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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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

281 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-15

Study Completion Date

2024-01-31

Brief Summary

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It remains unclear whether certain disadvantaged subgroups of society may be at heightened risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to incorporate a socioeconomic framework to characterize racial differences in cLBP severity and disability. Further, guided by the theory of fundamental causes, we aim to examine racial and socioeconomic status differences in biopsychosocial predictors of cLBP outcomes, particularly endogenous pain modulation.

Detailed Description

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Experimental session 1

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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Back Pain Lower Back Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic low back pain that has been going on consistently for the last 6 months.

Exclusion Criteria

* Surgery (fusion, Laminectomy) in the last year, accident or trauma in the last year, uncontrolled high blood pressure, heart disease, cancer, diabetes HbA1c \> 7%, Ankylosing Spondylitis, Infection, Parkinson's Disease, Multiple Sclerosis, Epilepsy, Stroke, Seizure (non-epileptic), Systemic Lupus Erythematosus, Fibromyalgia, Raynaud's disease, Major Depression/Bipolar Disorder, HIV
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Burel Goodin

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 39424112 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38692399 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38323608 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01MD010441

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F170119003

Identifier Type: -

Identifier Source: org_study_id

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