Recover Injury Research Centre, NHMRC Centre of Research Excellence in Recovery Following Road Traffic Injuries, The University of Queensland, Herston, Australia.
Department of Emergency Medicine, Gold Coast Hospital and Health Service, Gold Coast, Queensland, Australia.
Trials. 2018 Jan 17;19(1):44. doi: 10.1186/s13063-018-2450-9.
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.
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.
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.
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.
Clinical Trials Primary Registry: Australian and New Zealand Clinical Trials Registry.
ACTRN12617000059369 . Date of Registration: 11/01/2017. Primary Trial Sponsor: The University of Queensland, Brisbane QLD 4072 Australia.
挥鞭样损伤相关疾病（WAD）给澳大利亚社会带来了巨大的经济负担。多达 50%经历挥鞭样损伤的人将无法完全康复。挥鞭样损伤难以治疗，目前尚无早期管理方法可预防慢性疼痛。早期存在中枢敏化与不良恢复相关。普瑞巴林对中枢敏化的影响表明其具有在挥鞭样损伤后预防或调节这些过程并改善健康结局的潜力，但这尚未得到研究。本文介绍了一项随机对照试验的可行性研究方案，该试验将普瑞巴林联合循证建议与安慰剂联合循证建议用于有不良恢复风险的急性挥鞭样损伤患者，以评估其疗效。
这是一项双盲、安慰剂对照的随机可行性研究，将比较普瑞巴林联合循证建议（干预组）与安慰剂联合循证建议（对照组）对有不良恢复风险的急性挥鞭样损伤患者的疗效和潜在有效性。30 名（每组 15 名）年龄在 18-65 岁之间、损伤后 48 小时内、目前至少有中度疼痛（NRS：≥5/10）的 II 级 WAD 患者将从澳大利亚昆士兰州公立医院的急诊科招募。普瑞巴林将以 75mg bid 起始，并根据耐受情况滴定至 300mg bid，持续 4 周，然后进行 1 周的停药。
将测试试验程序的可行性，以及干预措施对结果的潜在影响。将使用标准方差分析技术比较治疗组在随机分组后 3 个月时颈部疼痛强度的主要结局。
可行性和潜在有效性数据将为一项适当规模的全试验提供信息，如果试验成功，将为这种昂贵且治疗困难的疾病提供一种有效且具有成本效益的干预措施。这也将对挥鞭样损伤以外的其他创伤性疾病的早期管理产生影响。
临床试验一级注册：澳大利亚和新西兰临床试验注册。
ACTRN12617000059369。注册日期：2017 年 1 月 11 日。主要试验赞助商：昆士兰大学，澳大利亚布里斯班 QLD 4072。
