Racial and Socioeconomic Differences in Chronic Low Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Back Pain Lower Back Chronic
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 281
- Locations
- 1
- Primary Endpoint
- Average Clinical Pain Severity
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Burel Goodin
Principal Investigator
University of Alabama at Birmingham
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
Outcomes
Primary Outcomes
Average Clinical Pain Severity
Time Frame: Baseline to one week.
The Brief Pain Inventory Short-Form (BPI-SF) was used to assess clinical pain severity. Four items assessed participants' average, least, and worst pain over the past 24hours, as well as current pain (0=no pain, 10=pain as bad as you can imagine). These 4 items were averaged for a total score (range: 0-10).
Secondary Outcomes
- Functional Performance(One week follow up)
- Average Pain Threshold (Heat)(Baseline)
- Average Pain Tolerance (Heat)(Baseline)
- Difference in Temporal Summation of Pain (Mechanical)(Baseline)
- Difference in Pressure Pain Thresholds Assessed Using Conditioned Pain Modulation(Baseline)
- Total Level of C-reactive Protein(One week follow up)
- Total Level of Vitamin D(One week follow up)
- Total Level of Oxytocin(One week follow up)
- Sleep Quality(Between baseline and one week follow-up)
- Self-reported Disability(One week follow up)
- Total Level of Fibrinogen(One week follow up)
- Total Level of Serum Amyloid A(One week follow up)
- Evoked Pain With Movement(One week follow up)