Brain Effect Mechanism of Spinal Manipulative Therapy on Lumbar Disc Herniation Analgesia Based on Multimodal Magnetic Resonance Imaging
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Disc Herniation
- Sponsor
- Zhou Xingchen
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Magnetic Resonance Spectrum （MRS）
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
The clinical symptoms of Lumbar Disc Herniation (LDH) can be effectively ameliorated through Spinal Manipulative Therapy (SMT), which is closely linked to the brain's pain-regulating mechanisms. Magnetic Resonance Imaging (MRI) offers an objective and visual means to study how the brain orchestrates the characteristics of analgesic effects. From the perspective of multimodal MRI, the investigators applied functional MRI (fMRI) and Magnetic Resonance Spectrum (MRS) techniques to comprehensively evaluate the characteristics of the effects of SMT on the brain region of LDH from the aspects of brain structure, brain function and brain metabolism. This multimodal MRI technique provides a biological basis for the clinical application of SMT in LDH.
Investigators
Zhou Xingchen
Prof.
The Third Affiliated hospital of Zhejiang Chinese Medical University
Eligibility Criteria
Inclusion Criteria
- •Participants must meet the diagnostic criteria for lumbar disc herniation, including protrusion types such as central, paracentral, far lateral, foraminal, and subarticular, with imaging findings that align with neurological localization.
- •The age range for participants is 18 to 65 years, encompassing any gender, and they must be right-handed.
- •Participants should be in the non-acute phase of the condition, experiencing mild to moderate pain and functional impairment, with the duration of symptoms exceeding 2 weeks.
- •Participants should have a Visual Analog Scale (VAS) score greater than 4 and Japanese Orthopaedic Association (JOA) scores less than
- •Eligible participants must not have taken analgesics, neurotropic nutrition drugs, or sedatives in the past month and should not have undergone systemic treatment.
- •Participants should not have received spinal manipulation or other physical therapies in the past month.
- •Participants must voluntarily agree to participate in this study and have signed an informed consent form.
Exclusion Criteria
- •Patients with concurrent internal medicine or gynecological conditions known to cause lower back pain, such as nephritis, urinary stones, gynecological inflammations, and uterine abnormalities.
- •Individuals with severe primary diseases impacting the cardiovascular, cerebrovascular, liver, or kidney systems.
- •Those with neurogenic functional disorders, psychiatric conditions, a history of significant head trauma, or a history of unconsciousness.
- •Individuals diagnosed with primary sciatica or dry sciatica.
- •Those with lumbar spondylolisthesis.
- •Patients suffering from lumbar tumors or tuberculosis.
- •Individuals with severe osteoporosis or localized skin lesions in the lumbar area.
- •Patients experiencing painful conditions beyond the lumbar region.
- •Those with diseases characterized by structural changes in the brain.
- •Individuals with impaired consciousness, severe visual or hearing impairments, speech disorders, or others who are unable to complete health assessments.
Outcomes
Primary Outcomes
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.
visual analogue scale (VAS)
Time Frame: up to one month
Pain intensity was evaluated by means of a visual analogue scale (VAS) \[10-point visual analogue scale: 0 = no pain; 10 = very severe pain\].
Japanese Orthopaedic Association Scores (JOA)
Time Frame: up to one months
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)
Time Frame: up to one months
The ALFF measures the activity of neurons in the brain that are not affected by external factors.
Regional Homogeneity (ReHo)
Time Frame: up to one months
The ReHo measures the consistency of the local functional activities of the brain's various regions.
Functional Connectivity (FC)
Time Frame: up to one months
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.