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

Primary Purpose

Lumbar Disc Herniation, Multimodal Brain Function, Analgesia Mechanism

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Group1 (lever positioning manipulation)
Group2 (placebo group)
Sponsored by
The Third Affiliated hospital of Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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). - 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. -

Sites / Locations

  • The Third Affiliated Hospital of Zhejiang Chinese Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Group1 (lever positioning manipulation)

Group2 (placebo group)

Group3 (healthy controls)

Arm Description

Patients with lumbar disc herniation treated by lever positioning manipulation

Patients with lumbar disc herniation treated by sham lever positioning manipulation

Healthy control group without any intervention.

Outcomes

Primary Outcome Measures

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].
Japanese Orthopaedic Association Scores (JOA)
Japanese Orthopaedic Association Scores (JOA), ranging from 0 (worst) to 100 (best), was used to evaluate the clinical state.
Amplitude of Low-Frequency Fluctuation (ALFF)
The ALFF measures the activity of neurons in the brain that are not affected by external factors.
Regional Homogeneity (ReHo)
The ReHo measures the consistency of the local functional activities of the brain's various regions.
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.
Diffusion Tensor Imaging (DTI)
The DTI is used to look at images of white matter fiber structures in the brain.
Magnetic Resonance Spectrum (MRS)
The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.

Secondary Outcome Measures

Full Information

First Posted
October 24, 2022
Last Updated
June 27, 2023
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05613179
Brief Title
Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI
Official Title
Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Multimodal Brain Function, Analgesia Mechanism, Lever Positioning Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group1 (lever positioning manipulation)
Arm Type
Experimental
Arm Description
Patients with lumbar disc herniation treated by lever positioning manipulation
Arm Title
Group2 (placebo group)
Arm Type
Active Comparator
Arm Description
Patients with lumbar disc herniation treated by sham lever positioning manipulation
Arm Title
Group3 (healthy controls)
Arm Type
No Intervention
Arm Description
Healthy control group without any intervention.
Intervention Type
Procedure
Intervention Name(s)
Group1 (lever positioning manipulation)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group2 (placebo group)
Intervention Description
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 Outcome Measure Information:
Title
visual analogue scale (VAS)
Description
Pain intensity was evaluated by means of a visual analogue scale (VAS) [10-point visual analogue scale: 0 = no pain; 10 = very severe pain].
Time Frame
up to one month
Title
Japanese Orthopaedic Association Scores (JOA)
Description
Japanese Orthopaedic Association Scores (JOA), ranging from 0 (worst) to 100 (best), was used to evaluate the clinical state.
Time Frame
up to one month
Title
Amplitude of Low-Frequency Fluctuation (ALFF)
Description
The ALFF measures the activity of neurons in the brain that are not affected by external factors.
Time Frame
up to one month
Title
Regional Homogeneity (ReHo)
Description
The ReHo measures the consistency of the local functional activities of the brain's various regions.
Time Frame
up to one month
Title
Functional Connectivity (FC)
Description
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.
Time Frame
up to one month
Title
Diffusion Tensor Imaging (DTI)
Description
The DTI is used to look at images of white matter fiber structures in the brain.
Time Frame
up to one month
Title
Magnetic Resonance Spectrum (MRS)
Description
The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.
Time Frame
up to one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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). - 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-zhen Lv, Dr.
Organizational Affiliation
The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, 310053, China
Official's Role
Study Director
Facility Information:
Facility Name
The Third Affiliated Hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310053
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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