Clinical trial NCT05613179: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Multimodal Brain Function
Analgesia Mechanism
Lever Positioning Manipulation
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

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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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Primary outcomes:
measure: visual analogue scale (VAS)
timeFrame: up to one month
measure: Japanese Orthopaedic Association Scores (JOA)
timeFrame: up to one month
measure: Amplitude of Low-Frequency Fluctuation (ALFF)
timeFrame: up to one month
measure: Regional Homogeneity (ReHo)
timeFrame: up to one month
measure: Functional Connectivity (FC)
timeFrame: up to one month
measure: Diffusion Tensor Imaging (DTI)
timeFrame: up to one month
measure: Magnetic Resonance Spectrum （MRS）
timeFrame: up to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, 310053, China
name: Zhi-zhen Lv, Dr.
role: STUDY_DIRECTOR
References: