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

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.