Evidence map›Paper›PMID 40465705›Full record

ArticlePloS one2025

Effects of cryotherapy on function, pain intensity, swelling, and dorsiflexion range of motion in acute ankle sprain: Protocol for the FROST randomised controlled trial.

Julio Miranda, Hytalo Jesus Silva, Fabiane Gontijo Correa, Rafaela Figueiredo, Gabriel Fonseca, Victor Guilherme Oliveira, Sérgio Samuel Borba Fonseca Silva, Samuel Pereira Santos, Itayano Mendes Lamas, Frederico Ataíde and 4 more

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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. 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

14 authors.

Julio MirandaPostgraduate Program in Rehabilitation and Functional Performance, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.ORCID https://orcid.org/0000-0002-7125-8813
Hytalo Jesus SilvaPostgraduate Program in Health Sciences, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.ORCID https://orcid.org/0000-0001-9611-2186
Fabiane Gontijo CorreaPostgraduate Program in Rehabilitation and Functional Performance, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.
Rafaela FigueiredoDepartment of Physiotherapy, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.
Gabriel FonsecaDepartment of Physiotherapy, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.
Victor Guilherme OliveiraDepartment of Physiotherapy, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.
Sérgio Samuel Borba Fonseca SilvaDepartment of Physiotherapy, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.
Samuel Pereira SantosNossa Senhora da Saúde Hospital, Diamantina, Brazil.
Itayano Mendes LamasNossa Senhora da Saúde Hospital, Diamantina, Brazil.
Frederico AtaídeNossa Senhora da Saúde Hospital, Diamantina, Brazil.
Anderson SantonsNossa Senhora da Saúde Hospital, Diamantina, Brazil.
Sérgio Antunes SantosPostgraduate Program in Rehabilitation and Functional Performance, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.
Germano CoelhoNossa Senhora da Saúde Hospital, Diamantina, Brazil.
Vinicius Cunha OliveiraPostgraduate Program in Rehabilitation and Functional Performance, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.ORCID https://orcid.org/0000-0002-8658-3774

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCryotherapy is a low-cost treatment option recommended by clinical practice guidelines in acute ankle sprain. However, the current quality of the evidence that supports cryotherapy is still unclear. New high-quality randomised controlled trials are needed. The aim of the Freeze On Sprain Trial (FROST) is to investigate the effectiveness of cryotherapy on function, pain intensity, swelling and dorsiflexion range of motion in people with an acute episode of ankle sprain.

methodsThis is a protocol of a two-arm randomised controlled trial. Eighty-two participants over 18 years old presenting grade I or II ankle sprain up to 72 hours from the episode will be randomly allocated to Ice Group (i.e., home prescription to apply cryotherapy on the injured ankle with elevation plus non-steroidal anti-inflammatory medication - NSAID) or No Ice Group (i.e., elevation plus NSAID). Our primary outcome is function measured by the Lower Extremity Functional Scale (LEFS) questionnaire. Our secondary outcomes are pain intensity (11-point numerical rating scale), swelling (figure-of-eight method) and dorsiflexion range of motion (goniometry). Participants will be assessed at baseline, 24 hours, 7-10 days, and 12 weeks after allocation. The analysis will follow the intention-to-treat principle using linear mixed models. DISCUSSION: The results of this study will clarify the effectiveness of cryotherapy in acute ankle sprain for better clinical decision-making processes.

trial registrationBrazilian Clinical Trials Registry (REBEC) RBR-8v9gr9c.

Indexed as

Ankle InjuriesCryotherapyEdemaRange of Motion, ArticularSprains and StrainsAdultAnti-Inflammatory Agents, Non-SteroidalFemaleHumansMalePainPain MeasurementTreatment OutcomeYoung AdultAnti-Inflammatory Agents, Non-Steroidal

Identifiers

PMID40465705
PMCPMC12136321

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.