Randomized Clinical Trial in Juvenile Fibromyalgia

产品说明：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况，与大量的疼痛，痛苦和残疾有关。目前尚无治疗纤维肌痛儿童患者的随机临床试验。目前的申请是一项随机、安慰剂对照临床试验，测试联合行为和药物治疗在治疗JPFS中的疗效。已发现药物干预与行为改变相结合的治疗在治疗慢性疼痛成人中有效，但在儿科人群中研究不足。在这项研究中，我们将测试疼痛应对技能训练（CST）和低剂量阿米替林（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。我们将检验这一假设，即应对技能训练联合低剂量阿米替林（CST+AMI）将上级应对技能训练+安慰剂（CST+安慰剂）或低剂量阿米替林+注意力（AMI+ATT）。此外，我们将测试接受CST+AMI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）将被随机分配至三种治疗条件之一。在急性治疗期，分配至CST的受试者将使用疼痛和睡眠日记自我监测8周，随后进行8次每周一次的应对技能培训。会议将侧重于教授青少年肌肉放松技术，分心，活动节奏，解决问题和使用平静的技术，使用专门为这个年龄组开发的治疗手册。ATT条件下的受试者将获得相同数量的治疗师支持和关注，但不是积极的行为干预。分配至AMI的受试者的阿米替林剂量将稳定在最大剂量20 mg/天。治疗前后将评估功能障碍、疼痛强度和抑郁症状。在维持阶段，受试者将继续服用药物（或安慰剂），并每隔8周返回接受2次CST加强治疗或2次ATT治疗（取决于分组）。功能障碍、疼痛强度和抑郁症状将在6个月的维持期后重新评估。这项研究的长期目标是建立有效的治疗JPFS，导致持续的利益，改善疼痛控制和功能能力。

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.