Evidence map›Paper›PMID 30794553›Full record

Trial reportPloS one2019

A randomised pilot equivalence trial to evaluate diamagnetically enhanced transdermal delivery of key ground substance components in comparison to an established transdermal non-steroidal anti-inflammatory formulation in males with prior knee injury.

Bill Vicenzino, Peter Lawrenson, Asaduzzaman Khan, Aiofe Stephenson, Luke Heales, Heather A E Benson, Anthony Wright

Open access · goldAbstract readComparative StudyEquivalence TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 35% 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, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. 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 at 2 institutions in 1 country.

Bill VicenzinoSchool of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.
Peter LawrensonSchool of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.
Asaduzzaman KhanSchool of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.
Aiofe StephensonSchool of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.
Luke HealesSchool of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.
Heather A E BensonSchool of Pharmacy and Biomedical Science, Curtin University, Perth, Western Australia, Australia.
Anthony WrightSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.ORCID 0000-0002-0289-6141
The University of Queensland · AUCurtin University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis pilot study assessed the efficacy of a knee guard device, which used magnetophoresis to transdermally deliver Glucosamine, Chondroitin and Hyaluronic Acid in a cohort of individuals with prior knee injury. The aim was to determine if the change in physical function and pain with the knee guard device was equivalent to the change produced by an established topical NSAID formulation containing diclofenac sodium 1%.

methodsA randomized, controlled, equivalence trial evaluated outcomes following treatment with the knee guard device or NSAID formulation. The study recruited 114 male participants (aged 40-55 years). Participants were randomly allocated to wear the knee guard device or to use a NSAID gel daily for two weeks. The primary outcomes were the knee injury osteoarthritis function score (KOOS-F) and an aggregated function score (AFS). The lower extremity functional scale (LEFS), pain numerical rating scale (PNRS), global rating of change (GROC) and other KOOS scores were also evaluated.

resultsMultiple linear regression analyses indicated that there were no significant differences between the interventions for changes in the primary outcomes of AFS and KOOS_F. The 95% confidence interval (-2.89 to 5.15) of the estimated treatment difference for KOOS-F was within the lower (-5.61) and upper (5.61) bounds of the 7% equivalence margin for that measure, The mean value for the AFS was within, but the 95% CI (-3.11 to 7.37) exceeded the 7% equivalence margin (-2.97 to 2.97) for that measure. There was a significant difference in PNRS, which favored the knee guard device.

conclusionThe knee guard device demonstrated equivalence for the KOOS-F measure but not the AFS measure of function over the two week trial period when compared to a widely available NSAID gel that has been shown to be superior to placebo. The knee guard produced a greater reduction in pain report (p = 0.002) than the NSAID gel. Users of the knee guard device experienced more skin irritation than participants using the NSAID gel. Further research is required to fully evaluate the therapeutic potential of this innovative treatment approach.

Indexed as

AdultAnti-Inflammatory Agents, Non-SteroidalChondroitinDrug CompoundingEquipment DesignGlucosamineHumansHyaluronic AcidKnee InjuriesMagnetic PhenomenaMaleMiddle AgedPain MeasurementPilot ProjectsTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalChondroitinGlucosamineHyaluronic Acid

Identifiers

PMID30794553
PMCPMC6386272
OpenAlexW2915792463

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.