The intervention programmes have been detailed previously.25 (link) In brief, participants assigned to foot orthoses received prefabricated, commercially available orthoses (Vasyli International), which were fitted to their shoes with comfort as a primary goal. These orthoses are customisable to some degree to optimise comfort through heat moulding and by adding wedge or heel raises. As a control for these orthoses we used flat inserts, manufactured from the same material (ethylenevinyl acetate) with identical covering fabric. These were of uniform thickness, with no inbuilt arch or wedging. Physiotherapy consisted of a combined therapy approach that has proved efficacious in patellofemoral pain syndrome19 (link) and included patellar mobilisation, patellar taping, a progressive programme of vasti muscle retraining exercises with electromyographic biofeedback, hamstring and anterior hip stretches, hip external rotator retraining, and a home exercise programme. Participants assigned to orthoses plus physiotherapy received both interventions as described and had an extra appointment with the physiotherapist if more time was required for adequate delivery of all treatment components.
The participants were encouraged to continue exercise and activities that did not provoke their pain. The use of non-study interventions was discouraged throughout the trial, although over the counter drugs were permitted. Any cointerventions used for symptoms of patellofemoral pain syndrome, as well as any adverse effects arising from intervention, were recorded in diaries, reported to the research assistant, or detailed in an exit questionnaire.