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15天或更多头痛日）是一种慢性疼痛状况，与大量疼痛，痛苦和残疾相关。在儿科头痛诊所，超过三分之一的患者患有CDH。针对青少年CDH的有效干预措施的发展可能会潜在地阻止这种非常衰弱和昂贵的疾病发展到成年期。目前尚无随机临床试验评估小儿患者CDH的治疗。目前的建议是一项随机对照临床试验，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。药物干预与行为改变相结合的治疗方法已被发现在治疗成人慢性疼痛（包括头痛）方面是有效的，但在儿科人群中的研究还不足。在这项研究中，我们将调查疼痛应对技能训练（CST）和阿米替林（AMI）的组合是否有效地减少青年CDH患者的头痛频率、功能残疾和抑郁症状。具体而言，我们将在治疗20周后检验应对技能训练联合阿米替林（CST+AMI）优于阿米替林+注意控制（AMI+ATT）的假设。此外，我们将在3个月、6个月、9个月和12个月的随访中测试接受CST+AMI治疗的受试者是否会明显减少头痛的频率、减少残疾和抑郁症状。年龄在10到17岁之间的受试者（N=132）将被随机分配到两种治疗条件之一。被分配到CST的受试者将完成每周8次的应对技能培训和每月两次的维护促进课程。课程将侧重于教授青少年生物反馈，肌肉放松技术，图像，分心，活动节奏，解决问题和使用镇静技术，使用专门开发并在青少年CDH中进行试点测试的治疗手册。在手动ATT条件下的受试者将得到相同数量的治疗师支持和关注，但没有积极的行为干预。在每个随访时间点进行辅助CST或ATT会议。阿米替林对所有受试者的剂量稳定在1mg /kg/天。在治疗前后评估头痛频率、功能障碍、疼痛和头痛特征、生活质量和抑郁症状，并在3、6、9和12个月时重新评估。长期目标是建立青年人CDH的有效治疗方法，从而在临床上显著减少头痛频率和功能残疾方面带来持续的益处。

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.