- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01196637
Thoracic Outlet Syndrome: Case Reports and Analysis With Ultrasound Imaging
September 8, 2010 updated by: EMG Labs of Arizona Arthritis & Rheumatology Associates
Thoracic Outlet Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Brachial Plexus Compression
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Paradise Valley, Arizona, United States, 85253
- EMG Labs of AARA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Thoracic outlet syndrome
These patients have documented thoracic outlet syndrome
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Normal Subjects
These patients have no thoracic outlet syndrome
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brachial plexus compression on ultrasound imaging in thoracic outlet syndrome patients
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
No brachial plexus compression in normal subjects
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Benjamin M Sucher, D.O., EMG Labs of AARA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
September 5, 2010
First Submitted That Met QC Criteria
September 5, 2010
First Posted (Estimate)
September 8, 2010
Study Record Updates
Last Update Posted (Estimate)
September 9, 2010
Last Update Submitted That Met QC Criteria
September 8, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOS-US BP JAOA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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