Brain Mechanisms of Juvenile Fibromyalgia

NCT ID: NCT03612258

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2024-07-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Functional Magnetic Resonance Imaging

Group Type: EXPERIMENTAL

Functional Magnetic Resonance Imaging

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Robert Coghill

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Coghill, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

Tong H, Maloney TC, Payne MF, Sunol M, Dudley JA, King CD, Ting TV, Kashikar-Zuck S, Coghill RC, Lopez-Sola M. Augmented pain-evoked primary sensorimotor cortex activation in adolescent girls with juvenile fibromyalgia. Pain. 2023 Oct 1;164(10):2316-2326. doi: 10.1097/j.pain.0000000000002933. Epub 2023 Jun 16.

Reference Type: DERIVED

PMID: 37326678 (View on PubMed)

Other Identifiers

CIN_brainjfm_001

Identifier Type: -

Identifier Source: org_study_id