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Fibromyalgia Integrative Training for Teens (FIT Teens)

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ClinicalTrials.gov Identifier: NCT01981096
Recruitment Status : Completed
First Posted : November 11, 2013
Results First Posted : September 10, 2018
Last Update Posted : September 10, 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:

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 or disease Intervention/treatment Phase
Juvenile Fibromyalgia Behavioral: Fibromyalgia integrative training Behavioral: Cognitive Behavioral Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fibromyalgia Integrative Training for Teens
Study Start Date : November 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Average Pain Intensity [ Time Frame: Baseline, post-treatment and 3-month follow-up ]
    Average pain intensity in the past week marked on a paper-pencil Visual Analog Scale (Min = 0 {no pain} to Max = 10 {pain as bad as it can be}). Lower scores mean better outcomes.


Secondary Outcome Measures :
  1. Functional Disability [ Time Frame: Baseline, post-treatment and 3-month follow-up ]
    Validated 15-item patient-report measure of difficulties in physical, social and recreational activities in the past 2 weeks (score Min = 0, Max = 60; Lower score means less disability/better outcome)

  2. Depressive Symptoms [ Time Frame: Baseline, Post-treatment, 3-month follow-up ]
    Children's Depression Inventory: a 27-item validated patient-report measure of depressive symptoms in the past 2 weeks (scores 0 = no depressive symptoms to 54 = most severe symptoms; lower score means less depression/better outcomes)



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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:

  • 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

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): NCT01981096


Locations
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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)
Investigators
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Principal Investigator: Susmita Kashikar-Zuck, PhD Cincinati Children's Hospital Medical Center

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01981096     History of Changes
Other Study ID Numbers: R21AR063412 ( U.S. NIH Grant/Contract )
R21AR063412 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2013    Key Record Dates
Results First Posted: September 10, 2018
Last Update Posted: September 10, 2018
Last Verified: August 2018

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:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases