Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain

NCT04488757 | Active Not Recruiting DMC

• 2 other identifiers: IRB-P000353031K23AT010643-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic widespread pain (CWP) is a common chronic pain condition in youth and often associated with significant pain-related and psychosocial impairment. Understanding the neurobiological mechanisms that may underlie pediatric chronic pain and pain-related impairment can inform future treatments to ameliorate patients' suffering, making it a critical area of empirical investigation.

Conditions

Chronic Widespread Pain; Stress, Psychological; Stress, Physiological

Keywords

Chronic Widespread Pain; Pediatric Pain; Allostatic Load; fMRI; Mind-Body Interventions

Outcome Measures

Primary Outcomes (8)

• Hippocampal Functioning

  measured via fMRI

  baseline

• Change in Morning Cortisol

  measured via 2 samples of saliva taken via passive drool over the course of two days. After analysis, morning cortisol will be dichotomously coded with participants receiving a "1" if they score over one standard deviation above the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load.

  baseline and 4-month follow-up

• Change in Dehydroepiandrosterone (DHEA)

  measured via 2 samples of saliva taken via passive drool over the course of two days. After analysis, DHEA will be dichotomously coded with participants receiving a "1" if they score over one standard deviation above the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load.

  baseline and 4-month follow-up

• Change in Flattened Cortisol

  measured via 10 samples of saliva taken via passive drool over the course of two days. After analysis, the presence of cortisol will be dichotomously coded with participants receiving a "1" if the change in cortisol levels across the day fell at or below one standard deviation below the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load.

  baseline and 4-month follow-up

• Change in Blood Pressure

  measured via blood pressure cuff by trained nurse. Results will be coded to capture levels that fall in the "normal", "prehypertension" and "hypertension" range with individuals scoring in the latter two ranges receiving a coding of "1" to be included in the allostatic load risk composite measure. Scoring of blood pressure ranges will be done using ezbmi- calculates deviation from expected BP/BMI by age/gender.

  baseline and 4-month follow-up

• Change in Body-Mass Index (BMI)

  measured via height and weight (in cm and kg) by a trained nurse. Results will be coded to capture individuals that score in the "underweight", "normal", "overweight" and "obese" ranges with individuals falling in all categories but "normal" receiving a coding of "1" to be included in the allostatic load risk ratio. Scoring of BMI ranges will be done using ezbmi- calculates deviation from expected BP/BMI by age/gender.

  baseline and 4-month follow-up

• Change in Waist-Hip Ratio (WHR)

  measured via tape measure around the smallest part of the waist and the widest part of the hips by a trained research coordinator. Results (waist measurement/hip measurement) will be coded dichotomously with individuals scoring a "1" whose WHR falls greater than or equal to one standard deviation above the mean of the sample. This scoring will also be included in the larger allostatic load risk ratio.

  baseline and 4-month follow-up

• Change in Heart Rate (HR)

  measured via pulse taken by a trained nurse. Results will be coded dichotomously with individuals scoring a "1" whose HR falls greater than or equal to one standard deviation above the mean of the sample. This scoring will also be included in the larger allostatic load risk ratio.

  baseline and 4-month follow-up

Secondary Outcomes (3)

• Change in Pain Intensity

  baseline and 4-month follow-up

• Change in Functional Disability

  baseline and 4-month follow-up

• Change in Sleep

  baseline and 4-month follow-up

Other Outcomes (5)

• Change in Treatment Engagement

  baseline and 4-month follow-up

• Change in Adverse Childhood Experiences (ACEs) exposure

  baseline and 4-month follow-up

• Change in Psychological Stress

  baseline and 4-month follow-up

Study Arms (1)

Study Arm

OTHER

All participants enrolled in the study will undergo baseline fMRI and baseline and follow-up (4-month post-baseline) assessment of stress physiology (i.e., allostatic load). Treatment as usual information will be gathered for all participants to assess observational intervention response.

Diagnostic Test: functional Magnetic Resonance Imaging (fMRI); Other: Allostatic Load Composite

Interventions

functional Magnetic Resonance Imaging (fMRI) DIAGNOSTIC_TEST

Participants will undergo a one hour fMRI scan with pain-induction using heat-based QST protocol.

Study Arm

Allostatic Load Composite OTHER

All participants will be asked to provide saliva samples to measure cortisol response over time and dehydroepiandrosterone (DHEA) in addition to physiological measurements such as blood pressure/pulse, height/weight, and waist-hip ratio. Measurements will be taken at baseline and 4-month follow-up.

Study Arm

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Between ages 11-17 years
• Referred to the Boston Children's Hospital Pain Treatment Service for evaluation of a CWP condition with duration \> 3 months
• Right-handed

You may not qualify if:

• Inability to speak sufficient English to complete questionnaires
• Severe cognitive impairment
• Prescription steroidal (interference with cortisol measures) or psychotropic medication
• Any other chronic pain diagnosis (e.g., migraines, abdominal pain, CRPS)
• fMRI contraindications (e.g., dental appliances)
• Healthy Control (HC) group:
• Between ages 11-17 years
• Right-handed
• Inability to speak sufficient English to complete questionnaires
• Severe cognitive impairment
• Prescription steroidal (interference with cortisol measures) or psychotropic medication
• Any chronic pain diagnosis
• Presence of documented chronic (\> 3 months) medical condition with an identifiable, organic cause (e.g., diabetes, cystic fibrosis)
• fMRI contraindications (e.g., dental appliances)

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Chronic Pain; Stress, Psychological

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sarah Nelson

  Boston Children's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Attending Psychologist

Model Details: All participants will undergo fMRI and stress physiology measurement. Intervention outcomes will be compared across two groups: 1. pediatric chronic widespread pain and 2. age and gender matched healthy controls.

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 28, 2020
• Study Start: November 4, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will be made available on a case-by-case basis.

Locations

US (1)