Racial and Socioeconomic Differences in Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Average Clinical Pain Severity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic low back pain that has been going on consistently for the last 6 months.
排除标准
- •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
结局指标
主要结局
Average Clinical Pain Severity
时间窗: 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).
次要结局
- 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)
研究者
Burel Goodin
Principal Investigator
University of Alabama at Birmingham