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Thoracic Outlet Syndrome: Case Reports and Analysis With Ultrasound Imaging

This study has been completed.
Sponsor:
Information provided by:
EMG Labs of Arizona Arthritis & Rheumatology Associates
ClinicalTrials.gov Identifier:
NCT01196637
First received: September 5, 2010
Last updated: September 8, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition
Thoracic Outlet Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Thoracic Outlet Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Brachial Plexus Compression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EMG Labs of Arizona Arthritis & Rheumatology Associates:

Primary Outcome Measures:
  • Brachial plexus compression on ultrasound imaging in thoracic outlet syndrome patients [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No brachial plexus compression in normal subjects [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Thoracic outlet syndrome
These patients have documented thoracic outlet syndrome
Normal Subjects
These patients have no thoracic outlet syndrome

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196637

Locations
United States, Arizona
EMG Labs of AARA
Paradise Valley, Arizona, United States, 85253
Sponsors and Collaborators
EMG Labs of Arizona Arthritis & Rheumatology Associates
Investigators
Principal Investigator: Benjamin M Sucher, D.O. EMG Labs of AARA
  More Information

No publications provided

Responsible Party: Benjamin M. Sucher, D.O. / Medical Director, EMG Labs of AARA
ClinicalTrials.gov Identifier: NCT01196637     History of Changes
Other Study ID Numbers: TOS-US BP JAOA
Study First Received: September 5, 2010
Last Updated: September 8, 2010
Health Authority: United States: Federal Government

Keywords provided by EMG Labs of Arizona Arthritis & Rheumatology Associates:
thoracic outlet syndrome
brachial plexopathy
ultrasonography

Additional relevant MeSH terms:
Thoracic Outlet Syndrome
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013