Brain Connectomic Mechanisms of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI

NCT07728149 · tracked via the Priya Life Science China tracker

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Phase

Not applicable

Started

2026-07

Last updated

2026-07-27

Condition(s) studied

Lumbar Disc Herniation

Investigational drug(s) / intervention(s)

Active Lever Positioning ManipulationSham Lever Positioning Manipulation

Active Lever Positioning Manipulation: Delivered three times weekly for 12 weeks, approximately 20 minutes per session, by an experienced rehabilitation practitioner. With the participant's hips and knees flexed and legs crossed, the practitioner identifies the target lumbar segment, stabilizes it with the elbow, holds the ankles, and lifts and pulls the legs upward and inward to the pre-thrust position. A rapid lever-pulling maneuver is then performed while the participant exhales.

Sham Lever Positioning Manipulation: Delivered three times weekly for 12 weeks, approximately 20 minutes per session, in the same setting and position as the active procedure. Preparatory positioning and practitioner contact are reproduced, but no rapid lever-pulling maneuver is performed. The position is held for 30 seconds with a 15-cm elastic lumbar belt placed around the lower abdomen and pelvis at L4-S1, light hand contact on the ankles, and gradual release.

Study summary

Low back and leg pain caused by lumbar disc herniation (LDH) is common. Lever positioning manipulation (LPM) is a spinal manual therapy used to relieve this pain, but how it affects the brain is unclear. This study will compare active LPM with a sham procedure and use multimodal magnetic resonance imaging (MRI) to investigate changes in brain networks associated with pain relief.

A total of 84 adults with LDH will be randomly assigned in a 1:1 ratio to active LPM or sham LPM, with three sessions per week for 12 weeks. An additional 42 age- and sex-matched healthy adults will undergo baseline assessments without treatment. Participants with LDH will be assessed before treatment, immediately after the first session, at week 6, and at week 12. Outcomes include pain intensity, lumbar function, disability, adverse events, and MRI measures of functional and structural brain connectivity. The study aims to identify brain connectomic mechanisms associated with LPM-induced analgesia.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

Inclusion Criteria: Patients with lumbar disc herniation (LDH): * Diagnosis of LDH based on clinical symptoms, physical examination findings, and lumbar imaging consistent with neurological localization; central, paracentral, far-lateral, foraminal, or subarticular lumbar disc protrusion. * Aged 18-65 years, of either sex, and right-handed. * In the non-acute phase of LDH, with symptom duration of more than 2 weeks. * Visual Analog Scale (VAS) score greater than 4 and Japanese Orthopaedic Association (JOA) score less than 15. * No use of analgesics, neurotrophic drugs, or sedatives within 1 month before enrollment. * No systematic treatment, spinal manipulation, or other physical therapies within 1 month before enrollment. * Able to understand the study procedures and complete clinical assessments and MRI scans. * Provides written informed consent. Healthy controls: * Aged 18-65 years, of either sex, and right-handed. * No history of LDH or chronic low back pain. * No current pain condition requiring treatment. * No neurological or psychiatric disorders. * No known structural brain abnormalities. * No MRI contraindications. * Able to complete clinical assessments and MRI scans. * Provides written informed consent. Exclusion Criteria: Patients with LDH: * Low back pain or sciatica caused by conditions other than LDH. * Lumbar spondylolisthesis, lumbar tumor, spinal tuberculosis, severe osteoporosis, or localized lumbar skin lesions that may interfere with treatment. * Severe cardiovascular, cerebrovascular, hepatic, renal, hematopoietic, neurological, or psychiatric disease. * History of severe head trauma, loss of consciousness, or known structural brain abnormality. * Impaired consciousness, severe visual or hearing impairment, speech disorder, or inability to complete clinical assessments. * Non-MRI-compatible metal implants, implanted electronic devices, cardiac pacemakers, severe claustrophobia, or inability to tolerate MRI scanning. * Asymptomatic LDH. * Pregnancy, lactation, or planned pregnancy during the study period. * Participation in another clinical trial within the previous 3 months. * Any condition judged by the investigators to make the patient unsuitable for participation. Healthy controls: * Any condition that may affect eligibility, MRI safety, or data quality.

Primary outcome measure(s)

Change in Pain Intensity Measured by the Visual Analog Scale (VAS) — Baseline, immediately after the first treatment session, week 6, and week 12; primary endpoint at week 12
Pain intensity will be assessed using the Visual Analog Scale (VAS). The prespecified primary endpoint is the between-group difference between active LPM and sham LPM in change from baseline to week 12. VAS will also be collected immediately after the first treatment session and at week 6.

Trial sites (1)

Facility	City	Region	Status
The Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

More The Third Affiliated hospital of Zhejiang Chinese Medical University trials in China

Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients With Sarcopenia Recruiting

EA for BPS: An RCT and Study for Central Mechanism Recruiting

Clinical Evaluation of Surrounding Electroacupuncture in the Treatment of Acute Lateral Ankle Sprain Recruiting

Peripheral-central Correlation Study on the Treatment of Chronic Tinnitus With "Dao qi Tong Luo" Based on the Theory of "Connecting the Two Ears to the Brain" Recruiting

Evaluation of Clinical Efficacy and Safety of Specific Mode Electroacupuncture Stimulation for Paclitaxel Across BBB Delivery in Patients With Postoperative Recurrence of Malignant Glioma: A Single-arm Trial Recruiting

Other trials for the same condition

The Influence of the Timing of Postoperative Rehabilitation Intervention on the Clinical Efficacy of Unilateral Biportal Endoscopic Spine System in the Treatment of Lumbar Disc Herniation Recruiting

A Biomechanical Study of the Lumbar Intervertebral Disc by Lever Positioning Manipulation Recruiting

Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery Recruiting

Comparative Study Between UBE and PETD for the Treatment of Lumbar Spinal Canal Stenosis Enrolling by invitation

Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07728149 on ClinicalTrials.gov ↗ ← All trials in China