Fibromyalgia Integrative Training for Teens

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fibromyalgia Integrative Training for Teens

Conditions
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Juvenile Fibromyalgia

Intervention / Treatment
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* Behavioral: Fibromyalgia integrative training
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibromyalgia Integrative Training<br>8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training | Behavioral: Fibromyalgia integrative training<br>* Combined intervention with neuromuscular exercise training and cognitive behavioral therapy<br>|
| Active Comparator: Cognitive Behavioral Therapy<br>8 week (16 session) cognitive-behavioral therapy treatment. | Behavioral: Cognitive Behavioral Therapy<br>* Therapy focused on training in behavioral pain coping skills<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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juvenile fibromyalgia, pain in children, musculoskeletal pain, cognitive behavioral therapy, coping skills training