Foot Orthoses and Footwear for the Management of Patellofemoral Osteoarthritis: A Pilot Randomized Trial.

TL;DR: To determine the feasibility of a full‐scale randomized controlled trial (RCT) comparing foot orthoses and footwear to footwear alone in individuals with patellofemoral (PF) osteoarthritis (OA).

Abstract: Determine the feasibility of a full-scale randomised controlled trial (RCT) comparing foot orthoses and footwear to footwear alone in people with patellofemoral osteoarthritis (PFOA). This four-month, parallel, two-arm pilot trial took place in Brisbane, Queensland and Hobart, Tasmania (August 2014 to October 2016). Forty-six people with PFOA were randomized by concealed allocation to: (i) foot orthoses plus prescribed footwear (n=24); or (ii) prescribed footwear (n=22). Study feasibility was the primary outcome (e.g. recruitment rate, adherence, adverse events, drop-out rate). Secondary outcomes included patient-reported outcome measures of pain, function and quality of life. Effect sizes with 95% confidence intervals were calculated at four months (primary end-point) (standardized mean differences (SMD) for between-group effects; standardized response means (SRM) for within-group effects). From 782 volunteers, 47 were eligible (6%) and 46 participated. One participant withdrew (2%) and 1 (2%) was lost to follow-up. Intervention adherence was high for both groups (9-10 hours wear per day). No serious adverse events were reported. More than 80% of questionnaires were completed at 4 months. Between-group effect sizes for patient-reported outcome measures were typically small, while moderate to large within-group response effects were observed in both groups. A full-scale RCT for PFOA is feasible with modifications to eligibility criteria. However, our observed small between-group effect sizes, combined with moderate to large within-group responses for both interventions, indicate that a full-scale trial is unlikely to find clinically meaningful differences. Secondary outcomes suggest that both interventions can be recommended for people with PFOA.

Summary

12 Foot orthoses and footwear for the management of patellofemoral

• In-kind support for the footwear 18 utilized in this study was provided by New Balance Australia, and for the foot orthoses by 19 Orthema Australasia and Orthema Switzerland.
• Study feasibility was the primary outcome (e.g. recruitment rate, adherence, 11 adverse events, drop-out rate).
• Between-group effect sizes for patient-reported 20 outcome measures were typically small, while moderate to large within-group response effects 21 were observed in both groups.

4 There was no clinically meaningful difference between footwear and footwear plus foot

• All rights reserved 1 INTRODUCTION 2 3 Worldwide, osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability [1], most 4 frequently affecting the knee [2].
• A sample size of 22 participants per group was established based on 8 feasibility with respect to time and funding [18].
• All participants completed patient-reported outcome measures at baseline, two and four 3 months.

Figures

Table 3. Within-group change scores and standardized response means (with 95% confidence intervals) for the 4-month time of primary interest.

Figure 1. EVA foot orthoses covered in 1.5mm medical grade neoprene (A), New Balance 857 motion control cross-trainer (B).

Table 2. Between-group 4-month mean differences (95% CIs), standardized mean differences (SMD, 95% CI), and sample size estimates.

Figure 3. Global rating of change and patient-reported outcomes for satisfaction and success of treatment at 4 months

Full text

This article has been accepted for publication and undergone full peer review but has not been through the
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version and the Version of Record. Please cite this article as doi: 10.1002/ACR.24098
This article is protected by copyright. All rights reserved
1
2 MS. NARELLE WYNDOW (Orcid ID : 0000-0002-1952-8433)
3 BILL VICENZINO (Orcid ID : 0000-0003-0253-5933)
4 DR. NATALIE J. COLLINS (Orcid ID : 0000-0001-9950-0192)
5
6
7 Article type : Original Article
8
9
10 Running Head: Footwear and orthoses in PF OA
11
12 Foot orthoses and footwear for the management of patellofemoral
13 osteoarthritis: a pilot randomized trial
14
15
1,2
Narelle Wyndow, Master Sports Med.
16
1,2
Kay M. Crossley, PhD
17
2
Bill Vicenzino, PhD
18
3
Kylie Tucker, PhD
19
1,2
Natalie J. Collins, PhD
20
21
1
La Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and
22 Engineering , La Trobe University, Bundoora, Victoria, Australia 3086
23
2
School of Health & Rehabilitation Sciences, The University of Queensland, Brisbane,
24 Queensland, Australia 4072.
25
3
School of Biomedical Sciences, The University of Queensland, Brisbane, Queensland, Australia
26 4072.
27
28 Corresponding Author:
29 Dr Natalie Collins
Accepted Article

This article is protected by copyright. All rights reserved
1 Telephone: +61 7 3365 2124
2 Email: n.collins1@uq.edu.au
3
4 Narelle Wyndow: n.wyndow@uq.edu.au
5 Professor Bill Vicenzino: b.vicenzino@uq.edu.au
6 Dr Kylie Tucker: k.tucker1@uq.edu.au
7 Professor Kay Crossley: k.crossley@latrobe.edu.au
8 Dr Natalie Collins: n.collins1@uq.edu.au
9
10 Competing Interests
11 The authors would like to declare no competing interests
12
13 Funding
14 NW is supported by a National Health and Medical Research Council Postgraduate Scholarship
15 (#2132179). KT was supported by a National Health and Medical Research Council Fellowship
16 (APP1009410), 2011-2015. NC was supported by a UQ Postdoctoral Research Fellowship and is
17 now supported by an Arthritis Queensland Fellowship (2018). In-kind support for the footwear
18 utilized in this study was provided by New Balance Australia, and for the foot orthoses by
19 Orthema Australasia and Orthema Switzerland. The Australian Podiatry Education and Research
20 Foundation (APERF) provided funding of $9,930 for radiographs and consumables. None of the
21 funding bodies had any role in the study design, or data analysis and interpretation.
22
23 Word count: 3798
Accepted Article

This article is protected by copyright. All rights reserved
1 ABSTRACT
2
3 OBJECTIVE: Determine the feasibility of a full-scale randomised controlled trial (RCT) comparing
4 foot orthoses and footwear to footwear alone in people with patellofemoral osteoarthritis
5 (PFOA).
6
7 METHODS: This four-month, parallel, two-arm pilot trial took place in Brisbane, Queensland and
8 Hobart, Tasmania (August 2014 to October 2016). Forty-six people with PFOA were randomized
9 by concealed allocation to: (i) foot orthoses plus prescribed footwear (n=24); or (ii) prescribed
10 footwear (n=22). Study feasibility was the primary outcome (e.g. recruitment rate, adherence,
11 adverse events, drop-out rate). Secondary outcomes included patient-reported outcome
12 measures of pain, function and quality of life. Effect sizes with 95% confidence intervals were
13 calculated at four months (primary end-point) (standardized mean differences (SMD) for
14 between-group effects; standardized response means (SRM) for within-group effects).
15
16 RESULTS: From 782 volunteers, 47 were eligible (6%) and 46 participated. One participant
17 withdrew (2%) and 1 (2%) was lost to follow-up. Intervention adherence was high for both
18 groups (9-10 hours wear per day). No serious adverse events were reported. More than 80% of
19 questionnaires were completed at 4 months. Between-group effect sizes for patient-reported
20 outcome measures were typically small, while moderate to large within-group response effects
21 were observed in both groups.
22
23 CONCLUSION: A full-scale RCT for PFOA is feasible with modifications to eligibility criteria.
24 However, our observed small between-group effect sizes, combined with moderate to large
25 within-group responses for both interventions, indicate that a full-scale trial is unlikely to find
26 clinically meaningful differences. Secondary outcomes suggest that both interventions can be
27 recommended for people with PFOA.
28
29 Significance and Innovations:
Accepted Article

This article is protected by copyright. All rights reserved
1  Both footwear and footwear plus foot orthoses interventions improve pain and function in
2 patellofemoral osteoarthritis
3  A full-scale RCT is feasible with modifications to eligibility criteria
4  There was no clinically meaningful difference between footwear and footwear plus foot
5 orthoses interventions.
6
7
8
9
10
11
12
13
14
15
16
17
Accepted Article

This article is protected by copyright. All rights reserved
1 INTRODUCTION
2
3 Worldwide, osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability [1], most
4 frequently affecting the knee [2]. The patellofemoral (PF) joint is frequently affected by OA,
5 either in isolation (~25%) or combined with tibiofemoral (TF) OA (~40%) [3]. PFOA affects
6 individuals in the work force [5, 6], can lead to total knee replacement [7], and has societal and
7 financial impacts [8]. Different biomechanics, and consequently management approaches, are
8 proposed to be associated with isolated PFOA compared to isolated TFOA, or combined TF and
9 PFOA [4]. For example, TFOA is typically associated with higher external knee adduction moment,
10 and may be managed with valgus knee braces and lateral wedge insoles [4], while PFOA is
11 commonly associated with knee valgus alignment and such interventions are not optimal for
12 PFOA [4]. Thus, effective non-surgical interventions specifically targeted to PFOA are needed.
13
14 PFOA shares many clinical similarities with PF pain in younger people, and has been proposed to
15 form a disease continuum related to aberrant biomechanics [9]. Supporting this, recent evidence
16 demonstrates that one quarter of young and middle-aged adults with PF pain have radiographic
17 evidence of PFOA [10]. As such, interventions that are effective for PF pain may provide similar
18 benefits in those with PFOA. In PF pain, foot orthoses (FO) can improve pain and function [11,
19 12], and produce similar outcomes to a multi-modal physiotherapy program [11]. However, the
20 effect of FO in people with PFOA has yet to be investigated. Further, the quality of footwear
21 worn impacts on PF pain [13], and footwear interventions can improve pain and function in TFOA
22 [14]. To determine the specific efficacy of FO in those with PFOA, the potential influence of
23 footwear on pain and function in PFOA needs to be controlled for in study design.
24
25 This study primarily aimed to investigate the feasibility of conducting a randomized clinical trial
26 (RCT) of adding FO to footwear in people with PFOA. Secondary aims explored outcomes of pain,
27 physical function and quality of life.
28
29 METHODS
30
Accepted Article