Intended for healthcare professionals


Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial

BMJ 2008; 337 doi: (Published 24 October 2008) Cite this as: BMJ 2008;337:a1735
  1. Natalie Collins, PhD candidate1,
  2. Kay Crossley, principal research fellow2,
  3. Elaine Beller, director, biostatistics3,
  4. Ross Darnell, statistician1,
  5. Thomas McPoil, regents professor4,
  6. Bill Vicenzino, head of division, physiotherapy1
  1. 1School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia 4072
  2. 2Melbourne School of Engineering, University of Melbourne, Australia
  3. 3Queensland Clinical Trials Centre, School of Population Health, University of Queensland
  4. 4Gait Research Laboratory, Department of Physical Therapies, Northern Arizona University, USA
  1. Correspondence to: B Vicenzino b.vicenzino{at}
  • Accepted 6 August 2008


Objective To compare the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy, and to investigate the effectiveness of foot orthoses plus physiotherapy.

Design Prospective, single blind, randomised clinical trial.

Setting Single centre trial within a community setting in Brisbane, Australia.

Participants 179 participants (100 women) aged 18 to 40 years, with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks’ duration, who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months.

Interventions Six weeks of physiotherapist intervention with off the shelf foot orthoses, flat inserts, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or foot orthoses plus physiotherapy.

Main outcome measures Global improvement, severity of usual and worst pain over the preceding week, anterior knee pain scale, and functional index questionnaire measured at 6, 12, and 52 weeks.

Results Foot orthoses produced improvement beyond that of flat inserts in the short term, notably at six weeks (relative risk reduction 0.66, 99% confidence interval 0.05 to 1.17; NNT 4 (99% confidence interval 2 to 51). No significant differences were found between foot orthoses and physiotherapy, or between physiotherapy and physiotherapy plus orthoses. All groups showed clinically meaningful improvements in primary outcomes over 52 weeks.

Conclusion While foot orthoses are superior to flat inserts according to participants’ overall perception, they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain. Given the long term improvement observed in all treatment groups, general practitioners may seek to hasten recovery by prescribing prefabricated orthoses.

Trial registration Australian Clinical Trials Registry ACTRN012605000463673 and NCT00118521.


  • We thank Vasyli International for providing the foot orthoses and flat inserts; Ausmedic and Access Health for supplying concessions on the purchase of equipment used in the physiotherapy interventions; the project physiotherapists and their practice staff; Jenny McConnell for her assistance in running the protocol workshops; and research assistants Jane Buckley, Bula Elwell, and Erica Williams.

  • Contributors: NC recruited and screened the participants, carried out the baseline and follow-up outcome measures and data entry and analysis, and prepared the manuscript. KC was involved in the methodological design and preparation of the manuscript. EB assisted in the trial design and carried out the randomisation procedures. RD advised on the statistical design of the trial and data analysis and interpretation. TM was involved in the National Health and Medical Research Council grant application and trial design and reviewed the manuscript. BV, in his capacity as sole chief investigator on the National Health and Medical Research Council grant, supervised the conduct of the trial, the suitability of included participants, data analysis, and preparation of the manuscript, and is guarantor.

  • Funding: This trial was funded primarily by the National Health and Medical Research Council of Australia (primary health care project grant No 301037). NC was the recipient of a National Health and Medical Research Council of Australia public health scholarship (No 351663). Vasyli International donated the foot orthoses and flat inserts. The work of the authors was independent of the funders.

  • Competing interests: BV has been reimbursed by Vasyli International for seminar presentations and has also received research funding from this company.

  • Ethical approval: University of Queensland’s medical research ethics committee.

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

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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