Background There have been no large randomised controlled trials to determine whether soccer headgear reduces the incidence or severity of sport-related concussion (SRC) in US high school athletes.
Objective We aimed to determine whether headgear reduces the incidence or severity (days out from soccer) of SRCs in soccer players.
Methods 2766 participants (67% female, age 15.6±1.2) (who undertook 3050 participant years) participated in this cluster randomised trial. Athletes in the headgear (HG) group wore headgear during the season, while those in the no headgear (NoHG) group did not. Staff recorded SRC and non-SRC injuries and soccer exposures. Multivariate Cox proportional hazards models were used to examine time-to-SRC between groups, while severity was compared with a Wilcoxon rank-sum test.
Results 130 participants (5.3% female, 2.2% male) sustained an SRC. The incidence of SRC was not different between the HG and NoHG groups for males (HR: 2.00 (0.63–6.43) p=0.242) and females (HR: 0.86 (0.54–1.36) p=0.520). Days lost from SRC were not different (p=0.583) between the HG group (13.5 (11.0–018.8) days) and the NoHG group (13.0 (9.0–18.8) days).
Conclusions Soccer headgear did not reduce the incidence or severity of SRC in high school soccer players.
Trial registration number NCT02850926.
- high school
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Contributors TM designed the study, collected the data, had full access to the data, interpreted the results and drafted the manuscript. AYP, EP and AS collected the data for the study, interpreted the results and provided critical reviews for the manuscript. SH designed the study, performed summary analyses and provided critical reviews for the manuscript. MAB designed the study and provided critical reviews for the manuscript. SAK performed summary analyses and provided critical reviews for the manuscript. Each author reviewed and approved this manuscript prior to submission and during the revision process.
Funding Funding for this study was provided by the National Operating Committee on Standards for Athletic Equipment (NOCSAE #04-16).
Competing interests None declared.
Patient consent for publication Next of kin consent obtained.
Ethics approval This study was approved by the University of Wisconsin Health Sciences Minimal Risk IRB (#2016-0202) in March 2016.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data sharing requests from appropriate researchers and entities will be considered on a case-by-case basis. Interested parties should contact the corresponding author (email@example.com).