Pregabalin versus placebo in targeting pro-nociceptive mechanisms to prevent chronic pain after whiplash injury in at-risk individuals – a feasibility study for a randomised controlled trial

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  • Nikles, J.
    • Other Affiliation: Recover Injury Research Centre, NHMRC Centre of Research Excellence in Recovery Following Road Traffic Injuries, The University of Queensland, Herston, Australia
  • Keijzers, G.
    • Other Affiliation: Department of Emergency Medicine, Gold Coast Hospital and Health Service, Gold Coast, Queensland, Australia; School of Medicine, Bond University, Gold Coast, QLD, Australia; School of Medicine, Griffith University, Gold Coast, QLD, Australia
  • Mitchell, G.
    • Other Affiliation: Faculty of Medicine, The University of Queensland, Herston, Australia
  • Schug, S.
    • Other Affiliation: School of Medicine and Pharmacology, The University of Western Australia, Perth, Australia
  • Ware, R.
    • Other Affiliation: Menzies Health Institute Queensland, Griffith University, Brisbane, Australia
  • McLean, S. A
    • Other Affiliation: Institute for Trauma Recovery, Department of Anesthesiology, University of North Carolina School of Medicine, Chapel Hill, USA
  • Connelly, L.
    • Other Affiliation: Recover Injury Research Centre, NHMRC Centre of Research Excellence in Recovery Following Road Traffic Injuries, The University of Queensland, Herston, Australia; Centre for the Business and Economics of Health, University of Queensland, Brisbane, Australia; Dipartimento di Sociologia e Diritto dell’Economia, University of Bologna, Bologna, Italy
  • Gibson, S.
    • Other Affiliation: Caulfield Pain Management and Research Centre, Melbourne, Australia
  • Farrell, S. F
    • Other Affiliation: Recover Injury Research Centre, NHMRC Centre of Research Excellence in Recovery Following Road Traffic Injuries, The University of Queensland, Herston, Australia; Menzies Health Institute Queensland, Griffith University, Brisbane, Australia
  • Sterling, M.
    • Other Affiliation: Recover Injury Research Centre, NHMRC Centre of Research Excellence in Recovery Following Road Traffic Injuries, The University of Queensland, Herston, Australia; Menzies Health Institute Queensland, Griffith University, Brisbane, Australia
Abstract
  • Background Whiplash-associated disorders (WAD) are an enormous and costly burden to Australian society. Up to 50% of people who experience a whiplash injury will never fully recover. Whiplash is resistant to treatment and no early management approach has yet been shown to prevent chronic pain. The early presence of central sensitization is associated with poor recovery. Pregabalin’s effects on central sensitization indicate the potential to prevent or modulate these processes after whiplash injury and to improve health outcomes, but this has not been investigated. This paper describes the protocol for a feasibility study for a randomised controlled trial of pregabalin plus evidence-based advice compared to placebo plus evidence-based advice for individuals with acute whiplash injury who are at risk of poor recovery. Methods This double blind, placebo-controlled randomised feasibility study will examine the feasibility and potential effectiveness of pregabalin and evidence-based advice (intervention) compared to placebo and evidence-based advice (control) for individuals with acute whiplash injury at risk of poor recovery. Thirty participants (15 per group) aged 18–65 years with Grade II WAD, within 48 hours of injury and currently experiencing at least moderate pain (NRS: ≥ 5/10) will be recruited from Emergency Departments of public hospitals in Queensland, Australia. Pregabalin will be commenced at 75 mg bd and titrated up to 300 mg bd as tolerated for 4 weeks followed by 1 week of weaning. Results The feasibility of trial procedures will be tested, as well as the potential effect of the intervention on the outcomes. The primary outcome of neck pain intensity at 3 months from randomisation will be compared between the treatment groups using standard analysis of variance techniques. Discussion Feasibility and potential effectiveness data will inform an appropriately powered full trial, which if successful, will provide an effective and cost-effective intervention for a costly and treatment resistant condition. It will also have implications for the early management of other traumatic conditions beyond whiplash. Trial registration Clinical Trials Primary Registry: Australian and New Zealand Clinical Trials Registry. Clinical Trial Registration Number: ACTRN12617000059369 . Date of Registration: 11/01/2017. Primary Trial Sponsor: The University of Queensland, Brisbane QLD 4072 Australia.
Date of publication
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Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • The Author(s).
Journal title
  • Trials
Journal volume
  • 19
Journal issue
  • 1
Page start
  • 44
Language
  • English
Bibliographic citation
  • Trials. 2018 Jan 17;19(1):44
Publisher
  • BioMed Central

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