Prognostic Value Assessment of Biomarkers in Acute Lumbar Radiculalgia : Contribution of the Diffusion Tensor in Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Predictive performance of DTI imaging on the therapeutic evolution
研究概览
简要总结
Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging.The aim of the study is to determine the prognostic quality of the DTI parameters to predict the therapeutic evolution of patients with lumbar radiculalgia at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥ 18 ans
- •Patient with Lumbar Radiculalgia (L4, L5 or S1)
- •Pain VAS (Visual analog scale) > 30/100
- •Less than 3 months of evolution
- •With a radiculalgia superior or equal to lumbalgia
- •Disco radicular conflict, verified by MRI
- •Able to receive information
- •Affiliated to French social security
排除标准
- •History of chronic lumbalgia and radiculalgia
- •History of lumbar surgery
- •Recent episode (less than 6 months) with the same radicular topography
- •Bilateral radicular compression on MRI
- •Patient requiring emergency surgery
- •Evolutive disease interfering with pain assesment (neoplasia, inflammatory rheumatism, peripheral neuropathy, central neurological disease)
- •MRI contraindication
研究组 & 干预措施
Lumbar radiculopathy
Patients with acute lumbar radiculopathy (less than 3 months of evolution)
干预措施: DTI sequence acquisition (Other)
结局指标
主要结局
Predictive performance of DTI imaging on the therapeutic evolution
时间窗: 6 months
DTI is a sensitive probe of cellular structure that works by measuring the diffusion of water molecules. The measured quantity is the diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient and has units of mm2/s. The objective is to know if the interpretation of DTI allow to predict the therapeutic evolution of patients. For instance, the patients will need in the future oral drugs? Or they will need rather an infiltration? Or they will need rather a surgery?
次要结局
- Correlation between DTI parameters and pain intensity(6 months)
- Correlation between DTI parameters evolution and neuropathic pain(6 months)
- Correlation between DTI parameters evolution and disability(6 months)