Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain (NCT04488757) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain
United States70 participantsStarted 2021-11-04
Plain-language 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.
Who can participate
Age range
11 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.