Fibromyalgia Integrative Training for Teens (FIT Teens)
Primary Purpose
Juvenile Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fibromyalgia integrative training
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Fibromyalgia focused on measuring juvenile fibromyalgia, pain in children, musculoskeletal pain, cognitive behavioral therapy, coping skills training
Eligibility 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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fibromyalgia Integrative Training
Cognitive Behavioral Therapy
Arm Description
8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training
8 week (16 session) cognitive-behavioral therapy treatment.
Outcomes
Primary Outcome Measures
Average Pain Intensity
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
Functional Disability
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)
Depressive Symptoms
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)
Full Information
NCT ID
NCT01981096
First Posted
October 24, 2013
Last Updated
February 9, 2022
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT01981096
Brief Title
Fibromyalgia Integrative Training for Teens
Acronym
FIT Teens
Official Title
Fibromyalgia Integrative Training for Teens
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Fibromyalgia
Keywords
juvenile fibromyalgia, pain in children, musculoskeletal pain, cognitive behavioral therapy, coping skills training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibromyalgia Integrative Training
Arm Type
Experimental
Arm Description
8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
8 week (16 session) cognitive-behavioral therapy treatment.
Intervention Type
Behavioral
Intervention Name(s)
Fibromyalgia integrative training
Intervention Description
Combined intervention with neuromuscular exercise training and cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Therapy focused on training in behavioral pain coping skills
Primary Outcome Measure Information:
Title
Average Pain Intensity
Description
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.
Time Frame
Baseline, post-treatment and 3-month follow-up
Secondary Outcome Measure Information:
Title
Functional Disability
Description
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)
Time Frame
Baseline, post-treatment and 3-month follow-up
Title
Depressive Symptoms
Description
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)
Time Frame
Baseline, Post-treatment, 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susmita Kashikar-Zuck, PhD
Organizational Affiliation
Cincinati Children's Hospital Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fibromyalgia Integrative Training for Teens
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