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A randomised control trial of short term efficacy of in-shoe foot orthoses compared with a wait and see policy for anterior knee pain and the role of foot mobility
  1. Kathryn Mills1,2,
  2. Peter Blanch2,
  3. Priya Dev3,
  4. Michael Martin3,
  5. Bill Vicenzino1
  1. 1Division of Physiotherapy, School of Rehabilitation and Health Sciences, University of Queensland, Brisbane, Australia
  2. 2Department of Physical Therapies, Australian Institute of Sport, Canberra, Australia
  3. 3School of Finance and Applied Statistics, Australian National University, Canberra, Australia
  1. Correspondence to Professor Bill Vicenzino, Division of Physiotherapy, School of Health and Rehabilitation Sciences, University of Queensland, Brisbane QLD 4072, Australia; b.vicenzino{at}


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

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  • Funding KM is supported by the Australian Research Council. Financial support for this research was received from the Australian Research Council (Australian Research Council Linkage Project Grant LP0668233).

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.