Randomized Clinical Trial in Juvenile Fibromyalgia

描述：青少年原发性纤维肌痛综合征(JPFS)是一种病因不明的慢性疼痛状态，与大量的疼痛、痛苦和残疾有关。目前还没有治疗纤维肌痛儿童患者的随机临床试验。目前的应用是一项随机、安慰剂对照的临床试验，测试联合行为和药物治疗对JPFS的疗效。药理学干预与行为改变相结合的治疗方法已被发现在治疗患有慢性疼痛的成年人方面是有效的，但在儿科人群中尚未得到充分研究。在这项研究中，我们将测试疼痛应对技能训练(CST)和小剂量阿米替林(AMI)的组合是否有效地减少JPFS青少年的功能障碍、疼痛和抑郁症状。我们将检验这样一种假设，即应对技能训练与小剂量阿米替林联合应用(CST AMI)将优于应对技能训练安慰剂(CST安慰剂)或小剂量阿米替林注意(AMIATT)。此外，我们将测试接受CST急性心肌梗死的受试者在6个月的维持期后是否会显著减少疼痛、残疾和抑郁症状。受试者(N=135)将被随机分配到三种治疗条件中的一种。在急性治疗阶段，被分配到CST的受试者将使用疼痛和睡眠日记进行自我监测，为期8周，然后每周进行8次应对技能培训。课程将重点教授青少年肌肉放松技术、分心、活动步调、解决问题和使用专门为这个年龄段开发的治疗手册的镇静技术。处于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。分配给急性心肌梗死患者的阿米替林剂量将稳定在每天20毫克的最大剂量。治疗前后将对功能障碍、疼痛强度和抑郁症状进行评估。在维持阶段，受试者将继续服用药物(或安慰剂)，并每隔8周返回参加2次CST强化疗程或2次ATT疗程(取决于小组分配)。在为期六个月的维护阶段结束后，将重新评估功能残疾、疼痛强度和抑郁症状。这项研究的长期目标是为JPF建立有效的治疗方法，在改善疼痛控制和功能能力方面带来持续的好处。

DESCRIPTION: Juvenile Primary Fibromyalgia Syndrome (JPFS) is a chronic pain condition of unknown etiology and is associated with a great deal of pain, suffering and disability. There are currently no randomized clinical trials for the treatment of pediatric patients suffering from fibromyalgia. The current application is a randomized, placebo controlled clinical trial testing the efficacy of combined behavioral and pharmacological treatment in the treatment of JPFS. Treatments combining pharmacological interventions with behavior change have been found to be efficacious in the treatment of adults with chronic pain but have been understudied in pediatric populations. In this study, we will test whether a combination of pain coping skills training (CST) and low-dose amitriptyline (AMI) is efficacious in reducing functional disability, pain and depressive symptoms in adolescents with JPFS. We will test the hypothesis that coping skills training combined with low-dose amitriptyline (CST+AMI) will be superior to coping skills training + placebo (CST+placebo) or low-dose amitriptyline + attention (AMI+ATT). Further, we will test whether subjects who receive CST+AMI will have significantly less pain, disability and depressive symptoms after a six-month maintenance phase. Subjects (N=135) will be randomly assigned to one of the three treatment conditions. During the acute treatment phase, subjects assigned to CST will self-monitor using pain and sleep diaries for 8 weeks, followed by 8 weekly sessions of coping skills training. Sessions will focus on teaching the adolescent muscle relaxation techniques, distraction, activity pacing, problem solving and use of calming techniques using a treatment manual specifically developed for this age group. Subjects in the ATT condition will receive the same amount of therapist support and attention but not the active behavioral intervention. Amitriptyline dosage for subjects assigned to AMI will be stabilized at a maximum dose of 20 mg per day. Functional disability, pain intensity and depressive symptoms will be assessed before and after treatment. In the maintenance phase, subjects will continue to take their medication (or placebo) and return for either 2 CST booster sessions or 2 ATT sessions (depending on group assignment) at intervals of 8 weeks. Functional disability, pain intensity and depressive symptoms will be reassessed after the six-month maintenance phase. The long term objectives of this research are to establish effective treatments for JPFS that lead to sustained benefits in terms of improved pain control and functional abilities.