Google Maps

NCT07728149

Overview

NCT ID: NCT07728149
Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical UniversityOTHER
Official Title: Brain Connectomic Mechanisms of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Sep 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 126Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Lijiang LvContact
lvlijiang0288@163.com+86-18958107858

Similar Studies

Participant Group/Arms

Active Lever Positioning ManipulationExperimental

Participants with lumbar disc herniation receive active lever positioning manipulation three times per week for 12 weeks, approximately 20 minutes per session. The procedure includes segment localization, stabilization, positioning to the pre-thrust point, and a rapid lever-pulling maneuver during exhalation.

Procedure: Active Lever Positioning Manipulation

Sham Lever Positioning ManipulationSham Comparator

Participants with lumbar disc herniation receive sham lever positioning manipulation three times per week for 12 weeks, approximately 20 minutes per session. The sham procedure reproduces the treatment setting, position, preparatory procedures, and practitioner contact but omits the rapid lever-pulling maneuver.

Procedure: Sham Lever Positioning Manipulation

Matched Healthy ControlsNo Intervention

Age- and sex-matched healthy adults undergo baseline clinical assessment and multimodal MRI only. They receive no study intervention and provide a reference for baseline brain connectivity measures.