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

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ClinicalTrials.gov Identifier: NCT04145778
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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
Thoracic Outlet Syndrome Other: non interventionnal study

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Study Type : Observational
Estimated 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 : August 3, 2020
Estimated Primary Completion Date : December 3, 2023
Estimated Study Completion Date : December 3, 2023


Group/Cohort Intervention/treatment
Patient Other: non interventionnal study
non interventionnal study

Control Other: non interventionnal study
non interventionnal study




Primary Outcome Measures :
  1. Comparing proximal force between patients with thoracic outlet syndrome and healthy subjects [ Time Frame: 1 year ]
    Isokinetic evaluation of the internal shoulder rotators

  2. Comparing distal force between patients with thoracic outlet syndrome and healthy subjects [ Time Frame: 1 year ]
    Isokinetic evaluation of the external shoulder rotators


Secondary Outcome Measures :
  1. Muscular fatigue in patients with thoracic outlet syndrome [ Time Frame: 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 [ Time Frame: 1 year ]
    Isokinetic evaluation of rotators in strength

  3. Evaluation of the effects in terms of fatigue of rehabilitation [ Time Frame: 1 year ]
    Isokinetic evaluation of rotators in fatigue

  4. Impact on pain [ Time Frame: 1 year ]
    Visual analogue pain scale (from 0 to 10: 0 absence of pain, 10 maximum pain imaginable)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145778


Locations
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France
CHU Nantes Recruiting
Nantes, France, 44093
Contact: Alban Fouasson-Chailloux, MD    0240846211    alban.fouassonchailloux@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04145778    
Other Study ID Numbers: RC19_0387
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thoracic Outlet Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases