Evidence map›Paper›PMID 39223075›Full record

ArticleJournal of foot and ankle research2024

Efficacy of arch contouring foot orthoses for midfoot osteoarthritis: Protocol for a randomised controlled trial.

Polly Q X Lim, Hylton B Menz, Karl B Landorf, Michelle R Kaminski, Andrew K Buldt, Merridy J Lithgow, Kade L Paterson, Jill Halstead, Shannon E Munteanu

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of foot and ankle research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Polly Q X LimDiscipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-2796-2272
Hylton B MenzDiscipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-2045-3846
Karl B LandorfDiscipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-3882-5206
Michelle R KaminskiDiscipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-1133-4853
Andrew K BuldtDiscipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-2020-2780
Merridy J LithgowDiscipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-4276-3079
Kade L PatersonDepartment of Physiotherapy, Centre for Health, Exercise and Sports Medicine, School of Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-0323-6129
Jill HalsteadUniversity of Leeds, NIHR Leeds Biomedical Research Centre, and Leeds Community Healthcare NHS Trust, Leeds, UK.ORCID https://orcid.org/0000-0002-9913-2569
Shannon E MunteanuDiscipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0001-6780-2743

Funding

Australian Podiatry Education and Research Foundation (APERF)
6 · The paper itself

Abstract

introductionMidfoot osteoarthritis (OA) is a painful and disabling condition. Arch contouring foot orthoses have been recommended for midfoot OA, yet there is no high-quality evidence from randomised controlled trials to support their use. This clinical trial aims to evaluate the efficacy of arch contouring foot orthoses for midfoot OA.

methodsThis will be a parallel-group randomised controlled superiority trial. One-hundred and forty community-dwelling people with painful midfoot OA will be randomised to receive either arch contouring foot orthoses or flat sham inserts. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks; the primary endpoint for assessing efficacy being 12 weeks. The primary outcome measure will be average midfoot pain whilst walking over the last 7 days on an 11-point numerical rating scale. Secondary outcome measures include function (walking/standing subscale of the Manchester-Oxford Foot Questionnaire), participants' perception of overall treatment effect (self-reported global rating of change on a 15-point Likert scale), physical activity (Incidental and Planned Exercise Questionnaire), general health-related quality of life (Short Form-12 Version® 2.0), use of co-interventions and adverse events. DISCUSSION: This trial will evaluate the efficacy of arch contouring foot orthoses for relieving pain and improving function, physical activity and health-related quality of life in people with midfoot OA. The findings will provide high-quality evidence as to whether arch contouring foot orthoses are efficacious and will help to inform clinical guidelines about the use of foot orthoses for midfoot OA.

trial registrationAustralian and New Zealand Clinical Trial Registry (ACTRN12623000953639).

Indexed as

Foot OrthosesOsteoarthritisAdultAgedEquivalence Trials as TopicFemaleHumansMaleMiddle AgedQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeWalkingclinical trial protocolfootfoot orthosesmidfootorthotic devicesosteoarthritisrandomised controlled trial

Identifiers

PMID39223075
PMCPMC11368563

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.