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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01342068
Other study ID # TOS-Dx and Tx
Secondary ID
Status Completed
Phase N/A
First received April 25, 2011
Last updated April 24, 2013
Start date June 2011
Est. completion date April 2013

Study information

Verified date February 2013
Source Nova Southeastern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Thoracic Outlet Syndrome (TOS) is a condition causing numbness, tingling and weakness in patient's upper limbs. Symptoms are due to compression and restriction of the nerves and blood vessels (neurovascular bundle) that extend from the neck into the upper limb exerted by a patient's various anatomical structures. Neurovascular bundle compression can result in decreased nerve conduction and blood flow through the arteries supplying structures downstream from the restricted site. These anatomical restrictions include tight scalene muscles in the neck, tightened pectorialis minor muscle in the chest and extra ribs growing from the C7 vertebra.

TOS can be diagnosed by using special tests designed to re-elicit neurovascular bundle compression. Upon obtaining a positive test, the patient can undergo osteopathic manipulative treatments (OMT) to change the anatomical restrictions allowing for a decrease of symptoms and even eradication of the syndrome altogether.

Although diagnosis and treatment of TOS is common in osteopathic medicine, the effectiveness of the diagnostic special tests and treatment has not been thoroughly investigated. This study aims to examine the effectiveness of the special tests (Adson's, Wright's hyperabduction and Halstead maneuver) in diagnosing a change in blood flow through the arteries of the upper arm compared to evaluation with Doppler ultrasound to measure blood flow while the tests are performed. Patients with positive tests will be treated with OMT including myofascial release, soft tissue, and articulation to relieve restricting structures. Upon completion of treatment, the special tests will be performed again along with the Doppler ultrasound to measure blood flow through blood vessels. Results then are analyzed statistically for significance of the ability correctly diagnose and treat TOS symptoms.

Results from this study will contribute towards the validity of teaching special tests in osteopathic medical schools and allow for a non-invasive treatment protocol for patients with TOS.


Description:

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Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Nova Southeastern University Davie Florida

Sponsors (1)

Lead Sponsor Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood flow velocity Doppler ultrasound was utilized to measure blood flow velocity during TOS special tests pre and post osteopathic manipulative treatment. 5 minutes No
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