NCT01196637

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
Last Updated

September 9, 2010

Status Verified

September 1, 2010

Enrollment Period

3 months

First QC Date

September 5, 2010

Last Update Submit

September 8, 2010

Conditions

Keywords

thoracic outlet syndromebrachial plexopathyultrasonography

Outcome Measures

Primary Outcomes (1)

  • Brachial plexus compression on ultrasound imaging in thoracic outlet syndrome patients

    4 months

Secondary Outcomes (1)

  • No brachial plexus compression in normal subjects

    4 months

Study Arms (2)

Thoracic outlet syndrome

These patients have documented thoracic outlet syndrome

Normal Subjects

These patients have no thoracic outlet syndrome

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EMG Labs of AARA

Paradise Valley, Arizona, 85253, United States

Location

MeSH Terms

Conditions

Thoracic Outlet SyndromeBrachial Plexus Neuropathies

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Benjamin M Sucher, D.O.

    EMG Labs of AARA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2010

First Posted

September 8, 2010

Study Start

June 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 9, 2010

Record last verified: 2010-09

Locations