Randomized Clinical Trial in Juvenile Fibromyalgia

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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.