Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

Conditions:Fibromyalgia, Neurology, Rheumatology, Pain
Therapuetic Areas:Musculoskeletal, Neurology, Rheumatology
Age Range:12 - 18
Start Date:January 2, 2018
End Date:January 2023
Contact:Megan Pfeiffer

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Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia

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.

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.

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
We found this trial at
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Mark Connelly, PhD
Phone: 816-701-1363
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
Kansas City, MO
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Principal Investigator: Susmita Kashikar-Zuck, PhD
Phone: 513-636-1846
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Stacy Ardoin, MD
Phone: 614-722-4712
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
Columbus, OH
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Principal Investigator: William Zempsky, MD
Phone: 860-933-7216
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
Hartford, CT
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50 Park Plaza
Boston, Massachusetts 02116
Principal Investigator: Deirdre Logan, PhD
Phone: 617-355-8973
Boston, MA
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Kenneth Schikler, MD
Phone: 502-588-4910
University of Louisville The University of Louisville is a state supported research university located in...
Louisville, KY
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555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Jen Stinson, PhD
Phone: 416-813-7654
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