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dc.contributor.authorNikles, J
dc.contributor.authorTate, RL
dc.contributor.authorMitchell, G
dc.contributor.authorPerdices, M
dc.contributor.authorMcGree, JM
dc.contributor.authorFreeman, C
dc.contributor.authorJacob, S
dc.contributor.authorTaing, MW
dc.contributor.authorSterling, M
dc.date.accessioned2020-01-20T05:09:07Z
dc.date.available2020-01-20T05:09:07Z
dc.date.issued2019
dc.identifier.issn2451-8654
dc.identifier.doi10.1016/j.conctc.2019.100480
dc.identifier.urihttp://hdl.handle.net/10072/390632
dc.description.abstractBackground: Whiplash associated disorder (WAD), a common and disabling condition, incurs huge burden and costs to Australia. Yet, current treatments for whiplash are not very effective; improved outcomes are urgently needed. Clinical guidelines recommend simple analgesia (paracetamol and non-steroidal anti-inflammatory drugs) but there have been no trials of guideline-recommended drugs. This study will investigate the effectiveness of evidence-based advice (EBA), paracetamol, naproxen, and both paracetamol and naproxen, in reducing daily neck pain and preventing chronic neck pain after whiplash injury. Methods: This study is a pilot series of multi-cycle, double-blinded, randomised N-of-1 trials, nested in a multiple baseline design. The design will comprise three baselines of 5, 8 or 11 days duration. Post enrolment, participants will be randomly assigned to one of the baselines. Fifteen participants with acute (<2 weeks) Grade II WAD, experiencing at least moderate pain (NRS: ≥ 5/10), and at risk of poor recovery will be recruited from hospitals in Queensland, Australia, and through local physiotherapists. Patients will receive EBA plus a randomised sequence of three cycles of ten day treatment triplets (paracetamol designated as a C phase, naproxen, designated as a D phase, and both paracetamol and naproxen, designated as an E phase). Discussion: We will test the effects of different treatments on the primary outcome of average neck pain intensity collected daily and at 4 and 7 months post-injury. Secondary outcomes, including disability, depression, post-traumatic stress symptoms, pain catastrophizing, and feasibility of study procedures, will also be evaluated. The results of this study will inform a larger trial aiming to strengthen the evidence on EBA and simple analgesics for WAD. Trial registration: Clinical Trials Primary Registry: Australian and New Zealand Clinical Trials Registry. Clinical trial registration number: ACTRN12618001291279. Date of registration: 31/07/2018. Primary trial sponsor: The University of Queensland, Brisbane QLD 4072 Australia. Funding: The University of Queensland.
dc.description.peerreviewedYes
dc.languageEnglish
dc.publisherElsevier
dc.publisher.placeUnited States
dc.relation.ispartofpagefrom100480: 1
dc.relation.ispartofpageto100480: 10
dc.relation.ispartofjournalContemporary Clinical Trials Communications
dc.relation.ispartofvolume16
dc.subject.fieldofresearchClinical Sciences
dc.subject.fieldofresearchcode1103
dc.titlePersonalised treatments for acute whiplash injuries: A pilot study of nested N-of-1 trials in a multiple baseline single-case experimental design
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationNikles, J; Tate, RL; Mitchell, G; Perdices, M; McGree, JM; Freeman, C; Jacob, S; Taing, MW; Sterling, M, Personalised treatments for acute whiplash injuries: A pilot study of nested N-of-1 trials in a multiple baseline single-case experimental design, Contemporary Clinical Trials Communications, 2019, 16, pp. 100480: 1-100480: 10
dc.date.updated2020-01-19T23:31:56Z
gro.rights.copyright© 2019 Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits unrestricted, non-commercial use, distribution and reproduction in any medium, providing that the work is properly cited.
gro.hasfulltextFull Text
gro.griffith.authorSterling, Michele


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