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 17–50 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% vs 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.
- injury prevention
- foot injuries
- overuse injury
- lower limb
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Handling editor Karim M Khan
Contributors DRB and GSM: responsible for acquisition of data and can take responsibility for the integrity of the data. DRB and HBM: involved in statistical analysis and interpretation of data. DRB: responsible for the preparation of the manuscript with all other authors involved in its review prior to submission for publication. All authors: were involved in study concept and design; read and approved the final manuscript.
Funding La Trobe University Sport, Exercise and Rehabilitation Research Focus Area.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Australian Defence Human Research Ethics Committee (764-14) and the La Trobe University Faculty Human Ethics Committee (FHEC 14/250).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Unpublished data are available upon request subject to ethical approval.