Status:
COMPLETED
Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Fibromyalgia
Myofascial Pain Syndrome
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in r...
Detailed Description
Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically persists into adulthood for the majority of patients. Whereas medications offer limited and short-term sympto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT03268421
Start Date
January 2 2018
End Date
December 21 2023
Last Update
February 14 2025
Active Locations (7)
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1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
2
Riley Children's Hospital-University of Indiana
Indianapolis, Indiana, United States, 46202
3
Boston Chilldren's Hospital
Boston, Massachusetts, United States, 02116
4
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108