Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

Fibromyalgia Clinical Trial

— FIT Teens  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268421
• Other study ID #: CIN001-FIT Teens
• Secondary ID: R01AR070474
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: December 21, 2023

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

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

Related Conditions & MeSH terms

• Collagen Diseases
• Fibromyalgia
• Muscular Diseases
• Musculoskeletal Disease
• Musculoskeletal Diseases
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Rheumatic Diseases

Intervention

Behavioral:
• Fibromyalgia Integrative Training for Teens
This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
• Cognitive Behavioral Therapy
This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
• Graded Aerobic Exercise
This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Boston Chilldren's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Riley Children's Hospital-University of Indiana	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional disability	The Functional Disability Inventory (FDI), a 15 item self-report measure will be used to assess participant's perceived difficulty in the performance of daily activities at home, school, recreational, and social domains due to pain. For this primary outcome, data from this questionnaires will be 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 will be the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).	Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
Secondary	Change in pain intensity	A Visual Analog Scale (VAS) will be used to assess average pain intensity over a one week period	Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up