A 34-week Phase III study for young Fibromyalgia patients ages 11 to 18 of both sexes is now recruiting. Designed to test the benefits of short- and longer-term coping skills training for young FM patients, the trial will be conducted by juvenile rheumatology clinics in four metropolitan areas:
n Louisville, Kentucky,
n Cincinnati, Ohio
n Dayton, Ohio
n Cleveland, Ohio. Owing to the multiple visits and long time frame of this study, patients must be located within traveling distance of a clinic. For questions see the contact information below.
Officially titled “Randomized Clinical Trial in Juvenile Fibromyalgia” (ClinicalTrials.gov # NCT00086047), this study is sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Background and Purpose
“Juvenile Primary Fibromyalgia Syndrome (JPFS) is a chronic pain condition that can cause considerable suffering and difficulty in an adolescent's day-to-day activities….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.”
The concept is that “Fibromyalgia Syndrome appears to be resistant to treatment in adulthood, so early behavioral treatment for JPFS with long-term beneficial effects would be useful.”
“This study will evaluate the efficacy of coping skills training (CST) when combined with usual medical care 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.”
The hypotheses are that:
n Adolescents who receive coping skills training combined with their usual medical care will show significantly greater reductions in functional disability, pain, and depressive symptoms at the end of the acute treatment phase than adolescents who receive Fibromyalgia education with their usual medical care.
n Adolescents who receive coping skills training with their usual medical care 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 Fibromyalgia education with their usual medical care.
Study Type: Phase III, Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measured: Functional disability
Secondary Outcomes Measured: Pain intensity; depressive symptoms
Expected Total Enrollment: 116
Last follow-up: April 2009
n Patients will be randomly assigned to one of two groups: CST plus usual medical care or education plus usual medical care.
n There will be 6 medical visits, spaced 4 to 5 weeks apart.
n In addition, patients will attend 8 individual sessions of CST or education over the first 8 weeks of the study.
n Coping skills training sessions will include training in cognitive-behavioral techniques of pain management for the adolescent and behavioral management techniques for their parents.
n Education sessions will include education on fibromyalgia and discussion about lifestyle issues, but no training in pain management procedures.
n Patients will be evaluated at Week 9 and will be followed for an additional 6-month maintenance phase.
n During this maintenance phase, adolescents will continue to receive their usual medical care and will attend 2 additional sessions of CST or education. There will be one final evaluation at the end of the maintenance phase.
Requirements for Inclusion:
n Diagnosis of JPFS based on widespread pain for over 3 months, at least 5 tender points, and associated features such as sleep difficulty, fatigue, and abdominal discomfort
n Average pain intensity greater than 4 on the Visual Analog Scale
n Functional disability score greater than 7
n Stable medications for 8 weeks prior to study entry
n Other chronic rheumatic diseases, such as juvenile rheumatoid arthritis or lupus
n Significant developmental delay or impairments, such as autism, cerebral palsy, or mental retardation
n Present or lifetime psychiatric diagnosis that meets DSM-IV criteria for panic disorder, bipolar disorder, major depressive disorder, or psychosis
n Opioid medications are disallowed when used on an ongoing basis for treatment of Fibromyalgia pain
Locations and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00086047
Principal Investigator: Susmita Kashikar-Zuck, PhD 513-636-6337
Kosair Charities Pediatric Center, Louisville, Kentucky,
Kenneth Schikler, MD 502-852-3721
Cincinnati Children's Hospital Medical Center
Susmita Kashikar-Zuck, PhD
Megan Johnston, BA
Children's Medical Center of Dayton
Murray Passo, MD 513-636-4676
Cleveland Clinic Foundation, Division of Pediatrics
Sonya Crook, RN 216-444-3290 firstname.lastname@example.org
Health Authority: U.S. Federal Government