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.

中文翻译：

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足球头盔会降低运动相关脑震荡的发生率吗？一项针对青少年运动员的集群随机对照试验

背景 没有大型随机对照试验来确定足球头盔是否能降低美国高中运动员运动相关脑震荡 (SRC) 的发生率或严重程度。目的 我们旨在确定头饰是否能降低足球运动员 SRC 的发生率或严重程度（离开足球的天数）。方法 2766 名参与者（67% 女性，年龄 15.6±1.2）（参与 3050 年）参加了这项集群随机试验。头饰（HG）组的运动员在赛季期间佩戴头饰，而无头饰（NoHG）组的运动员则没有。工作人员记录了 SRC 和非 SRC 伤害以及足球暴露情况。多变量 Cox 比例风险模型用于检查组间的 SRC 时间，同时将严重性与 Wilcoxon 秩和检验进行比较。结果 130 名参与者（5.3% 女性，2. 2% 男性）持续 SRC。SRC 的发生率在男性（HR：2.00 (0.63–6.43) p=0.242）和女性（HR：0.86 (0.54–1.36) p=0.520）的 HG 和 NoHG 组之间没有差异。HG 组（13.5 (11.0–018.8) 天）和 NoHG 组（13.0 (9.0–18.8) 天）从 SRC 损失的天数没有差异 (p=0.583)。结论 足球帽并不能降低高中足球运动员 SRC 的发生率或严重程度。试验注册号 NCT02850926。结论 足球帽并不能降低高中足球运动员 SRC 的发生率或严重程度。试验注册号 NCT02850926。结论 足球帽并不能降低高中足球运动员 SRC 的发生率或严重程度。试验注册号 NCT02850926。