10.1002/mus.10013.
Results Reference
background
PubMed Identifier
12823890
Citation
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.
Results Reference
background
PubMed Identifier
12058085
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. doi: 10.1212/wnl.58.11.1597.
Results Reference
background
PubMed Identifier
15177259
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. doi: 10.1016/j.nic.2004.02.002.
Results Reference
background
PubMed Identifier
15656907
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. doi: 10.1186/1471-2474-6-2.
Results Reference
background
PubMed Identifier
15640981
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. doi: 10.1016/j.apmr.2004.02.027. Erratum In: Arch Phys Med Rehabil. 2005 Apr;86(4):846.
Results Reference
background
PubMed Identifier
19782873
Citation
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.
Results Reference
derived
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Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
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