Drug & Non-Drug Treatment of Pediatric Chronic Headache

描述(申请人提供)：慢性每日头痛(CDH；定义为每月头痛15天或以上)是一种慢性疼痛状况，与大量疼痛、痛苦和残疾有关。在儿科头痛诊所就诊的患者中，超过三分之一的人患有CDH。为患有CDH的青少年制定有效的干预措施，可能会防止一种非常虚弱和昂贵的疾病发展到成年。目前还没有评估儿童CDH治疗的随机临床试验。目前的建议是一项随机对照临床试验，测试行为和药物联合治疗10至17岁青年每日慢性头痛的疗效。药物干预和行为改变相结合的治疗方法已被发现对包括头痛在内的成人慢性疼痛有效，但在儿科人群中研究不足。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)联合使用是否能有效减少青少年CDH患者的头痛频率、功能障碍和抑郁症状。具体地说，我们将检验这一假设，即在治疗20周后，应对技能训练联合阿米替林(CST AMI)将优于阿米替林注意力控制(AMIATT)。此外，我们将测试接受CST急性心肌梗死的受试者在3、6、9和12个月的随访中是否会显著减少头痛的频率、减少残疾和抑郁症状。10至17岁的受试者(N=132)将被随机分配到两种治疗条件中的一种。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会议。课程将重点教授青少年生物反馈、肌肉放松技术、意象、分心、活动步调、问题解决和镇静技术的使用，使用专门编制的治疗手册，并在患有CDH的青少年中进行试点测试。处于机械化ATT状态的受试者将得到相同数量的治疗师支持和关注，但不会得到积极的行为干预。助推器CST或ATT课程将在每个后续时间点进行。所有受试者的阿米替林剂量将稳定在1毫克/公斤/天。在治疗前和治疗后评估头痛频率、功能残疾、疼痛和头痛特征、生活质量和抑郁症状，并在3、6、9和12个月重新评估。长期目标是为年轻人的CDH建立有效的治疗方法，在临床上显著减少头痛频率和功能残疾方面带来持续的好处。

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.