Clinical trial NCT05723081: Oklahoma Study of Native American Pain Risk III: Stress and Resilience
Official title: The Impact of Structural Racism and Discrimination (SRD) on Mechanisms of the Native American Pain Disparity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Discrimination, Racial
Stress Physiology
Pain
Keywords: Structural racism and discrimination
Stress reactivity
Quantitative sensory testing
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Oklahoma State University
name: University of Tulsa
First posted: 2023-02-10
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be adults who self-identify as Native American/American Indian.

Brief summary: The goal of this observational study is to learn about the relationship between environmental structural racism and discrimination and chronic pain risk in Native American adults. The main questions it aims to answer are:

1. How does environmental structural racism and discrimination affect chronic pain-promoting mechanisms in Native Americans?
2. What psychosocial factors buffer the negative effects of environmental structural racism and discrimination on chronic pain-promoting mechanisms?

Detailed description: Native Americans experience higher rates of chronic pain than the general U.S. population, and previous research has shown that pain-free Native Americans transition to chronic pain at almost three times the rate of non-Hispanic Whites. Yet, little is known about the mechanisms that contribute to this pain disparity.

This study aims to better understand the role of environmental and society-wide stressors, like structural racism and discrimination, in contributing to this pain disparity. It is believed that these environmental and social stressors may contribute to chronic pain risk by increasing an individual's mental and physical stress levels. In turn, increased stress may alter how an individual responds to pain, both physically and emotionally, which may place them at greater risk for developing chronic pain in the future.

Eligibility criteria: Inclusion Criteria:

* Self-identify as Native American/American Indian

Exclusion Criteria:

* \<18 years of age
* Self-reported history of cardiovascular, neuroendocrine, musculoskeletal, or neurological disorders
* Surrent chronic pain, defined as persistent, bothersome pain on more days than not for at least 3 months)
* Self-reported current substance dependence
* Sse of medication that could interfere with testing (e.g., recent use of analgesics, antidepressants, or anti-anxiety medications)
* Inability to speak English
* Current psychosis (assessed by Psychosis Screening Questionnaire)
* Serious cognitive impairment (assessed by \<20 score on the Montreal Cognitive Assessment \[MoCA\])
* Possible peripheral neuropathy (assessed by nerve conduction study)

Primary outcomes:
measure: Pain inhibition
timeFrame: baseline
measure: Inhibition of pain-related spinal reflex
timeFrame: baseline
measure: Inhibition of pain-evoked cortical potentials
timeFrame: baseline
measure: Psychological stress
timeFrame: baseline
measure: Somatic threat sensitivity
timeFrame: baseline
measure: Allostatic load
timeFrame: baseline
measure: Environmental structural racism and discrimination
timeFrame: baseline
measure: Cultural connectedness
timeFrame: baseline
Secondary outcomes:
measure: Temporal summation of pain
timeFrame: baseline
measure: Temporal summation of spinal nociception
timeFrame: baseline
measure: Pain tolerance
timeFrame: basline
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Oklahoma - Schusterman Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Jamie L Rhudy, PhD
role: PRINCIPAL_INVESTIGATOR
References: