Brain Mechanisms of Juvenile Fibromyalgia

Fibromyalgia Clinical Trial

— JFM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03612258
• Other study ID #: CIN_brainjfm_001
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: July 31, 2025

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Catherine Jackson
• Phone: 513-636-0669
• Email: Catherine.Jackson[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional brain activation differences	Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls	Baseline
Secondary	Functional brain activation differences	Functional Magnetic Resonance Imaging: differences in response to painful, non-painful sensory, and emotion-eliciting stimuli before and after treatment	Baseline and 8 weeks