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

May 1, 2022 updated by: University Hospital, Brest

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients justifying an ultrasound evaluation for suspicion of muscle injury

Description

Inclusion Criteria:

  • Patients justifying an ultrasound evaluation for suspicion of muscle injury

Exclusion Criteria:

  • Inflammatory muscle disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elasticity
Time Frame: Inclusion
ultrasound
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2021

Primary Completion (ACTUAL)

June 9, 2021

Study Completion (ACTUAL)

June 9, 2021

Study Registration Dates

First Submitted

May 1, 2022

First Submitted That Met QC Criteria

May 1, 2022

First Posted (ACTUAL)

May 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 1, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ISEULT (29BRC20.0211)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three month and ending five years following the publication

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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