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

Br J Sports Med. 2012 Mar;46(4):247-52. doi: 10.1136/bjsports-2011-090204. Epub 2011 Sep 18.


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.

Clinical trial registration: ACTRN12611000492954.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Arthralgia / therapy*
  • Foot
  • Humans
  • Knee Joint
  • Movement / physiology
  • Orthotic Devices*
  • Patient Satisfaction
  • Posture
  • Shoes*
  • Single-Blind Method
  • Treatment Outcome
  • Watchful Waiting*
  • Young Adult