Development of a Serum Biomarker-Based Approach to Monitor Opioid Adherence and Minimize Substance Misuse in Chronic Pain Management
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Serum protein levels as a marker for pain
研究概览
简要总结
The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.
详细描述
At the heart of the opioid epidemic is the lack of an objective measure of pain, which will help evaluate the validity of the patients' perception that the current dosage of opioid is sufficient of insufficient to alleviate pain. This study will test the quantifiable proteins such as S100B and BDNF will serve as objective measures (biomarkers) of pain.
Fibromyalgia patients will be recruited into two groups-- one that uses opioids and the other that does not. Blood will be collected every 6 months for two years. The serum will be used to assay for levels of S100B and BDNF, The pressure-pain threshold (PPT) data, as part of standard of care, will also be collected. Correlation will the be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Fibromyalgia
排除标准
- •Evidence of a history of substance abuse, neurological or oncologic disease, ischemic heart disease, kidney or hepatic insufficiency.
结局指标
主要结局
Serum protein levels as a marker for pain
时间窗: 2-4 years
Serum proteins will be assayed from patients. The correlation between the serum levels and the visual analog pain scale will be determined. 0 on the visual analog pain scale represents that their is no pain. 10 on the visual analog pain scale represents severe pain.
次要结局
- Determine if correlation may be established between impact of fibromyalgia and opioid doses(2-4 years)
- Determine if correlation may be established between sleep index and opioid doses(2-4 years)
研究者
Venkat Venkataraman, PhD
Assistant Professor
Rowan University