Evidence map›Paper›PMID 30021556›Full record

Trial reportBMC musculoskeletal disorders2018

Custom foot orthoses improve first-step pain in individuals with unilateral plantar fasciopathy: a pragmatic randomised controlled trial.

Chris Bishop, Dominic Thewlis, Susan Hillier

Open access · goldAbstract readPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC musculoskeletal disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 9% 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

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Running shoes for preventing lower limb running injuries in adults.The Cochrane database of systematic reviews · 2022
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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

3 authors at 1 institution in 1 country.

Chris BishopAlliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Adelaide, East Campus, North Terrace, SA, 5000, Australia. Christopher.bishop@unisa.edu.au.ORCID http://orcid.org/0000-0002-1251-8785
Dominic ThewlisAlliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Adelaide, East Campus, North Terrace, SA, 5000, Australia.
Susan HillierSansom Institute for Health Research, University of South Australia, Adelaide, Australia.
University of South Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFoot orthoses are routinely used to treat plantar fasciopathy in clinical practice. However, minimal evidence exists as to the effect of both truly custom designed foot orthoses, as well as that of the shoe the foot orthoses are placed into. This study investigated the effect of wearing custom foot orthoses and new athletic footwear on first-step pain, average 24-h pain and plantar fascia thickness in people with unilateral plantar fasciopathy over 12 weeks.

methodsA parallel, three-arm randomised controlled trial with blinding of participants and assessors. 60 participants diagnosed with unilateral plantar fasciopathy were randomised to either custom foot orthoses and new shoes (orthoses group), a sham insole with a new shoes (shoe group) or a sham insole placed in the participant's regular shoes (control group). Primary outcome was first-step pain. Secondary outcomes were average 24-h pain and plantar fascia thickness measured on ultrasound. Outcomes were assessed at baseline, 4 week and 12 week trial time-points.

resultsAt 4 weeks, the orthoses group reported less first-step pain (p = 0.002) compared to the control group. At 12 weeks, the orthoses group reported less first-step pain compared to both the shoe (p = < 0.001) and sham (p = 0.01) groups. Both the orthoses (p = < 0.001) and shoe (p = 0.006) groups reported less average 24-h pain compared to the control group at 4 and 12 weeks. The orthoses group demonstrated reduced plantar fascia thickness on ultrasound compared to both the shoe (p = 0.032) and control groups (p = 0.011).

conclusionsCustom foot orthoses in new shoes improve first-step pain and reduce plantar fascia thickness over a period of 12 weeks compared to new shoes alone or a sham intervention.

trial registrationAustralian New Zealand Clinical Trials Registry ( ACTRN 12613000446763 ). Submitted on the 10th of April 2013 and registered on the 18th of April 2013.

Indexed as

AdultDouble-Blind MethodEquipment DesignFasciitis, PlantarFemaleFoot OrthosesHumansMaleMiddle AgedPain ManagementTreatment OutcomeWalkingYoung AdultFoot orthosesFootwearPainPlantar fasciaUltrasound

Identifiers

PMID30021556
PMCPMC6052580
OpenAlexW2884806982

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.