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BackgroundLateral ankle sprains are common in indoor sports. High shoe–surface friction is considered a risk factor for non-contact lateral ankle sprains. Spraino is a novel low-friction patch that can be attached to the outside of sports shoes to minimise friction at the lateral edge, which could mitigate the risk of such injury. We aimed to determine preliminary effectiveness (incidence rate and severity) and safety (harms) of Spraino to prevent lateral ankle sprains among indoor sport athletes.MethodsIn this exploratory, parallel-group, two-arm pilot randomised controlled trial, 510 subelite indoor sport athletes with a previous lateral ankle sprain were randomly allocated (1:1) to Spraino or ‘do-as-usual’. Allocation was concealed and the trial was outcome assessor blinded. Match and training exposure, number of injuries and associated time loss were captured weekly via text messages. Information on harms, fear-of-injury and ankle pain was also documented.Results480 participants completed the trial. They reported a total of 151 lateral ankle sprains, of which 96 were categorised as non-contact, and 50 as severe. All outcomes favoured Spraino with incidence rate ratios of 0.87 (95% CI 0.62 to 1.23) for all lateral ankle sprains; 0.64 (95% CI 0.42 to 0.98) for non-contact lateral ankle sprains; and 0.47 (95% CI 0.25 to 0.88) for severe lateral ankle sprains. Time loss per injury was also lower in the Spraino group (1.8 vs 2.8 weeks, p=0.014). Six participants reported minor harms because of Spraino.ConclusionCompared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.Trial registration number NCT03311490.

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: NCT03311490FundingInnovation Fund Denmark (7038–00087A)

Correspondence to Filip Gertz Lysdal, Sport Sciences, Department of Health Science and Technology, Aalborg University, Aalborg 9220, Denmark; fgly@hst.aau.dk Lateral ankle sprains are common in indoor sports, and most of these injuries occur via a ‘non-contact’ injury mechanism in which the only contact is between the shoe and the floor.1 2 Shoe–surface friction is generally high in indoor sports, and this attribute is considered a risk factor for non-contact lower extremity injuries.3 Spraino is a novel low-friction patch that is attached to the outside of sports shoes, specifically designed to prevent ‘friction-related’ ankle sprains in indoor sports by minimising friction at the lateral edge of the shoe sole. Match and training exposure, injury incidence and time loss were captured weekly via text messages over a 9-month period. The incidence and prevalence of ankle sprain injury: a systematic review and meta-analysis of prospective epidemiological studies.

IntroductionThe noncontact lateral ankle sprain is the most common injury in indoor and court sports. Here, it is predominantly described as occurring via a mechanism that typically incites from an initial “bad landing” – with the foot in inverted position. Descriptions of the actual foot landing posture prior to injury has, however, only been documented in few quantitative cases, or simply retrospectively reported by the incurring athletes during prospective trials. Therefore, we aimed to determine the initial foot landing posture using video-recorded injuries.Materials and MethodsIn this explorative, observational, non-consecutive, case-series study, two independent, blinded, analysists systematically retrieved and analysed 585 video-recorded lateral ankle sprain injuries.Results445 injuries remained after 79 duplicates, and 61 videos with no clear view or non-lateral joint excursion, had been excluded. Of these, 113 (25%) were noncontact and 32 (7%) were indirect-contact injuries. Among the 113 noncontact injuries, 18 (16%) were characterised by initial contact on the lateral side, while 95 (84%) had a medial- or flat landing posture prior to injury. Among the 32 indirect-contact injuries, 9 (28%) injuries had initial contact on the lateral side, while 23 (72%) had a medial- or flat landing posture.ConclusionContrary to our expectations, most noncontact injuries were not caused by an initial “bad landing” with the foot in an initially inverted position. It is important to concede that the noncontact lateral ankle sprain can indeed occur and progress irrespective of initial foot landing posture. Joint stiffness might be more important than joint position.

IntroductionRecreational runners often experience pain and discomfort, impacting their performance and participation. ZOLES are novel 3D-printed insoles designed from individual anthropometric data and foot morphology. This study aimed to evaluate the effectiveness and safety of ZOLES insoles in reducing pain and increasing foot-footwear comfort among recreational parkrun™ participants.Materials and MethodsIn this parallel group randomised controlled trial (NCT06034210; protocol published, PMID: 38350194), 210 recreational runners (age ≥35) were randomised 1:1 to receive ZOLES 3D-printed insoles or a ‘do-as-usual’ control group. The primary outcome was running-related pain, measured weekly over 10 weeks using 11-point numeric rating scales, and analysed with intention-to-treat. Secondary outcomes included Global Rating of Change (GRoC), foot-footwear comfort, 5k completion time, and adverse effects.Results208 participants completed the trial (99 ZOLES, 109 control) with a weekly response rate of 98.9%. Baseline pain scores were similar between groups (2.91 vs. 3.03). Both groups experienced reductions in pain: -1.42 points (95% CI: −1.88, -0.94) in the ZOLES group and -0.98 points (95% CI: −1.37, -0.58) in the control group, with a non-significant between-group difference of -0.44 points (95% CI: −1.04, 0.17; p=0.095). More participants in the ZOLES group reported overall improvement (GRoC) (43% vs. 24%; p=0.0059) and improved foot comfort (p=0.034). There was no difference in 5k completion times (p=0.463). Seven non-serious harms, mostly blisters, were reported.ConclusionZOLES 3D-printed insoles did not significantly reduce running-related pain, despite a higher rate of perceived overall improvement and improved foot-footwear comfort. 5k-parkrun™ times were unaffected, and only minor adverse events were reported.

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: fgly@hst.aau.dk