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NCT Number: NCT05723081

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

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?

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Key information

Conditions

Discrimination, Racial Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prejudice Racism Signs and Symptoms Social Behavior Social Discrimination Stress Physiology Systemic Racism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Pain inhibition

    Time frame: baseline

    Pain inhibition will be assessed using a conditioned pain modulation task with cold water as the conditioning stimulus and electric stimulations as the test stimulus.

  2. Inhibition of pain-related spinal reflex

    Time frame: baseline

    Pain-related spinal reflex inhibition assessed from electromyogram will be assessed using a conditioned pain modulation task with cold water as the conditioning stimulus and electric stimulations as the test stimulus.

  3. Inhibition of pain-evoked cortical potentials

    Time frame: baseline

    Inhibition of pain-evoked cortical potentials from electroencephalography will be assessed using a conditioned pain modulation task with cold water as the conditioning stimulus and electric stimulations as the test stimulus.

  4. Psychological stress

    Time frame: baseline

    A single latent variable measuring psychological stress will be created using principal components analysis to combine scores from three self-report questionnaires: the Perceived Stress Scale (PSS), the Global Distress Index of the Symptom Checklist-90-Revised (SCL-90-R), and the PTSD Checklist-Civilian (PCL-C).

  5. Somatic threat sensitivity

    Time frame: baseline

    A single latent variable measuring somatic threat sensitivity will be created using principal components analysis to combine scores from the Pain Catastrophizing Scale and a pain-related anxiety visual analog scale.

  6. Allostatic load

    Time frame: baseline

    A single latent variable for allostatic load will be created using principal components analysis to combine cardiovascular (i.e., resting blood pressure and heart rate, stress-evoked blood pressure and heart rate, and a fasting lipids profile [HDL, LDL total cholesterol, and triglycerides]), metabolic (i.e., BMI, waist-to-hip ratio, HbA1c), neuroendocrine (i.e., diurnal salivary cortisol, stress-evoked salivary cortisol), immune (i.e., hs-CRP), and parasympathetic (i.e., resting heart rate variability) variables.

  7. Environmental structural racism and discrimination

    Time frame: baseline

    An index comprised of 11 environmental justice variables from the Environmental Protection Agency's publicly available Environmental Screening and Mapping Tool (EJSCREEN) will be created for each participant at the 2010 Census Block Group level. The 11 variables will be combined into a single index using principal components analysis.

  8. Cultural connectedness

    Time frame: baseline

    A single latent variable of cultural connectedness will be created using principal components analysis to combine scores from five self-report scales: the Cultural Connectedness Scale, the Community Mastery Scale, the Vancouver Index of Acculturation, the American Indian Enculturation Scale, and the Native American Spirituality Scale

Secondary outcomes

  1. Temporal summation of pain

    Time frame: baseline

    Temporal summation of pain will be measured by assessing the change in a participant's pain ratings in response identical noxious stimuli delivered in rapid succession.

  2. Temporal summation of spinal nociception

    Time frame: baseline

    Temporal summation of spinal nociception will be measured by assessing the change in a participant's pain-related reflex magnitude (assessed from electromyography) in response identical noxious stimuli delivered in rapid succession.

  3. Pain tolerance

    Time frame: basline

    Pain tolerance will be measured with ischemic and cold pain tasks. Participants will continuously rate their pain in response to painful tonic stimuli, and pain tolerance will be quantified as the time (in seconds) that it takes for participants to report that they can no longer tolerate the pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Jamie L Rhudy, PhD

CONTACT

[email protected]

918-660-3050

PLAN Lab

CONTACT

[email protected]

918-660-3048

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Oklahoma State University
  • University of Tulsa

Registry information

Official study title

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

Acronym: OK-SNAPIII

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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