Oklahoma Study of Native American Pain Risk III: Stress and Resilience (OK-SNAPIII)

March 27, 2025 updated by: University of Oklahoma

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

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?

Study Overview

Status

Recruiting

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.

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Recruiting
        • University of Oklahoma - Schusterman Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will be adults who self-identify as Native American/American Indian.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Native Americans
Native Americans / American Indians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline
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.
baseline
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).
baseline
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.
baseline
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.
baseline
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.
baseline
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline
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.
basline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jamie L Rhudy, PhD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Immediately following publication of all findings, the data will be freely available to any researcher who requests a copy. All data files will be de-identified so there is no possibility of connecting the information with the original participants. The electronic data will be stored as de-identified SPSS data files or Excel data files. The raw (i.e., unprocessed) physiology data (e.g., EMG, EKG, EEG) will also be made available to interested researchers. These raw data files will be stored as de-identified files. To obtain access to the data, interested parties can contact the PI (jamie-rhudy@utulsa.edu).

IPD Sharing Time Frame

De-identified data will become available following publication of all findings (around 6/1/2030).

IPD Sharing Access Criteria

To obtain access to the data, interested parties can contact the PI (jamie-rhudy@utulsa.edu).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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