Muscle InjuryNCT03782389
The Role of Periodic Health Examination in Determining Indirect Muscle Injury Risk in Elite Football (Soccer)
An observational study of Muscle Injury and Sprains and Strains, run by Manchester United Football Club.
Trial summary
Preseason periodic health examination (PHE) is used routinely in elite football (soccer) and can be used to inform injury prevention strategies. Indirect muscle injuries (IMI) are a considerable burden to elite teams. Read more about this study
- Who is it for?
- Ages 16 to 40 years, men only
- Conditions the study is for
- Muscle Injury, Sprains and Strains
- What is being tested?
- Preseason Periodic Health Examination Completion
- How many people
- 321 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2013to 19 May 2018
- 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 16 to 40 years
- Men only
- Child, Adult
Study population: The population under study was of male elite football players aged 16-40 years old at an English Premier League club.
Who may be able to join
- had an outfield position (i.e. not a goalkeeper);
- participated in PHE testing for the relevant season.
Who cannot join
- if players were on trial or not contracted to the club at the time of PHE.
About this study
Official title: The Role of Periodic Health Examination in Determining Lower Extremity Muscle Injury Risk in Elite Football (Soccer): A Protocol for an Investigation Into Multivariable Prognostic Model Development, Validation and Prognostic Factor Exploration
Preseason periodic health examination (PHE) is used routinely in elite football (soccer) and can be used to inform injury prevention strategies. Indirect muscle injuries (IMI) are a considerable burden to elite teams. This investigation aims to evaluate whether measurements from PHE can be used in a multivariable model to predict IMI risk in elite players, or to establish prognostic factors that are associated with IMIs.
Read the detailed description
BACKGROUND Indirect muscle injuries (IMIs) are a considerable burden to elite football (soccer) teams and prevention of these injuries offers many benefits. Preseason medical, musculoskeletal and performance screening (termed periodic health examination (PHE)) is used to help determine players at risk of injuries such as IMIs, where identification of PHE-derived prognostic factors (PF) may inform IMI prevention strategies. Furthermore, using several PFs in combination within a multivariable prognostic model may allow individualised IMI risk estimation and specific targeting of prevention strategies, based upon an individual's PF profile. No such models have been developed in elite football and the current IMI prognostic factor evidence is limited. This study aims to: 1) to develop and internally validate a prognostic model for individualised IMI risk prediction during a season in elite footballers, using the extent of the prognostic evidence and clinical reasoning; 2) explore potential PHE-derived PFs associated with IMI outcomes in elite footballers, using available PHE data from a professional team.
METHODS A retrospective review has been completed of PHE and injury data, routinely collected over 5 years (from 1st July 2013 to 19th May 2018) from a population of elite male players at an English Premier League football club. Of 60 candidate PFs, 15 were excluded. Ten factors will be included in model development, identified from a systematic review, missing data assessment, measurement reliability evaluation and clinical reasoning. A full multivariable logistic regression model will be fitted, to ensure adjustment before backward elimination. The performance and internal validation of the model will be assessed. The remaining 35 candidate PFs are eligible for further exploration, using univariable logistic regression to obtain unadjusted risk estimates. Exploratory PFs will be grouped according to type and incorporated into multivariable logistic regression models to determine risk estimates.
DISCUSSION This study will offer insights into clinical usefulness of a model to predict IMI risk in elite football and highlight the practicalities of model development in this setting. Exploration may identify other relevant PFs for future confirmatory studies, model updating, or influence future injury prevention research.
- Conditions
- Muscle Injury, Sprains and Strains
- Being tested
- Preseason Periodic Health Examination Completion
- Keywords
- Athlete, injury prevention, muscle strain, prediction, prognosis, screening, sport
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preseason Periodic Health Examination CompletionOther
all available players completed a mandatory PHE on one of three days during the first week of the season. Typically, the musculoskeletal and performance components of the PHE included: 1) anthropometric measurements; 2) medical history (i.e. previous injury history); 3) musculoskeletal examination tests; 4) functional movement and balance tests; 5) strength and power tests.
| Study group | Role | What they receive |
|---|---|---|
| Elite football players aged 16-40 years | Not described Receives: Other: Preseason Periodic Health Examination Completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with an indirect muscle injury.
Indirect muscle injury defined according to Terminology and Classification of Muscle Injuries Consensus Statement
Measured: 11 Months (1 football season)
Secondary outcomes (3)
Number of participants with an indirect muscle injury affecting the hamstring muscle group.
If there is a sufficient number of outcomes, indirect muscle injuries (defined according to the Terminology and Classification of Muscle Injuries Consensus Statement) that affect the hamstring muscle group may be subgrouped and analysed accordingly.
Measured: 11 Months (1 football season)
Number of participants with an indirect structural muscle injury.
If there is a sufficient number of outcomes, indirect muscle injuries will be categorised into structural injuries (defined as type 3 or 4 injury using the Terminology and Classification of Muscle Injuries Consensus Statement) and analysed accordingly.
Measured: 11 Months (1 football season)
Number of participants with an indirect functional muscle injury.
If sufficient there is a sufficient number of outcomes, indirect muscle injuries will be categorised into functional injuries (defined as type 1a to 2b injuries using the Terminology and Classification of Muscle Injuries Consensus Statement) and analysed accordingly.
Measured: 11 Months (1 football season)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Jul 2013
- Primary completion19 May 2018
- Study completion19 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester United Football Club
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Keele University, Manchester Metropolitan University
- Responsible party
- Principal investigator, Tom Hughes, Manchester United Football Club
- Investigators
- Richard Riley, PhD, Study director, Centre for Prognosis Research, Keele University. UKJamie Sergeant, PhD, Study director, Arthritis Research UK Centre for Epidemiology, University of Manchester. UK.Michael Callaghan, PhD, Study director, Dept of Health Professions, Manchester Metropolitan University. UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782389
- Sponsor's protocol ID
- MUFC1
- Status last verified
- Dec 2018
- First submitted
- 12 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hughes T, Riley R, Callaghan MJ, Sergeant JC. Can prognostic factors for indirect muscle injuries in elite football (soccer) players be identified using data from preseason screening? An exploratory analysis using routinely collected periodic health examination records. BMJ Open. 2023 Jan 24;13(1):e052772. doi: 10.1136/bmjopen-2021-052772.
PubMed 36693686Hughes T, Riley RD, Callaghan MJ, Sergeant JC. The Value of Preseason Screening for Injury Prediction: The Development and Internal Validation of a Multivariable Prognostic Model to Predict Indirect Muscle Injury Risk in Elite Football (Soccer) Players. Sports Med Open. 2020 May 27;6(1):22. doi: 10.1186/s40798-020-00249-8.
PubMed 32462372
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Periodic Health Examination in Determining Lower Extremity Muscle Injury Risk in Elite Football (Soccer): A Protocol for an Investigation Into Multivariable Prognostic Model Development, Validation and Prognostic Factor Exploration
- ClinicalTrials.gov ID
- NCT03782389
- Acronym / sponsor ID
- MUFC1
- Conditions
- Muscle Injury, Sprains and Strains
- Keywords
- Athlete, injury prevention, muscle strain, prediction, prognosis, screening, sport
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Manchester United Football ClubUniversity, hospital or other
- Collaborators
- University of Manchester, Keele University, Manchester Metropolitan University
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 19 May 2018 (actual)
- Study completion
- 19 May 2018 (actual)
- First posted
- 20 Dec 2018 (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.
Preseason periodic health examination (PHE) is used routinely in elite football (soccer) and can be used to inform injury prevention strategies. Indirect muscle injuries (IMI) are a considerable burden to elite teams. This investigation aims to evaluate whether measurements from PHE can be used in a multivariable model to predict IMI risk in elite players, or to establish prognostic factors that are associated with IMIs.
Detailed description
BACKGROUND Indirect muscle injuries (IMIs) are a considerable burden to elite football (soccer) teams and prevention of these injuries offers many benefits. Preseason medical, musculoskeletal and performance screening (termed periodic health examination (PHE)) is used to help determine players at risk of injuries such as IMIs, where identification of PHE-derived prognostic factors (PF) may inform IMI prevention strategies. Furthermore, using several PFs in combination within a multivariable prognostic model may allow individualised IMI risk estimation and specific targeting of prevention strategies, based upon an individual's PF profile. No such models have been developed in elite football and the current IMI prognostic factor evidence is limited. This study aims to: 1) to develop and internally validate a prognostic model for individualised IMI risk prediction during a season in elite footballers, using the extent of the prognostic evidence and clinical reasoning; 2) explore potential PHE-derived PFs associated with IMI outcomes in elite footballers, using available PHE data from a professional team.
METHODS A retrospective review has been completed of PHE and injury data, routinely collected over 5 years (from 1st July 2013 to 19th May 2018) from a population of elite male players at an English Premier League football club. Of 60 candidate PFs, 15 were excluded. Ten factors will be included in model development, identified from a systematic review, missing data assessment, measurement reliability evaluation and clinical reasoning. A full multivariable logistic regression model will be fitted, to ensure adjustment before backward elimination. The performance and internal validation of the model will be assessed. The remaining 35 candidate PFs are eligible for further exploration, using univariable logistic regression to obtain unadjusted risk estimates. Exploratory PFs will be grouped according to type and incorporated into multivariable logistic regression models to determine risk estimates.
DISCUSSION This study will offer insights into clinical usefulness of a model to predict IMI risk in elite football and highlight the practicalities of model development in this setting. Exploration may identify other relevant PFs for future confirmatory studies, model updating, or influence future injury prevention research.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elite football players aged 16-40 years | – | Other: Preseason Periodic Health Examination Completion |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Male only
- Age groups
- Child, Adult
- Study population
- The population under study was of male elite football players aged 16-40 years old at an English Premier League club.
Key inclusion criteria (2 listed)
- had an outfield position (i.e. not a goalkeeper);
- participated in PHE testing for the relevant season.
Key exclusion criteria (1 listed)
- if players were on trial or not contracted to the club at the time of PHE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preseason Periodic Health Examination Completionall available players completed a mandatory PHE on one of three days during the first week of the season. Typically, the musculoskeletal and performance components of the PHE included: 1) anthropometric measurements; 2) medical history (i.e. previous injury history); 3) musculoskeletal examination tests; 4) functional movement and balance tests; 5) strength and power tests. | Other | Elite football players aged 16-40 years |
Primary outcome
Number of participants with an indirect muscle injury.
Time frame: 11 Months (1 football season)
Indirect muscle injury defined according to Terminology and Classification of Muscle Injuries Consensus Statement
3 secondary outcomes
Number of participants with an indirect muscle injury affecting the hamstring muscle group.
Time frame: 11 Months (1 football season)
Number of participants with an indirect structural muscle injury.
Time frame: 11 Months (1 football season)
Number of participants with an indirect functional muscle injury.
Time frame: 11 Months (1 football season)
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 20 Dec 2018.
- Derived from this study: PubMed 36693686Hughes T, Riley R, Callaghan MJ, Sergeant JC. Can prognostic factors for indirect muscle injuries in elite football (soccer) players be identified using data from preseason screening? An exploratory analysis using routinely collected periodic health examination records. BMJ Open. 2023 Jan 24;13(1):e052772. doi: 10.1136/bmjopen-2021-052772.
- Derived from this study: PubMed 32462372Hughes T, Riley RD, Callaghan MJ, Sergeant JC. The Value of Preseason Screening for Injury Prediction: The Development and Internal Validation of a Multivariable Prognostic Model to Predict Indirect Muscle Injury Risk in Elite Football (Soccer) Players. Sports Med Open. 2020 May 27;6(1):22. doi: 10.1186/s40798-020-00249-8.
- Individual participant dataSharing planned: No
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.
Richard Riley, PhD study director
Centre for Prognosis Research, Keele University. UK
Jamie Sergeant, PhD study director
Arthritis Research UK Centre for Epidemiology, University of Manchester. UK.
Michael Callaghan, PhD study director
Dept of Health Professions, Manchester Metropolitan University. UK
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Injury and Sprains and Strains, run by Manchester United Football Club.
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 2 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 20 Dec 2018. 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 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?
Number of participants with an indirect muscle injury. (time frame: 11 Months (1 football season)). 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 NCT03782389, which also lists 2 linked publications.
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 20 Dec 2018.