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

NCT04145778 | Recruiting

• 1 other identifier: RC19_0387
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Outlet Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Muscular fatigue in patients with thoracic outlet syndrome

  1 year

• Evaluation of the effects in terms of strength of rehabilitation

  1 year

• Evaluation of the effects in terms of fatigue of rehabilitation

  1 year

• Impact on pain

  1 year

• Evolution of cardiorespiratory performance

  1 month

Study Arms (2)

Patient

Other: 6-minute walk test

Control

Other: 6-minute walk test

Interventions

6-minute walk test OTHER

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.

Control; Patient

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alban FOUASSON-CHAILLOUX

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alban FOUASSON-CHAILLOUX

CONTACT

+33-2 40 84 62 11; Alban.FOUASSONCHAILLOUX@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 31, 2019
• Study Start: August 3, 2020
• Primary Completion: August 3, 2024
• Study Completion: December 3, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

FR (1)