Brain Effect Mechanism of Spinal Manipulative Therapy on... | NCT06277739

NCT06277739

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group1 (Spinal Manipulation Therapy)	Experimental	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.	Procedure: Spinal Manipulative Therapy
Group2 Sham Laser Treatment)	Placebo Comparator	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.	Other: Sham Laser Treatment
Group3 (healthy controls)	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinal Manipulative Therapy	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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
Regional Homogeneity (ReHo)	The ReHo measures the consistency of the local functional activities of the brain's various regions.	up to one months
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
Magnetic Resonance Spectrum （MRS）	The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.	up to one month

Eligibility Module

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.