Thoracic Outlet SyndromeNCT01196637
Thoracic Outlet Syndrome: Case Reports and Analysis With Ultrasound Imaging
An observational study of Thoracic Outlet Syndrome, run by EMG Labs of Arizona Arthritis & Rheumatology Associates at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Outlet Syndrome
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Outlet Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Brachial Plexus Compression
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.
Read the detailed 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.
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- thoracic outlet syndrome, brachial plexopathy, ultrasonography
- Medical subject headings
- Thoracic Outlet Syndrome, Brachial Plexus Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic outlet syndrome | These patients have documented thoracic outlet syndrome | |
| Normal Subjects | These patients have no thoracic outlet syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial plexus compression on ultrasound imaging in thoracic outlet syndrome patients
Measured: 4 months
Secondary outcomes (1)
No brachial plexus compression in normal subjects
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMG Labs of Arizona Arthritis & Rheumatology Associates
- Sponsor type
- University, hospital or other
- Investigators
- Benjamin M Sucher, D.O., Principal investigator, EMG Labs of AARA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196637
- Sponsor's protocol ID
- TOS-US BP JAOA
- Status last verified
- Sep 2010
- First submitted
- 5 Sep 2010
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Outlet Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Brachial Plexus Compression
- ClinicalTrials.gov ID
- NCT01196637
- Acronym / sponsor ID
- TOS-US BP JAOA
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- thoracic outlet syndrome, brachial plexopathy, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- EMG Labs of Arizona Arthritis & Rheumatology AssociatesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic outlet syndrome | – | –These patients have documented thoracic outlet syndrome |
| Normal Subjects | – | –These patients have no thoracic outlet syndrome |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- symptoms consistent with thoracic outlet syndrome, and
- no electrical testing abnormality, and
- positive arm abduction stress tests.
- no upper limb symptoms, or
- normal nerve testing, and
Key exclusion criteria (6 listed)
- nerve test abnormalities, or
- negative arm abduction stress test
- abnormalities on nerve testing, or
- positive arm abduction stress tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brachial plexus compression on ultrasound imaging in thoracic outlet syndrome patients
Time frame: 4 months
1 secondary outcome
No brachial plexus compression in normal subjects
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Sucher, D.O. principal investigator
EMG Labs of AARA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Outlet Syndrome, run by EMG Labs of Arizona Arthritis & Rheumatology Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial plexus compression on ultrasound imaging in thoracic outlet syndrome patients (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2010.