Randomized Clinical Trial in Juvenile Fibromyalgia

青少年纤维肌痛的随机临床试验

• 批准号: 6780724
• 负责人: Susmita Kashikar-Zuck
• 金额: $ 41.62万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6780724
• 关键词: adolescence (12-20); amitriptyline; analgesia; behavior therapy; chronic pain; clinical research; clinical trials; depression; fibromyalgia; functional ability; human subject; human therapy evaluation; longitudinal human study; muscle relaxation; nervous system disorder chemotherapy; patient oriented research

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.

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病症，与大量疼痛、痛苦和残疾相关。目前尚无治疗患有纤维肌痛的儿科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，测试行为和药物联合治疗在 JPFS 治疗中的疗效。研究发现，将药物干预与行为改变相结合的治疗方法对于治疗患有慢性疼痛的成人有效，但在儿科人群中的研究还不够。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) 的组合是否能有效减少 JPFS 青少年的功能障碍、疼痛和抑郁症状。我们将检验以下假设：应对技能训练联合低剂量阿米替林 (CST+AMI) 将优于应对技能训练 + 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 的受试者在六个月的维持阶段后是否会明显减轻疼痛、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之一。在急性治疗阶段，分配到 CST 的受试者将使用疼痛和睡眠日记进行为期 8 周的自我监测，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巧、分散注意力、活动节奏、解决问题和使用专门为该年龄段开发的治疗手册的镇定技巧。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。分配至 AMI 的受试者的阿米替林剂量将稳定在每天 20 毫克的最大剂量。将在治疗前后评估功能障碍、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 2 次 CST 加强疗程或 2 次 ATT 疗程（取决于小组分配）。在六个月的维持阶段后，将重新评估功能障碍、疼痛强度和抑郁症状。这项研究的长期目标是建立 JPFS 的有效治疗方法，从而在改善疼痛控制和功能能力方面带来持续的益处。