Muscle InjuryISEULT-ReproNCT05361928
IS ElastomEtry Useful in Muscle Lesion evaluaTion-REPROducibility Study
An observational study of Muscle Injury, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Muscle Injury
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2021to 9 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients justifying an ultrasound evaluation for suspicion of muscle injury
Who may be able to join
- Patients justifying an ultrasound evaluation for suspicion of muscle injury
Who cannot join
- Inflammatory muscle disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Muscle Injury
- Keywords
- muscle
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity
ultrasound
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start10 Jan 2021
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361928
- Sponsor's protocol ID
- ISEULT (29BRC20.0211)
- Acronym
- ISEULT-Repro
- Status last verified
- May 2022
- First submitted
- 1 May 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IS ElastomEtry Useful in Muscle Lesion evaluaTion-REPROducibility Study
- ClinicalTrials.gov ID
- NCT05361928
- Acronym / sponsor ID
- ISEULT-Repro / ISEULT (29BRC20.0211)
- Conditions
- Muscle Injury
- Keywords
- muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients justifying an ultrasound evaluation for suspicion of muscle injury
Key inclusion criteria (1 listed)
- Patients justifying an ultrasound evaluation for suspicion of muscle injury
Key exclusion criteria (1 listed)
- Inflammatory muscle disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elasticity
Time frame: Inclusion
ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: Yes. Yes All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Injury, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elasticity (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.