背景:鞭打相关障碍(WAD),一种常见的和致残的情况,给澳大利亚带来了巨大的负担和成本。然而,目前鞭打治疗效果不是很好;迫切需要改善结局.临床指南推荐简单的镇痛(扑热息痛和非甾体抗炎药),但没有指南推荐药物的试验。本研究将调查循证建议(EBA)的有效性,扑热息痛,萘普生,扑热息痛和萘普生,减少日常颈部疼痛和预防鞭打损伤后的慢性颈部疼痛。
方法:本研究是一系列多周期试验,双盲,随机N-of-1试验,嵌套在多基线设计中。设计将包括三个基线,持续时间为5、8或11天。登记后,参与者将被随机分配到其中一个基线。15名急性(<2周)II级WAD的参与者,经历至少中度疼痛(NRS:≥5/10),并且有康复不良的风险将从昆士兰州的医院招募,澳大利亚,通过当地的物理治疗师。患者将接受EBA加三个周期的随机序列,为期十天的治疗三联(扑热息痛指定为C期,萘普生,指定为D阶段,扑热息痛和萘普生,指定为E相)。
结论:我们将测试不同治疗方法对每日和伤后4和7个月收集的平均颈部疼痛强度的主要结果的影响。次要结果,包括残疾,抑郁症,创伤后应激症状,痛苦的灾难,和研究程序的可行性,也将进行评估。这项研究的结果将为一项更大的试验提供信息,旨在加强EBA和WAD简单镇痛药的证据。
背景:临床试验主要注册:澳大利亚和新西兰临床试验注册。
背景:ACTRN12618001291279。
■31/07/2018。
■昆士兰大学,布里斯班QLD4072澳大利亚。
背景:昆士兰大学.
BACKGROUND: 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).
CONCLUSIONS: 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.
BACKGROUND: Clinical Trials Primary Registry: Australian and New Zealand Clinical Trials Registry.
BACKGROUND: ACTRN12618001291279.
UNASSIGNED: 31/07/2018.
UNASSIGNED: The University of Queensland, Brisbane QLD 4072 Australia.
BACKGROUND: The University of Queensland.