Evidence map›Paper›PMID 33795024›Full record

ArticlePilot and feasibility studies2021

Self-management advice, exercise and foot orthoses for plantar heel pain: the TREADON pilot and feasibility randomised trial.

Linda S Chesterton, Martin J Thomas, Gordon Hendry, Ying Chen, David Goddin, Nicola Halliday, Sarah A Lawton, Martyn Lewis, Christian D Mallen, Hylton B Menz and 2 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 31% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
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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

12 authors at 5 institutions in 3 countries.

Linda S ChestertonPrimary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Martin J ThomasPrimary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Gordon HendrySchool of Health and Life Sciences, Glasgow Caledonian University, Glasgow, G4 0BA, UK.
Ying ChenPrimary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.
David GoddinKeele Clinical Trials Unit, David Weatherall Building, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Nicola HallidayKeele Clinical Trials Unit, David Weatherall Building, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Sarah A LawtonKeele Clinical Trials Unit, David Weatherall Building, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Martyn LewisPrimary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Christian D MallenPrimary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Hylton B MenzPrimary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Nadine E FosterPrimary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Edward RoddyPrimary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK. e.roddy@keele.ac.uk.ORCID http://orcid.org/0000-0002-8954-7082
Arthritis UK · GBKeele University · GBMidlands Partnership NHS Foundation Trust · GBGlasgow Caledonian University · GBLa Trobe University · AU

Funding

Department of Health ICA-CL-2016-02-014National Health and Medical Research Council 1135995National Institute for Health Research NIHR-RP-011-015National Institute for Health Research RP-2014-04-026Research for Patient Benefit Programme PB-PG-0614-34021Research Trainees Coordinating Centre NIHR300818
6 · The paper itself

Abstract

backgroundPlantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP.

methodsThis was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation.

resultsEighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64-100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5-0.6, 0.4 and < 0.3, respectively.

conclusionsWe demonstrated the feasibility of conducting a future main randomised clinical trial comparing the clinical and cost-effectiveness of SMA, exercises and/or foot orthoses for PHP. TRIAL REGISTRATION NUMBER: ISRCTN 12160508 . Prospectively registered 5

Indexed as

ExerciseFoot orthosesPilot and feasibility trialPlantar heel pain/fasciitisRandomised trial

Identifiers

PMID33795024
PMCPMC8015033
OpenAlexW3141391130

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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.