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Study Description
Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that persists into adulthood for the majority of patients. The previous research has demonstrated that cognitive-behavioral therapy (CBT) is effective in reducing functional disability in adolescents with JFM. However, in order to achieve stronger and clinically meaningful improvement in functional disability and reduce pain, changing sedentary behavior and increasing engagement in moderate-vigorous physical activity is a crucial component of JFM pain management. Incorporation of physical exercise has emerged as a logical next step to enhance CBT, yet regular participation in any physical activity is difficult to initiate and maintain in JFM patients.
The multidisciplinary team of experts in Behavioral Medicine, Rheumatology, Exercise Science and Pain Medicine have developed a novel intervention - the Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances established CBT techniques with specialized neuromuscular exercise training derived from evidence-based pediatric injury prevention research. Innovative features include progressive neuromuscular training designed to limit delayed-onset muscle soreness and seamless integration with CBT to enhance psychological coping skills and decrease fear of movement. This treatment approach is extremely promising in its wide-ranging impact on treatment of JFM as well as other chronic musculoskeletal pain conditions in children.
ELIGIBILITY CRITERIA:
Inclusion Criteria:
- Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and confirmed by 2010 American College of Rheumatology (ACR) criteria modified for pediatric use
- Functional Disability Score ≥ 13, indicating at least moderate disability
- Average pain intensity in the past week ≥ 4 on a 0 -10 cm Visual Analog Scale
- Stable medications prior to enrollment
Exclusion Criteria:
- Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous)
- Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of major depression) or documented developmental delay
- Any medical condition determined by their physician to be a contraindication for physical exercise
- Taking opioid pain medication
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Location(s):
Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106
University of Louisville, Louisville, Kentucky, United States, 40202
Boston Chilldren's Hospital, Boston, Massachusetts, United States, 02116
Children's Mercy Hospital, Kansas City, Missouri, United States, 64108
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital, Columbus, Ohio, United States, 43205
Hospital for Sick Children, Toronto, Ontario, Canada, M5G 1X8
Study Website:
https://clinicaltrials.gov/ct2/show/NCT03268421?term=NCT03268421&rank=1