Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation; Multimodal Brain Function; Analgesia Mechanism; Lever Positioning Manipulation
• Intervention / Treatment: Procedure: Group1 (lever positioning manipulation); Procedure: Group2 (placebo group)

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310053
      • The Third Affiliated hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. patients suffering from low back pain and/or radicular leg pain;
2. persistent pain for at least six months that was nonresponsive to conservative treatments;
3. 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.
4. Lumbar protrusion level discopathy on MRI corresponding to the level of pain.

5. 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).

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   Exclusion Criteria:

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group1 (lever positioning manipulation); Patients with lumbar disc herniation treated by lever positioning manipulation	Procedure: Group1 (lever positioning manipulation); The specific lever positioning manipulation is as follows: the patient lies prone at the mouth-open position with muscles relaxed, waist exposed, knees and hips bent, and ankle joints crossed. The practitioner uses the right elbow olecranon to point at the lumbar vertebrae, then hold the patient's two ankle joints in both hands to cause the lumbar vertebra to make hyperextension and flexion movements through the arms and pull the patient backward and upwards hard. When pulling upwards to the trigger point, the practitioner pulls wit lever quickly with a technique and then senses a clatter or looseness at the positioning point. When the practitioner pulls with lever manipulation, the patient is asked to exhale and then inhale at the end of the manipulation.
No Intervention: Group3 (healthy controls); Healthy control group without any intervention.
Active Comparator: Group2 (placebo group); Patients with lumbar disc herniation treated by sham lever positioning manipulation	Procedure: Group2 (placebo group); The specific sham lever positioning manipulation is as follows: the patient lies prone with his mouth open, muscles relaxed, waist exposed, knees bent at the hip and ankles crossed. The practitioner points to the lumbar spine with the right elbow olecranon, and then holds the patient's two ankles in both hands, so that the lumbar spine through the arm for overextension and flexion, and forcefully pulls the patient back and up. When pulling up to the trigger point, maintain this movement for a short period of time, depending on the patient's endurance, about 1-5 minutes. After finishing, ask the patient to rest in prone position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale (VAS)	Pain intensity was evaluated by means of a visual analogue scale (VAS) [10-point visual analogue scale: 0 = no pain; 10 = very severe pain].	up to one month
Japanese Orthopaedic Association Scores (JOA)	Japanese Orthopaedic Association Scores (JOA), ranging from 0 (worst) to 100 (best), was used to evaluate the clinical state.	up to one month
Amplitude of Low-Frequency Fluctuation (ALFF)	The ALFF measures the activity of neurons in the brain that are not affected by external factors.	up to one month
Regional Homogeneity (ReHo)	The ReHo measures the consistency of the local functional activities of the brain's various regions.	up to one month
Functional Connectivity (FC)	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.	up to one month
Diffusion Tensor Imaging (DTI)	The DTI is used to look at images of white matter fiber structures in the brain.	up to one month
Magnetic Resonance Spectrum （MRS）	The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.	up to one month

Collaborators and Investigators

• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Investigators: Study Director: Zhi-zhen Lv, Dr., The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, 310053, China

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Intervertebral Disc Displacement; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen; Analgesics
• Other Study ID Numbers: ZSLL-KY-2022-049-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No