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Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00987571
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : October 1, 2009
Sponsor:
Information provided by:
EMG Labs of Arizona Arthritis & Rheumatology Associates

Tracking Information
First Submitted Date September 29, 2009
First Posted Date October 1, 2009
Last Update Posted Date October 1, 2009
Study Start Date April 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2009)
Median nerve compressive narrowing on ultrasound imaging in carpal tunnel syndrome patients [ Time Frame: 5 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 30, 2009)
No median nerve compressive narrowing in normal subjects [ Time Frame: 5 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression
Official Title Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression
Brief Summary Carpal tunnel syndrome is caused by compression of the median nerve at the wrist. The hypothesis is that ultrasound imaging can be used to visualize nerve compression in carpal tunnel patients during hand activity, and normal subjects will not demonstrate any nerve compression.
Detailed Description Two patients with carpal tunnel syndrome underwent nerve testing to document that they had median nerve abnormality at the wrist. They subsequently had ultrasound imaging of the wrist at rest and during a stress test using hand activity. Two control subjects had nerve testing to prove that they had no nerve abnormality at the carpal tunnel. The carpal tunnel syndrome patients demonstrated nerve compression on the ultrasound images during the stress tests and the normal subjects showed no nerve compression.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with upper extremity symptoms of pain, numbness, and tingling; Adult subjects with no upper extremity pain, numbness, or tingling
Condition Carpal Tunnel Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • Carpal Tunnel patients
    These patients have documented carpal tunnel syndrome
  • Normal Subjects
    These individuals have no carpal tunnel syndrome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 30, 2009)
4
Original Actual Enrollment Same as current
Actual Study Completion Date September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients must have symptoms consistent with carpal tunnel syndrome and electrodiagnostic testing that demonstrates abnormal median nerve function at the wrist, consistent with carpal tunnel syndrome.
  • Normal subjects must have no upper limb symptoms to support carpal tunnel syndrome and normal nerve testing.

Exclusion Criteria:

  • Patients excluded if nerve testing was not consistent with carpal tunnel syndrome.
  • Normals excluded if nerve testing demonstrated any median nerve abnormality.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00987571
Other Study ID Numbers CTS-US Med N JAOA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Benjamin M. Sucher, D.O./Medical Director, EMG Labs of AARA
Study Sponsor EMG Labs of Arizona Arthritis & Rheumatology Associates
Collaborators Not Provided
Investigators
Principal Investigator: Benjamin M Sucher, DO EMG Labs of AARA
PRS Account EMG Labs of Arizona Arthritis & Rheumatology Associates
Verification Date September 2009