Evidence map›Paper›PMID 34893092›Full record

Trial reportJournal of foot and ankle research2021

HAPPi Kneecaps! A double-blind, randomised, parallel group superiority trial investigating the effects of sHoe inserts for adolescents with patellofemoral PaIn: phase II feasibility study.

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 2 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of foot and ankle research, 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
0.6field-weighted citation impact, top 36% 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, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. 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

12 authors at 5 institutions in 2 countries.

Isobel C O'SullivanSchool of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, Australia.
Kay M CrossleyLa Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.
Steven J KamperFaculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Marienke van MiddelkoopDepartment of General Practice, Erasmus MC Medical University Center, Rotterdam, The Netherlands.
Bill VicenzinoSchool of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, Australia.
Melinda M Franettovich SmithSchool of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, Australia.
Hylton B MenzSchool of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.
Anne J SmithSchool of Allied Health, Curtin University, Perth, Australia.
Kylie TuckerSchool of Biomedical Sciences, The University of Queensland, Brisbane, Australia.
Karina T O'LearySurgical Treatment and Rehabilitation Services, Metro North Hospital and Health Service, Herston, Australia.
Nathalia CostaSchool of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, Australia.
Natalie J CollinsSchool of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, 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

National Health and Medical Research Council 1135995National Health and Medical Research Council 1194769
6 · The paper itself

Abstract

backgroundPatellofemoral pain (PFP) affects one-third of adolescents and can persist into adulthood, negatively impacting health and quality of life. Foot orthoses are a recommended treatment for adults with PFP, but have not been evaluated in adolescents. The primary objective was to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating effects of contoured, prefabricated foot orthoses on knee pain severity and patient-perceived global change, compared to flat insoles. The secondary objective was to describe outcomes on a range of patient-reported outcome measures.

methodsWe recruited adolescents aged 12-18 years with PFP of ≥2 months duration into a double-blind, randomised, parallel-group feasibility trial. Participants were randomised to receive prefabricated contoured foot orthoses or flat shoe insoles, and followed for 3 months. Participants and outcome assessors were blinded to group allocation. Primary outcomes were feasibility of a full-scale RCT (number of eligible/enrolled volunteers; recruitment rate; adherence with the intervention and logbook completion; adverse effects; success of blinding; drop-out rate), and credibility and expectancy of interventions. Secondary outcomes were patient-reported measures of pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions.

results36 out of 279 (12.9%) volunteers (27 female, mean (SD) age 15 (2) years, body mass 60 (13) kg) were eligible and enrolled, at a recruitment rate of 1.2 participants/week. 17 participants were randomised to receive foot orthoses, and 19 to flat insoles. 15 participants returned logbooks; 7/15 (47%) adhered to the intervention. No serious adverse events were reported. 28% (10/36, 4 pandemic-related) of participants dropped out before 3 months. Blinding was successful. Both groups found the inserts to be credible.

conclusionsBased on a priori criteria for feasibility, findings suggest that a full-scale RCT comparing contoured foot orthoses to flat insoles in adolescents with PFP would not be feasible using the current protocol. Prior to conducting a full-scale RCT, feasibility issues should be addressed, with protocol modifications to facilitate participant retention, logbook completion and shoe insert wear.

trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000957190 . Date registered: 8/07/2019.

Indexed as

PatellaPatellofemoral Pain SyndromeAdolescentAdultAustraliaFeasibility StudiesFemaleHumansShoesAdolescentsFeasibilityFoot orthosesPatellofemoral painPhysiotherapy

Identifiers

PMID34893092
PMCPMC8661346
OpenAlexW4225761949

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.