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ISEULT-Repro: IS ElastomEtry Useful in Muscle Lesion evaluaTion-REPROducibility Study

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT05361928
Collaborator
(none)
31
Enrollment
1
Location
4.9
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our objective is to evaluate the inter and intra observer reproducibility of the measure of elasticity using Acoustic Radiation Force Impulse (ARFI) ultrasonography of mucles of patients with and without hamstring injury.

76 patients will be evaluated cross sectionally twice by two ultrasonographists.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Muscle trauma mainly results from sporting activities and accounts for 10 to 55% of sports injuries.

    Information on ARFI muscle trauma management is scarce. The present study sought to assess the initial ARFI characteristics of muscle in sports people with and without injury.

    Our objective here is to evaluate the inter and intra observer reproducibility of the measure of elasticity using Acoustic Radiation Force Impulse (ARFI) ultrasonography of muscles of patients with and without hamstring injury.

    76 patients will be evaluated cross sectionally twice by two ultrasonographists(and then we will evaluate the evolution after 3 months for patient with injury according to the ARFI results).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    31 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    IS ElastomEtry Useful in Muscle Lesion evaluaTion-REPROducibility Study
    Actual Study Start Date :
    Jan 10, 2021
    Actual Primary Completion Date :
    Jun 9, 2021
    Actual Study Completion Date :
    Jun 9, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Elasticity [Inclusion]

      ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients justifying an ultrasound evaluation for suspicion of muscle injury
    Exclusion Criteria:
    • Inflammatory muscle disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT05361928
    Other Study ID Numbers:
    • ISEULT (29BRC20.0211)
    First Posted:
    May 5, 2022
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    muscle

    Study Results

    No Results Posted as of May 5, 2022