Discrimination, RacialOK-SNAPIIINCT05723081
Oklahoma Study of Native American Pain Risk III: Stress and Resilience
An observational study of Discrimination, Racial and Stress Physiology, run by University of Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Discrimination, Racial, Stress Physiology, Pain
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be adults who self-identify as Native American/American Indian.
Who may be able to join
- Self-identify as Native American/American Indian
Who cannot join
- <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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma - Schusterman Center
Tulsa, Oklahoma, 74135
PLAN lab, 918-660-3048, tulsa.plan@gmail.com
Jamie L Rhudy, PhD, 918-660-3050, jamie-rhudy@ouhsc.edu
About this study
Official title: 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:
- How does environmental structural racism and discrimination affect chronic pain-promoting mechanisms in Native Americans?
- What psychosocial factors buffer the negative effects of environmental structural racism and discrimination on chronic pain-promoting mechanisms?
Read the 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.
- Conditions
- Discrimination, Racial, Stress Physiology, Pain
- Keywords
- Structural racism and discrimination, Stress reactivity, Quantitative sensory testing
- Medical subject headings
- Racism, Pain, Systemic Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Native Americans | Native Americans / American Indians |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline
Secondary outcomes (3)
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start3 Feb 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discrimination, RacialStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma State University, University of Tulsa
- Responsible party
- Sponsor
- Investigators
- Jamie L Rhudy, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723081
- Sponsor's protocol ID
- HSC16494/TU2229
- Acronym
- OK-SNAPIII
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Structural Racism and Discrimination (SRD) on Mechanisms of the Native American Pain Disparity
- ClinicalTrials.gov ID
- NCT05723081
- Acronym / sponsor ID
- OK-SNAPIII / HSC16494/TU2229
- Conditions
- Discrimination, Racial, Stress Physiology, Pain
- Keywords
- Structural racism and discrimination, Stress reactivity, Quantitative sensory testing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma State University, University of Tulsa
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How does environmental structural racism and discrimination affect chronic pain-promoting mechanisms in Native Americans?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Native Americans | – | –Native Americans / American Indians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be adults who self-identify as Native American/American Indian.
Key inclusion criteria (1 listed)
- Self-identify as Native American/American Indian
Key exclusion criteria (9 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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).
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.
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.
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.
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
3 secondary outcomes
Temporal summation of pain
Time frame: baseline
Temporal summation of spinal nociception
Time frame: baseline
Pain tolerance
Time frame: basline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie L Rhudy, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Discrimination, Racial and Stress Physiology, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PLAN Lab (918-660-3048, tulsa.plan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain inhibition (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.