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

NCT07728149 | Not Yet Recruiting

• 1 other identifier: ZSLL-KY-20222-049-02
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Keywords

Lever Positioning Manipulation; Multimodal MRI; Brain Connectome

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Measured by the Visual Analog Scale (VAS)

  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.

  Baseline, immediately after the first treatment session, week 6, and week 12; primary endpoint at week 12

Secondary Outcomes (5)

• Change in Lumbar Function Measured by the Japanese Orthopaedic Association (JOA) Score

  Baseline, immediately after the first treatment session, week 6, and week 12

• Change in Disability Measured by the Oswestry Disability Index (ODI)

  Baseline, immediately after the first treatment session, week 6, and week 12

• Change in Resting-State Functional Brain Network Topology

  Baseline, immediately after the first treatment session, week 6, and week 12; main longitudinal comparison from baseline to week 12

• Change in White-Matter Structural Connectivity

  Baseline, immediately after the first treatment session, week 6, and week 12; main longitudinal comparison from baseline to week 12

• Change in Brain Structure-Function Coupling

  Baseline, immediately after the first treatment session, week 6, and week 12; main longitudinal comparison from baseline to week 12

Other Outcomes (3)

• Change in Group-Level Gray-Matter Structural Covariance Networks

  Baseline, immediately after the first treatment session, week 6, and week 12; exploratory longitudinal comparison from baseline to week 12

• Association Between Changes in Connectome Metrics and Clinical Outcomes

  Baseline through week 12; change scores for the main exploratory association calculated from baseline to week 12

• Incidence of Adverse Events

  From the first treatment session through the end of the 12-week intervention

Study Arms (3)

Active Lever Positioning Manipulation

EXPERIMENTAL

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 Manipulation

SHAM 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 Controls

NO 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.

Interventions

Active Lever Positioning Manipulation PROCEDURE

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.

Active Lever Positioning Manipulation

Sham Lever Positioning Manipulation PROCEDURE

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.

Sham Lever Positioning Manipulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lijiang Lv

CONTACT

+86-18958107858; lvlijiang0288@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are masked to treatment allocation. Treating practitioners are not masked because of the nature of the manual intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants with LDH are randomized 1:1 to active lever positioning manipulation or sham lever positioning manipulation. A matched healthy control cohort undergoes baseline assessments without intervention.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

CN (1)