Thoracic Outlet SyndromeEFORDNCT04145778
Evaluation of the Muscular FORCE in the Upper Limbs of Patients Presenting a Thoracic Outlet Syndrome
An observational study of Thoracic Outlet Syndrome, run by Nantes University Hospital at 1 site in France.
Trial summary
The thoracic outlet syndrome is a rare but debilitating pathology, responsible for upper limb pain. Its frequency is probably underestimated because of diagnostic difficulties. This syndrome encompasses several entities including compressions of neurological, venous or arterial origin. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- 6-minute walk test
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2020to 3 Dec 2024
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients with an thoracic outlet syndrome will be needed, which corresponds to the annual recruitment in this care within the department of the University Hospital of Nantes. Patients will be included during their usual management of rehabilitation at the center. 50 healthy subjects will be included, in order to have a patient for a healthy subject. We will call on the staff and student volunteers of the rehabilitation center we will match on age, sex and weight. For both groups, we will only use major topics that do not benefit from any legal protection measures
Who may be able to join
- Age> 18 years
- Rehabilitative management of an thoracic outlet syndrome in the physical and rehabilitation department of Nantes University Hospital
- Having given their consent by non-oral opposition.
- Affiliated to a social security scheme
Who cannot join
- Mineurs
- Majeurs under tutorship, curatorship or safeguard of justice
- Pregnant or lactating women, protected persons
- Patients with other pathology of the upper limb or shoulder (osteoarthritis, tendinopathies, amputation, ...).
- Patients with non-stabilized pathologies, heart, respiratory, metabolic or neurological conditions
- Associated pathology able to interfere with carrying out assessments
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Nantes
Nantes, 44093
Alban Fouasson-Chailloux, MD, 0240846211, alban.fouassonchailloux@chu-nantes.fr
About this study
Official title: Evaluation of the Muscular FORCE in the Upper Limbs of Patients Presenting a Thoracic Outlet Syndrome : Monocentric Case-control Study
The thoracic outlet syndrome is a rare but debilitating pathology, responsible for upper limb pain. Its frequency is probably underestimated because of diagnostic difficulties. This syndrome encompasses several entities including compressions of neurological, venous or arterial origin. In addition to pain, the majority of patients report fatigability and loss of strength in the upper limbs. However, the quantification of this loss of strength and fatigability has hardly been studied.
In addition, the rehabilitation treatment is the first-line treatment of this pathology. It most often includes a muscle building phase.
Read more
In this project, we would like to evaluate the proximal and distal force of patients presenting a thoracic outlet syndrome by comparing them to a population free from any pathology in the upper limbs. This evaluation would involve an isokinetic strength analysis of shoulder rotators at the proximal level, using an isokinetic dynamometer. At the distal level, the evaluation would be done using force clamps.Similarly, performing a 6-minute walk test will assess whether there is a difference between patients and controls, which may also impact endurance in addition to the pathology.
In a second step, we will also be able to evaluate the effects of the reeducation on the strength and the muscular fatigability of the patients presenting a thoracic outlet syndrome.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- 6-minute walk test
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk testOther
The 6-minute walk test is performed as part of routine practice for patients with BMDS to assess patients' overall endurance. In order to compare patients' global endurance with controls, this walking test will also be offered to 50 of the healthy subjects already recruited in the study.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Not described Receives: Other: 6-minute walk test | |
| Control | Not described Receives: Other: 6-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing proximal force between patients with thoracic outlet syndrome and healthy subjects
Isokinetic evaluation of the internal shoulder rotators
Measured: 1 year
Comparing distal force between patients with thoracic outlet syndrome and healthy subjects
Isokinetic evaluation of the external shoulder rotators
Measured: 1 year
Secondary outcomes (5)
Muscular fatigue in patients with thoracic outlet syndrome
Isokinetic evaluation of internal and external shoulder rotator fatigue at 180 ° / s
Measured: 1 year
Evaluation of the effects in terms of strength of rehabilitation
Isokinetic evaluation of rotators in strength
Measured: 1 year
Evaluation of the effects in terms of fatigue of rehabilitation
Isokinetic evaluation of rotators in fatigue
Measured: 1 year
Impact on pain
Visual analogue pain scale (from 0 to 10: 0 absence of pain, 10 maximum pain imaginable)
Measured: 1 year
Evolution of cardiorespiratory performance
Evalution of changes in cardiorespiratory performance using a 6-minute walk test.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start3 Aug 2020
- Primary completion3 Aug 2024 (estimated)
- Study completion3 Dec 2024 (estimated)
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.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alban FOUASSON-CHAILLOUX, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145778
- Sponsor's protocol ID
- RC19_0387
- Acronym
- EFORD
- Status last verified
- Feb 2024
- First submitted
- 28 Oct 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Muscular FORCE in the Upper Limbs of Patients Presenting a Thoracic Outlet Syndrome : Monocentric Case-control Study
- ClinicalTrials.gov ID
- NCT04145778
- Acronym / sponsor ID
- EFORD / RC19_0387
- Conditions
- Thoracic Outlet Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 3 Aug 2024 (estimated)
- Study completion
- 3 Dec 2024 (estimated)
- First posted
- 31 Oct 2019 (actual)
- 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.
The thoracic outlet syndrome is a rare but debilitating pathology, responsible for upper limb pain. Its frequency is probably underestimated because of diagnostic difficulties. This syndrome encompasses several entities including compressions of neurological, venous or arterial origin. In addition to pain, the majority of patients report fatigability and loss of strength in the upper limbs. However, the quantification of this loss of strength and fatigability has hardly been studied.
In addition, the rehabilitation treatment is the first-line treatment of this pathology. It most often includes a muscle building phase.
In this project, we would like to evaluate the proximal and distal force of patients presenting a thoracic outlet syndrome by comparing them to a population free from any pathology in the upper limbs. This evaluation would involve an isokinetic strength analysis of shoulder rotators at the proximal level, using an isokinetic dynamometer. At the distal level, the evaluation would be done using force clamps.Similarly, performing a 6-minute walk test will assess whether there is a difference between patients and controls, which may also impact endurance in addition to the pathology.
In a second step, we will also be able to evaluate the effects of the reeducation on the strength and the muscular fatigability of the patients presenting a thoracic outlet syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: 6-minute walk test |
| Control | – | Other: 6-minute walk test |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with an thoracic outlet syndrome will be needed, which corresponds to the annual recruitment in this care within the department of the University Hospital of Nantes. Patients will be included during their usual management of rehabilitation at the center. 50 healthy subjects will be included, in order to have a patient for a healthy subject. We will call on the staff and student volunteers of the rehabilitation center we will match on age, sex and weight. For both groups, we will only use major topics that do not benefit from any legal protection measures
Key inclusion criteria (4 listed)
- Age> 18 years
- Rehabilitative management of an thoracic outlet syndrome in the physical and rehabilitation department of Nantes University Hospital
- Having given their consent by non-oral opposition.
- Affiliated to a social security scheme
Key exclusion criteria (6 listed)
- Mineurs
- Majeurs under tutorship, curatorship or safeguard of justice
- Pregnant or lactating women, protected persons
- Patients with other pathology of the upper limb or shoulder (osteoarthritis, tendinopathies, amputation, ...).
- Patients with non-stabilized pathologies, heart, respiratory, metabolic or neurological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walk testThe 6-minute walk test is performed as part of routine practice for patients with BMDS to assess patients' overall endurance. In order to compare patients' global endurance with controls, this walking test will also be offered to 50 of the healthy subjects already recruited in the study. | Other | Control, Patient |
Primary outcome
Comparing proximal force between patients with thoracic outlet syndrome and healthy subjects
Time frame: 1 year
Isokinetic evaluation of the internal shoulder rotators
Comparing distal force between patients with thoracic outlet syndrome and healthy subjects
Time frame: 1 year
Isokinetic evaluation of the external shoulder rotators
5 secondary outcomes
Muscular fatigue in patients with thoracic outlet syndrome
Time frame: 1 year
Evaluation of the effects in terms of strength of rehabilitation
Time frame: 1 year
Evaluation of the effects in terms of fatigue of rehabilitation
Time frame: 1 year
Impact on pain
Time frame: 1 year
Evolution of cardiorespiratory performance
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Alban FOUASSON-CHAILLOUX principal investigator
Nantes University Hospital
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 Nantes University Hospital at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alban FOUASSON-CHAILLOUX (+33-2 40 84 62 11, Alban.FOUASSONCHAILLOUX@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing proximal force between patients with thoracic outlet syndrome and healthy subjects (time frame: 1 year). The study lists 2 primary outcomes in all. 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 15 Feb 2024.