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

NCT05723081 | Recruiting DMC

• 1 other identifier: HSC16494/TU2229
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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

Conditions

Discrimination, Racial; Stress Physiology; Pain

Keywords

Structural racism and discrimination; Stress reactivity; Quantitative sensory testing

Outcome Measures

Primary Outcomes (8)

• Pain inhibition

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (3)

• Temporal summation of pain

  baseline

• Temporal summation of spinal nociception

  baseline

• Pain tolerance

  basline

Study Arms (1)

Native Americans

Native Americans / American Indians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Self-identify as Native American/American Indian

You may not qualify if:

• \<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)

Sponsors & Collaborators

• University of Oklahoma: lead
• Oklahoma State University: collaborator
• University of Tulsa: collaborator

Study Sites (1)

University of Oklahoma - Schusterman Center

Tulsa, Oklahoma, 74135, United States

RECRUITING

Biospecimen

Retention: NONE RETAINED

Participants will provide 20 saliva samples during the study to measure salivary cortisol. Participants will also provide small samples of blood via finger stick to assess glucose regulation (HbA1c), systemic inflammation (hs-CRP), and a lipid profile (i.e., HDL, LDL, triglycerides, cholesterol.)

MeSH Terms

Conditions

Racism; Pain; Systemic Racism

Condition Hierarchy (Ancestors)

Prejudice; Social Behavior; Behavior; Social Discrimination; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jamie L Rhudy, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PLAN Lab

CONTACT

918-660-3048; tulsa.plan@gmail.com

Jamie L Rhudy, PhD

CONTACT

918-660-3050; jamie-rhudy@ouhsc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 10, 2023
• Study Start: February 3, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified data will become available following publication of all findings (around 6/1/2030).
• Access Criteria: To obtain access to the data, interested parties can contact the PI (jamie-rhudy@utulsa.edu).

Locations

US (1)