Clinical trial NCT03338192: Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
Official title: Racial and Socioeconomic Differences in Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain Lower Back Chronic
Keywords: Low back pain
Chronic pain
Health disparities in chronic low back pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-11-09
Enrollment: 281
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Clinical Pain Severity
timeFrame: Baseline to one week.
Secondary outcomes:
measure: Average Pain Threshold (Heat)
timeFrame: Baseline
measure: Average Pain Tolerance (Heat)
timeFrame: Baseline
measure: Difference in Temporal Summation of Pain (Mechanical)
timeFrame: Baseline
measure: Difference in Pressure Pain Thresholds Assessed Using Conditioned Pain Modulation
timeFrame: Baseline
measure: Total Level of C-reactive Protein
timeFrame: One week follow up
measure: Total Level of Fibrinogen
timeFrame: One week follow up
measure: Total Level of Serum Amyloid A
timeFrame: One week follow up
measure: Total Level of Vitamin D
timeFrame: One week follow up
measure: Total Level of Oxytocin
timeFrame: One week follow up
measure: Sleep Quality
timeFrame: Between baseline and one week follow-up
measure: Self-reported Disability
timeFrame: One week follow up
measure: Evoked Pain With Movement
timeFrame: One week follow up
measure: Functional Performance
timeFrame: One week follow up
Other outcomes:
measure: Depressive Symptoms
timeFrame: Baseline
measure: Average Perceived Injustice (Pain-related)
timeFrame: Baseline
measure: Perceived Discrimination
timeFrame: Baseline
measure: Social Support
timeFrame: Baseline
measure: Total Psychological Pain Resilience
timeFrame: Baseline
measure: Average Dietary Caffeine Consumption
timeFrame: Between baseline and one week follow up
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham Department of Psychology
name: Burel Goodin, PhD
role: PRINCIPAL_INVESTIGATOR
References: