Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-04

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents

NCT04685343

Primary Dysmenorrhea

COMPLETED NA

Neural Mechanisms of Treatment Response to ADAPT

NCT03518216

Functional Abdominal Pain Syndrome Anxiety

COMPLETED NA

Brain Mechanisms of Attention and Pain in Youth With FAPD

NCT05892055

Functional Abdominal Pain Syndrome

WITHDRAWN

Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

NCT04964726

Emotional Dysfunction Early Life Stress

COMPLETED NA

Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain

NCT05763758

Experimental Pain Low Back Pain

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pediatric chronic widespread pain (CWP) is a serious public health problem resulting in high levels of healthcare utilization and disability. Youth with CWP also frequently report exposure to adverse childhood experiences (ACEs; abuse/neglect, violent/conflictual home environment, etc.) and a significant subset continue to experience physical and psychosocial impairment long-term. Certain mind-body interventions such as mindfulness-based stress reduction (MBSR) or meditation may be particularly appropriate for youth with CWP as they have been shown to modulate stress-induced maladaptation of the HPA-axis, autonomic nervous system, cardiovascular system, and brain structure (e.g., hippocampus). However, it is currently unknown if these targets are affected in youth with CWP. Preliminary research indicates that allostatic load (AL), or "wear and tear" on the nervous system due to stress, may contribute to pain chronicity. Similarly, evidence suggests that the hippocampus, a brain structure that is among the most deleteriously affected by stress, plays a role in pain perception. However, no study to-date has examined AL and hippocampal functioning in relation to stress exposure in youth with CWP. Mind-body interventions such as MBSR or meditation are an important and safe therapy option for both pain and stress reduction in youth with CWP and may modulate the negative impact of ACEs, so there is a critical need to know if these mechanisms are engaged in this population. The current study utilizes multifactorial physiological and neuroimaging measurement techniques to enhance our understanding of the potential role of these mechanisms in pain-related impairment and responsiveness to mind-body interventions over time. The aims of this study are to better characterize AL, assessed via a multifactorial composite, and hippocampal functioning via fMRI in pediatric CWP as specific targets for mind-body interventions that can lead to treatment optimization and improved compliance.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Widespread Pain Stress, Psychological Stress, Physiological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Arm

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.

Group Type OTHER

functional Magnetic Resonance Imaging (fMRI)

Intervention Type DIAGNOSTIC_TEST

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

Allostatic Load Composite

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

functional Magnetic Resonance Imaging (fMRI)

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

Intervention Type DIAGNOSTIC_TEST

Allostatic Load Composite

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* Between ages 11-17 years
* Right-handed

Exclusion Criteria

* 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:

* 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)

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes