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. 2019 Apr 20;9(4):e025315.
doi: 10.1136/bmjopen-2018-025315.

The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis

Natalie J Collins  1   2 , Jade M Tan  2   3 , Hylton B Menz  2   3 , Trevor G Russell  1 , Anne J Smith  4 , Bill Vicenzino  1 , Shannon E Munteanu  2   3 , Rana S Hinman  5 , Terry P Haines  6 , Harvi F Hart  2   7 , Brooke E Patterson  2 , Gearoid Cleary  1 , Joel W Donnar  2 , Liam R Maclachlan  1 , Kay M Crossley  2
Affiliations

The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis

Natalie J Collins et al. BMJ Open. .

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.

Keywords: clinical trials; knee; rheumatology.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Flow of participants through the study. RCT, randomised clinical trial.
Figure 2
Figure 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram of enrolment, interventions and assessments for the FOot OrThoses for PAtellofemoral osteoarTHritis (FOOTPATH) study.
Figure 3
Figure 3
Prefabricated foot orthoses in full length (A) and three-quarter length (B), and flat inserts (C).
Figure 4
Figure 4
Prescription algorithm for fitting prefabricated foot orthoses. Steps 1 to 3 are to be followed sequentially. Numbered options within each variable are to be trialled sequentially (eg, red orthoses, then blue orthoses, then green orthoses). XS, extra small; S, small; M, medium; L, large; XL, extra large; RF, rearfoot; FF, forefoot.
Figure 5
Figure 5
Prescription algorithm for fitting flat inserts. XS, extra small; S, small; M, medium; L, large; XL, extra large.
See this image and copyright information in PMC

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