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

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.

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 Overview

• Status: Recruiting
• Conditions: Thoracic Outlet Syndrome
• Intervention / Treatment: Other: 6-minute walk test

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Alban FOUASSON-CHAILLOUX; Phone Number: +33-2 40 84 62 11; Email: Alban.FOUASSONCHAILLOUX@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44093
    • Recruiting
    • CHU Nantes
    • Contact: Alban Fouasson-Chailloux, MD; Phone Number: 0240846211; Email: alban.fouassonchailloux@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	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.
Patient	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing proximal force between patients with thoracic outlet syndrome and healthy subjects	Isokinetic evaluation of the internal shoulder rotators	1 year
Comparing distal force between patients with thoracic outlet syndrome and healthy subjects	Isokinetic evaluation of the external shoulder rotators	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Alban FOUASSON-CHAILLOUX, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Estimated): August 3, 2024
• Study Completion (Estimated): December 3, 2024

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Syndrome; Thoracic Outlet Syndrome
• Other Study ID Numbers: RC19_0387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No