Assessing the Predictability of Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of Blood-oxygen level dependent (BOLD) response
研究概览
简要总结
The goal of this observational study is to better understand the role of the brain in chronic low back pain patients.
详细描述
Chronic pain affects millions of people worldwide, and the main cardinal sign of any arthritis condition is pain. Several arthritis conditions can cause chronic low back pain (CLBP).The mechanisms that contribute to CLBP are not yet fully understood, but considering the role of the brain in the context of chronic pain, it is only logical to investigate structural and functional brain properties in CLBP, in order to improve diagnosis and treatment of this condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain (≥ 6 months) with or without pain radiating to the legs or radiating to the neck
- •Positive medial branch blocks, suggesting that the pain originates from the lumbar facet joints
- •Average pain intensity of ≥ 3/10 in the 24-hour period before the initial visit
- •Pain primarily localized in the lower back
排除标准
- •Inadequate pain relief or relief of less than three months following selective thermoablation of medial lumbar branches by radiofrequency
- •Neurological, cardiovascular, or pulmonary disorders
- •Comorbid pain syndrome
- •History of surgical intervention in the back
- •A corticosteroid infiltration within the past year
- •Pregnancy (current or planned during the course of the study)
- •Contra-indication to Magnetic Resonance Imaging (MRI)
结局指标
主要结局
Change of Blood-oxygen level dependent (BOLD) response
时间窗: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
Blood-oxygen level dependent (BOLD) response will be measured by using functional Magnetic Resonance Imaging (fMRI).
Change of Microstructural and connectivity properties of white matter tracts
时间窗: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
Microstructural and connectivity properties will be measured by using diffusion Magnetic Resonance Imaging (dMRI).
Change of Grey matter volume
时间窗: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
Grey matter volume (milliliters cube) will be measured by acquiring a T1weighted (T1w) image using Magnetic Resonance Imaging.
Change of Brain's venous system
时间窗: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
Brain vasculature will be measured by using Susceptibility Weighted Imaging (SWI).
Change of Brain's arteries system
时间窗: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
Brain vasculature will be measured by using Time-of-Flight Magnetic Resonance Angiography (ToF MRA).
次要结局
- Change of Global function score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Change of Anxiety score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Change Central sensitization component score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Patient Gender score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Change of Insomnia severity score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Patient Expectations score(This will be acquired 1 week before their treatment)
- Change of Pain Severity score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Change of Pain Interference score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Change of Neuropathic pain components score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Change of Depression score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Change of Fear of movement score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Change of Global Impression score(Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment))
- Change of Pain Catastrophizing score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Change of Functional disability score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))
- Number of traumatic events(Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment))
- Change Polygenic methylation score(Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment))