Evidence map›Paper›PMID 37858226›Full record

ArticleJournal of foot and ankle research2023

Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis.

Michelle D Smith, Viana Vuvan, Natalie J Collins, David J Hunter, Nathalia Costa, Melinda M Franettovich Smith, Bill Vicenzino

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of foot and ankle research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 26% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

7 authors at 3 institutions in 1 country.

Michelle D SmithThe University of Queensland, School of Health and Rehabilitation Sciences, Physiotherapy, Brisbane, QLD, 4072, Australia. m.smith5@uq.edu.au.ORCID http://orcid.org/0000-0002-7860-1581
Viana VuvanThe University of Queensland, School of Health and Rehabilitation Sciences, Physiotherapy, Brisbane, QLD, 4072, Australia.
Natalie J CollinsThe University of Queensland, School of Health and Rehabilitation Sciences, Physiotherapy, Brisbane, QLD, 4072, Australia.
David J HunterSydney Musculoskeletal Health, Kolling Institute, Rheumatology Department, The University of Sydney, Royal North Shore Hospital, Sydney, Australia.
Nathalia CostaThe University of Queensland, School of Health and Rehabilitation Sciences, Physiotherapy, Brisbane, QLD, 4072, Australia.
Melinda M Franettovich SmithThe University of Queensland, School of Health and Rehabilitation Sciences, Physiotherapy, Brisbane, QLD, 4072, Australia.
Bill VicenzinoThe University of Queensland, School of Health and Rehabilitation Sciences, Physiotherapy, Brisbane, QLD, 4072, Australia.
The University of Queensland · AUQueensland University of Technology · AUThe University of Sydney · AU

Funding

Australian Rheumatology Association Project Grant
6 · The paper itself

Abstract

backgroundAnkle osteoarthritis (OA) is a serious problem with high associated pain and disability. While education and exercise are recommended for the initial management of OA, this has not been investigated in ankle OA. The primary aim of this study is to establish the feasibility of running a full-scale randomised controlled trial (RCT) investigating a combined education and exercise program compared to a general advice program for people with ankle OA. The secondary aims are to collect preliminary data which will inform sample size calculations, and understand the perspectives of people with ankle OA on their participation in the trial.

methodsThirty individuals aged 35 years or older with symptomatic radiographic ankle OA will be recruited from the community and randomised to receive either a combined education and exercise program or a general advice program, both of which will be delivered by a physiotherapist in a group setting. Primary outcomes of feasibility include responses to study advertisements, number of eligible participants, recruitment rate, adherence with the intervention, fidelity of the intervention, adverse events, drop-out rate, and credibility and expectancy of the intervention. Secondary participant-reported outcomes will include global rating of change, patient acceptable symptom state, severity of ankle pain and stiffness, self-reported function, quality of life, satisfaction with treatment, and use of co-interventions. Follow up will be at 8 weeks and 3 months. Physical measures of 40 m walking speed, timed stairs descent, heel raise endurance and ankle dorsiflexion range of motion will be collected at baseline and 8 weeks. Primary feasibility outcomes will be reported descriptively, and estimates of the variability of secondary participant-reported and physical outcomes will be calculated. Semi-structured interviews will be conducted with participants to understand perspectives about the intervention and participation in the trial, with data analyzed thematically. DISCUSSION: Study findings will establish the feasibility of running a full-scale RCT to investigate a combined education and exercise program compared to a general advice program for people with ankle OA. This study is a necessary first step to advance the international research agenda of evaluating the efficacy of exercise in the management of ankle OA.

trial registrationACTRN12623000017628. Registered 10 January 2023, https://www.anzctr.org.au/ACTRN12623000017628.aspx .

Indexed as

Osteoarthritis, KneeAdultAnkleExercise TherapyFeasibility StudiesHumansPainQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeAnkle osteoarthritisEducationExerciseFeasibility

Identifiers

PMID37858226
PMCPMC10588035
OpenAlexW4387798087

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.