A randomised control trial to compare comfort, rate of injury and speed whilst running using prefabricated orthotics inserted into running shoes versus running with no additional orthotics inside the running shoe

Abstract

<p class="abstract"><strong>Background:</strong> Running is one of the most accessible and most popular sports globally. However, an increase in popularity has been followed by an increase in running-related injuries. An orthotic is a device fitted into the shoe for the proposed function of improving cushioning, sensory feedback, and comfort whilst also reducing the incidence of running-related injuries. The current study was a randomised control trial to assess the injury incidence, performance and comfort of runners using a prefabricated orthotic, compared to runners not using a prefabricated orthotic.</p><p class="abstract"><strong>Methods:</strong> One hundred and six runners will be randomised either into the intervention group or the control group. The intervention group will be supplied with prefabricated orthotics and the control group won’t be supplied with orthotics. Data will be collected regarding running-related injuries, distance run, time spent running and comfort during running. The study will span eight weeks. The first two and last two weeks will collect injury-related data only. Weeks three, four, five and six will collect both running and injury-related data. Participants must supply data from at least ten runs and eight injury reports. </p><p class="abstract"><strong>Conclusions: </strong>Running with orthotics has been shown to provide cushioning and improved proprioception, thereby decreasing the incidence of running-related injuries, improving performance, and increasing comfort. This paper aims to present a scientifically sound protocol to add to the existing knowledge surrounding the use of orthotics for runners.</p><p class="abstract"><strong>Trial Registration:</strong> This trial was registered in May 2021 (NCT04901442).</p>