Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study

NCT03338192 | Completed Results

• 2 other identifiers: F170119003R01MD010441
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain Lower Back Chronic

Keywords

Low back pain; Chronic pain; Health disparities in chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Average Clinical Pain Severity

  The Brief Pain Inventory Short-Form (BPI-SF) was used to assess clinical pain severity. Four items assessed participants' average, least, and worst pain over the past 24hours, as well as current pain (0=no pain, 10=pain as bad as you can imagine). These 4 items were averaged for a total score (range: 0-10).

  Baseline to one week.

Secondary Outcomes (13)

• Average Pain Threshold (Heat)

  Baseline

• Average Pain Tolerance (Heat)

  Baseline

• Difference in Temporal Summation of Pain (Mechanical)

  Baseline

• Difference in Pressure Pain Thresholds Assessed Using Conditioned Pain Modulation

  Baseline

• Total Level of C-reactive Protein

  One week follow up

Other Outcomes (6)

• Depressive Symptoms

  Baseline

• Average Perceived Injustice (Pain-related)

  Baseline

• Perceived Discrimination

  Baseline

Study Arms (2)

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.

Other: QST

Caucasian/White QST

This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.

Other: QST

Interventions

QST 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.

African American/Black QST; Caucasian/White QST

Eligibility Criteria

• Age: 19 Years - 85 Years
• Gender Eligibility Details: Biological gender of either male or female.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and woman white Caucasian and African American with Chrionic low back pain between the ages of 19-85.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Related Publications (4)

• 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 Dec;37S:105566. doi: 10.1016/j.jpain.2025.105566. Epub 2025 Dec 9.

  PMID: 41381165 DERIVED

• 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.

  PMID: 39424112 DERIVED

• 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.

  PMID: 38692399 DERIVED

• 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.

  PMID: 38323608 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Specimens will be labeled with unique identifiers (subject numbers) that correspond to each separate participant. Blood samples will be processed for serum and plasma and stored at -80 and then used to detect levels of Vitamin D, C-reactive protein and Oxytocin.

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to a delay in the initial award notification, start up was delayed in the first year. Recruitment increased and the protocol infrastructure was complete when the Covid 19 pandemic stopped all protocol recruitment and all study tasks. After the pandemic, recruitment was slower, the study timeline indicated recruitment completion at the end of 2022, but we had to request a No Cost Extension from January 2022 to January 2023 to complete recruitment numbers.

Results Point of Contact

• Title: Burel Goodin
• Organization: Washington University Pain Center in St. Louis

burel@wustl.edu

3142736403

Study Officials

• Burel Goodin, PhD

  University of Alabama at Birmingham Department of Psychology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 9, 2017
• Study Start: October 15, 2017
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 30, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)