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Trial record 4 of 17 for:    Thoracic Outlet Syndrome

Thoracic Outlet Syndrome: Case Reports and Analysis With Ultrasound Imaging

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: NCT01196637
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : September 9, 2010
Sponsor:
Information provided by:
EMG Labs of Arizona Arthritis & Rheumatology Associates

Tracking Information
First Submitted Date September 5, 2010
First Posted Date September 8, 2010
Last Update Posted Date September 9, 2010
Study Start Date June 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2010)
Brachial plexus compression on ultrasound imaging in thoracic outlet syndrome patients [ Time Frame: 4 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 5, 2010)
No brachial plexus compression in normal subjects [ Time Frame: 4 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 Thoracic Outlet Syndrome: Case Reports and Analysis With Ultrasound Imaging
Official Title Thoracic Outlet Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Brachial Plexus Compression
Brief Summary Thoracic outlet syndrome is caused by compression of the brachial plexus, in most cases under the pectoralis minor muscle in the infraclavicular region of the shoulder. The hypothesis is that ultrasound imaging can be used to visualize brachial plexus compression and distortion of the pectoralis muscle during arm activity, such as abduction, and that normal subjects will not demonstrate any plexus compression or muscle distortion.
Detailed Description Four patients with thoracic outlet syndrome (TOS) underwent clinical exam and nerve testing to prove that they had TOS and no other nerve abnormality. They subsequently had ultrasound imaging of the shoulder (infraclavicular region) at rest and during arm abduction stress testing. Two control subjects had similar clinical exams and nerve testing to prove they did not have TOS, and then underwent similar ultrasound stress testing. The TOS patients demonstrated brachial plexus compression and pectoralis minor muscle distortion during the stress tests, and the normal subjects showed no plexus compression or muscle distortion.
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 limb symptoms of pain, numbness, tingling, or weakness, aggravated by arm abduction; Adult patients with no upper limb symptoms
Condition Thoracic Outlet Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • Thoracic outlet syndrome
    These patients have documented thoracic outlet syndrome
  • Normal Subjects
    These patients have no thoracic outlet 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 8, 2010)
6
Original Enrollment Not Provided
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

INCLUSION CRITERIA:

Thoracic outlet patients must have:

  • symptoms consistent with thoracic outlet syndrome, and
  • no electrical testing abnormality, and
  • positive arm abduction stress tests.

Normal subjects must have:

  • no upper limb symptoms, or
  • normal nerve testing, and
  • negative arm abduction stress test

EXCLUSION CRITERIA:

Thoracic outlet patients excluded if they have:

  • nerve test abnormalities, or
  • negative arm abduction stress test

Normals excluded if they have:

  • abnormalities on nerve testing, or
  • positive arm abduction stress tests
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01196637
Other Study ID Numbers TOS-US BP 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, D.O. EMG Labs of AARA
PRS Account EMG Labs of Arizona Arthritis & Rheumatology Associates
Verification Date September 2010