METHODS: A total of 60 LDH patients and 30 healthy controls, matched by gender, age, and years of education, will be enrolled in this study. The LDH patients will be divided into two groups (Group 1, n = 30; Group 2, n = 30) using a random number table method. Group 1 will receive LPM treatment once every two days, for a total of 12 times over 4 weeks. Group 2 will receive sham LPM treatment during the same period as Group 1. All 30 healthy controls will be divided into Group 3. Multimodal MRI will be performed on Group 1 and Group 2 at three time points (TPs): before LPM (TP1), after one LPM session (TP2), and after a full course of LPM treatment. The healthy controls (Group 3) will not undergo LPM and will be subject to only a single multimodal MRI scan. Participants in both Group 1 and Group 2 will be required to complete clinical questionnaires. These assessments will focus on pain intensity and functional disorders, using the Visual Analog Scale (VAS) and the Japanese Orthopaedic Association (JOA) scoring systems, respectively.
CONCLUSIONS: The purpose of this study is to investigate the multimodal brain response characteristics of LDH patients after treatment with LPM, with the goal of providing a biological basis for clinical applications.
BACKGROUND: https://clinicaltrials.gov/ct2/show/NCT05613179 , identifier: NCT05613179.
方法:共60例LDH患者和30例健康对照,与性别相匹配,年龄,和多年的教育,将参加这项研究。使用随机数字表法将LDH患者分为两组(第1组,n=30;第2组,n=30)。第1组将每两天接受一次LPM治疗,在4周内共12次。第2组将在与第1组相同的时期内接受假LPM治疗。所有30名健康对照将被分为第3组。将在三个时间点(TP)对第1组和第2组进行多模态MRI:在LPM之前(TP1),在一个LPM会话(TP2)之后,经过整个疗程的LPM治疗。健康对照(组3)将不经历LPM并且将仅经受单个多模态MRI扫描。第1组和第2组的参与者将被要求完成临床问卷。这些评估将侧重于疼痛强度和功能障碍,使用视觉模拟量表(VAS)和日本骨科协会(JOA)评分系统,分别。
结论:本研究的目的是探讨LDH患者LPM治疗后的多模态脑反应特征,目的是为临床应用提供生物学基础。
背景:https://clinicaltrials.gov/ct2/show/NCT05613179,标识符:NCT05613179。