Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05814497

Conditions

Migraine in Children

Complex Regional Pain Syndromes

Musculoskeletal Pain

Functional Abdominal Pain Syndrome

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Accepted

Interventions

Multisensory Task

Graphesthesia

Divided attention

Study Details

Brief summary:

The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are:

  • Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain?
  • What are predictors of recovery from chronic pain?
  • What brain systems are associated with the spread of pain?

For this study participants will undergo:

  • Functional Magnetic Resonance Imaging (fMRI)
  • Quantitative Sensory Testing
  • Psychological Assessments

Conditions

Migraine in Children

Complex Regional Pain Syndromes

Musculoskeletal Pain

Functional Abdominal Pain Syndrome

Fibromyalgia

Study ID

NCT05814497

Start date

May 1, 2023

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), diffuse MSK (widespread MSK pain), or CRPS
  • If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit.
  • Male or female, age 10 -17 (inclusive)
  • English speaking, able to complete interviews and questionnaires in English

Exclusion Criteria:

  • Weight/size incompatible with MRI scanner
  • Orthodontic braces, metallic or electronic implants, or other metal objects in the body which obscure or interfere with the MRI, or pose a risk from heating, movement, or malfunction in the MRI environment
  • Claustrophobia
  • Youth who are pregnant
  • Any comorbid rheumatic disease, diagnosis of epilepsy, other neurological diseases, or medical condition (e.g. diabetes, cancer, IBD)
  • Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
  • Skin conditions or past skin damage on the arms or legs in or near sites of sensory testing
  • Outside the age range (9 years old or younger; 18 years or older) at the time of consent
  • History of > 1 month opioid treatment.

Study Design

Enrollment

255 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy Controls

Healthy controls with no history of chronic pain.

experimental: Headache and Migraine

Individuals who have migraine with headaches.

experimental: Functional Abdominal Pain Disorder (FAPD)

Individuals who have functional abdominal pain disorder.

experimental: Localized and Diffuse/Widespread Musculoskeletal Pain (MSK)

Individuals with chronic musculoskeletal pain.

experimental: Complex Regional Pain Syndrome (CRPS)

Individuals with complex regional pain syndrome.

Interventions

Multisensory Task

Reversing checkerboard, tones, and finger opposition.

Graphesthesia

Trace numbers on skin.

Divided attention

Divide attention between two noxious stimuli.

Primary outcome measure

  • FMRI: BOLD resting connectivity of the amygdala [ Time Frame: Baseline ]
  • Resting Cerebral Blood Flow (CBF) [ Time Frame: Baseline ]
  • FMRI: Multisensory task activity [ Time Frame: Baseline ]
  • FMRI: Spatial task activity [ Time Frame: Baseline ]
  • FMRI: BOLD resting connectivity of the posterior parietal cortex [ Time Frame: Baseline ]
  • FMRI: Graphesthesia Activation [ Time Frame: Baseline ]
  • Pain Ratings [ Time Frame: Baseline ]
  • Pain Ratings [ Time Frame: 1 Year Followup ]
  • Spatial Distribution of Pain [ Time Frame: Baseline ]
  • Spatial Distribution of Pain [ Time Frame: 1 Year Followup ]

Central Contacts and Locations

Central contacts

Catherine Jackson, MSc

5136360669Catherine.Jackson@cchmc.org

Hannah Schildmeyer, BS

Hannah.Schildmeyer@cchmc.org

Locations

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Catherine Jackson, MSc

513-636-0669Catherine.Jackson@cchmc.org

Hannah Schildmeyer, BS

Hannah.Schildmeyer@cchmc.org

Principal Investigator:

Robert Coghill, PhD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • chronic pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-06-05.