Evidence map›Paper›PMID 31005917›Full record

ArticleBMJ open2019

The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis.

Natalie J Collins, Jade M Tan, Hylton B Menz, Trevor G Russell, Anne J Smith, Bill Vicenzino, Shannon E Munteanu, Rana S Hinman, Terry P Haines, Harvi F Hart and 5 more

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

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 27% 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

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Physical Therapist Management of Anterior Knee Pain.Current reviews in musculoskeletal medicine · 2020
    Review
  4. 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

15 authors at 6 institutions in 2 countries.

Natalie J CollinsDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.ORCID 0000-0001-9950-0192
Jade M TanLa Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
Hylton B MenzLa Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
Trevor G RussellDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.
Anne J SmithSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.
Bill VicenzinoDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.
Shannon E MunteanuLa Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
Rana S HinmanCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Terry P HainesSchool of Primary and Allied Health Care, Monash University, Melbourne, Victoria, Australia.
Harvi F HartLa Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
Brooke E PattersonLa Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
Gearoid ClearyDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.
Joel W DonnarLa Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
Liam R MaclachlanDivision of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.
Kay M CrossleyLa Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
La Trobe University · AUThe University of Queensland · AUCurtin University · AUMonash University · AUThe University of Melbourne · AUWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatellofemoral (PF) osteoarthritis (OA) is a common and burdensome subgroup of knee OA, with very little evidence for effective treatments. Prefabricated foot orthoses are an affordable and accessible intervention that have been shown to reduce PF pain in younger adults. Similarities between PF pain and PFOA, as well as our pilot work, suggest that foot orthoses may also be an effective intervention for PFOA. The primary objective of this study is to compare the 3 month efficacy of prefabricated foot orthoses and flat shoe inserts in people with PFOA, on knee pain severity. METHODS AND ANALYSIS: The FOOTPATH Study (FOot OrThoses for PAtellofemoral osteoarTHritis) is a multicentre, randomised, participant- and assessor-blinded superiority trial with two parallel groups, a 3 month observation period (pre-randomisation) and 12 month follow-up. 160 participants with a clinical diagnosis of PFOA will be recruited from three sites in Australia, and randomised to one of two groups (prefabricated foot orthoses or flat shoe inserts). The primary outcome is worst knee pain severity during a self-nominated aggravating activity in the previous week (100 mm visual analogue scale) at 3 months, with a secondary endpoint at 12 months. Secondary outcomes include global rating of change, symptoms, function, health-related quality of life, kinesiophobia, self-efficacy and use of co-interventions for knee pain. Blinded, intention-to-treat analyses of primary and secondary patient-reported outcomes will be performed, as well as economic analyses. ETHICS AND DISSEMINATION: Ethical approval has been granted by La Trobe University's Human Ethics Committee and The University of Queensland's Medical Research Ethics Committee. Study outcomes will be disseminated via peer-reviewed journals, conference presentations targeting a range of healthcare disciplines and an open access website with clinician resources. TRIAL REGISTRATION NUMBER: ANZCTRN12617000385347; Pre-results.

Indexed as

Foot OrthosesOsteoarthritis, KneeAustraliaDouble-Blind MethodEquivalence Trials as TopicHumansMulticenter Studies as TopicPain MeasurementPatient Reported Outcome MeasuresRandomized Controlled Trials as TopicTasmaniaclinical trialskneerheumatology

Identifiers

PMID31005917
PMCPMC6500302
OpenAlexW2936669196

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.