Lumbar Disc HerniationNCT07728149
Brain Connectomic Mechanisms of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI
A study testing Active Lever Positioning Manipulation in people with Lumbar Disc Herniation, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Active Lever Positioning Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310053
Lijiang Lv, +86-18958107858, lvlijiang0288@163.com
About this study
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.
Read the detailed description
This is a single-center, prospective, randomized, participant- and outcome-assessor-masked, sham-controlled study with a matched healthy control cohort. Eighty-four participants with lumbar disc herniation will be randomly allocated 1:1 to active lever positioning manipulation or sham lever positioning manipulation using a computer-generated block randomization sequence prepared by an independent statistician. Allocation will be concealed in sequentially numbered, opaque, sealed envelopes. Forty-two age- and sex-matched healthy controls will complete baseline clinical and MRI assessments only.
Active and sham treatments will be delivered three times weekly for 12 weeks, with approximately 20 minutes per session. The sham procedure will reproduce the treatment setting, participant position, preparatory procedures, and practitioner contact but will omit the rapid lever-pulling maneuver. Analgesics, neurotrophic drugs, sedatives, spinal manipulation, acupuncture, traction, and other therapies that could affect pain or MRI outcomes will be prohibited during the treatment period.
Participants with LDH will be assessed at baseline before randomization, immediately after the first treatment session, at week 6, and at week 12. The primary outcome is change in pain intensity measured by the Visual Analog Scale from baseline to week 12. Secondary clinical outcomes include lumbar function measured by the Japanese Orthopaedic Association score and disability measured by the Oswestry Disability Index. Multimodal MRI will be used to evaluate longitudinal changes in functional network topology, white-matter structural connectivity, and structure-function coupling. Exploratory analyses will examine gray-matter covariance and associations between clinical improvement and imaging changes. Safety will be assessed through adverse-event monitoring and vital-sign checks at each treatment session.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Active Lever Positioning Manipulation, Sham Lever Positioning Manipulation
- Keywords
- Lever Positioning Manipulation, Multimodal MRI, Brain Connectome
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Lever Positioning ManipulationProcedure or surgery
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 ManipulationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Lumbar neurological and functional status will be assessed using the Japanese Orthopaedic Association (JOA) score. Change from baseline will be compared between the active LPM and sham LPM groups.
Measured: Baseline, immediately after the first treatment session, week 6, and week 12
Change in Disability Measured by the Oswestry Disability Index (ODI)
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a patient-reported measure of limitations in daily activities. Change from baseline will be compared between the active LPM and sham LPM groups.
Measured: Baseline, immediately after the first treatment session, week 6, and week 12
Change in Resting-State Functional Brain Network Topology
Resting-state functional MRI will be parcellated using the 116-region Automated Anatomical Labeling atlas. Pearson correlation matrices and graph-theoretical metrics reflecting network integration, segregation, and nodal importance will quantify functional topology. Longitudinal change will be compared between active LPM and sham LPM.
Measured: 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
Diffusion tensor imaging will be parcellated with the 116-region Automated Anatomical Labeling atlas. Whole-brain deterministic streamline tractography will generate structural networks. Edges will be weighted by mean fractional anisotropy along streamlines connecting region pairs, with absent connections coded as zero. Longitudinal change will be compared between active LPM and sham LPM.
Measured: 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
Functional and white-matter structural connectivity matrices will use the same 116-region Automated Anatomical Labeling parcellation. For each participant, structure-function coupling will be quantified by the correspondence between functional and structural edge weights across the connectome. Longitudinal change will be compared between active LPM and sham LPM.
Measured: Baseline, immediately after the first treatment session, week 6, and week 12; main longitudinal comparison from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lijiang Lv, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728149
- Sponsor's protocol ID
- ZSLL-KY-20222-049-02
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided