Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Functional Connectivity (FC)
研究概览
简要总结
In order to further investigate the key brain targets and central response mechanism characteristics of analgesia, the dominant disease of LDH was taken as the object of this study, which was divided into operation group, comfort group and healthy subjects group. Firstly, DTI probabilistic tracking method was used to detect the changes of the brain white matter in each group. Then, the low-frequency amplitude (mfalff) and local consistency (ReHo) of each group were compared by fMRI scanning imaging technology, and the features of local brain functional connectivity (FC) of pain matrix related brain regions as seed points were analyzed. Finally, MRS Technique was used to detect the brain signals of related metabolites glutamic acid (Glu) and 1-aminobutyric acid (GABA), so as to elucidate the network regulation of lever-positioning operation on the analgesic brain effect of LDH and the biochemical mechanism of central nervous system. This multimodal MRI technique provides biological basis for the clinical application of lever localization in LDH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients suffering from low back pain and/or radicular leg pain;
- •persistent pain for at least six months that was nonresponsive to conservative treatments;
- •at least one epidural or facet joint corticosteroid injection in the last past year without pain relief or with an improvement in pain of less than two months.
- •Lumbar protrusion level discopathy on MRI corresponding to the level of pain.
- •No interventional pain treatment was applied within the last three months and patients needed a pain score equal or greater than four on the visual analogic scale (VAS).
排除标准
- •1.patients with motor deficits, systemic infection, coagulation disorders, pregnancy； 2.VAS pain score lower than four； 3.Patients with any other condition that prevents an MRI scan from being performed.
结局指标
主要结局
Functional Connectivity (FC)
时间窗: up to one month
The FC represents the strength Of functional connections between brain regions, and can reflect the temporal correlation between the Region Of Interest (ROI) and the whole brain networking function.
visual analogue scale (VAS)
时间窗: up to one month
Pain intensity was evaluated by means of a visual analogue scale (VAS) \[10-point visual analogue scale: 0 = no pain; 10 = very severe pain\].
Amplitude of Low-Frequency Fluctuation (ALFF)
时间窗: up to one month
The ALFF measures the activity of neurons in the brain that are not affected by external factors.
Regional Homogeneity (ReHo)
时间窗: up to one month
The ReHo measures the consistency of the local functional activities of the brain's various regions.
Magnetic Resonance Spectrum （MRS）
时间窗: up to one month
The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.
Japanese Orthopaedic Association Scores (JOA)
时间窗: up to one month
Japanese Orthopaedic Association Scores (JOA), ranging from 0 (worst) to 100 (best), was used to evaluate the clinical state.
Diffusion Tensor Imaging (DTI)
时间窗: up to one month
The DTI is used to look at images of white matter fiber structures in the brain.
次要结局
未报告次要终点
研究者
Zhou Xingchen
Clinical Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University