NCT01342068

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 25, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

April 25, 2011

Last Update Submit

April 24, 2013

Conditions

Keywords

Thoracic outlet syndromeOsteopathic medicineOsteopathic Manual ManipulationsOMTWright's TestAdson's TestHalstead's ManeuverTOSVascular Sonography

Outcome Measures

Primary Outcomes (1)

  • Blood flow velocity

    Doppler ultrasound was utilized to measure blood flow velocity during TOS special tests pre and post osteopathic manipulative treatment.

    5 minutes

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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'

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University

Davie, Florida, 33314, United States

Location

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yasmin Qureshi, DPT

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 25, 2011

First Posted

April 26, 2011

Study Start

June 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 25, 2013

Record last verified: 2013-02

Locations