Background: Concussion is a serious problem in many contact sports, including rugby union football. The study's primary aim was to measure the efficacy of padded headgear in reducing the rates of head injury or concussion.
Methods: A cluster randomized controlled trial with three arms was conducted with rugby union football teams as the unit of randomization. Teams consisted of males participating in under 13-, 15-, 18-, and 20-yr age group competitions. The interventions were "standard" and "modified" padded headgear. Headgear wearing and injury were measured for each study team at each game over two seasons.
Results: Eighty-two teams participated in year 1 and 87 in year 2. A total of 1493 participants (10,040 player hours) were in the control group, 1128 participants (8170 player hours) were assigned to the standard headgear group, and 1474 participants (10,650 player hours) were assigned to the modified headgear group. The compliance rates were low in all groups, but 46% of participants wore standard headgear. An intention-to-treat analysis showed no differences in the rates of head injury or concussion between controls and headgear arms. Incidence rate ratios for standard headgear wearers referenced to controls were 0.95 and 1.02 for game and missed game injuries. Analyses of injury rates based on observed wearing patterns also showed no significant differences. Incidence rate ratios for standard headgear wearers referenced to nonwearers were 1.11 and 1.10 for game and missed game injuries.
Conclusions: Padded headgear does not reduce the rate of head injury or concussion. The low compliance rates are a limitation. Although individuals may choose to wear padded headgear, the routine or mandatory use of protective headgear cannot be recommended.