Journal Article

027 Spraino® reduces the risk of lateral ankle sprain injury among indoor sport athletes: a pilot randomized controlled trial with 510 participants

Delahunt, Eamonn, Grønlykke, Thor, Tolstrup, Janne, Mann, Stephanie, Bandholm, Thomas, Lysdal, Filip Gertz, Clausen, Mikkel, Petersen, Pelle, Kersting, Uwe, Thorborg, Kristian

2020

Overview

BackgroundHigh shoe-surface friction is a proposed risk factor for ‘non-contact’ lateral ankle sprain (LAS) injuries. Spraino® is a novel product that minimizes friction at the lateral edge of the shoe, thereby potentially mitigating the risk.ObjectiveTo determine preliminary effect and safety of Spraino® when used to prevent LAS injury among indoor sport athletes.DesignA double-blinded, prospective, two-arm pilot randomised controlled trial (RCT). Participants were allocated (1:1) to Spraino® or to a ‘do-as-usual’ control group. The random allocation was concealed for investigators and participants. Group allocations were outcome-assessor-blinded.SettingIndoor sports clubs competing at divisional- or league level in handball, badminton and basketball in Denmark.Participants510 elite- and sub-elite indoor sport athletes with at least one previous LAS injury within the preceding 24 months were enrolled; 480 completed the trial.InterventionSpraino®; a low-friction patch applied to the lateral side of the shoe.Main outcome measurementsThe trial was explorative with evenly-valued outcome measures related to incidence and severity of self-reported LAS injuries, pain in the ankle, fear of injury and intervention-related adverse events.ResultsA total of 151 LAS injuries were reported within the trial period, of which 96 were categorized as non-contact injuries. A total of 50 injuries were severe. All metrics favoured Spraino® with computed incidence rate ratios of 0.87 (95% CI, 0.62–1.23) for any LAS injury, 0.64 (95% CI, 0.42–0.97) for non-contact LAS injuries, and 0.41 (95% CI, 0.19–0.89) for severe non-contact LAS injuries. The relative time-loss for the total number of injuries was 0.65 (95% CI, 0.45–0.93). Fear-of-injury and ankle pain was also lower in the Spraino® group. Six participants reported minor harms due to slipping on the floor because of Spraino®.ConclusionsSpraino® was found to be effective and safe when used to prevent LAS injuries in indoor sports. Findings should be replicated in a confirmatory RCT.Trial registrationClinicalTrials.gov: NCT03311490.FundingInnovation Fund Denmark (7038-00087A)Correspondence to: [e-mail]