Evidence map›Paper›PMID 32741375›Full record

ArticleJournal of foot and ankle research2020

HAPPi Kneecaps! Protocol for a participant- and assessor-blinded, randomised, parallel group feasibility trial of foot orthoses for adolescents with patellofemoral pain.

Isobel C O'Sullivan, Kay M Crossley, Steven J Kamper, Marienke van Middelkoop, Bill Vicenzino, Melinda M Franettovich Smith, Hylton B Menz, Anne J Smith, Kylie Tucker, Karina T O'Leary and 1 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of foot and ankle research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 34% 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

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
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

11 authors at 5 institutions in 2 countries.

Isobel C O'SullivanDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.
Kay M CrossleyLa Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
Steven J KamperSchool of Public Health, University of Sydney, Camperdown, New South Wales, Australia.
Marienke van MiddelkoopDepartment of General Practice, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Bill VicenzinoDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.
Melinda M Franettovich SmithDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.
Hylton B MenzLa Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
Anne J SmithSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.
Kylie TuckerSchool of Biomedical Sciences, The University of Queensland, Brisbane, Australia.
Karina T O'LearyDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.
Natalie J CollinsDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia. n.collins1@uq.edu.au.ORCID http://orcid.org/0000-0001-9950-0192
The University of Queensland · AULa Trobe University · AUCurtin University · AUErasmus MC · NLThe University of Sydney · AU

Funding

Arthritis Australia Project Grant (Molly Saint Grant)National Health and Medical Research Council Senior Research Fellowship (1135995)The University of Queensland UQ Development Fellowship (UQFEL1832429)The University of Queensland UQ Graduate School Scholarship
6 · The paper itself

Abstract

backgroundPatellofemoral pain (PFP) is a common cause of knee pain in adolescents, but there are limited evidence-based treatment options for this population. Foot orthoses can improve pain and function in adults with PFP, and may be effective for adolescents. The primary aim of this study is to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating the effects of contoured foot orthoses on knee pain severity and patient-perceived global change, compared to flat shoe insoles, in adolescents with PFP. The secondary aim is to provide an estimate of treatment effects for foot orthoses, compared to flat insoles, in adolescents with PFP.

methodsThis randomised, controlled, participant- and assessor-blinded, feasibility trial has two parallel groups. Forty adolescents (aged 12-18 years) with clinical symptoms of PFP will be recruited from Queensland, Australia. Participants will be randomised to receive either prefabricated contoured foot orthoses or flat shoe insoles. Both interventions will be fit by a physiotherapist, and worn for 3 months. Feasibility will be evaluated through assessing willingness of volunteers to enrol, number of eligible participants, recruitment rate, adherence with the study protocol, adverse effects, success of blinding, and drop-out rate. Secondary outcomes will evaluate knee-related pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions, at 6 weeks and 3 months. Primary outcomes will be reported descriptively, while estimates of standard deviation and between-group differences (with 95% confidence intervals) will be reported for secondary outcomes. DISCUSSION: Findings of this study will inform the feasibility of a full-scale RCT investigating the efficacy of contoured foot orthoses in adolescents with PFP. This full-scale study is necessary to improve the evidence base for management of adolescent PFP, and enhance outcomes for this population.

trial registrationACTRN12619000957190 .

Indexed as

AdolescentAustraliaChildFeasibility StudiesFemaleFoot OrthosesHumansMalePainPatellaPatellofemoral Pain SyndromePhysical TherapistsProspective StudiesQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexAdolescentsFeasibilityFoot orthosesPatellofemoral pain

Identifiers

PMID32741375
PMCPMC7397622
OpenAlexW3046514364

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.