Evidence map›Paper›PMID 25917211›Full record

Trial reportClinical rheumatology2016

Foot orthoses in the treatment of symptomatic midfoot osteoarthritis using clinical and biomechanical outcomes: a randomised feasibility study.

Jill Halstead, Graham J Chapman, Janine C Gray, Andrew J Grainger, Sarah Brown, Richard A Wilkins, Edward Roddy, Philip S Helliwell, Anne-Maree Keenan, Anthony C Redmond

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical rheumatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 4 pooled it
3.8field-weighted citation impact, top 8% 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

24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  17. Review
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  19. Article
  20. 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 5 institutions in 1 country.

Jill HalsteadSection of Clinical Biomechanics and Physical Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor, Chapel Allerton Hospital, Harehills Lane, Leeds, LS7 4SA, UK. j.halstead-rastrick@leeds.ac.uk.
Graham J ChapmanSection of Clinical Biomechanics and Physical Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor, Chapel Allerton Hospital, Harehills Lane, Leeds, LS7 4SA, UK.
Janine C GrayLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Andrew J GraingerLeeds NIHR Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, UK.
Sarah BrownLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Richard A WilkinsSection of Clinical Biomechanics and Physical Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor, Chapel Allerton Hospital, Harehills Lane, Leeds, LS7 4SA, UK.
Edward RoddyResearch Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
Philip S HelliwellSection of Clinical Biomechanics and Physical Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor, Chapel Allerton Hospital, Harehills Lane, Leeds, LS7 4SA, UK.
Anne-Maree KeenanSection of Clinical Biomechanics and Physical Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor, Chapel Allerton Hospital, Harehills Lane, Leeds, LS7 4SA, UK.
Anthony C RedmondSection of Clinical Biomechanics and Physical Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor, Chapel Allerton Hospital, Harehills Lane, Leeds, LS7 4SA, UK.
NIHR Leeds Musculoskeletal Biomedical Research Unit · GBUniversity of Leeds · GBChapel Allerton Hospital · GBKeele University · GBVersus Arthritis · GB

Funding

Arthritis Research UK 19996Arthritis Research UK 20083Department of Health PDA/03/07/047Versus Arthritis 19996
6 · The paper itself

Abstract

This randomised feasibility study aimed to examine the clinical and biomechanical effects of functional foot orthoses (FFOs) in the treatment of midfoot osteoarthritis (OA) and the feasibility of conducting a full randomised controlled trial. Participants with painful, radiographically confirmed midfoot OA were recruited and randomised to receive either FFOs or a sham control orthosis. Feasibility measures included recruitment and attrition rates, practicality of blinding and adherence rates. Clinical outcome measures were: change from baseline to 12 weeks for severity of pain (numerical rating scale), foot function (Manchester Foot Pain and Disability Index) and patient global impression of change scale. To investigate the biomechanical effect of foot orthoses, in-shoe foot kinematics and plantar pressures were evaluated at 12 weeks. Of the 119 participants screened, 37 were randomised and 33 completed the study (FFO = 18, sham = 15). Compliance with foot orthoses and blinding of the intervention was achieved in three quarters of the group. Both groups reported improvements in pain, function and global impression of change; the FFO group reporting greater improvements compared to the sham group. The biomechanical outcomes indicated the FFO group inverted the hindfoot and increased midfoot maximum plantar force compared to the sham group. The present findings suggest FFOs worn over 12 weeks may provide detectable clinical and biomechanical benefits compared to sham orthoses. This feasibility study provides useful clinical, biomechanical and statistical information for the design and implementation of a definitive randomised controlled trial to evaluate the effectiveness of FFOs in treating painful midfoot OA.

Indexed as

Foot OrthosesAdultAgedBiomechanical PhenomenaDouble-Blind MethodFeasibility StudiesFemaleFootHumansMaleMiddle AgedOsteoarthritisPainPatient CompliancePressureShoesFeasibilityFootFunctional foot orthosesGaitMidfoot osteoarthritisOsteoarthritisRandomised trial

Identifiers

PMID25917211
PMCPMC4819552
OpenAlexW2014742307

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.