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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
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

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

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

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)
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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

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Fibromyalgia Integrative Training for Teens

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