Brain Effect Mechanism of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI

Lumbar Disc Herniation Clinical Trial

Official title:

Brain Effect Mechanism of Spinal Manipulative Therapy on Lumbar Disc Herniation Analgesia Based on Multimodal Magnetic Resonance Imaging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06277739
• Other study ID #: 20220117020315695
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: February 2024
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Procedure:
• Spinal Manipulative Therapy
The participant was placed in a side-lying position facing the clinician with the more painful side facing upward. The clinician passively flexed the participant's hips and knees to induce lumbar spine flexion until they felt the spinous process of the affected lumbar vertebrae begin to move. Next, the clinician passively rotated the participant's torso opposite to the side they were lying on until they felt rotation in the vertebra above the suspected lesion. The clinician applied a rapid thrust to the shoulder (anterior to posterior force) and pelvis (posterior to anterior force) resulting in a rotation force couple on the hypomobile segment. If a cavitation (ie, an audible pop) occurred, the treatment was considered complete. If no cavitation was produced, the participant was repositioned and the manipulation was attempted again. A maximum of 2 attempts per side was permitted. If no cavitation was produced after the 4 attempts (ie, 2 per side), the treatment was considered complete.

Other:
• Sham Laser Treatment
The laser manufacturer (MedX Health Corp) provided a MedX 1100 system that did not deliver any significant amount of light energy or heat but otherwise appeared operational to participants and clinicians. The sham laser was delivered over the painful region with the study participant positioned as described for spinal manipulation and spinal mobilization treatments.

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhou Xingchen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	up to one month
Primary	Japanese Orthopaedic Association Scores (JOA)	Japanese Orthopaedic Association Scores (JOA), ranging from 0 (worst) to 100 (best), was used to evaluate the clinical state.	up to one months
Primary	Amplitude of Low-Frequency Fluctuation (ALFF)	The ALFF measures the activity of neurons in the brain that are not affected by external factors.	up to one months
Primary	Regional Homogeneity (ReHo)	The ReHo measures the consistency of the local functional activities of the brain's various regions.	up to one months
Primary	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.	up to one months
Primary	Magnetic Resonance Spectrum (MRS)	The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.	up to one month