NCT02958254

Brief 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. Setting: University Participants: X football players of an amateur football team (X healthy volunteers and X patients with a previous hamstring injury).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

4.4 years

First QC Date

November 2, 2016

Last Update Submit

May 30, 2022

Conditions

Keywords

hamstringultrasonographyvalidationmagnetic resonance imagingmuscle thickness

Outcome Measures

Primary Outcomes (2)

  • Hamstring muscles thickness in millimeters by Ultrasound

    30 minutes

  • Hamstring muscles thickness in millimeters by Magnetic Resonance Image

    1 hour

Secondary Outcomes (2)

  • Cross-Sectional Area of the hamstring muscles in square millimeters by Ultrasound

    30 minutes

  • Cross-Sectional Area of the hamstring muscles in square millimeters by Magnetic Resonance Image

    1 hour

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers from an amateur soccer team

You may qualify if:

  • Practice at least twice per week
  • Playing soccer more than 5 years
  • Inform Consent signed

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21335353BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Josep Benítez-Martínez

    University of Valencia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 8, 2016

Study Start

December 1, 2016

Primary Completion

April 26, 2021

Study Completion

February 15, 2022

Last Updated

June 2, 2022

Record last verified: 2022-05