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Trial record 2 of 6 for:    "Thoracic outlet syndrome"

The Effectiveness of Diagnosis and Treatment of Thoracic Outlet Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yasmin Qureshi, MHS, MSPT, Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT01342068
First received: April 25, 2011
Last updated: April 24, 2013
Last verified: February 2013
  Purpose

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.


Condition
Thoracic Outlet Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Effectiveness of Diagnosis and Treatment of Thoracic Outlet Syndrome

Resource links provided by NLM:


Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:
  • Blood flow velocity [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Doppler ultrasound was utilized to measure blood flow velocity during TOS special tests pre and post osteopathic manipulative treatment.


Enrollment: 31
Study Start Date: June 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from a variety of settings:

  1. First and second year medical students from Nova Southeastern University College of Osteopathic Medicine with symptoms of Thoracic outlet syndrome.
  2. Patients from the Sanford Ziff Osteopathic Manipulation Clinic that exhibit symptoms of Thoracic outlet syndrome
  3. Patients from the Nova Southeastern University Sports Medicine Clinic that exhibit symptoms of Thoracic outlest syndrome.
Criteria

Inclusion Criteria:

  • positive Roo's test indicative of thoracic outlet syndrome
  • one positive provocative test for thoracic outlet syndrome from:Adson's, Wright's or Halstead's indicative of the specific tissue that is impeding blood flow to the upper extremity.

Exclusion Criteria:

  • known medical history of cervical disc disease (such as herniated discs, degenerative disc disease
  • known medical history of upper extremity nerve entrapment syndromes such as carpal tunnel syndrome, pronator teres syndrome, anterior interosseus syndrome, ulnar groove, cubital tunnel, Guyon's canal or radial tunnel syndrome.
  • medical history of diabetic/thyroid related neuropathies and medicine induced paresthesias
  • medical history of atherosclerosis or any type of clotting or other vascular disorders such as thromboembolism of the upper extremity
  • excessive pain during Patients with excessive pain during passive shoulder range of motion procedures such as in 'frozen shoulder'
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342068

Locations
United States, Florida
Nova Southeastern University
Davie, Florida, United States, 33314
Sponsors and Collaborators
Nova Southeastern University
Investigators
Principal Investigator: Yasmin Qureshi, DPT Nova Southeastern University
  More Information

No publications provided

Responsible Party: Yasmin Qureshi, MHS, MSPT, Assistant Professor, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT01342068     History of Changes
Other Study ID Numbers: TOS-Dx and Tx
Study First Received: April 25, 2011
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nova Southeastern University:
Thoracic outlet syndrome
Osteopathic medicine
Osteopathic Manual Manipulations
OMT
Wright's Test
Adson's Test
Halstead's Maneuver
TOS
Vascular Sonography

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

ClinicalTrials.gov processed this record on November 25, 2014