OBJECTIVES: To evaluate the effectiveness of prefabricated foot orthoses for the prevention of lower limb overuse injuries in naval recruits. METHODS: This study was a participant-blinded and assessor-blinded, parallel-group randomised controlled trial. Three-hundred and six participants aged 17 to 50 years who undertook 11 weeks of initial defence training at the Royal Australian Navy Recruit School (Cerberus, Australia) were randomised to a control group (flat insoles, n = 153) or an intervention group (contoured, prefabricated foot orthoses, n = 153). The combined incidence of medial tibial stress syndrome, patellofemoral pain, Achilles tendinopathy and plantar fasciitis/plantar heel pain during the 11-week training period were compared using incidence rate ratios (IRR). Data were analysed using the intention-to-treat principle. RESULTS: Sixty-seven injuries (21.9%) were recorded. The control and intervention group sustained 40 (26.1%) and 27 (17.6%) injuries, respectively (IRR 0.66, 95% CI 0.39 to 1.11, p = 0.098). This corresponds to a 34% reduction in risk of developing medial tibial stress syndrome, patellofemoral pain, Achilles tendinopathy or plantar fasciitis/plantar heel for the intervention group compared with the control group. Participants in the prefabricated orthoses group were more likely to report at least one adverse event (20.3% versus 12.4%; relative risk (RR) 1.63, 95% CI 0.96 to 2.76; p = 0.068; number needed to harm 13, 95% CI 6 to 253). The most common adverse events were foot blisters (n = 20, 6.6%), arch pain (n = 10, 3.3%) and shin pain (n = 8, 2.6%). CONCLUSION: Prefabricated foot orthoses may be beneficial for reducing the incidence of lower limb injury in naval recruits undertaking defence training. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry ACTRN12615000024549.
Reproduced with permission from the BMJ Publishing Group.

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