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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01196637
Other study ID # TOS-US BP JAOA
Secondary ID
Status Completed
Phase N/A
First received September 5, 2010
Last updated September 8, 2010
Start date June 2010
Est. completion date September 2010

Study information

Verified date September 2010
Source EMG Labs of Arizona Arthritis & Rheumatology Associates
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States EMG Labs of AARA Paradise Valley Arizona

Sponsors (1)

Lead Sponsor Collaborator
EMG Labs of Arizona Arthritis & Rheumatology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brachial plexus compression on ultrasound imaging in thoracic outlet syndrome patients 4 months No
Secondary No brachial plexus compression in normal subjects 4 months No
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