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

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ClinicalTrials.gov Identifier: NCT03338192
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Burel Goodin, University of Alabama at Birmingham

Tracking Information
First Submitted Date November 7, 2017
First Posted Date November 9, 2017
Last Update Posted Date June 11, 2020
Actual Study Start Date October 15, 2017
Estimated Primary Completion Date November 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2017)
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.
Original Primary Outcome Measures
 (submitted: November 8, 2017)
Identify the difference between race and socioeconomic (SES) status in cLBP severity using a demographic questionnaire. [ Time Frame: Baseline to one week. ]
The Hollingshead Four-Factor Index of SES will be used to and objective measure to assess four domains including educational attainment, retired/employed status, marital status, and occupational category/prestige. The minimum score is 8 and the maximum is 66.The minimum score reflects the lower SES status.
Change History
Current Secondary Outcome Measures
 (submitted: December 19, 2017)
  • 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"
  • 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.
  • 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.
  • 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.
  • C-reactive protein [ Time Frame: One week follow up ]
    A marker of systemic pro-inflammation
  • Fibrinogen [ Time Frame: One week follow up ]
    A marker of systemic pro-inflammation
  • Serum amyloid A [ Time Frame: One week follow up ]
    A marker of systemic pro-inflammation
  • Vitamin D [ Time Frame: One week follow up ]
    hormone
  • Oxytocin [ Time Frame: One week follow up ]
    Hormone
  • Sleep quality [ Time Frame: Between baseline and one week follow-up ]
    Measured via actigraphy
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 13, 2017)
  • Depressive symptoms [ Time Frame: Baseline ]
    Measured using the Center for Epidemiological Studies - Depression Scale
  • Perceived injustice [ Time Frame: Baseline ]
    Measured using the Injustice Experiences Questionnaire
  • Perceived discrimination [ Time Frame: Baseline ]
    Measured using the Everyday Discrimination Scale
  • Social support [ Time Frame: Baseline ]
    Measured using the Multidimensional Survey of Perceived Social Support Scale
  • Psychological pain resilience [ Time Frame: Baseline ]
    Measured using the Psychological Pain Resilience Scale
  • Dietary caffeine consumption [ Time Frame: Between baseline and one week follow up ]
    Measured using a daily diary of dietary intake across seven days
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
Official Title Racial and Socioeconomic Differences in Chronic Low Back Pain
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition Back Pain Lower Back Chronic
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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Other: QST
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 8, 2017)
240
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 8, 2022
Estimated Primary Completion Date November 8, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Biological gender of either male or female.
Ages 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Burel Goodin, PhD (205) 934-8910 bgoodin1@uab.edu
Contact: Tammie Quinn, BA (205) 356-1730 tquinn@uab.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03338192
Other Study ID Numbers F170119003
R01MD010441 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Burel Goodin, University of Alabama at Birmingham
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
PRS Account University of Alabama at Birmingham
Verification Date June 2020