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

• ClinicalTrials.gov Identifier: NCT03338192
• Recruitment Status: Recruiting
• First Posted: November 9, 2017
• Last Update Posted: April 8, 2019
• Sponsor: University of Alabama at Birmingham
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Burel Goodin, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment
Back Pain Lower Back Chronic	Other: QST

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 Design

• Study Type: Observational
• Estimated Enrollment: 240 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Racial and Socioeconomic Differences in Chronic Low Back Pain
• Actual Study Start Date: October 15, 2017
• Estimated Primary Completion Date: November 8, 2021
• Estimated Study Completion Date: November 8, 2022

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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"
2. 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.
3. 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.
4. 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.
5. C-reactive protein [ Time Frame: One week follow up ]
   A marker of systemic pro-inflammation
6. Fibrinogen [ Time Frame: One week follow up ]
   A marker of systemic pro-inflammation
7. Serum amyloid A [ Time Frame: One week follow up ]
   A marker of systemic pro-inflammation
8. Vitamin D [ Time Frame: One week follow up ]
   hormone
9. Oxytocin [ Time Frame: One week follow up ]
   Hormone
10. Sleep quality [ Time Frame: Between baseline and one week follow-up ]
    Measured via actigraphy
11. 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.
12. 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).
13. 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.

Other Outcome Measures:

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

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-reative protein and Oxytocin.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Biological gender of either male or female.
• 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.

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

Contacts and Locations

Contacts

Contact: Burel Goodin, PhD; (205) 934-8910; bgoodin1@uab.edu

Contact: Tammie Quinn, BA; (205) 356-1730; tquinn@uab.edu

Locations

United States, Alabama

UAB; Recruiting

Birmingham, Alabama, United States, 35294

Contact: Tammie Quinn 205-934-8743 tquinn@uab.edu

Principal Investigator: Burel Goodin, PhD

Sponsors and Collaborators

University of Alabama at Birmingham

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

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

More Information

• Responsible Party: Burel Goodin, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03338192 History of Changes
• Other Study ID Numbers: F170119003; R01MD010441 ( U.S. NIH Grant/Contract )
• First Posted: November 9, 2017
• Last Update Posted: April 8, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Burel Goodin, University of Alabama at Birmingham:

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

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms