Evidence map›Paper›PMID 41629976›Full record

ArticleTrials2026

A Phase III triple-blind randomised placebo-controlled trial to evaluate effectiveness of early treatment with pregabalin to reduce pain severity after whiplash road traffic injury: study protocol for the PRioRTI Trial {1}.

Michele Sterling, Scott F Farrell, Lisa Ferguson, Geoffrey Mitchell, Stephan Schug, Robert S Ware, Michael Dinh, Antonio Celenza, Luke Connelly, Paul W Hodges and 5 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Michele SterlingRECOVER Injury Research Centre, The University of Queensland, Brisbane, Australia. m.sterling@uq.edu.au.ORCID http://orcid.org/0000-0003-1772-2248
Scott F FarrellRECOVER Injury Research Centre, The University of Queensland, Brisbane, Australia.
Lisa FergusonRECOVER Injury Research Centre, The University of Queensland, Brisbane, Australia.
Geoffrey MitchellSchool of Medicine, The University of Queensland, Brisbane, Australia.
Stephan SchugMedical School, University of Western Australia, Perth, Australia.
Robert S WareGriffith Biostatistics Unit, Griffith University, Gold Coast, Australia.
Michael DinhRoyal Prince Alfred Hospital, Sydney, Australia.
Antonio CelenzaMedical School, University of Western Australia, Perth, Australia.
Luke ConnellyCentre for the Business and Economics of Health, The University of Queensland, Brisbane, Australia.
Paul W HodgesThe University of Queensland, Centre for Innovation in Pain and Health Research, Brisbane, Australia.
David M KlyneThe University of Queensland, Centre for Innovation in Pain and Health Research, Brisbane, Australia.
Rachel ElphinstonRECOVER Injury Research Centre, The University of Queensland, Brisbane, Australia.
Jane NiklesRECOVER Injury Research Centre, The University of Queensland, Brisbane, Australia.
James McAuleySchool of Health Sciences, University of New South Wales, Sydney, Australia.
Chung-Wei Christine LinInstitute for Musculoskeletal Health, Sydney Local Health District and The University of Sydney, Sydney, Australia.

Funding

MRFF APP2022935
6 · The paper itself

Abstract

backgroundThere are few effective treatments for acute whiplash-associated disorder (WAD) following a road traffic crash. Early clinical features of central sensitisation, for example widespread hyperalgesia, predict poor recovery. Pregabalin's effects on central sensitisation suggest the potential to prevent or modulate these processes after whiplash injury and prevent later chronic pain. Preliminary evidence indicates that pregabalin provided in the Emergency Department and within 96 hours of injury shows promise to prevent chronic pain. This trial aims to definitively evaluate, in patients at risk for poor recovery following whiplash injury, the effectiveness of early (within 96 hours of injury) pregabalin, compared to placebo, to reduce pain severity.

methodsThe PReventing chronic pain after whiplash Road Traffic Injury (PRioRTI) study is a 12-month randomised, placebo-controlled, triple-blind trial. Individuals with acute WAD (aged 18-70 years) and at risk of poor recovery (pain ≥ 5/10) will be recruited from hospital Emergency Departments in Australia. Participants will be randomly assigned 1:1 to receive pregabalin or placebo. All participants will additionally receive an evidence-based advice booklet. Pregabalin will be commenced at 75 mg bd and titrated to 300 mg bd over 4 weeks, then weaned for 2 weeks. Participants will complete online questionnaires at 6 weeks and 3, 6 and 12 months post-randomisation. The primary outcome will be average pain intensity over 24 hours (0-10 numerical rating scale) at 3 months post-randomisation. Secondary outcomes include disability, patient global impression of recovery, psychological distress, quality of life and the number of adverse events. A cost-effectiveness analysis will be conducted. Potential mediators of treatment effects will be explored. A process evaluation will be conducted to explore barriers and facilitators for future implementation. DISCUSSION: There are few effective treatments for acute WAD. To address this gap, the PRioRTI trial aims to improve health outcomes by targeting central nociceptive processes very soon after whiplash injury using a readily available medication, pregabalin. If successful, the results of this trial will address an urgent unmet need to reduce pain severity after injury and will have clear implications for the early treatment of patients with whiplash injury. TRIAL REGISTRATION {2A AND 2B}: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12624001359527. Registered 13th November 2024.

Indexed as

Accidents, TrafficAnalgesicsChronic PainPregabalinWhiplash InjuriesAdolescentAdultAgedAustraliaFemaleHumansMaleMiddle AgedPain MeasurementRandomized Controlled Trials as TopicSeverity of Illness IndexAnalgesicsPregabalinAcute painCentral nervous system sensitisationChronic painPregabalinRandomised controlled trialWhiplash associated disordersWhiplash injuries

Identifiers

PMID41629976
PMCPMC12955281

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.