Headstrong Intervention for Recurrent Pediatric Headache

描述（由申请人提供）：复发性儿科头痛是一种慢性疼痛综合征，影响了200多万美国儿童，经常导致严重的功能残疾和衰弱。此外，这种综合征对患者的家庭和卫生保健系统造成了巨大的成本。本研究的目的是评估一种新的具有成本效益的方法治疗复发性儿童头痛的效果，该方法允许儿童通过CD-ROM程序（称为“Headstrong TM”）学习如何自我管理头痛。该拨款提案是根据PA-01-115提交的，该提案要求研究寻求确定和改进针对特定疼痛状况的创新和有效治疗策略。一项随机试验将用于评估Headstrong TM干预的有效性。108名年龄在7-12岁、诊断为复发性偏头痛、肌肉收缩或慢性每日头痛综合征的儿科患者将被纳入研究。入组后，使用头痛日记对每位患者的基线头痛频率、持续时间和强度进行为期一个月的评估。在这一个月的基线期间，我们还将收集数据来检查与头痛相关的残疾和与健康相关的生活质量。基线后，患者将被随机分配到标准医疗护理加Headstrong TM干预组或标准医疗护理加教育条件组（也提供CD-ROM程序，其中包含复发性头痛的信息，如类型、病因和触发因素）。两个小组将在一个月的时间里完成各自项目中的模块。在治疗后1个月和治疗后3个月、6个月和12个月的随访中，将继续收集相关措施。主要研究结果将是头痛的频率、持续时间和强度，由每日头痛日记测量。次要终点包括与头痛相关的残疾结局和生活质量。

DESCRIPTION (provided by applicant): Recurrent pediatric headache is a chronic pain syndrome affecting more than two million American children and often resulting in significant functional disability and debilitation. Moreover, this syndrome represents a substantial cost to the patient's family and the health care system. The goal of the present study is to evaluate the efficacy of a new cost-effective approach to the treatment of recurrent pediatric headache that allows children to learn how to self-manage their headaches via a CD-ROM program (called "Headstrong TM"). This grant proposal is being submitted in response to PA-01-115, which called for research seeking to identify and refine innovative and effective treatment strategies for specific pain conditions. A randomized trial will be used to evaluate the effectiveness of the Headstrong TM intervention. One-hundred and eight (108) pediatric patients, ages 7-12 years, with a diagnosed recurrent migraine, muscle-contraction, or chronic daily headache syndrome will be enrolled in the study. After enrollment, each patient's baseline headache frequency, duration, and intensity will be assessed for one month using headache diaries. During this one-month baseline period, we will also collect data to examine headache-related disability and health related quality of life. After baseline, patients will be randomly assigned to the standard medical care plus Headstrong TM intervention or the standard medical care plus Education condition (also a CD-ROM program with information about recurrent headaches, such as types, etiology, and triggers). Both groups will work through modules in their respective programs over the course of one month. Dependent measures will then continue to be collected at one-month post-treatment and three-, six-, and twelve-month post-treatment follow-up. The primary study outcome will be headache frequency, duration, and intensity as measured by daily headache diaries. Secondary endpoints will include headache-related disability outcomes and quality of life.