Muscle InjuryNCT02958254
Ultrasound Measurements Hamstring Muscles Thickness
An observational study of Muscle Injury and Muscle Atrophy, run by University of Valencia.
Trial summary
No previous studies have compared the association between muscle thickness (MT) and muscle cross-sectional area (CSA) in healthy volunteers. The main aim of this study is to investigate the validity of ultrasound in assessing the muscle thickness of hamstrings muscle. Study design: A cross-sectional-validity study. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Injury, Muscle Atrophy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 15 Feb 2022
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers from an amateur soccer team
Who may be able to join
- Practice at least twice per week
- Playing soccer more than 5 years
- Inform Consent signed
Who cannot join
- 18 years or older
- Had metal implants or pace makers
- Weighted more than 200 kg (MRI table limitations)
- Were unable to complete testing
- Injuries players:
- History and diagnosis of hamstring injury
Show all 13Show fewer
- Assessment with diagnosis image technique (ultrasound or MRI)
- At least 2 of the next criteria:
- When the injury happened disability to practise with the team at least one week;
- Lost at least one match
- Felt pain when trying to kick the ball or run fast
- Receive specific treatment (medical or physiotherapy) for the injury
- Needed a period plan to return to play
About this study
Official title: Ultrasound Measurements of Hamstring Muscles Thickness Are a Valid Tool
No previous studies have compared the association between muscle thickness (MT) and muscle cross-sectional area (CSA) in healthy volunteers. The main aim of this study is to investigate the validity of ultrasound in assessing the muscle thickness of hamstrings muscle.
Study design:
A cross-sectional-validity study.
Setting:
University
Participants:
X football players of an amateur football team (X healthy volunteers and X patients with a previous hamstring injury).
Read the detailed description
X healthy volunteers, from an amateur football team, and X football players with previous history of hamstring injury from an orthopaedic clinic, comprised the subjects in this study. Hamstring muscle injury was defined as "a traumatic distraction or overuse injury to the hamstring muscle leading to a player being unable to fully participate in training or match play".
The Control Group (CG) were healthy, had neither surgery/trauma in their lower extremities, nor history of hamstring injury, and there were no abnormal findings in their physical examination. The exclusion criteria included participants who: (1) had metal implants or pace makers, (2) weighted more than 200 kg (MRI table limitations), and (3) were unable to complete testing. In the Injured Group, patients were also excluded if their previous injury was originated from a non-muscular source (e.g., inguinal or femoral hernia, nerve entrapment, lumbosacral pathology), or if still had symptoms, had not returned to practice and had not been participating in track and field since their last injury.
The Study Group (SG) had history and diagnosis of hamstring injury assessment with diagnosis image technique (ultrasound or MRI), and at least 2 of the next criteria: 1. When the injury happened disability to practise with the team at least one week; 2. Lost at least one match; 3. Felt pain when trying to kick the ball or run fast; 4. Receive specific treatment (medical or physiotherapy) for the injury; 5. Needed a period plan to return to play.
Participants were screened for contraindications to MRI before ultrasound assessment and an MRI scan of the hamstring muscles of both legs were performed. MRI was performed within 24 h of the ultrasound scan. The subjects were instructed not to consume alcohol or perform any moderate to heavy exercise for 24 hours prior to each imaging session.
Muscle thickness was defined as the distance between the bone-muscle interface and the adipose tissue-muscle interface. The measurement was made from the most superficial edge of the bright line representing the interface of the bony cortex and the muscle to the most superficial edge of the bright line representing the interface of the outer fascial layer of the muscle and the subcutaneous adipose tissue. When the bone was not in contact of the muscle the two fascial layer were used.
- Conditions
- Muscle Injury, Muscle Atrophy
- Keywords
- hamstring, ultrasonography, validation, magnetic resonance imaging, muscle thickness
- Medical subject headings
- Muscular Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring muscles thickness in millimeters by Ultrasound
Measured: 30 minutes
Hamstring muscles thickness in millimeters by Magnetic Resonance Image
Measured: 1 hour
Secondary outcomes (2)
Cross-Sectional Area of the hamstring muscles in square millimeters by Ultrasound
Measured: 30 minutes
Cross-Sectional Area of the hamstring muscles in square millimeters by Magnetic Resonance Image
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion26 Apr 2021
- Study completion15 Feb 2022 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep C. Benitez Martinez, University of Valencia
- Investigators
- Josep Benítez-Martínez, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958254
- Sponsor's protocol ID
- H1458067703008
- Status last verified
- May 2022
- First submitted
- 2 Nov 2016
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ekstrand J, Hagglund M, Walden M. Epidemiology of muscle injuries in professional football (soccer). Am J Sports Med. 2011 Jun;39(6):1226-32. doi: 10.1177/0363546510395879. Epub 2011 Feb 18.
PubMed 21335353
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measurements of Hamstring Muscles Thickness Are a Valid Tool
- ClinicalTrials.gov ID
- NCT02958254
- Acronym / sponsor ID
- H1458067703008
- Conditions
- Muscle Injury, Muscle Atrophy
- Keywords
- hamstring, ultrasonography, validation, magnetic resonance imaging, muscle thickness
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- 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.
No previous studies have compared the association between muscle thickness (MT) and muscle cross-sectional area (CSA) in healthy volunteers. The main aim of this study is to investigate the validity of ultrasound in assessing the muscle thickness of hamstrings muscle.
Study design:
A cross-sectional-validity study.
Setting:
University
Participants:
X football players of an amateur football team (X healthy volunteers and X patients with a previous hamstring injury).
Detailed description
X healthy volunteers, from an amateur football team, and X football players with previous history of hamstring injury from an orthopaedic clinic, comprised the subjects in this study. Hamstring muscle injury was defined as "a traumatic distraction or overuse injury to the hamstring muscle leading to a player being unable to fully participate in training or match play".
The Control Group (CG) were healthy, had neither surgery/trauma in their lower extremities, nor history of hamstring injury, and there were no abnormal findings in their physical examination. The exclusion criteria included participants who: (1) had metal implants or pace makers, (2) weighted more than 200 kg (MRI table limitations), and (3) were unable to complete testing. In the Injured Group, patients were also excluded if their previous injury was originated from a non-muscular source (e.g., inguinal or femoral hernia, nerve entrapment, lumbosacral pathology), or if still had symptoms, had not returned to practice and had not been participating in track and field since their last injury.
The Study Group (SG) had history and diagnosis of hamstring injury assessment with diagnosis image technique (ultrasound or MRI), and at least 2 of the next criteria: 1. When the injury happened disability to practise with the team at least one week; 2. Lost at least one match; 3. Felt pain when trying to kick the ball or run fast; 4. Receive specific treatment (medical or physiotherapy) for the injury; 5. Needed a period plan to return to play.
Participants were screened for contraindications to MRI before ultrasound assessment and an MRI scan of the hamstring muscles of both legs were performed. MRI was performed within 24 h of the ultrasound scan. The subjects were instructed not to consume alcohol or perform any moderate to heavy exercise for 24 hours prior to each imaging session.
Muscle thickness was defined as the distance between the bone-muscle interface and the adipose tissue-muscle interface. The measurement was made from the most superficial edge of the bright line representing the interface of the bony cortex and the muscle to the most superficial edge of the bright line representing the interface of the outer fascial layer of the muscle and the subcutaneous adipose tissue. When the bone was not in contact of the muscle the two fascial layer were used.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers from an amateur soccer team
Key inclusion criteria (3 listed)
- Practice at least twice per week
- Playing soccer more than 5 years
- Inform Consent signed
Key exclusion criteria (13 listed)
- 18 years or older
- Had metal implants or pace makers
- Weighted more than 200 kg (MRI table limitations)
- Were unable to complete testing
- History and diagnosis of hamstring injury
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
Hamstring muscles thickness in millimeters by Ultrasound
Time frame: 30 minutes
Hamstring muscles thickness in millimeters by Magnetic Resonance Image
Time frame: 1 hour
2 secondary outcomes
Cross-Sectional Area of the hamstring muscles in square millimeters by Ultrasound
Time frame: 30 minutes
Cross-Sectional Area of the hamstring muscles in square millimeters by Magnetic Resonance Image
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Background: PubMed 21335353Ekstrand J, Hagglund M, Walden M. Epidemiology of muscle injuries in professional football (soccer). Am J Sports Med. 2011 Jun;39(6):1226-32. doi: 10.1177/0363546510395879. Epub 2011 Feb 18.
- Individual participant dataSharing planned: Undecided
Related trials for Muscle Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruiting
Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury
Acute Kidney Injury, Acute Kidney Injury KDIGO 2
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
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.
Josep Benítez-Martínez principal investigator
University of Valencia
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Injury and Muscle Atrophy, run by University of Valencia.
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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Hamstring muscles thickness in millimeters by Ultrasound (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958254, which also lists 1 linked publication.
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 2 Jun 2022.