Evidence map›Paper›PMID 28449699›Full record

Trial reportTrials2017

Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial.

Shannon E Munteanu, Karl B Landorf, Jodie A McClelland, Edward Roddy, Flavia M Cicuttini, Alan Shiell, Maria Auhl, Jamie J Allan, Andrew K Buldt, Hylton B Menz

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 20% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 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. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Foot osteoarthritis: latest evidence and developments.Therapeutic advances in musculoskeletal disease · 2018
    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

10 authors at 3 institutions in 2 countries.

Shannon E MunteanuDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia. s.munteanu@latrobe.edu.au.
Karl B LandorfDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia.
Jodie A McClellandDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia.
Edward RoddyArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.
Flavia M CicuttiniDepartment of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.
Alan ShiellDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia.
Maria AuhlDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia.
Jamie J AllanDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia.
Andrew K BuldtDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia.
Hylton B MenzDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia.
La Trobe University · AUKeele University · GBMonash University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoarthritis (OA).

methodsNinety participants with first MTPJ OA will be randomised to receive full-length shoe-stiffening insert(s) (Carbon Fibre Spring Plate, Paris Orthotics, Vancouver, BC, Canada) plus rehabilitation therapy or sham shoe insert(s) plus rehabilitation therapy. Outcome measures will be obtained at baseline, 4, 12, 24 and 52 weeks; the primary endpoint for assessing effectiveness being 12 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include the function domain of the FHSQ, severity of first MTPJ pain (using a 100-mm Visual Analogue Scale), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 and EuroQol (EQ-5D-5L™) questionnaires), use of rescue medication and co-interventions, self-reported adverse events and physical activity levels (using the Incidental and Planned Activity Questionnaire). Data will be analysed using the intention-to-treat principle. Economic analysis (cost-effectiveness and cost-utility) will also be performed. In addition, the kinematic effects of the interventions will be examined at 1 week using a three-dimensional motion analysis system and multisegment foot model. DISCUSSION: This study will determine whether shoe-stiffening inserts are a cost-effective intervention for relieving pain associated with first MTPJ OA. The biomechanical analysis will provide useful insights into the mechanism of action of the shoe-stiffening inserts.

trial registrationAustralian New Zealand Clinical Trials Registry, identifier: ACTRN12616000552482 . Registered on 28 April 2016.

Indexed as

Clinical ProtocolsFoot OrthosesBiomechanical PhenomenaCost-Benefit AnalysisHumansMetatarsophalangeal JointOsteoarthritisOutcome Assessment, Health CarePatient ComplianceShoesFoot orthosesHallux rigidusMetatarsophalangeal jointOsteoarthritis

Identifiers

PMID28449699
PMCPMC5408786
OpenAlexW2608636870

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.