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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic Diseases; Muscular Diseases; Fibromyalgia; Musculoskeletal Disease; Myofascial Pain Syndrome
• Intervention / Treatment: Behavioral: Fibromyalgia Integrative Training for Teens; Behavioral: Cognitive Behavioral Therapy; Behavioral: Graded Aerobic Exercise

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 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.

• Study Type: Interventional
• Enrollment (Actual): 389
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Children's Hospital-University of Indiana
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Boston Chilldren's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: FIT Teens
Active Comparator: 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.	Behavioral: 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.; Other Names: CBT; coping skills
Active Comparator: Graded Aerobic Exercise; Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.	Behavioral: 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.; Other Names: GAE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Susmita Kashikar-Zuck, PhD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• Kashikar-Zuck S, Briggs MS, Bout-Tabaku S, Connelly M, Daffin M, Guite J, Ittenbach R, Logan DE, Lynch-Jordan AM, Myer GD, Ounpuu S, Peugh J, Schikler K, Sugimoto D, Stinson JN, Ting TV, Thomas S, Williams SE, Zempsky W; Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol. Contemp Clin Trials. 2021 Apr;103:106321. doi: 10.1016/j.cct.2021.106321. Epub 2021 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; pain in children; juvenile fibromyalgia; musculoskeletal pain; neuromuscular exercise; coping skills training; graded aerobic exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Connective Tissue Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Rheumatic Diseases; Collagen Diseases; Musculoskeletal Diseases; Muscular Diseases
• Other Study ID Numbers: CIN001-FIT Teens; R01AR070474 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No