Clinical trial NCT04488757: Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain
Official title: Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Widespread Pain
Stress, Psychological
Stress, Physiological
Keywords: Chronic Widespread Pain
Pediatric Pain
Allostatic Load
fMRI
Mind-Body Interventions
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-07-28
Enrollment: 70
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Hippocampal Functioning
timeFrame: baseline
measure: Change in Morning Cortisol
timeFrame: baseline and 4-month follow-up
measure: Change in Dehydroepiandrosterone (DHEA)
timeFrame: baseline and 4-month follow-up
measure: Change in Flattened Cortisol
timeFrame: baseline and 4-month follow-up
measure: Change in Blood Pressure
timeFrame: baseline and 4-month follow-up
measure: Change in Body-Mass Index (BMI)
timeFrame: baseline and 4-month follow-up
measure: Change in Waist-Hip Ratio (WHR)
timeFrame: baseline and 4-month follow-up
measure: Change in Heart Rate (HR)
timeFrame: baseline and 4-month follow-up
Secondary outcomes:
measure: Change in Pain Intensity
timeFrame: baseline and 4-month follow-up
measure: Change in Functional Disability
timeFrame: baseline and 4-month follow-up
measure: Change in Sleep
timeFrame: baseline and 4-month follow-up
Other outcomes:
measure: Change in Treatment Engagement
timeFrame: baseline and 4-month follow-up
measure: Change in Adverse Childhood Experiences (ACEs) exposure
timeFrame: baseline and 4-month follow-up
measure: Change in Psychological Stress
timeFrame: baseline and 4-month follow-up
measure: Change in Anxiety
timeFrame: baseline and 4-month follow-up
measure: Change in Depression
timeFrame: baseline and 4-month follow-up
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital/Harvard Medical School
name: Sarah Nelson
role: PRINCIPAL_INVESTIGATOR
References: