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

NCT07728149 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-07-27

No results posted yet for this 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.

Conditions

  • Lumbar Disc Herniation

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • The Third Affiliated hospital of Zhejiang Chinese Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728149 on ClinicalTrials.gov