Drug & Non-Drug Treatment of Pediatric Chronic Headache

描述（由申请人提供）：慢性每日头痛（CDH;定义为每月头痛天数≥ 15天）是一种与大量疼痛、痛苦和残疾相关的慢性疼痛病症。超过三分之一的儿童头痛门诊患者患有CDH。为患有CDH的青少年制定有效的干预措施可能会防止这种非常衰弱和昂贵的疾病发展到成年。目前还没有随机临床试验评估儿童CDH的治疗。目前的提议是一项随机对照临床试验，旨在测试10至17岁青少年慢性每日头痛的行为和药物联合治疗的疗效。已发现药物干预与行为改变相结合的治疗方法在治疗患有慢性疼痛（包括头痛）的成人中有效，但在儿科人群中研究不足。在这项研究中，我们将探讨疼痛应对技能训练（CST）和阿米替林（AMI）的组合是否有效地减少头痛的频率，功能障碍和抑郁症状的青年CDH。具体来说，我们将测试的假设，即应对技能训练联合阿米替林（CST+AMI）将上级阿米替林+注意力控制（AMI+ATT）治疗20周后。此外，我们将测试接受CST+AMI的受试者是否在3、6、9和12个月随访时头痛频率显著降低，残疾和抑郁症状减少。年龄为10 - 17岁的受试者（N=132）将被随机分配至两种治疗条件之一。分配到CST的受试者将完成8次每周的应对技能培训和2次每月的维护促进培训。会议将侧重于教授青年生物反馈，肌肉放松技术，图像，分心，活动节奏，解决问题和使用平静的技术，使用专门开发的治疗手册，并在青少年中进行试点测试。手动ATT条件下的受试者将获得相同数量的治疗师支持和关注，但不接受积极的行为干预。科技委或特设工作组的加强会议将在每个后续行动时间点举行。所有受试者的阿米替林将稳定在1 mg/kg/天的剂量。头痛频率、功能障碍、疼痛和头痛特征、生活质量和抑郁症状将在治疗前后进行评估，并在第3、6、9和12个月进行重新评估。长期目标是为青年CDH建立有效的治疗方法，在头痛频率和功能障碍的临床显著减少方面产生持续的益处。

DESCRIPTION (provided by applicant): Chronic daily headache (CDH; defined as 15 or more headache days per month) is a chronic pain condition associated with a great deal of pain, suffering and disability. Over one-third of patients seen in pediatric headache clinics have CDH. Development of effective interventions for youth with CDH could potentially prevent the progression of a very debilitating and costly condition into adulthood. There are currently no randomized clinical trials evaluating the treatment of CDH in pediatric patients. The current proposal is a randomized, controlled clinical trial testing the efficacy of combined behavioral and pharmacological treatment of chronic daily headache in youth age 10 to 17. Treatments combining pharmacological interventions with behavior change have been found to be efficacious in the treatment of adults with chronic pain, including headaches, but have been understudied in pediatric populations. In this study, we will investigate whether a combination of pain coping skills training (CST) and amitriptyline (AMI) is efficacious in reducing headache frequency, functional disability, and depressive symptoms in youth with CDH. Specifically, we will test the hypothesis that coping skills training combined with amitriptyline (CST+AMI) will be superior to amitriptyline + an attention control (AMI+ATT) after 20 weeks of treatment. Further, we will test whether subjects who receive CST+AMI will have significantly less frequent headache and reduced disability and depressive symptoms at 3, 6, 9, and 12 month follow-ups. Subjects (N=132) age 10 to 17 will be randomly assigned to one of the two treatment conditions. Subjects assigned to CST will complete 8 weekly sessions of coping skills training and two monthly maintenance-promoting sessions. Sessions will focus on teaching the youth biofeedback, muscle relaxation techniques, imagery, distraction, activity pacing, problem solving and use of calming techniques using a treatment manual specifically developed and pilot tested in youth with CDH. Subjects in the manualized ATT condition will receive the same amount of therapist support and attention but not the active behavioral intervention. Booster CST or ATT sessions will occur at each follow-up time point. Amitriptyline for all subjects will be stabilized at a dose of 1 mg/kg/day. Headache frequency, functional disability, pain and headache characteristics, quality of life, and depressive symptoms will be assessed before and after treatment, and reassessed at 3, 6, 9, and 12 months. The long term objective is to establish effective treatments for CDH in youth that lead to sustained benefits in terms of clinically significant reductions in headache frequency and functional disability.