Chronic Widespread PainNCT04488757
Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain
A study testing functional Magnetic Resonance Imaging (fMRI) and Allostatic Load Composite in people with Chronic Widespread Pain and Stress, Psychological, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Widespread Pain, Stress, Psychological, Stress, Physiological
- What is being tested?
- functional Magnetic Resonance Imaging (fMRI) and Allostatic Load Composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Being tested
- functional Magnetic Resonance Imaging (fMRI), Allostatic Load Composite
- Keywords
- Chronic Widespread Pain, Pediatric Pain, Allostatic Load, fMRI, Mind-Body Interventions
- Medical subject headings
- Chronic Pain, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional Magnetic Resonance Imaging (fMRI)Diagnostic test
Participants will undergo a one hour fMRI scan with pain-induction using heat-based QST protocol.
Allostatic Load CompositeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Other | 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. Receives: Diagnostic Test: functional Magnetic Resonance Imaging (fMRI); Other: Allostatic Load Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hippocampal Functioning
measured via fMRI
Measured: baseline
Change in Morning Cortisol
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.
Measured: baseline and 4-month follow-up
Change in Dehydroepiandrosterone (DHEA)
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.
Measured: baseline and 4-month follow-up
Change in Flattened Cortisol
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.
Measured: baseline and 4-month follow-up
Change in Blood Pressure
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.
Measured: baseline and 4-month follow-up
Change in Body-Mass Index (BMI)
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.
Measured: baseline and 4-month follow-up
Change in Waist-Hip Ratio (WHR)
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.
Measured: baseline and 4-month follow-up
Change in Heart Rate (HR)
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.
Measured: baseline and 4-month follow-up
Secondary outcomes (3)
Change in Pain Intensity
measured via numeric rating scale (range: 0-10). Higher rating indicates more intense pain.
Measured: baseline and 4-month follow-up
Change in Functional Disability
measured via self-report Functional Disability Inventory (range: 0-60). Higher rating indicates greater functional disability.
Measured: baseline and 4-month follow-up
Change in Sleep
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.
Measured: baseline and 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start4 Nov 2021
- Primary completion31 Mar 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Widespread PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Sarah Nelson, Boston Children's Hospital
- Investigators
- Sarah Nelson, Principal investigator, Boston Children's Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488757
- Sponsor's protocol ID
- IRB-P00035303
- Other IDs
- 1K23AT010643-01A1
- Status last verified
- May 2026
- First submitted
- 21 Jul 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain
- ClinicalTrials.gov ID
- NCT04488757
- Acronym / sponsor ID
- IRB-P00035303
- Keywords
- Chronic Widespread Pain, Pediatric Pain, Allostatic Load, fMRI, Mind-Body Interventions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Other | Diagnostic Test: functional Magnetic Resonance Imaging (fMRI), Other: Allostatic Load CompositeAll 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional Magnetic Resonance Imaging (fMRI)Participants will undergo a one hour fMRI scan with pain-induction using heat-based QST protocol. | Diagnostic test | Study Arm |
| Allostatic 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. | Other | Study Arm |
Primary outcome
Hippocampal Functioning
Time frame: baseline
measured via fMRI
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Change in Pain Intensity
Time frame: baseline and 4-month follow-up
Change in Functional Disability
Time frame: baseline and 4-month follow-up
Change in Sleep
Time frame: baseline and 4-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Nelson principal investigator
Boston Children's Hospital/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional Magnetic Resonance Imaging (fMRI) and Allostatic Load Composite in people with Chronic Widespread Pain and Stress, Psychological, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hippocampal Functioning (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.