Clinical trial NCT06277739: Brain Effect Mechanism of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI
Official title: Brain Effect Mechanism of Spinal Manipulative Therapy on Lumbar Disc Herniation Analgesia Based on Multimodal Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Lumbar Disc Herniation
Spinal Manipulative Therapy
MRI
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-02-26
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: 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.


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 15.
* 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.
* Individuals with dental implants, metal stents, or other elements that may compromise MRI imaging.
* Those with a fear of MRI or other reasons that prevent undergoing MRI scans.
* Patients diagnosed with lumbar disc herniation but who are asymptomatic.

Primary outcomes:
measure: visual analogue scale (VAS)
timeFrame: up to one month
measure: Japanese Orthopaedic Association Scores (JOA)
timeFrame: up to one months
measure: Amplitude of Low-Frequency Fluctuation (ALFF)
timeFrame: up to one months
measure: Regional Homogeneity (ReHo)
timeFrame: up to one months
measure: Functional Connectivity (FC)
timeFrame: up to one months
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 School of Clinical Medicine, Zhejiang Chinese Medical University
name: Zhi-zhen Lv, Ph.D.
role: STUDY_DIRECTOR
References: