Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and difficulty in an adolescent's day-to-day activities. The purpose of this study is to determine whether coping skills training combined with amitriptyline (AMI) can reduce pain and disability in adolescents with fibromyalgia.

Juvenile Primary Fibromyalgia Syndrome (JPFS) is a debilitating chronic pain condition that occurs in adolescence and is characterized by persistent pain, multiple tender points, sleep difficulty, and fatigue. The cause of JPFS is unknown and there is no known cure. Children and adolescents with JPFS have difficulty with daily functioning, miss a great deal of school, and experience increased emotional distress compared to their peers. AMI, an antidepressant, is often prescribed to help fibromyalgia patients sleep better, helping them function better in the daytime. Fibromyalgia syndrome appears to be resistant to treatment in adulthood, so behavioral and pharmacological treatment developed for JPFS with long-term beneficial effects would be useful. This study will evaluate the efficacy of combined coping skills training (CST) and low-dose AMI in reducing functional disability, pain intensity, and depressive symptoms in adolescents with JPFS. This study will also determine whether improvements can be sustained long-term.

This study will last 42 weeks. Participants will be recruited from three pediatric rheumatology clinics. Patients will be randomly assigned to one of three groups: combined treatment (CST + AMI); behavioral treatment only (CST + placebo); and fibromyalgia "attention" education with pharmacological treatment (attention + AMI). There will be 9 medical safety visits, spaced 4 to 5 weeks apart, in which patients will undergo a physical exam and will be examined for side effects. Patients will attend 8 individual sessions of CST or attention education over the first 18 weeks of the study. CST sessions will include training in cognitive-behavioral techniques of pain management for the adolescent and behavioral management techniques for their parents. Attention education sessions will include education on fibromyalgia and discussion about lifestyle issues, but no training in pain management procedures.

Patients will be evaluated after 18 weeks and will be followed for an additional 6-month maintenance phase. During this maintenance phase, adolescents will continue to take AMI or placebo and will attend 2 additional sessions of CST or attention education. There will be one final evaluation at the end of the maintenance phase.

Ages Eligible for Study:  13 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of JPFS based on the criteria outlined by the American College of Rheumatology (i.e., widespread pain on both sides of the body above and below the waist, and pain in 11 out of 18 tender point sites)
• Average pain intensity greater than 4 on the Visual Analog Scale
• Functional disability score greater than 7
• Willing to use acceptable forms of contraception

Exclusion Criteria:

• Other chronic rheumatic diseases, such as juvenile rheumatoid arthritis or lupus
• Current or prior treatment with amitriptyline
• Abnormal findings on electrocardiogram (EKG) or liver or thyroid bloodwork
• Current or past history of low blood pressure caused by standing up (orthostatic hypotension)
• Significant developmental delay or impairments, such as autism, cerebral palsy, or mental retardation
• Present or lifetime psychiatric diagnosis that meets DSM-IV criteria for anxiety disorders, bipolar disorder, major depressive disorder, or psychosis
• Pregnancy
• Taking opioids, anticonvulsants, antipsychotics, antimanics, psychostimulants, barbiturates, benzodiazepines, muscle relaxants, sedatives, steroids, tramadol, or herbal products (valerian, melatonin, St. John's wort, ginseng, tryptophan)
• If patients are taking nonsteroidal anti-inflammatory drugs (NSAIDS), they must agree not to exceed the following maximum daily doses: 1000 mg naproxen (or 15 mg/kg/day, whichever is smaller), 2400 mg ibuprofen (or 40 mg/kg/day, whichever is smaller), 2000 mg nabumetone, or 25 mg rofecoxib