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Brain Mechanisms of Juvenile Fibromyalgia (JFM)

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Fibromyalgia

Treatments

Diagnostic Test: Functional Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT03612258
CIN_brainjfm_001

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 patients

Sex

Female

Ages

13 to 17 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

153 participants in 1 patient group

Functional Magnetic Resonance Imaging
Experimental group
Treatment:
Diagnostic Test: Functional Magnetic Resonance Imaging

Trial contacts and locations

1

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Central trial contact

Catherine Jackson

Data sourced from clinicaltrials.gov

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