- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04488757
Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah Nelson, PhD
- Phone Number: 6173557040
- Email: sarah.nelson@childrens.harvard.edu
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
-
Contact:
- Ayeong Kim
-
Principal Investigator:
- Sarah Nelson, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
Participants will undergo a one hour fMRI scan with pain-induction using heat-based QST protocol.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hippocampal Functioning
Time Frame: baseline
|
measured via fMRI
|
baseline
|
Change in Morning Cortisol
Time Frame: baseline and 4-month follow-up
|
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)
Time Frame: baseline and 4-month follow-up
|
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
Time Frame: baseline and 4-month follow-up
|
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
Time Frame: baseline and 4-month follow-up
|
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)
Time Frame: baseline and 4-month follow-up
|
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)
Time Frame: baseline and 4-month follow-up
|
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)
Time Frame: baseline and 4-month follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Intensity
Time Frame: baseline and 4-month follow-up
|
measured via numeric rating scale (range: 0-10).
Higher rating indicates more intense pain.
|
baseline and 4-month follow-up
|
Change in Functional Disability
Time Frame: baseline and 4-month follow-up
|
measured via self-report Functional Disability Inventory (range: 0-60).
Higher rating indicates greater functional disability.
|
baseline and 4-month follow-up
|
Change in Sleep
Time Frame: baseline and 4-month follow-up
|
measured via Patient Reported Outcome Measurement Information System (PROMIS) sleep disturbance scale short-form (8a).
Raw scores are converted to T-scores (range: 0-100).
Higher rating indicates greater impairment in sleep.
|
baseline and 4-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Treatment Engagement
Time Frame: baseline and 4-month follow-up
|
measured via participant self-report of treatment as usual (e.g., engagement in physical therapy, cognitive-behavioral therapy, acupuncture, etc.).
Observational measure without metrics for risk or impairment.
|
baseline and 4-month follow-up
|
Change in Adverse Childhood Experiences (ACEs) exposure
Time Frame: baseline and 4-month follow-up
|
measured via Childhood Trust Events Scale (CTES).
Items on this measure are coded dichotomously (0 = no; 1 = yes) and will be summed to provide a total metric of ACEs exposure (range: 0-26).
|
baseline and 4-month follow-up
|
Change in Psychological Stress
Time Frame: baseline and 4-month follow-up
|
measured via Patient Reported Outcome Measurement Information System (PROMIS) psychological stress scale short-form (8a).
Raw scores are converted to T-scores (range: 0-100).
Higher rating indicates greater amounts of psychological stress.
|
baseline and 4-month follow-up
|
Change in Anxiety
Time Frame: baseline and 4-month follow-up
|
measured via Patient Reported Outcome Measurement Information System (PROMIS) anxiety scale short-form (8a).
Raw scores are converted to T-scores (range: 0-100).
Higher rating indicates greater amounts of anxiety.
|
baseline and 4-month follow-up
|
Change in Depression
Time Frame: baseline and 4-month follow-up
|
measured via Patient Reported Outcome Measurement Information System (PROMIS) depression scale short-form (8a).
Raw scores are converted to T-scores (range: 0-100).
Higher rating indicates greater amounts of depressive symptoms.
|
baseline and 4-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Nelson, Boston Children's Hospital/Harvard Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00035303
- 1K23AT010643-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Dr. Nelson and collaborators acknowledge their willingness to share data and materials with other eligible investigators through academically established means.
Finalized data sets will be available to other researchers who seek to conduct further analysis on any and all variables of the study, in full compliance with HIPAA and institutional IRB oversight. Interested researchers would need the permission of the PI of this study (Nelson). Any data-sharing agreement would include the purpose of the secondary analyses and the credentials of the researchers, and will be in full HIPAA compliance, as the data will be de-identified. This data-sharing agreement will meet the NIH's policy for data sharing.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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