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

February 1, 2024 updated by: Burel Goodin, University of Alabama at Birmingham

Racial and Socioeconomic Differences in Chronic Low Back Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

284

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tammie Quinn, BA
  • Phone Number: (205) 356-1730
  • Email: tquinn@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pain Severity
Time Frame: Baseline to one week.
Participants will self-report a number between 0 - 100 describing the intensity of their low back pain, such that 0 = no pain and 100 = the most intense pain imaginable. Any integer from 0 to 100 can be provided.
Baseline to one week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain threshold
Time Frame: Baseline
Pain threshold refers to the intensity at which a stimulus is first perceived as painful. Heat stimuli will be delivered using a computer-controlled thermal stimulation system with a 30 millimeter X 30 millimeter probe. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain threshold, participants will be instructed to press the button when the sensation "first becomes painful"
Baseline
Pain tolerance
Time Frame: Baseline
Pain tolerance refers to the maximum amount of pain produced by a stimulus that a person is able/willing to tolerate. Heat stimuli will again be delivered using the computer-controlled thermal stimulation system. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain tolerance, participants will be instructed to press the button when they are "no longer willing to tolerate" the painful sensation.
Baseline
Temporal summation of pain
Time Frame: Baseline
Temporal summation of pain refers to a form of endogenous pain facilitation characterized by the perception of increased pain despite constant or even reduced peripheral afferent input. Temporal summation is presumed to be the psychophysical manifestation of wind-up. Wind-up is a phenomenon where repetitive stimulation of C primary afferents at rates greater than 0.3 Hertz produces a slowly increasing response of second-order neurons in the spinal cord.
Baseline
Conditioned pain modulation
Time Frame: Baseline
A routinely used quantitative sensory testing protocol for the measurement of endogenous pain inhibition is conditioned pain modulation, which refers to the reduction in pain from one stimulus (the test stimulus) produced by the application of a second pain stimulus at a remote body site (the conditioning stimulus). Conditioned pain modulation is believed to reflect the perceptual manifestation of diffuse noxious inhibitory controls, whereby ascending projections from one noxious stimulus activate supraspinal structures that trigger descending inhibitory projections to the dorsal horn.
Baseline
C-reactive protein
Time Frame: One week follow up
A marker of systemic pro-inflammation
One week follow up
Fibrinogen
Time Frame: One week follow up
A marker of systemic pro-inflammation
One week follow up
Serum amyloid A
Time Frame: One week follow up
A marker of systemic pro-inflammation
One week follow up
Vitamin D
Time Frame: One week follow up
hormone
One week follow up
Oxytocin
Time Frame: One week follow up
Hormone
One week follow up
Sleep quality
Time Frame: Between baseline and one week follow-up
Measured via actigraphy
Between baseline and one week follow-up
Self-reported disability
Time Frame: One week follow up
To be assessed with the Oswestry Low Back Pain Questionnaire. This measure is patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those with low back pain.
One week follow up
Evoked pain with movement
Time Frame: One week follow up
Participants will complete a serious of movements including getting in and out of bed as well as lifting a crate from the ground to a tabletop. They will provide a rating from 0 - 100 indicating how painful it was to complete each movement (0 = no pain, 100 = most intense pain imaginable).
One week follow up
Functional performance
Time Frame: One week follow up
Participants will complete the short physical performance battery. This assessment represents is a group of measures that combines the results of the gait speed, chair stand and balance tests.
One week follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: Baseline
Measured using the Center for Epidemiological Studies - Depression Scale
Baseline
Perceived injustice
Time Frame: Baseline
Measured using the Injustice Experiences Questionnaire
Baseline
Perceived discrimination
Time Frame: Baseline
Measured using the Everyday Discrimination Scale
Baseline
Social support
Time Frame: Baseline
Measured using the Multidimensional Survey of Perceived Social Support Scale
Baseline
Psychological pain resilience
Time Frame: Baseline
Measured using the Psychological Pain Resilience Scale
Baseline
Dietary caffeine consumption
Time Frame: Between baseline and one week follow up
Measured using a daily diary of dietary intake across seven days
Between baseline and one week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Burel Goodin, PhD, University of Alabama at Birmingham Department of Psychology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2017

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F170119003
  • R01MD010441 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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