Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

Completed · Not applicable

Conditions studied: Fibromyalgia, Myofascial Pain Syndrome, Muscular Diseases, Musculoskeletal Disease, Rheumatic Diseases

In brief

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 reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.

Key facts

Study ID

NCT03268421

Run by

Children's Hospital Medical Center, Cincinnati

People needed

389

Starts

2018-01-02

Expected to finish

2023-12-21

Last updated by the study team

2025-02-14

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Riley Children's Hospital-University of Indiana — Indianapolis, Indiana, United States
• Boston Chilldren's Hospital — Boston, Massachusetts, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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