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

Back Pain Lower Back Chronic Clinical Trial

— ERASED  

Official title:

Racial and Socioeconomic Differences in Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338192
• Other study ID #: F170119003
• Secondary ID: R01MD010441
• Status: Completed
• Start date: October 15, 2017
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depressive symptoms	Measured using the Center for Epidemiological Studies - Depression Scale	Baseline
Other	Perceived injustice	Measured using the Injustice Experiences Questionnaire	Baseline
Other	Perceived discrimination	Measured using the Everyday Discrimination Scale	Baseline
Other	Social support	Measured using the Multidimensional Survey of Perceived Social Support Scale	Baseline
Other	Psychological pain resilience	Measured using the Psychological Pain Resilience Scale	Baseline
Other	Dietary caffeine consumption	Measured using a daily diary of dietary intake across seven days	Between baseline and one week follow up
Primary	Clinical Pain Severity	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	Pain threshold	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
Secondary	Pain tolerance	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
Secondary	Temporal summation of pain	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
Secondary	Conditioned pain modulation	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
Secondary	C-reactive protein	A marker of systemic pro-inflammation	One week follow up
Secondary	Fibrinogen	A marker of systemic pro-inflammation	One week follow up
Secondary	Serum amyloid A	A marker of systemic pro-inflammation	One week follow up
Secondary	Vitamin D	hormone	One week follow up
Secondary	Oxytocin	Hormone	One week follow up
Secondary	Sleep quality	Measured via actigraphy	Between baseline and one week follow-up
Secondary	Self-reported disability	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
Secondary	Evoked pain with movement	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
Secondary	Functional performance	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