Clinical trial NCT04145778: Evaluation of the Muscular FORCE in the Upper Limbs of Patients Presenting a Thoracic Outlet Syndrome
Official title: Evaluation of the Muscular FORCE in the Upper Limbs of Patients Presenting a Thoracic Outlet Syndrome : Monocentric Case-control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Outlet Syndrome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparing proximal force between patients with thoracic outlet syndrome and healthy subjects
timeFrame: 1 year
measure: Comparing distal force between patients with thoracic outlet syndrome and healthy subjects
timeFrame: 1 year
Secondary outcomes:
measure: Muscular fatigue in patients with thoracic outlet syndrome
timeFrame: 1 year
measure: Evaluation of the effects in terms of strength of rehabilitation
timeFrame: 1 year
measure: Evaluation of the effects in terms of fatigue of rehabilitation
timeFrame: 1 year
measure: Impact on pain
timeFrame: 1 year
measure: Evolution of cardiorespiratory performance
timeFrame: 1 month
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Nantes University Hospital
name: Alban FOUASSON-CHAILLOUX
role: PRINCIPAL_INVESTIGATOR
References: