- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05723081
Oklahoma Study of Native American Pain Risk III: Stress and Resilience (OK-SNAPIII)
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?
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: PLAN Lab
- Phone Number: 918-660-3048
- Email: tulsa.plan@gmail.com
Study Contact Backup
- Name: Jamie L Rhudy, PhD
- Phone Number: 918-660-3050
- Email: jamie-rhudy@ouhsc.edu
Study Locations
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74135
- Recruiting
- University of Oklahoma - Schusterman Center
-
Contact:
- PLAN Lab
- Phone Number: 918-660-3048
- Email: tulsa.plan@gmail.com
-
Contact:
- Jamie L Rhudy, PhD
- Phone Number: 918-660-3050
- Email: jamie-rhudy@ouhsc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Jamie L Rhudy, PhD, University of Oklahoma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSC16494/TU2229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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