McGeary Donald D, Penzien Donald B, Resick Patricia A, McGeary Cindy A, Jaramillo Carlos A, Eapen Blessen C, Young-McCaughan Stacey, Nabity Paul S, Moring John C, Houle Timothy T, Keane Terence M, Peterson Alan L
Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
South Texas Veterans Health Care System, San Antonio, TX, USA.
Contemp Clin Trials Commun. 2021 Jan 6;21:100699. doi: 10.1016/j.conctc.2021.100699. eCollection 2021 Mar.
Posttraumatic headache (PTH) is a common debilitating condition arising from head injury and is highly prevalent among military service members and veterans with traumatic brain injury (TBI). Diagnosis and treatment for PTH is still evolving, and surprisingly little is known about the putative mechanisms that drive these headaches. This manuscript describes the design of a randomized clinical trial of two nonpharmacological (i.e., behavioral) interventions for posttraumatic headache. Design of this trial required careful consideration of PTH diagnosis and inclusion criteria, which was challenging due to the lack of standard clinical characteristics in PTH unique from other types of headaches. The treatments under study differed in clinical focus and dose (i.e., number of treatment sessions), but the trial was designed to balance the treatments as well as possible. Finally, while the primary endpoints for pain research can vary from assessments of pain intensity to objective and subjective functional measures, this trial of PTH interventions chose carefully to establish clinically relevant endpoints and to maximize the opportunity to detect significant differences between groups with two primary outcomes. All these issues are discussed in this manuscript.
创伤后头痛（PTH）是一种因头部受伤而引发的常见使人衰弱的病症，在患有创伤性脑损伤（TBI）的军人和退伍军人中极为普遍。PTH的诊断和治疗仍在不断发展，令人惊讶的是，对于引发这些头痛的假定机制知之甚少。本手稿描述了一项针对创伤后头痛的两种非药物（即行为）干预措施的随机临床试验的设计。该试验的设计需要仔细考虑PTH的诊断和纳入标准，由于PTH缺乏有别于其他类型头痛的标准临床特征，这颇具挑战性。所研究的治疗方法在临床重点和剂量（即治疗疗程数）方面有所不同，但该试验旨在尽可能平衡这些治疗方法。最后，虽然疼痛研究的主要终点可能从疼痛强度评估到客观和主观功能测量各不相同，但这项PTH干预试验谨慎选择以建立临床相关终点，并最大限度地利用两个主要结果来检测组间显著差异的机会。本手稿将讨论所有这些问题。
