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Recruiting NCT05723081

Oklahoma Study of Native American Pain Risk III: Stress and Resilience

— Observational Discrimination, Racial Stress Physiology Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Discrimination, Racial, Stress Physiology, Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Impact of Structural Racism and Discrimination (SRD) on Mechanisms of the Native American Pain Disparity

Overview

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.

Primary outcome measures

  • Pain inhibition [Time frame: baseline]
  • Inhibition of pain-related spinal reflex [Time frame: baseline]
  • Inhibition of pain-evoked cortical potentials [Time frame: baseline]
  • Psychological stress [Time frame: baseline]
  • Somatic threat sensitivity [Time frame: baseline]
  • Allostatic load [Time frame: baseline]
  • Environmental structural racism and discrimination [Time frame: baseline]
  • Cultural connectedness [Time frame: baseline]
Secondary outcome measures (3)
  • Temporal summation of pain [Time frame: baseline]
  • Temporal summation of spinal nociception [Time frame: baseline]
  • Pain tolerance [Time frame: basline]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Oklahoma - Schusterman Center — Tulsa

Identifiers

NCT: NCT05723081 · HSC16494/TU2229

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗