Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Brain Regional Gray Matter Density
研究概览
简要总结
This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.
详细描述
In this study, all the participants will be receiving placebo. However this study will be single blinded in that participants will be told that they will be given a pill that may or may not help with their pain. The researcher, however, will know that all participants are receiving placebo
At the initial visit, participants will undergo screening to determine that they meet all inclusion and exclusion criteria. They will sign consent and then complete pain assessment instruments as well as one high resolution anatomical scan (T1) and one functional scan (a resting scar) in a 3 Tesla magnet. A single scanning session comprised of a 10 minute functional scan (a resting scan) will be done two weeks from the first scan and pain assessment instruments will be completed at this visit as well. After finishing this second scan (done two weeks after the initial scan), the participants will have completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 40-85 years
- •ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
- •VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening)
- •Knee OA for a minimum of 12 months
- •Need for daily pain medication to manage symptoms of OA
排除标准
- •Currently taking MAO inhibitors or any centrally acting drug for analgesia
- •Narrow angle glaucoma
- •Uncontrolled hypertension
- •Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state
- •If a female, pregnant, trying to become pregnant, or lactating
- •Major depressive disorder
- •Substantial alcohol use or history of significant liver disease
- •Diabetes, type 1 or type 2
- •Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk
- •Standard MRI safety exclusions
研究组 & 干预措施
Placebo
placebo capsule
干预措施: Duloxetine (Drug)
Placebo
placebo capsule
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Brain Regional Gray Matter Density
时间窗: 2 weeks
Gray matter density (GMD) of the prefrontal cortex region identified as placebo biomarker. Placebo responders/non-responders were identified based on the VAS score. A minimum of 20% decrease in VAS score was needed to be qualified as responders. GMD is a value between 0 and 1 representing the intensity of every brain voxels. The GMD of the prefrontal cortex region represent the average GMD of every voxels in this region.
次要结局
- WOMAC Pain Index(2 weeks)
- Overall Brain Neocortical Gray Matter Volume(2 weeks)
研究者
Apkar Apkarian
Professor
Northwestern University