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.

Study hypotheses: 1) Adolescents who receive combined behavioral and pharmacological treatment will show significantly greater reductions in functional disability, pain, and depressive symptoms at the end of the acute treatment phase than adolescents who receive behavioral treatment only or pharmacological treatment with attention only. 2) Adolescents who receive combined behavioral and pharmacological treatment will show significantly lower levels of functional disability, pain, and depressive symptoms at the end of a six-month maintenance phase than adolescents who receive behavioral treatment only or pharmacological treatment with attention only.

Condition	Treatment or Intervention	Phase
Fibromyalgia Juvenile Fibromyalgia	Drug: Amitriptyline  Behavior: Coping skills training  Behavior: Fibromyalgia attention education	Phase III

Further Study Details: 

Primary Outcomes: Functional disability
Secondary Outcomes: Pain intensity; depressive symptoms
Expected Total Enrollment:  141

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:  12 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 or any other tricyclic antidepressant
• 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
• History of glaucoma

Susmita Kashikar-Zuck, PhD      513-636-6337    Susmita.Kashikar-Zuck@cchmc.org

Kentucky
      Kosair Charities Pediatric Center, Louisville,  Kentucky,  40202,  United States; Not yet recruiting
Ohio
      Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229,  United States; Recruiting
      Children's Medical Center of Dayton, Dayton,  Ohio,  45404,  United States; Recruiting

Study chairs or principal investigators

Susmita Kashikar-Zuck, PhD,  Principal Investigator,  Children's Hospital Medical Center - Cincinnati   

Study ID Numbers:  NIAMS-120; R01 AR050028-01A1
Record last reviewed:  March 2005
Last Updated:  March 18, 2005
Record first received:  June 22, 2004
ClinicalTrials.gov Identifier:  NCT00086047
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08