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Brain Mechanisms of Juvenile Fibromyalgia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03612258
Acronym
JFM
Enrollment
153
Registered
2018-08-02
Start date
2018-02-28
Completion date
2024-07-31
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Pain, Neuroimaging, Sensory sensitivity, Fatigue

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.

Interventions

DIAGNOSTIC_TESTFunctional Magnetic Resonance Imaging

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

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional brain activation differencesBaselineFunctional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls

Secondary

MeasureTime frameDescription
Functional brain activation differencesBaseline and 8 weeksFunctional Magnetic Resonance Imaging: differences in response to painful, non-painful sensory, and emotion-eliciting stimuli before and after treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026