Functional MRI Neural Correlates of Medication Efficacy in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. Duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. We will use functional magnetic resonance imaging (FMRI) to investigate the neural and functional correlates of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 18-60
- •Back Pain
- •Must be able to comply with study visit schedule and other study requirements
- •Capable of performing the experimental tasks
排除标准
- •Contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body)
- •Known hypersensitivity to duloxetine or any of the inactive ingredients
- •Uncontrolled narrow-angle glaucoma
研究组 & 干预措施
Placebo - sugar pill
干预措施: Placebo (Drug)
Duloxetine
干预措施: duloxetine (Drug)
结局指标
主要结局
Pain
时间窗: 3 months
Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study. Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine. Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline. Values were converted to percent change in pain: \[(baseline pain - end point pain)/baseline pain\] x 100.
Neural Correlates of Pain Relief
时间窗: 3 months
Scores reflect the average connectivity strength of that region of interest to the rest of the cortex. There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3). Subscales are averaged.
次要结局
未报告次要终点
研究者
Sean Mackey
Redlich Professor
Stanford University