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

Pain Clinical Trial

— OK-SNAPIII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723081
• Other study ID #: HSC16494/TU2229
• Status: Recruiting
• Start date: February 3, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: January 2024
• Source: University of Oklahoma
• Contact: PLAN Lab
• Phone: 918-660-3048
• Email: tulsa.plan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Discrimination, Racial
• Pain
• Stress Physiology

Locations

Country	Name	City	State
United States	University of Oklahoma - Schusterman Center	Tulsa	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
University of Oklahoma	Oklahoma State University, University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Temporal summation of pain	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
Secondary	Temporal summation of spinal nociception	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
Secondary	Pain tolerance	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