Evidence map›Paper›PMID 17892539›Full record

Trial reportBMC musculoskeletal disorders2007

Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial.

Kim Bennell, Kelly-Ann Bowles, Craig Payne, Flavia Cicuttini, Richard Osborne, Anthony Harris, Rana Hinman

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00415259 nacompletednot on this map

Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis

TypeinterventionalSponsorUniversity of MelbourneRan2005 to 2008Enrolled200ConditionsOsteoarthritisArmsLaterally wedged shoe insoles, Control insole group
NCT01763515 phase2 / phase3unknown statusnot on this mapstarted 2012, after this paper: background citation

The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis

TypeinterventionalSponsorIsfahan University of Medical SciencesRan2012 to 2013Enrolled120ConditionsOsteoarthritis, KneeArmsLaterally wedged insoles
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Review
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.

Kim BennellCentre for Health, Exercise & Sports Medicine, School of Physiotherapy, University of Melbourne, Australia. k.bennell@unimelb.edu.au
Kelly-Ann Bowles
Craig Payne
Flavia Cicuttini
Richard Osborne
Anthony Harris
Rana Hinman

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA. METHODS/

designTwo hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. DISCUSSION: Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA.

trial registrationACTR12605000503628; NCT00415259.

Indexed as

Clinical ProtocolsOrthotic DevicesCost-Benefit AnalysisDisease ProgressionDouble-Blind MethodFemaleHumansMaleMiddle AgedOsteoarthritis, KneePain MeasurementSurveys and QuestionnairesTreatment Outcome

Identifiers

PMID17892539
PMCPMC2147062

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.