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The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis
  1. Natalie J Collins1,2,
  2. Jade M Tan2,3,
  3. Hylton B Menz2,3,
  4. Trevor G Russell1,
  5. Anne J Smith4,
  6. Bill Vicenzino1,
  7. Shannon E Munteanu2,3,
  8. Rana S Hinman5,
  9. Terry P Haines6,
  10. Harvi F Hart2,7,
  11. Brooke E Patterson2,
  12. Gearoid Cleary1,
  13. Joel W Donnar2,
  14. Liam R Maclachlan1,
  15. Kay M Crossley2
  1. 1Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia
  2. 2La Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia
  3. 3Discipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia
  4. 4School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia
  5. 5Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia
  6. 6School of Primary and Allied Health Care, Monash University, Melbourne, Victoria, Australia
  7. 7School of Physical Therapy and Bone and Joint Institute, University of Western Ontario, London, Ontario, Canada
  1. Correspondence to Dr Natalie J Collins; n.collins1{at}uq.edu.au

Abstract

Introduction Patellofemoral (PF) osteoarthritis (OA) is a common and burdensome subgroup of knee OA, with very little evidence for effective treatments. Prefabricated foot orthoses are an affordable and accessible intervention that have been shown to reduce PF pain in younger adults. Similarities between PF pain and PFOA, as well as our pilot work, suggest that foot orthoses may also be an effective intervention for PFOA. The primary objective of this study is to compare the 3 month efficacy of prefabricated foot orthoses and flat shoe inserts in people with PFOA, on knee pain severity.

Methods and analysis The FOOTPATH Study (FOot OrThoses for PAtellofemoral osteoarTHritis) is a multicentre, randomised, participant- and assessor-blinded superiority trial with two parallel groups, a 3 month observation period (pre-randomisation) and 12 month follow-up. 160 participants with a clinical diagnosis of PFOA will be recruited from three sites in Australia, and randomised to one of two groups (prefabricated foot orthoses or flat shoe inserts). The primary outcome is worst knee pain severity during a self-nominated aggravating activity in the previous week (100 mm visual analogue scale) at 3 months, with a secondary endpoint at 12 months. Secondary outcomes include global rating of change, symptoms, function, health-related quality of life, kinesiophobia, self-efficacy and use of co-interventions for knee pain. Blinded, intention-to-treat analyses of primary and secondary patient-reported outcomes will be performed, as well as economic analyses.

Ethics and dissemination Ethical approval has been granted by La Trobe University’s Human Ethics Committee and The University of Queensland’s Medical Research Ethics Committee. Study outcomes will be disseminated via peer-reviewed journals, conference presentations targeting a range of healthcare disciplines and an open access website with clinician resources.

Trial registration number ANZCTRN12617000385347; Pre-results.

  • rheumatology
  • knee
  • clinical trials

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors NJC, KMC, HBM, TGR, AJS, RSH, BV and TPH conceived the study and obtained funding. NJC, KMC and HBM designed the trial protocol with input from TGR, AJS, RSH, BV, TPH, SEM and JMT. AJS and TPH provided statistical expertise. AJS will conduct primary statistical analysis. NJC drafted the manuscript with input from KMC, HBM, TGR, AJS, RSH, BV, TPH, SEM, JMT, HFH, BEP, GC, JWD and LRM. All authors have read and approved the final manuscript.

  • Funding This work is supported by the National Health and Medical Research Council (Australia) (ID: 1106852; 2016-2019). NJC previously held a University of Queensland Postdoctoral Research Fellowship (2015-2017). HBM is currently a National Health and Medical Research Council Senior Research Fellow (ID: 1135995). RSH currently holds an Australian Research Council (ARC) Future Fellowship (ID: FT130100175). Vasyli Medical (Labrador, Australia) will provide the foot orthoses, flat inserts and sandals.

  • Competing interests BV reports non-financial support from Vionic, outside the submitted work. He is a member (non-paid affiliation) of the Vasyli Think Tank, which was founded in 2011 to foster collaboration and cooperative thought among a leading group of health professionals specialising in the field of lower limb biomechanics.

  • Ethics approval Ethical approval has been granted by La Trobe University’s Human Ethics Committee (HEC16-113) and The University of Queensland’s Medical Research Ethics Committee (2017000284).

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

  • Patient consent for publication Not required.

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