Fibromyalgia Integrative Training for Teens (FIT Teens)

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).

Study Overview

• Status: Completed
• Conditions: Juvenile Fibromyalgia
• Intervention / Treatment: Behavioral: Fibromyalgia integrative training; Behavioral: Cognitive Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, post-treatment and 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline, post-treatment and 3-month follow-up
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)	Baseline, Post-treatment, 3-month follow-up

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Susmita Kashikar-Zuck, PhD, Cincinati Children's Hospital Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 5, 2013
• First Posted (ESTIMATE): November 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; pain in children; juvenile fibromyalgia; musculoskeletal pain; coping skills training
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: R21AR063412 (NIH)