Fibromyalgia Clinical Trial
Official title:
Randomized Clinical Trial in Juvenile Fibromyalgia
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, when combined with usual medical care, can reduce
pain and disability in adolescents with fibromyalgia.
Study hypotheses: 1) 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. 2) 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.
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. 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.
This study will last 34 weeks. Participants will be recruited from three pediatric
rheumatology clinics. Patients will be randomly assigned to one of two groups: CST plus usual
medical care or education plus usual medical care. There will be 6 medical visits, spaced 4
to 5 weeks apart. In addition, patients will attend 8 individual sessions of CST or education
over the first 8 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. Education sessions will include education on
fibromyalgia and discussion about lifestyle issues, but no training in pain management
procedures.
Patients will be evaluated at Week 9 and will be followed for an additional 6-month
maintenance phase. 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.
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