Exploring how social factors influence pain expression and assessment

Sociocultural & Biobehavioral Influences on Pain Expression and Assessment

This study is trying to see how social factors affect how people show and report pain, especially in disadvantaged groups, to find better ways to assess and treat pain fairly.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 700 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT03258580 on ClinicalTrials.gov

What this trial studies

This study investigates the behavioral, psychophysiological, and social processes that contribute to biases and disparities in pain experiences and treatment. It focuses on how interpersonal dynamics, such as pain expression and assessment, may differ across various demographics, particularly among disadvantaged populations. The research employs interventions like thermal and electric stimulation, as well as pain assessment feedback, to evaluate these influences. By understanding these factors, the study aims to develop interventions that improve pain assessment accuracy and reduce biases in treatment.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 60 who are fluent in English and can provide informed consent.

Not a fit: Patients with major medical conditions, mood disorders, or those who do not reside in the United States may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to more equitable pain assessment and treatment for diverse populations.

How similar studies have performed: Other studies have indicated that addressing social factors in pain assessment can lead to improved outcomes, suggesting this approach has potential for success.

Eligibility criteria

* INCLUSION CRITERIA:

All Sub-Studies:

* Healthy
* Between 18 and 60 years old
* Fluent in English
* Able to provide written informed consent

EXCLUSION CRITERIA:

All Sub-Studies:

* Unable to comply with study procedures
* Has a major-medical condition or medical history that in a clinician's assessment could affect ability to comply with study procedures, including neurological conditions (including stroke, blindness or deafness, or a history of brain damage)
* Has a current mood disorder, anxiety disorder, or substance use disorder, or has a history of psychosis, hospitalization for a mental health condition, or recurrent psychiatric episodes.
* NIH staff member who is a subordinate/relative/co-worker of any investigator on the protocol
* Prior completion of a different sub-study within this protocol.
* Is born outside of the states or territories of the United States of America
* Does not currently reside in a state or territory of the United States of America

Sub-study 1:

* Has a major-medical condition or medical history that in a clinician's assessment could affect heat sensitivity or pain thresholds. This may include cardiovascular, autonomic, or neurological conditions or a chronic systemic disease (e.g., diabetes)
* Has a medical condition that in a clinician's assessment might affect somatosensation (e.g., Raynaud's disease, peripheral neuropathy, or circulatory disorder)
* Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months)
* Has a dermatological condition affecting the testing region, such as scars, burns, or recent tattoos that might influence cutaneous sensibility
* Regular use of prescription medication that has a significant effect on pain or heat perception. Excluded medications include central-acting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbituates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an "as needed" basis is acceptable as long as the last dose was not taken was within 5 half-lives of testing.
* Is left handed

Sub-study 4, FMRI participants:

* Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months)
* Is left-handed
* Any FMRI contraindications, including:

  * Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body.
  * Implanted cardiac pacemaker or auto-defibrillator.
  * Insulin pump.
  * Irremovable body piercing.
* Pregnant women (based on urine test completed within 24 hours prior to scan).
* Those with an abnormality on a structural MRI that has functional consequences based on clinician assessment.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Lauren Y Atlas, Ph.D. — National Center for Complementary and Integrative Health (NCCIH)
• Study coordinator: Adebisi O Ayodele, C.R.N.P.

Conditions Normal Physiology; Healthy Volunteers; Pain; Visual Analogue Pain Scale; Healthy Volunteer; EYE TRACKING; Eye Movement