Not Yet RecruitingNot Applicable

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

China126 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * S…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07728149

SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Lijiang Lv

+86-18958107858 lvlijiang0288@163.com

View on ClinicalTrials.gov More Lumbar Disc Herniation trials