A Cross-Sectional Trial of Methylglyoxylated-Protein Levels in Adults With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Methylglyoxal Evaluation
研究概览
简要总结
The investigators will test the hypothesis that patients with low back pain associated with lumbar disc aberrancy will have elevated MGO-protein levels circulating in the blood that are comparable to patients with painful diabetic neuropathy.
详细描述
This is a cross-sectional, non-interventional study conducted solely at KU Medical Center in which patients will be recruited and sorted based on the following status: 1) healthy, 2) painful diabetic neuropathy, 3) chronic low back pain as a result of non-operative lumbar aberrancy. Once recruited, subjects will undergo a venous blood draw to measure MGO-protein levels, HbA1c, blood glucose, NFL protein levels and GLO1 activity. Subjects will also complete questionnaires to better understand how MGO levels correlate with pain status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent provided by the subject
- •Able to read/speak English
- •TYPE 2 DIABETES
- •All healthy inclusion criteria AND
- •Blood glucose levels > 126 mg/dl
- •Diagnosed with neuropathy or experience painful numbness or tingling in their hands or feet
- •LOW BACK PAIN
- •All healthy inclusion criteria AND
- •Chronic (persistent pain lasting longer than 3 months) low back pain as a direct result of non-operative lumbar disc aberrancy (disc herniation, protrusion, or extrusion)
- •Aberrancy occurring within 12 months of pre-screening
排除标准
- •Current clinically significant cardiac or neurological disease
- •Diagnosis of IBS, osteoarthritis, fibromyalgia, complex regional pain syndrome (CRPS), postherpetic neuralgia
- •Lumbar surgery due to disc aberrancy
- •Therapeutic spinal injections within the last 3 months (steroid, ablations, etc.)
- •Chronic use of steroids or non
- •steroidal anti-inflammatory drugs (NSAIDS) within 3 months of pre-screen
- •Past or present use of spinal cord stimulators
结局指标
主要结局
Methylglyoxal Evaluation
时间窗: 12 months
Number of participants with elevated blood methylglyoxal-derived hydroimidazolone (MG-H1, nM) with chronic pain.
次要结局
- Glyoxylase 1 Activity(12 months)
- Pain Status using the Brief Pain Index(12 months)
- HbA1c(12 months)
- Blood Glucose(12 months)
- Body Mass Index(12 months)
- Neuropathy Status using the Michigan Neuropathy Screening Index(12 months)
- Neurofilament Light(12 months)
研究者
Doug Wright
Professor of Anatomy and Cell Biology
University of Kansas Medical Center