Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia (FIT Teens)

  • STATUS
    Recruiting
  • End date
    Dec 10, 2023
  • participants needed
    420
  • sponsor
    Children's Hospital Medical Center, Cincinnati
Updated on 10 August 2022
aerobic exercise
behavioral therapy
cognitive therapy
fibromyalgia

Summary

This study evaluates 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 will receive the FIT Teens training; one third will receive CBT training; and one third of participants will receive the GAE training.

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 symptom relief for JFM, our research group has demonstrated that cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional disability and depressive symptoms in adolescents with this condition. However, 60% of patients receiving CBT did not show clinically significant improvement in functional disability, and pain levels remained in the moderate range despite being reduced overall. Our multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science has developed and tested the feasibility of a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances the established CBT intervention with a novel neuromuscular exercise training program derived from evidence-based pediatric injury prevention research. Pilot testing showed excellent patient engagement, no adverse effects and very promising early results indicating this treatment to have even stronger effects on disability and pain outcomes than CBT alone. This trial evaluates whether the FIT Teens intervention is more effective than CBT alone or graded aerobic exercise alone and whether treatment effects are sustainable over 1 year follow-up.

Details
Condition Fibromyalgia, Myofascial Pain Syndrome, Muscular Diseases, Musculoskeletal Disease, Rheumatic Diseases
Treatment Cognitive behavioral therapy, Fibromyalgia Integrative Training for Teens, Graded Aerobic Exercise
Clinical Study IdentifierNCT03268421
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

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
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