Brain Mechanisms of Juvenile Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Diagnostic Test: Functional Magnetic Resonance Imaging

• Registration Number: NCT03612258
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

This study evaluates whether differences exist between adolescent females with juvenile-onset fibromyalgia and healthy controls in processing of pain and emotion at the neural level as assessed by functional magnetic resonance imaging (fMRI). The study includes a longitudinal component to evaluate changes in neural processing of pain and emotion before and after different treatment strategies.

Detailed Description

Juvenile-onset fibromyalgia (JFM) is a chronic, widespread pain condition that primarily affects females. Previous work has shown increased sensitivity to painful and non-painful sensory stimuli in adults with fibromyalgia, as well as brain processing abnormalities associated with these stimuli. These abnormalities in adults are highly predictive of fibromyalgia status (as opposed to healthy status) in adults. Although JFM has some similar symptoms and features to fibromyalgia in adults, the neural mechanisms of JFM may be partially different, given the moment of sharp brain development characterising JFM. fMRI scans will be completed before and after different treatments for JFM (e.g. neuromuscular training + cognitive behavioral therapy, graded aerobic exercise) to investigate the effects of treatment on brain measures related to pain, fatigue and emotion processing.

Study Timeline

• Study Start: 2018-02-28
• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-02
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

Inclusion Criteria

• Diagnosis of Juvenile Fibromyalgia (by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology criteria)
• Right handed
• Functional Disability Index score ≥ 7, indicating at least mild disability
• Stable medication regimen for 3 weeks prior to MRI scan

Exclusion Criteria

• Non-MRI compatible metal objects in the body (including braces, permanent upper retainers)
• Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematosus)
• Major psychiatric diagnoses (e.g. bipolar disorder, obsessive compulsive disorder, schizophrenia) or documented developmental delay
• Taking opioid pain medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional Magnetic Resonance Imaging	Functional Magnetic Resonance Imaging	-

Primary Outcome Measures

Name	Time	Method
Functional brain activation differences	Baseline	Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls

Secondary Outcome Measures

Name	Time	Method
Functional brain activation differences	Baseline and 8 weeks	Functional Magnetic Resonance Imaging: differences in response to painful, non-painful sensory, and emotion-eliciting stimuli before and after treatment

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States