Supraspinal Processing of Sensory Aspects of Pain

Fibromyalgia Clinical Trial

— SCP  

Official title:

Supraspinal Processing of Sensory Aspects of Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814497
• Other study ID #: 2022-0556
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: September 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Catherine Jackson, MSc
• Phone: 5136360669
• Email: Catherine.Jackson[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Chronic pain affects approximately 20% of both adults and children in the US and is a source of substantial disability and health care costs. Chronic pain can be challenging to diagnose due to the presence of poorly understood symptoms. When diagnosed, current pharmacologic treatments for pain are remarkably ineffective, while effective non-pharmacologic treatments remain under-utilized. These shortcomings in the diagnosis and treatment of pain arise from tremendous gaps in our knowledge about the basic central nervous system systems that process nociceptive information and instantiate an experience of pain. These gaps are further amplified in the case of pediatric chronic pain due to a lack of basic/translational research. The team of basic scientists and clinician scientists is uniquely positioned to perform human pediatric studies integrating functional neuroimaging with quantitative sensory testing and psychological assessments to delineate brain systems engaged during chronic pain. The study will examine four distinct chronic pain syndromes: migraine, complex regional pain syndrome, functional abdominal pain, and musculoskeletal pain. The study seeks to 1) Identify shared and distinct brain systems engaged by different forms of pediatric chronic pain, 2) Determine if predictors of recovery differ across different chronic pain conditions, 3) Delineate brain systems associated with the spread of pain. To accomplish these aims, the study will recruit 400 patients with chronic pain and 100 healthy participants (age range 10-17). The study will follow all participants longitudinally for 1 year after initiation of treatment to assess the degree of recovery and spread of pain. This basic science investigation will provide a critical foundation of basic knowledge for future clinical trials of diagnostic markers for different forms of chronic pain and for the development of new treatments for chronic pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Complex Regional Pain Syndromes
• Fibromyalgia
• Functional Abdominal Pain Syndrome
• Migraine in Children
• Musculoskeletal Pain
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Multisensory Task
Reversing checkerboard, tones, and finger opposition.
• Graphesthesia
Trace numbers on skin.
• Divided attention
Divide attention between two noxious stimuli.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	University of Barcelona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FMRI: BOLD resting connectivity of the amygdala	BOLD resting connectivity of the amygdala	Baseline
Primary	Resting Cerebral Blood Flow (CBF)	CBF derived from resting arterial spin labeled MRI	Baseline
Primary	FMRI: Multisensory task activity	BOLD activation during multisensory task	Baseline
Primary	FMRI: Spatial task activity	BOLD activation during spatial summation and divided attention	Baseline
Primary	FMRI: BOLD resting connectivity of the posterior parietal cortex	BOLD resting connectivity of the posterior parietal cortex	Baseline
Primary	FMRI: Graphesthesia Activation	BOLD activation during graphesthesia task	Baseline
Primary	Pain Ratings	Visual analog scale (VAS) ratings of pain intensity and pain unpleasantness. The VAS is a scale of 0-10, with higher scores indicating a worse outcome.	Baseline
Primary	Pain Ratings	Visual analog scale (VAS) ratings of pain intensity and pain unpleasantness. The VAS is a scale of 0-10, with higher scores indicating a worse outcome.	1 Year Followup
Primary	Spatial Distribution of Pain	Body map assessment of location of pain	Baseline
Primary	Spatial Distribution of Pain	Body map assessment of location of pain	1 Year Followup