Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
NCT ID: NCT03338192
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
281 participants
OBSERVATIONAL
2017-10-15
2024-01-31
Brief Summary
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Detailed Description
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Resting Blood Pressure and Body Mass Index will be assessed. Participants will complete the Rapid Estimation of Adult Literacy Measure-Short Form (REALM-SF) to determine health literacy. Participants will complete multiple questionnaires to measure Socioeconomic Status, Clinical Pain Assessment and Depression Scale. All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Between Experimental Session 1 and Experimental Session 2
Sleep assessment: Sleep data will be collected by participants in their own homes using objective and subjective measures of their sleep. Participant instructions for how to collect and record their own sleep data will be provided at the end of study session 1.
Experimental Session 2
Experimental session 2 will take place in the CCTS Clinical Research Unit (CRU) All blood will be collected as part of a single draw by research nurses. Participants will complete multiple questionnaires to measure Clinical Pain Assessment and Coping Strategies. Participants will then complete a battery of ecologically valid movement tasks that include: 1) getting in and out of a bed; 2) sitting in a chair, transitioning to a standing position, and then sitting again, and 3) lifting, Performance Battery (SPPB) and the Timed Up and Go test (TUG). Blood will be processed and stored and then used to measure Vitamin D, CRP assays and Oxytocin. Finally follow up data will be collected by phone once per week for four weeks following the completion of study session 2.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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African American/Black QST
This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.
QST
All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Caucasian/White QST
This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.
QST
All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Interventions
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QST
All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
85 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Burel Goodin
Principal Investigator
Principal Investigators
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Burel Goodin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham Department of Psychology
Locations
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UAB
Birmingham, Alabama, United States
Countries
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References
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Thomas PA, Ditta PV, Stocking SQ, Webb C, Meints SM, Owens MA, Quinn T, Aroke EN, Morris MC, Sorge RE, Goodin BR, Overstreet DS. The effects of neighborhood disadvantage and adverse childhood experiences on conditioned pain modulation in adults with chronic low back pain. J Pain. 2025 Jan;26:104706. doi: 10.1016/j.jpain.2024.104706. Epub 2024 Oct 16.
Thomas PA, Goodin BR, Meints SM, Owens MA, Wiggins AM, Quinn T, Long L, Aroke EN, Morris MC, Sorge RE, Overstreet DS. Adverse Childhood Experiences and Chronic Low Back Pain in Adulthood: The Role of Emotion Regulation. J Pain. 2024 Sep;25(9):104551. doi: 10.1016/j.jpain.2024.104551. Epub 2024 Apr 29.
Overstreet DS, Strath LJ, Sorge RE, Thomas PA, He J, Wiggins AM, Hobson J, Long DL, Meints SM, Aroke EN, Goodin BR. Race-specific associations: inflammatory mediators and chronic low back pain. Pain. 2024 Jul 1;165(7):1513-1522. doi: 10.1097/j.pain.0000000000003154. Epub 2024 Feb 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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F170119003
Identifier Type: -
Identifier Source: org_study_id
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