ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03268421
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

August 29, 2017
August 31, 2017
March 21, 2018
January 2, 2018
May 2022   (Final data collection date for primary outcome measure)
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).

Same as current
Complete list of historical versions of study NCT03268421 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia
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.
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.
Interventional
Not Applicable
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
  • Fibromyalgia
  • Myofascial Pain Syndrome
  • Muscular Diseases
  • Musculoskeletal Disease
  • Rheumatic Diseases
  • 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
  • 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
  • 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
  • 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.
    Intervention: Behavioral: Fibromyalgia Integrative Training for 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.
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • Active Comparator: Graded Aerobic Exercise
    Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.
    Intervention: Behavioral: Graded Aerobic Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
Same as current
January 2023
May 2022   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 18 Years   (Child, Adult)
No
Contact: Megan Pfeiffer 513-636-1846 megan.pfeiffer@cchmc.org
Contact: LeighAnn Chamberlin 513-636-9739 leighann.chamberlin@cchmc.org
Canada,   United States
 
 
NCT03268421
CIN001-FIT Teens
R01AR070474 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Susmita Kashikar-Zuck, PhD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP