Headstrong Intervention for Recurrent Pediatric Headache

小儿复发性头痛是一种慢性疼痛综合征，影响着200多万美国儿童 并且经常导致显著的功能性残疾和衰弱。此外，这种综合征代表了一种 这对患者的家庭和医疗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科头痛的疗效， 儿童学习如何通过光盘程序（称为“Headstrong ™”）自我管理他们的头痛。这 赠款提案是为了响应PA-01-115而提交的，该提案呼吁进行研究， 为特定的疼痛状况完善创新和有效的治疗策略。 一项随机试验将用于评估Headstrong TM干预的有效性。一百 和八（108）名儿童患者，年龄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患者将入组本研究。入组后，每例患者的基线 将使用头痛日记评估一个月的头痛频率、持续时间和强度。期间 在这一个月的基线期内，我们还将收集数据，以检查与头痛有关的残疾和健康状况， 相关的生活质量。基线后，患者将被随机分配至标准医疗护理加 顽固TM干预或标准医疗护理加教育条件（也是一个光盘程序 关于复发性头痛的信息，例如类型、病因和诱因）。两组都将工作 通过模块在各自的程序在该公司。一个月的时间。相关措施将 在治疗后1个月以及治疗后3个月、6个月和12个月继续采集 随访主要研究结局将是头痛-频率、持续时间和强度， 头痛日记次要终点将包括头痛相关残疾结局和 生活_ .....

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 "HeadstrongTM"). This grant proposal is being submitted in response to PA-01-115, which called for research seeking to identify and refine innovative and effective treament 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 assesed 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 co._se 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. _ .....