Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04488757

Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
Boston Children's Hospital · Academic / Other
Sex
All
Age
11 Years – 17 Years
Healthy volunteers
Accepted

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.

Detailed description

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTfunctional Magnetic Resonance Imaging (fMRI)Participants will undergo a one hour fMRI scan with pain-induction using heat-based QST protocol.
OTHERAllostatic Load CompositeAll 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.

Timeline

Start date
2021-11-04
Primary completion
2026-03-31
Completion
2026-08-31
First posted
2020-07-28
Last updated
2026-02-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04488757. Inclusion in this directory is not an endorsement.