Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 9 of 643 for:    fibromyalgia

Fibromyalgia Integrative Training for Teens (FIT Teens)

This study is ongoing, but not recruiting participants.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati Identifier:
First received: October 24, 2013
Last updated: July 28, 2016
Last verified: July 2016

The purpose of this pilot randomized trial is to determine whether the fibromyalgia integrative training (FIT Teens) intervention is superior to cognitive-behavioral therapy (CBT) alone in reducing pain among adolescents with juvenile fibromyalgia (JFM).

Hypothesis 1: Patients in the FIT Teens group will show significantly greater reduction in pain intensity than the CBT group at final study assessment (i.e., 3-month follow up).

Hypothesis 2: Patients in both the FIT Teens and CBT groups will show significant reductions in functional disability and depressive symptoms at final study assessment (i.e., 3-month follow up).

Condition Intervention
Juvenile Fibromyalgia
Behavioral: Fibromyalgia integrative training
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fibromyalgia Integrative Training for Teens

Resource links provided by NLM:

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Average Pain Intensity [ Time Frame: One week ] [ Designated as safety issue: No ]
    Average pain intensity marked on a paper-pencil Visual Analog Scale (0-10 cm).

Secondary Outcome Measures:
  • Functional Disability [ Time Frame: Past 2 weeks ] [ Designated as safety issue: No ]
    Validated 15-item patient-report measure of difficulties in physical, social and recreational activities (scored 0-60)

  • Depressive Symptoms [ Time Frame: Past 2 weeks ] [ Designated as safety issue: No ]
    Children's Depression Inventory: a 27-item validated patient-report measure of depressive symptoms

Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibromyalgia Integrative Training
8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training
Behavioral: Fibromyalgia integrative training
Combined intervention with neuromuscular exercise training and cognitive behavioral therapy
Active Comparator: Cognitive Behavioral Therapy
8 week (16 session) cognitive-behavioral therapy treatment.
Behavioral: Cognitive Behavioral Therapy
Therapy focused on training in behavioral pain coping skills

Detailed Description:
CBT has been found to have beneficial effects on improving coping among adolescents with JFM and increasing patients' ability to engage in daily activities. The purpose of this study is to evaluate whether CBT can be enhanced with specialized neuromuscular training, in the new fibromyalgia integrative training (FIT Teens) intervention, to produce stronger pain reduction than CBT alone. Neuromuscular training originates from the field of pediatric sports medicine and has been successfully used for injury prevention but has never before been utilized for pain management in JFM. This type of training emphasizes education and proper training in fundamental movement skills prior to the initiation of more vigorous physical activity and exercise. It is expected that the neuromuscular training integrated with established CBT techniques will enhance patients' ability to engage in exercise and to achieve better JFM pain control. Adolescents with JFM will be randomly assigned to receive either the 8-week FIT Teens intervention or an 8-week CBT program with assessments at baseline, post-treatment and 3-month follow-up.

Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females ages 12-18
  • Juvenile fibromyalgia (JFM) diagnosed by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology (ACR) criteria and confirmation with a tender point exam of ≥ 11 of 18 tender points upon palpation
  • 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

Exclusion Criteria:

  • Comorbid rheumatic disease (e.g., juvenile arthritis, systemic lupus erythematous)
  • untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses)
  • documented developmental delay
  • any medical condition determined by their physician to be a contraindication for participation
  • on stable medications for 4 weeks prior to enrollment
  • currently in CBT or structured physical therapy program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01981096

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Susmita Kashikar-Zuck, PhD Cincinati Children's Hospital Medical Center
  More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT01981096     History of Changes
Other Study ID Numbers: R21AR063412 
Study First Received: October 24, 2013
Last Updated: July 28, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases processed this record on September 30, 2016