Côté Pierre, Cassidy J David, Carette Simon, Boyle Eleanor, Shearer Heather M, Stupar Maja, Ammendolia Carlo, van der Velde Gabrielle, Hayden Jill A, Yang Xiaoqing, van Tulder Maurits, Frank John W
Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
Trials. 2008 Dec 24;9:75. doi: 10.1186/1745-6215-9-75.
Whiplash injuries are an important public health problem that is associated with significant disability and high health care utilization. Recent cohort studies suggest that physician care may be the most effective treatment for patients with whiplash-associated disorders. However, these findings have not been tested in a randomized controlled trial. The purpose of this study is to determine which of physician care or two rehabilitation programs of care is most effective in improving recovery of patients with recent whiplash associated disorders.
We designed a pragmatic randomized clinical trial. A total of 444 participants (148 in each of three arms) who reside in Southern Ontario, Canada will be recruited from a large insurer. We will include individuals who are 18 years of age or older and who are diagnosed with Grade I or II Whiplash-associated Disorders. Participants will be randomized to physician-based education and activation or one of two rehabilitation programs of care currently in use in Ontario. Our primary outcome, self-rated global recovery and all secondary outcomes (neck pain intensity, whiplash disability, health-related quality of life, depressive symptomatology and satisfaction with care) will be measured at baseline by a trial coordinator and at 6 weeks, 3, 6, 9 and 12 months follow-up by an interviewer who is blind to the participants' baseline characteristics and treatment allocation. We will also collect information on general health status, other injuries, comorbidities, expectation of recovery, work status, pain coping, legal representation, and co-interventions. The primary intention-to-treat analysis will compare time to recovery between the three interventions. This trial will have 90% power at an alpha of 0.05 to detect a 20% difference in the rate of perceived recovery at one year. Secondary analyses will compare the health outcomes, rate of recurrence and the rate of adverse events between intervention groups.
The results of this study will provide the public, clinicians and policy makers much needed evidence on the effectiveness of common approaches used to manage whiplash-associated disorders.
ClinicalTrials.gov identifier NCT00546806.
挥鞭样损伤是一个重要的公共卫生问题，与严重残疾和高医疗保健利用率相关。最近的队列研究表明，医生治疗可能是挥鞭样相关疾病患者最有效的治疗方法。然而，这些发现尚未在随机对照试验中得到验证。本研究的目的是确定医生治疗或两种康复护理方案中哪一种在改善近期挥鞭样相关疾病患者的康复方面最有效。
我们设计了一项实用的随机临床试验。将从一家大型保险公司招募总共444名居住在加拿大安大略省南部的参与者（三个组每组148人）。我们将纳入18岁及以上且被诊断为I级或II级挥鞭样相关疾病的个体。参与者将被随机分配到基于医生的教育与激活组或安大略省目前使用的两种康复护理方案之一。我们的主要结局指标，即自我评定的总体康复情况以及所有次要结局指标（颈部疼痛强度、挥鞭样损伤残疾程度、健康相关生活质量、抑郁症状以及对护理的满意度）将在基线时由一名试验协调员进行测量，并在6周、3个月、6个月、9个月和12个月随访时由一名对参与者的基线特征和治疗分配不知情的访谈者进行测量。我们还将收集有关一般健康状况、其他损伤、合并症、康复期望、工作状态、疼痛应对、法律代理以及联合干预的信息。主要的意向性分析将比较三种干预措施之间的康复时间。本试验在α为0.05时将有90%的把握度检测出一年时感知康复率的20%差异。次要分析将比较各干预组之间的健康结局、复发率和不良事件发生率。
本研究结果将为公众、临床医生和政策制定者提供关于用于管理挥鞭样相关疾病的常见方法有效性的急需证据。
ClinicalTrials.gov标识符NCT00546806。
