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Completed

NCT Number: NCT05613179

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.

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Key information

Conditions

Lumbar Disc Herniation Analgesia Mechanism Bone Diseases Hernia Intervertebral Disc Displacement Lever Positioning Manipulation Multimodal Brain Function Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

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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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Treatment and study plan

Group1 (lever positioning manipulation)

Procedure

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.

Group2 (placebo group)

Procedure

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.

Primary outcomes

  1. visual analogue scale (VAS)

    Time frame: 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].

  2. Japanese Orthopaedic Association Scores (JOA)

    Time frame: up to one month

    Japanese Orthopaedic Association Scores (JOA), ranging from 0 (worst) to 100 (best), was used to evaluate the clinical state.

  3. Amplitude of Low-Frequency Fluctuation (ALFF)

    Time frame: up to one month

    The ALFF measures the activity of neurons in the brain that are not affected by external factors.

  4. Regional Homogeneity (ReHo)

    Time frame: up to one month

    The ReHo measures the consistency of the local functional activities of the brain's various regions.

  5. Functional Connectivity (FC)

    Time frame: 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.

  6. Diffusion Tensor Imaging (DTI)

    Time frame: up to one month

    The DTI is used to look at images of white matter fiber structures in the brain.

  7. Magnetic Resonance Spectrum （MRS）

    Time frame: up to one month

    The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2022
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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