Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

NCT03268421 | Completed Results DMC

• 2 other identifiers: CIN001-FIT TeensR01AR070474
• Study Type: interventional
• Target: 389
• Locations: 2 countries
• Sites: 7

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.

Conditions

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

Keywords

juvenile fibromyalgia; pain in children; musculoskeletal pain; cognitive behavioral therapy; coping skills training; neuromuscular exercise; graded aerobic exercise

Outcome Measures

Primary Outcomes (1)

• Functional Disability Inventory

  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).

  Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up

Secondary Outcomes (1)

• Pain Intenstiy

  Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up

Study Arms (3)

Fibromyalgia Integrative Training for Teens

EXPERIMENTAL

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

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Graded Aerobic Exercise

ACTIVE COMPARATOR

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

Behavioral: Graded Aerobic Exercise

Interventions

Fibromyalgia Integrative Training for Teens BEHAVIORAL

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.

Also known as: FIT Teens

Fibromyalgia Integrative Training for Teens

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT, coping skills

Cognitive Behavioral Therapy

Graded Aerobic Exercise BEHAVIORAL

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.

Also known as: GAE

Graded Aerobic Exercise

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (7)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Riley Children's Hospital-University of Indiana

Indianapolis, Indiana, 46202, United States

Location

Boston Chilldren's Hospital

Boston, Massachusetts, 02116, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (4)

• 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.

  PMID: 33618033 BACKGROUND

• Kashikar-Zuck S, Barnett KA, Williams SE, Pfeiffer M, Thomas S, Beasley K, Chamberlin LA, Mundo K, Ittenbach RF, Peugh J, Gibler RC, Lynch-Jordan A, Ting TV, Gadd B, Taylor J, Goldstein-Leever A, Connelly M, Logan DE, Williams A, Wakefield EO, Myer GD; FIT Teens Clinical Trial Study Group and the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic. Contemp Clin Trials Commun. 2022 Nov 29;30:101039. doi: 10.1016/j.conctc.2022.101039. eCollection 2022 Dec.

  PMID: 36467389 BACKGROUND

• Kashikar-Zuck S, Thomas S, Bonnette S, Gibler RC, DiCesare C, Schille A, Hulburt T, Briggs MS, Ounpuu S, Myer GD; FIT Teens Clinical Trial Study Group. Comparison of Pain Characteristics, Strength, and Movement Patterns in Adolescents With Juvenile Fibromyalgia and High Versus Low Fear of Movement. J Pain. 2024 Sep;25(9):104586. doi: 10.1016/j.jpain.2024.104586. Epub 2024 May 31.

  PMID: 38823603 DERIVED

• Lynch-Jordan AM, Connelly M, Guite JW, King C, Goldstein-Leever A, Logan DE, Nelson S, Stinson JN, Ting TV, Wakefield EO, Williams AE, Williams SE, Kashikar-Zuck S; Fibromyalgia Integrative Training for Teens Clinical Trial Study Group and the Childhood Arthritis and Rheumatology Research Alliance Pain Workgroup Investigators. Clinical Characterization of Juvenile Fibromyalgia in a Multicenter Cohort of Adolescents Enrolled in a Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1795-1803. doi: 10.1002/acr.25077. Epub 2023 Feb 16.

  PMID: 36537193 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Musculoskeletal Pain

Interventions

Cognitive Behavioral Therapy; Coping Skills

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Susmita Kashikar-Zuck, PhD
• Organization: Cincinnati Children's Hospital

susmita.kashikar-zuck@cchmc.org

513-636-6337

Study Officials

• Susmita Kashikar-Zuck, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-pharmacologic trial comparing behavioral and exercise-based treatments

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: January 2, 2018
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); CA (1)