Evidence map›Paper›PMID 33302926›Full record

ArticleBMC musculoskeletal disorders2020

Foot orthoses for first metatarsophalangeal joint osteoarthritis: study protocol for the FORT randomised controlled trial.

Kade L Paterson, Rana S Hinman, Ben R Metcalf, Sarah E Jones, Hylton B Menz, Shannon E Munteanu, Jessica Kasza, Kim L Bennell

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC musculoskeletal disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 40% of its field
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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Non-surgical interventions for treating osteoarthritis of the big toe joint.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Review
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

8 authors at 3 institutions in 1 country.

Kade L PatersonCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia. kade.paterson@unimelb.edu.au.ORCID http://orcid.org/0000-0002-0323-6129
Rana S HinmanCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia.
Ben R MetcalfCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia.
Sarah E JonesCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia.
Hylton B MenzSchool of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.
Shannon E MunteanuSchool of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia.
Jessica KaszaSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
Kim L BennellCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Australia.
The University of Melbourne · AULa Trobe University · AUMonash University · AU

Funding

National Health and Medical Research Council 1091302National Health and Medical Research Council 1135995National Health and Medical Research Council 1154217National Health and Medical Research Council 1174229National Health and Medical Research Council 1174431
6 · The paper itself

Abstract

backgroundFirst metatarsophalangeal (MTP) joint osteoarthritis (OA) is a painful and debilitating condition affecting nearly one in 10 people aged over 50 years. Non-drug, non-surgical treatments are recommended by OA clinical guidelines, yet there have only ever been two randomised controlled trials (RCTs) evaluating such strategies in people with first MTP joint OA. Foot orthoses are a common non-drug, non-surgical strategy used by allied health professionals for people with first MTP joint OA, however, it is unknown whether these devices are effective in improving the symptoms associated with the condition. This clinical trial aimed to determine whether contoured foot orthoses lead to greater reductions in first MTP joint pain on walking compared to sham flat insoles in people with first MTP joint OA.

methodsThe FORT trial (Foot ORthoses for big Toe joint osteoarthritis) is a two-arm participant- and assessor-blinded, multi-site RCT conducted in Melbourne, Sydney, Brisbane and the Gold Coast, Australia. We are recruiting 88 community-dwelling people with symptomatic radiographic first MTP joint OA. Following baseline assessment, participants are randomized to receive either: i) contoured foot orthoses; or ii) sham flat insoles following baseline assessment. Participants have two visits with a study podiatrist where they are provided with their allocated insoles, to be worn daily for 12 weeks at all times when wearing shoes. The primary outcome is self-reported first MTP joint pain on walking (numerical rating scale), assessed at baseline and 12 weeks. Secondary outcomes include additional measures of first MTP joint and foot pain, physical function, quality of life, participant-perceived global ratings of change (pain and function), and level of physical activity. DISCUSSION: This study will provide novel evidence about whether contoured foot orthoses improve pain and other symptoms compared to sham insoles in people with first MTP joint OA. Outcomes will help to inform clinical guidelines and practice about the use of foot orthoses for managing symptoms in this under-researched group of people with OA.

trial registrationProspectively registered with the Australian New Zealand Clinical Trials Registry (reference: ACTRN12619000926134 ) on 3/07/2019.

Indexed as

Foot OrthosesMetatarsophalangeal JointOsteoarthritisOsteoarthritis, KneeAgedAustraliaHumansRandomized Controlled Trials as TopicTreatment OutcomeBiomechanicsClinical trialFootInsolesMetatarsophalangealOAOrthosesOsteoarthritisPainRCT

Identifiers

PMID33302926
PMCPMC7726603
OpenAlexW3113121819

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.