The Role of Periodic Health Examination in Determining Indirect Muscle Injury Risk in Elite Football (Soccer)

Muscle Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782389
• Other study ID #: MUFC1
• Status: Completed
• Start date: July 1, 2013
• Est. completion date: May 19, 2018

Study information

• Verified date: December 2018
• Source: Manchester United Football Club
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: May 19, 2018
• Est. primary completion date: May 19, 2018
• Gender: Male
• Age group: 16 Years to 40 Years

Eligibility

Inclusion Criteria:

• had an outfield position (i.e. not a goalkeeper);

• participated in PHE testing for the relevant season.

Exclusion Criteria:

• if players were on trial or not contracted to the club at the time of PHE.

Related Conditions & MeSH terms

• Muscle Injury
• Sprains and Strains
• Wounds and Injuries

Intervention

Other:
• Preseason Periodic Health Examination Completion
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Manchester United Football Club	Keele University, Manchester Metropolitan University, University of Manchester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with an indirect muscle injury.	Indirect muscle injury defined according to Terminology and Classification of Muscle Injuries Consensus Statement	11 Months (1 football season)
Secondary	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.	11 Months (1 football season)
Secondary	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.	11 Months (1 football season)
Secondary	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.	11 Months (1 football season)