Objectives To investigate the short-term clinical efficacy of in-shoe foot orthoses over a wait-and-see policy in the treatment of anterior knee pain (AKP) and evaluate the ability of foot posture measures to predict outcome.

Design Single-blind, randomised control trial.

Participants Forty participants (18–40 years) with clinically diagnosed AKP of greater than 6-week duration, who had not been treated with orthoses in the previous 5 years.

Intervention Prefabricated orthoses perceived as most comfortable from a selection of 3 different hardness values compared with a wait-and-see control group.

Outcome measures Participant-perceived global improvement, Kujala Patellofemoral Score, usual and worst pain severity over the previous week and the Patient Specific Functional Scale measures at 6 weeks.

Results Foot orthoses produced a significant global improvement compared with the control group (p = 0.008, relative risk reduction = 8.47%, numbers needed to treat = 2). Significant differences also occurred in measures of function (standardised mean difference = 0.71). Within the intervention group, individuals who exhibited a change in midfoot width from weight bearing to non-weight bearing of >11.25 mm were more likely to report a successful outcome (correct classification 77.8%).

Conclusion This is the first study to show orthoses provide greater improvements in AKP than a wait-and-see approach. Individuals with greater midfoot mobility are more likely to experience success from treatment.

Trial Registration ACTRN12611000492954