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

Sponsor
Nantes University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04145778
Collaborator
(none)
300
1
40
7.5

Study Details

Study Description

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.

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.

Condition or Disease Intervention/Treatment Phase
  • Other: non interventionnal study

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of the Muscular FORCE in the Upper Limbs of Patients Presenting a Thoracic Outlet Syndrome : Monocentric Case-control Study
Actual Study Start Date :
Aug 3, 2020
Anticipated Primary Completion Date :
Dec 3, 2023
Anticipated Study Completion Date :
Dec 3, 2023

Arms and Interventions

Arm Intervention/Treatment
Patient

Other: non interventionnal study
non interventionnal study

Control

Other: non interventionnal study
non interventionnal study

Outcome Measures

Primary Outcome Measures

  1. Comparing proximal force between patients with thoracic outlet syndrome and healthy subjects [1 year]

    Isokinetic evaluation of the internal shoulder rotators

  2. Comparing distal force between patients with thoracic outlet syndrome and healthy subjects [1 year]

    Isokinetic evaluation of the external shoulder rotators

Secondary Outcome Measures

  1. Muscular fatigue in patients with thoracic outlet syndrome [1 year]

    Isokinetic evaluation of internal and external shoulder rotator fatigue at 180 ° / s

  2. Evaluation of the effects in terms of strength of rehabilitation [1 year]

    Isokinetic evaluation of rotators in strength

  3. Evaluation of the effects in terms of fatigue of rehabilitation [1 year]

    Isokinetic evaluation of rotators in fatigue

  4. Impact on pain [1 year]

    Visual analogue pain scale (from 0 to 10: 0 absence of pain, 10 maximum pain imaginable)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Nantes Nantes France 44093

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT04145778
Other Study ID Numbers:
  • RC19_0387
First Posted:
Oct 31, 2019
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021