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

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Completed

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

Treatments: Procedure: Group2 (placebo group); Procedure: Group1 (lever positioning manipulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT05613179

ZSLL-KY-2022-049-01

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

   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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group1 (lever positioning manipulation)

Experimental group

Description:

Patients with lumbar disc herniation treated by lever positioning manipulation

Treatment:

Procedure: Group1 (lever positioning manipulation)

Group2 (placebo group)

Active Comparator group

Description:

Patients with lumbar disc herniation treated by sham lever positioning manipulation

Treatment:

Procedure: Group2 (placebo group)

Group3 (healthy controls)

No Intervention group

Description:

Healthy control group without any intervention.