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

NCT05613179 | Completed DMC

• 1 other identifier: ZSLL-KY-2022-049-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Disc Herniation; Multimodal Brain Function; Analgesia Mechanism; Lever Positioning Manipulation

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Group1 (lever positioning manipulation)

EXPERIMENTAL

Patients with lumbar disc herniation treated by lever positioning manipulation

Procedure: Group1 (lever positioning manipulation)

Group2 (placebo group)

ACTIVE COMPARATOR

Patients with lumbar disc herniation treated by sham lever positioning manipulation

Procedure: Group2 (placebo group)

Group3 (healthy controls)

NO INTERVENTION

Healthy control group without any intervention.

Interventions

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.

Group1 (lever positioning 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.

Group2 (placebo group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

Related Publications (1)

• Zhou XC, Chen LH, Wu S, Wang KZ, Wei ZC, Li T, Huang YS, Hua ZH, Xia Q, Lv ZZ, Lv LJ. Brain effect mechanism of lever positioning manipulation on LDH analgesia based on multimodal MRI: a study protocol. BMC Complement Med Ther. 2024 Jun 24;24(1):246. doi: 10.1186/s12906-024-04549-4.

  PMID: 38915038 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhi-zhen Lv, Dr.

  The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, 310053, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 14, 2022
• Study Start: September 1, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)