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

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Fibromyalgia; Muscular Diseases; Musculoskeletal Disease; Myofascial Pain Syndrome; Rheumatic Diseases

Treatments: Behavioral: Graded Aerobic Exercise; Behavioral: Fibromyalgia Integrative Training for Teens; Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03268421

R01AR070474 (U.S. NIH Grant/Contract)

CIN001-FIT Teens

Details and patient eligibility

About

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.

Full 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 evaluated 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.

Enrollment: 389 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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389 participants in 3 patient groups

Fibromyalgia Integrative Training for Teens

Experimental group

Description:

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.

Treatment:

Behavioral: Fibromyalgia Integrative Training for Teens

Cognitive Behavioral Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Graded Aerobic Exercise

Active Comparator group

Description:

Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.

Treatment:

Behavioral: Graded Aerobic Exercise