Mechanistic and Clinical Evaluation of Lever-Positioning Manipulation in Lumbar Disc Herniation: A Study Protocol for a Randomized Controlled Trial Using Rs-fMRI.

IF 2.5 3区 医学 Q2 CLINICAL NEUROLOGY
Journal of Pain Research Pub Date : 2025-05-12 eCollection Date: 2025-01-01 DOI:10.2147/JPR.S523613
Yunxing Xie, Honggen Du, An Liang, Juncheng Yao, Jianpeng Qu, Xiayang Zeng
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Abstract

Background: Lumbar disc herniation (LDH) is a prevalent clinical chronic pain disorder characterized by low back pain, lower limb pain, numbness, and claudication, among other symptoms. Lever positioning manipulation (LPM) has been demonstrated to alleviate pain by stimulating the paraspinal muscles and improving vertebral mechanical balance. Additionally, it has been shown to influence functional changes in the brain by acting on lumbar vertebral proprioceptors.

Patients and methods: This was a randomized controlled study in which 60 eligible participants were randomly assigned to one of three groups: an observation group (LPM group), a control group (Inclined plate manipulation (IPM) group) and a normal control group (No Intervention Group). The ratio of participants in each group was 1:1:1. The LPM and IPM groups received treatment for five sessions per week over two weeks. The control group did not receive any form of intervention. The primary observation was rs-fMRI imaging of functional brain areas, whereas the secondary observations included surface electromyography, lumbar proprioceptive function, and VAS and JOA scores. All of these parameters were assessed before and after treatment. All analyses were conducted in accordance with the principles of treatment. Once data collection is complete, data will be analysed using SPSS 20.0 with ANOVA and rank-sum tests for comparisons. We will conduct follow-up monitoring at the first and third month after the end of treatment.

Conclusion: The objective of this study was to observe the changes in the relevant brain regions of LDH patients through LPM treatment of LDH patients, combined with rs-fMRI and lumbar proprioceptor detection, to elaborate the neural pathways of cortical changes, and to provide new ideas and methods for the treatment of LDH.

Registration for trial: Chinese Clinical Trial Registry ChiCTR2400082255 on 25 March 2024.

杠杆定位手法治疗腰椎间盘突出症的机制和临床评价:Rs-fMRI随机对照试验研究方案。
背景:腰椎间盘突出症(LDH)是一种常见的临床慢性疼痛疾病,其特征是腰痛、下肢疼痛、麻木和跛行,以及其他症状。杠杆定位操作(LPM)已被证明可以通过刺激棘旁肌肉和改善椎体机械平衡来减轻疼痛。此外,它已被证明通过作用于腰椎本体感受器来影响大脑的功能变化。患者和方法:这是一项随机对照研究,60名符合条件的参与者被随机分为三组:观察组(LPM组)、对照组(斜板手法组)和正常对照组(无干预组)。每组参与者的比例为1:1:1。LPM组和IPM组每周治疗5次,持续2周。对照组没有接受任何形式的干预。主要观察是功能性脑区的rs-fMRI成像,而次要观察包括表面肌电图、腰椎本体感觉功能、VAS和JOA评分。在治疗前后评估所有这些参数。所有分析均按照治疗原则进行。数据收集完成后,将使用SPSS 20.0对数据进行分析,并采用方差分析和秩和检验进行比较。我们将在治疗结束后的第一个月和第三个月进行随访监测。结论:本研究的目的是通过LPM治疗LDH患者,结合rs-fMRI和腰椎本体感受器检测,观察LDH患者脑相关区域的变化,阐述皮质变化的神经通路,为LDH的治疗提供新的思路和方法。试验注册:中国临床试验注册中心ChiCTR2400082255, 2024年3月25日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Pain Research
Journal of Pain Research CLINICAL NEUROLOGY-
CiteScore
4.50
自引率
3.70%
发文量
411
审稿时长
16 weeks
期刊介绍: Journal of Pain Research is an international, peer-reviewed, open access journal that welcomes laboratory and clinical findings in the fields of pain research and the prevention and management of pain. Original research, reviews, symposium reports, hypothesis formation and commentaries are all considered for publication. Additionally, the journal now welcomes the submission of pain-policy-related editorials and commentaries, particularly in regard to ethical, regulatory, forensic, and other legal issues in pain medicine, and to the education of pain practitioners and researchers.
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