Evidence map›Paper›PMID 38337536›Full record

ArticleJournal of clinical medicine2024

Topical Treatment Is Effective and Safe for Acute Ankle Sprains: The Multi-Center Double-Blind Randomized Placebo-Controlled TRAUMED Trial.

Ludger Gerdesmeyer, Johannes Vester, Christian Schneider, Britt Wildemann, Christine Frank, Myron Schultz, Bernd Seilheimer, Alta Smit, Gino Kerkhoffs

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 45% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 1 citations in OpenAlex.

  1. Pooled it
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

9 authors at 4 institutions in 2 countries.

Ludger GerdesmeyerOrthopedics and Trauma Surgery, Kiel Municipal Hospital, 24116 Kiel, Germany.
Johannes Vesteridv Data Analysis & Study Planning, 82131 Gauting, Germany.
Christian SchneiderOrthopedic Center Theresie, 80339 Munich, Germany.ORCID 0000-0003-4834-4382
Britt WildemannExperimental Trauma Surgery, Jena University Hospital, Friedrich Schiller University Jena, 07747 Jena, Germany.ORCID 0000-0002-8365-1188
Christine FrankHeel GmbH, 76532 Baden-Baden, Germany.ORCID 0009-0007-8173-2877
Myron SchultzHeel GmbH, 76532 Baden-Baden, Germany.
Bernd SeilheimerHeel GmbH, 76532 Baden-Baden, Germany.ORCID 0000-0002-9108-5892
Alta SmitHeel GmbH, 76532 Baden-Baden, Germany.
Gino KerkhoffsDepartment of Orthopedic Surgery and Sports Medicine, Amsterdam Movement Sciences, Amsterdam University Medical Centers, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.
Heel (Germany) · DEAmsterdam University Medical Centers · NLJena University Hospital · DEPTV Group (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTopical NSAIDs are widely used to treat ankle sprains. Traumed (Tr14) gel is a multicomponent formulation, demonstrating inflammation-resolution properties.

methodsThis multicenter, double-blind trial investigated the efficacy and safety of Tr14 gel versus placebo gel and non-inferiority versus 1% diclofenac gel, applied 3×/day for 7 days after acute lateral ankle sprain (EudraCT Number: 2016-004792-50). The primary outcome was AUC for pain on passive movement, assessed by VAS from baseline to Days 4 and 7.

resultsThe trial population included 625 patients aged 18 to 78 years. The AUC scores were 187.88 and 200.75 on Day 4 (

conclusionsTr14 gel is effective and safe in acute ankle sprains, compared to placebo gel and diclofenac gel, and has faster pain resolution.

trial registrationThe trial was registered in clinicaltrialsregister.eu, EudraCT number 2016-004792-50 on 07.06.2017.

Indexed as

ankle sprainanti-inflammatory agentsdiclofenacinjurymusculoskeletal painTr14TRAUMEDtraumeeltreatment

Identifiers

PMID38337536
PMCPMC10856131
OpenAlexW4391450375

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.