Objectives To test (i) if greater foot pronation (measured as midfoot width mobility) is associated with better outcomes with foot orthoses treatment, compared with hip exercises and (ii) if hip exercises are superior to foot orthoses, irrespective of midfoot width mobility.
Methods A two-arm parallel, randomised superiority clinical trial was conducted in Australia and Denmark. Participants (18–40 years) were included who reported an insidious onset of knee pain (≥6 weeks duration); ≥3/10 numerical pain rating, that was aggravated by activities (eg, stairs, squatting, running). Participants were stratified by midfoot width mobility (high ≥11 mm change in midfoot width) and site, randomised to foot orthoses or hip exercises and blinded to objectives and stratification. Success was defined a priori as much better or better on a patient-perceived 7-point scale at 12 weeks.
Results Of 218 stratified and randomised participants, 192 completed 12-week follow-up. This study found no difference in success rates between foot orthoses versus hip exercises in those with high (6/21 vs 9/20; 29% vs 45%, respectively) or low (42/79 vs 37/72; 53% vs 51%) midfoot width mobility. There was no association between midfoot width mobility and treatment outcome (Interaction effect p=0.19). This study found no difference in success rate between foot orthoses versus hip exercises (48/100 vs 46/92; 48% vs 50%).
Conclusion Midfoot width mobility should not be used to help clinicians decide which patient with patellofemoral pain might benefit most from foot orthoses. Clinicians and patients may consider either foot orthoses or hip exercises in managing patellofemoral pain.
Trial registration number ACTRN12614000260628.
- knee injuries
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Correction notice This article has been corrected since it published Online First. The author affiliations have been updated.
Contributors MM contributed to the study conception and design, recruitment of participants, management of study proceedings, data collection and drafting and revision of the manuscript. AC, TM, RN and KMC contributed to the study conception and design, and drafting and revision of the manuscript. MSR contributed to the study design, recruitment of participants, management of study proceedings, data collection and reviewed the manuscript. JK contributed to the statistical analysis and reviewed the manuscript. BV contributed to the study conception and design, recruitment of participants, data management and the drafting and revision of the manuscript. BV and MM act as guarantors to affirm that this manuscript is an honest, accurate and transparent account of the study being reported; that no important aspects of the study have been omitted and that any discrepancies from the study as planned (and, if relevant, registered) have been explained. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding This study was funded by National Health and Medical Research Council (Ref: 631717) and Vionics International.
Disclaimer The funders of the study had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review or approval of the manuscript.
Competing interests BV reports grants from Commonwealth of Australia National Health and Medical Research Council (Ref: 631717) and from Vionics International for this research. MM is supported by an Australian Postgraduate Award. BV and TM are voluntary (non-compensated) members by invitation on the Vasyli Think Tank.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.