Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia
Key facts
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Where
- Boston, Cincinnati, Columbus, Hartford, Indianapolis, and Kansas City, United StatesSee the 6 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Completed
- People taking part
- 389 people enrolled
- Started
- 2 Jan 2018
- Ended
- 21 Dec 2023
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Fibromyalgia Integrative Training for Teens
- Cognitive Behavioral Therapy
- Graded Aerobic Exercise
- Record updated
- 14 February 2025
Who can take part
- Age
- 12 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Taking opioid pain medication
- 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
Where in United States
Also in 1 other country, 1 site
- Boston Chilldren's HospitalBoston, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesNo longer taking part
- Nationwide Children's HospitalColumbus, United StatesNo longer taking part
- Connecticut Children's Medical CenterHartford, United StatesNo longer taking part
- Riley Children's Hospital/University of IndianaIndianapolis, United StatesNo longer taking part
- Children's Mercy HospitalKansas City, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Fibromyalgia Integrative Training for TeensTreatment being tested
Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance.
- Cognitive Behavioral TherapyExisting treatment, for comparison
Cognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem-solving, and using calming self-statements.
- Graded Aerobic ExerciseExisting treatment, for comparison
Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia
- Record updated
- 14 February 2025