Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain

Boston Children's Hospital

Status: Active, not recruiting

Conditions: Stress, Physiological; Stress, Psychological; Chronic Widespread Pain

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04488757

1K23AT010643-01A1 (U.S. NIH Grant/Contract)

IRB-P00035303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Chronic Widespread Pain (CWP) group:

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

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:

Inclusion Criteria:

• 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 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Study Arm

Other group

Description:

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.

Treatment:

Diagnostic Test: functional Magnetic Resonance Imaging (fMRI)

Other: Allostatic Load Composite