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

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ClinicalTrials.gov Identifier: NCT03268421
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Disease Rheumatic Diseases Behavioral: Fibromyalgia Integrative Training for Teens Behavioral: Cognitive Behavioral Therapy Behavioral: Graded Aerobic Exercise Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-pharmacologic trial comparing behavioral and exercise-based treatments
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: GAE




Primary Outcome Measures :
  1. Change in functional disability [ Time Frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up ]

    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).



Secondary Outcome Measures :
  1. Change in pain intensity [ Time Frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up ]
    A Visual Analog Scale (VAS) will be used to assess average pain intensity over a one week period



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 for 4 weeks 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268421


Contacts
Contact: Megan Pfeiffer 513-636-1846 megan.pfeiffer@cchmc.org
Contact: LeighAnn Chamberlin 513-636-9739 leighann.chamberlin@cchmc.org

Locations
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Tessa Fagle    860-837-5880    TFagle@connecticutchildrens.org   
Principal Investigator: Jessica Guite, PhD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kristin Klein    502-588-4910    kristin.klein@louisville.edu   
Principal Investigator: Kenneth Schikler, MD         
United States, Massachusetts
Boston Chilldren's Hospital Recruiting
Boston, Massachusetts, United States, 02116
Contact: Maureen Burns    617-355-8973    maureen.burns@childrens.harvard.edu   
Principal Investigator: Deirdre Logan, PhD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Nichole Curran    816-701-1363    nmcurran@cmh.edu   
Principal Investigator: Mark Connelly, PhD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Megan Pfeiffer    513-636-1846    megan.pfeiffer@cchmc.org   
Principal Investigator: Susmita Kashikar-Zuck, PhD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Lauren Volz    614-722-4712    Lauren.Volz@nationwidechildrens.org   
Principal Investigator: Stacy Ardoin, MD         
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Lauren Harris    416-813-7654 ext 302314    lauren.harris@sickkids.ca   
Principal Investigator: Jen Stinson, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Susmita Kashikar-Zuck, PhD Children's Hospital Medical Center, Cincinnati

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03268421     History of Changes
Other Study ID Numbers: CIN001-FIT Teens
R01AR070474 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:
juvenile fibromyalgia
pain in children
musculoskeletal pain
cognitive behavioral therapy
coping skills training
neuromuscular exercise
graded aerobic exercise

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases