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ENMG AFC: Electromyography in Thoracic Outlet Syndrome

Sponsor
Nantes University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05360303
Collaborator
(none)
100
Enrollment
1
Location
12
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Record the ENMG data carried out systematically in patients treated by rehabilitation for thoracic outlet syndrome in order to assess their characteristics and judge the relevance of these data in the context of the diagnosis and their possible modifications following the rehabilitation treatment.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Interest of Electroneuromyography in the Diagnosis of Thoracic Outlet Syndrome
    Anticipated Study Start Date :
    Jun 15, 2022
    Anticipated Primary Completion Date :
    Jun 15, 2023
    Anticipated Study Completion Date :
    Jun 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Trial population

    No Intervention but evaluation of the electroneuromyography at the M1 visit for patients with a clinical diagnostic of thoracic outlet syndrome.

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of the presence of ENMG abnormality and in particular on the medial cutaneous nerve of the forearm of patients with a clinical diagnosis of TOS [0 Month]

      Conduction abnormality of the medial cutaneous nerve of the forearm

    Secondary Outcome Measures

    1. Evaluation of ENMG changes following rehabilitation treatment of patients [1 Month]

      evolution of electrophysiological changes following treatment

    2. Evaluation of ENMG changes following rehabilitation treatment of patients [1 Month]

      evolution of the Visual Analog Score for pain (scale from 0 to 10 ; 10 being the worst outcome)

    3. Evaluation of ENMG changes following rehabilitation treatment of patients [1 Month]

      evolution of the Quick Disabilities of the Arm, Shoulder and Hand Score (scale from 0 to 100 ; 100 being the worst outcome)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Inpatient rehabilitation for thoracic outlet syndrome

    • Patients' agreement

    Exclusion Criteria:

    • < 18 years old

    • Not able to consent

    • Pregnancy

    • Musculoskeletal disorders of the upper limbs

    • Acute cardiac, pulmonary, metabolic or neurological diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital) Nantes France

    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:
    NCT05360303
    Other Study ID Numbers:
    • RC22_0229
    First Posted:
    May 4, 2022
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nantes University Hospital
    Thoracic outlet syndrome
    electromyography
    neurogenic
    rehabilitation
    diagnosis
    Additional relevant MeSH terms:
    Thoracic Outlet Syndrome
    Syndrome

    Study Results

    No Results Posted as of May 4, 2022