Evaluation of the Muscular FORCE in the Upper Limbs of Patients Presenting a Thoracic Outlet Syndrome

Thoracic Outlet Syndrome Clinical Trial

— EFORD  

Official title:

Evaluation of the Muscular FORCE in the Upper Limbs of Patients Presenting a Thoracic Outlet Syndrome : Monocentric Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04145778
• Other study ID #: RC19_0387
• Status: Recruiting
• Start date: August 3, 2020
• Est. completion date: December 3, 2024

Study information

• Verified date: February 2024
• Source: Nantes University Hospital
• Contact: Alban FOUASSON-CHAILLOUX
• Phone: +33-2 40 84 62 11
• Email: Alban.FOUASSONCHAILLOUX[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 3, 2024
• Est. primary completion date: August 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Thoracic Outlet Syndrome

Intervention

Other:
• 6-minute walk test
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.

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing proximal force between patients with thoracic outlet syndrome and healthy subjects	Isokinetic evaluation of the internal shoulder rotators	1 year
Primary	Comparing distal force between patients with thoracic outlet syndrome and healthy subjects	Isokinetic evaluation of the external shoulder rotators	1 year
Secondary	Muscular fatigue in patients with thoracic outlet syndrome	Isokinetic evaluation of internal and external shoulder rotator fatigue at 180 ° / s	1 year
Secondary	Evaluation of the effects in terms of strength of rehabilitation	Isokinetic evaluation of rotators in strength	1 year
Secondary	Evaluation of the effects in terms of fatigue of rehabilitation	Isokinetic evaluation of rotators in fatigue	1 year
Secondary	Impact on pain	Visual analogue pain scale (from 0 to 10: 0 absence of pain, 10 maximum pain imaginable)	1 year
Secondary	Evolution of cardiorespiratory performance	Evalution of changes in cardiorespiratory performance using a 6-minute walk test.	1 month