Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

Not Applicable

Completed

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

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

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	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.
Fibromyalgia Integrative Training for Teens	Fibromyalgia Integrative Training for Teens	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.
Graded Aerobic Exercise	Graded Aerobic Exercise	Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.

Primary Outcome Measures

Name	Time	Method
Functional Disability Inventory	Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up	Functional Disability Inventory (FDI) is a validated 15-item self-report measure, developed to assess perceived difficulty in the performance of daily activities in home, school, recreational, and social domains due to pain. Total sum scores are calculated and range from 0 - 60, with higher scores indicating greater functional disability. Clinical reference points are: No/Minimal disability (0 to 12), Mild disability (13 to 20), Moderate disability (21 to 29) and Severe disability (≥30). For this primary outcome, data from this questionnaire was used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs. The main outcome measure for this comparison is the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).

Secondary Outcome Measures

Name	Time	Method
Pain Intenstiy	Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up	Pain intensity was measured using the Visual Analog Scale (VAS), which is a validated measure of pain intensity in children and adolescents. Participants were shown a line with the written anchors of "no pain" and "pain as bad as I can imagine" on either end. The line represents a 0-10 scale, where higher scores are representative of higher pain intensity with a score of 4-6 indicating at least moderate pain levels and a score of 7-10 indicating severe pain levels. This measure was completed daily for one week and scores averaged over that time. For this secondary outcome, data from this measure were used to compare baseline response to 3 month follow up to examine whether a reduction in pain intensity occurred.

Locations (7): Hospital for Sick Children
🇨🇦
Toronto, Ontario, Canada
Connecticut Children's Medical Center
🇺🇸
Hartford, Connecticut, United States
Nationwide Children's Hospital
🇺🇸
Columbus, Ohio, United States
Riley Children's Hospital-University of Indiana
🇺🇸
Indianapolis, Indiana, United States
Children's Mercy Hospital
🇺🇸
Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States
Boston Chilldren's Hospital
🇺🇸
Boston, Massachusetts, United States