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OpenTrials
Completed

NCT Number: NCT03612258

Brain Mechanisms of Juvenile Fibromyalgia

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.

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Key information

Age range

13 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

functional magnetic resonance imaging

Diagnostic Test

Functional Magnetic Resonance Imaging scans will be completed to assess neural responses to painful, non-painful sensory, and emotion-eliciting stimuli.

Primary outcomes

  1. Functional brain activation differences

    Time frame: Baseline

    Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls

Secondary outcomes

  1. Functional brain activation differences

    Time frame: Baseline and 8 weeks

    Functional Magnetic Resonance Imaging: differences in response to painful, non-painful sensory, and emotion-eliciting stimuli before and after treatment

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Brain Mechanisms of Altered Sensory Perception and Self-Referential Processing in Juvenile Fibromyalgia

Acronym: JFM

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2018
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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