Lumbar Disc HerniationNCT07914842
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
A study testing Lever Positioning Manipulation in people with Lumbar Disc Herniation, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 2 sites in China.
Trial summary
Lever positioning manipulation (LPM) is used to treat pain associated with lumbar disc herniation (LDH), but treatment-associated changes in cortical functional organization remain 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?
- Lever Positioning Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 29 Oct 2026to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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:
- 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 score greater than 4 and Japanese Orthopaedic Association 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310053
Lijiang Lv, +86-18958107858, lvlijiang0288@163.com
Zhejiang Hospital
Hangzhou, Zhejiang
About this study
Official title: Brain Connectomic Mechanisms of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI
Lever positioning manipulation (LPM) is used to treat pain associated with lumbar disc herniation (LDH), but treatment-associated changes in cortical functional organization remain unclear. This prospective nonrandomized study will examine cortical surface-based resting-state functional magnetic resonance imaging (MRI) measures before and after a 4-week course of LPM.
The target is 30 participants with LDH completing treatment-period assessments and 30 age- and sex-matched healthy controls completing baseline assessment. Participants who withdraw will be replaced as needed, and all enrolled and replacement participants will be counted. Participants with LDH will receive LPM three times weekly for 4 weeks, approximately 20 minutes per session. MRI and clinical scales will be collected before treatment and at week 4 after the first session. Healthy controls will undergo baseline MRI only and receive no intervention. The eight primary imaging outcome groups cover amplitude of low-frequency fluctuations (ALFF), regional homogeneity (ReHo), global functional connectivity density, seed-to-vertex connectivity, region-to-region connectivity, within- and between-network connectivity, functional connectivity gradients, and gradient eccentricity. Clinical outcomes include VAS, JOA, ODI, SAS and SDS scores. Adverse events will be monitored throughout treatment.
Read the detailed description
This is a prospective, nonrandomized, outcome-assessor-masked interventional study with an LDH group receiving lever positioning manipulation and a healthy control group receiving no intervention. Clinical recruitment and treatment will be conducted at the Third Affiliated Hospital of Zhejiang Chinese Medical University. MRI will be acquired at Zhejiang Hospital in Hangzhou. Group membership is based on disease status. The target is 30 participants completing the required assessments in each group. Participants who withdraw will be replaced as needed; all enrolled participants, withdrawals and replacements will be accounted for in cumulative enrollment and participant flow. The anticipated enrollment estimate will be updated as replacement recruitment requires.
Participants with LDH will receive lever positioning manipulation three times weekly for 4 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. Outcome assessors will be masked to group assignment; participants and treating practitioners will not be masked. Concomitant medications and therapies will be managed according to the approved protocol.
Participants with LDH will undergo MRI and clinical assessments at baseline before treatment and at week 4 after the first treatment session. Healthy controls will undergo baseline MRI and general eligibility assessments only; they will not receive treatment or complete the patient clinical outcome scales. No additional routine follow-up is planned after the week-4 assessment.
Cortical surface-based resting-state MRI analyses will evaluate eight primary outcome groups: amplitude of low-frequency fluctuations, regional homogeneity, global functional connectivity density, seed-to-vertex functional connectivity, region-to-region functional connectivity, within-network and between-network connectivity, functional connectivity gradient scores, and functional gradient eccentricity. The primary imaging comparison is within-participant change from baseline to week 4 in the LDH group. Healthy controls provide a baseline reference only.
Clinical outcomes will assess pain with the Visual Analog Scale, neurological and functional status with the Japanese Orthopaedic Association score, disability with the Oswestry Disability Index, anxiety symptoms with the Chinese-language Zung Self-Rating Anxiety Scale, and depressive symptoms with the Chinese-language Zung Self-Rating Depression Scale.
Adverse events and vital signs will be assessed at each treatment session throughout the 4-week treatment period. Adverse events will be recorded regardless of causal relationship, and severity and relationship to the intervention will be assessed. Serious adverse events will be reported according to institutional requirements. Prespecified quality-control and statistical procedures will account for the multiple imaging outcome families and missing observations.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Lever Positioning Manipulation
- Keywords
- Lever Positioning Manipulation, Resting-State Functional MRI, Cortical Surface, Functional Connectivity, Functional Gradients
- 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.
Lever Positioning ManipulationProcedure or surgery
Delivered to participants with LDH by an experienced rehabilitation practitioner three times weekly for 4 weeks, approximately 20 minutes per session. 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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Disc Herniation (LDH) | Experimental | Participants with lumbar disc herniation receive lever positioning manipulation three times weekly for 4 weeks, approximately 20 minutes per session. Clinical outcome scales and MRI are obtained before treatment and at week 4 after the first session. The target is 30 participants completing the required assessments; withdrawals will be replaced as needed and included in cumulative enrollment. Receives: Procedure: Lever Positioning Manipulation |
| Healthy Controls (HC) | No intervention | Age- and sex-matched healthy controls undergo baseline eligibility assessment and MRI only, without study intervention or patient clinical outcome scales. The target is 30 participants completing the baseline assessment. Withdrawals before completion will be replaced as needed and included in cumulative enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cortical Surface-Based Mean-Normalized Amplitude of Low-Frequency Fluctuations
Resting-state functional MRI will assess the amplitude of low-frequency blood oxygen level-dependent (BOLD) fluctuations on the cortical surface. Mean-normalized ALFF in the 0.01-0.08 Hz band will be calculated relative to the mean cortical ALFF. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Cortical Surface-Based Regional Homogeneity
Regional homogeneity will be calculated as Kendall's coefficient of concordance between the BOLD time series at each cortical vertex and its one-ring surface neighbors. Scores range from 0 to 1, with higher values indicating greater local temporal concordance. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Cortical Surface-Based Global Functional Connectivity Density
Global functional connectivity density will be quantified as the proportion of other cortical vertices whose BOLD time series have a Pearson correlation greater than 0.6 with each vertex. Self-connections will be excluded. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Cortical Surface-Based Seed-to-Vertex Functional Connectivity
Left and right insular cortex seeds will be defined using independent anatomical labels. Seed-to-vertex functional connectivity will be calculated using Pearson correlation followed by Fisher z transformation. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Cortical Region-to-Region Functional Connectivity
Cortical regions will be defined using the Schaefer 400-region parcellation. Region-to-region functional connectivity will be calculated using Pearson correlation between regional BOLD time series followed by Fisher z transformation. Changes in unique region-pair connectivity values from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Within-Network and Between-Network Cortical Functional Connectivity
Using the seven Yeo networks, within-network and between-network connectivity will be quantified as mean Fisher-z-transformed region-to-region connectivity. The measures include seven within-network and 21 between-network values. Within-participant changes from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Cortical Functional Connectivity Gradient Scores
The first three cortical functional connectivity gradients will be estimated from regional connectivity profiles using diffusion-map embedding and aligned to a fixed independent reference. Regional gradient coordinates will be reported in arbitrary units. Within-participant changes from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Cortical Functional Gradient Eccentricity
Functional gradient eccentricity will be calculated as each cortical region's Euclidean distance from the centroid of all regions in the space of the first three aligned functional gradients. Values will be reported in arbitrary units. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Secondary outcomes (5)
Change in Pain Intensity Measured by the Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10-cm horizontal Visual Analog Scale, recorded on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Change from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
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 score, reported on a 0-29 scale. Higher scores indicate better status. Change from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Disability Measured by the Oswestry Disability Index (ODI)
Low-back-pain-related disability will be assessed using the Oswestry Disability Index, reported on a 0-100% scale. Higher scores indicate greater disability. Change from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Anxiety Symptoms Measured by the Zung Self-Rating Anxiety Scale (SAS)
Anxiety symptoms will be assessed using a Chinese-language version of the 20-item Zung Self-Rating Anxiety Scale. The total raw score ranges from 20 to 80 and is converted to a standard/index score ranging from 25 to 100 by multiplying by 1.25. Higher standard scores indicate more severe anxiety symptoms. Change in standard score from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Depressive Symptoms Measured by the Zung Self-Rating Depression Scale (SDS)
Depressive symptoms will be assessed using a Chinese-language version of the 20-item Zung Self-Rating Depression Scale. The total raw score ranges from 20 to 80 and is converted to a standard/index score ranging from 25 to 100 by multiplying by 1.25. Higher standard scores indicate more severe depressive symptoms. Change in standard score from baseline to week 4 will be assessed in participants with LDH.
Measured: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start29 Oct 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This nonrandomized study will include an LDH group receiving lever positioning manipulation for 4 weeks and a healthy control group receiving no intervention. Group membership is based on disease status. The target is 30 participants completing the required assessments in each group. Participants who withdraw will be replaced as needed, and cumulative enrollment will include withdrawals and replacement participants. LDH participants undergo MRI at baseline and week 4; healthy controls undergo MRI at baseline only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- Investigators
- Lijiang Lv, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914842
- Sponsor's protocol ID
- LPM-SURFACE-2026-01
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of de-identified individual participant data has not yet been made.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connectomic Mechanisms of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI
- ClinicalTrials.gov ID
- NCT07914842
- Acronym / sponsor ID
- LPM-SURFACE-2026-01
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lever Positioning Manipulation, Resting-State Functional MRI, Cortical Surface, Functional Connectivity, Functional Gradients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lever positioning manipulation (LPM) is used to treat pain associated with lumbar disc herniation (LDH), but treatment-associated changes in cortical functional organization remain unclear. This prospective nonrandomized study will examine cortical surface-based resting-state functional magnetic resonance imaging (MRI) measures before and after a 4-week course of LPM.
The target is 30 participants with LDH completing treatment-period assessments and 30 age- and sex-matched healthy controls completing baseline assessment. Participants who withdraw will be replaced as needed, and all enrolled and replacement participants will be counted. Participants with LDH will receive LPM three times weekly for 4 weeks, approximately 20 minutes per session. MRI and clinical scales will be collected before treatment and at week 4 after the first session. Healthy controls will undergo baseline MRI only and receive no intervention. The eight primary imaging outcome groups cover amplitude of low-frequency fluctuations (ALFF), regional homogeneity (ReHo), global functional connectivity density, seed-to-vertex connectivity, region-to-region connectivity, within- and between-network connectivity, functional connectivity gradients, and gradient eccentricity. Clinical outcomes include VAS, JOA, ODI, SAS and SDS scores. Adverse events will be monitored throughout treatment.
Detailed description
This is a prospective, nonrandomized, outcome-assessor-masked interventional study with an LDH group receiving lever positioning manipulation and a healthy control group receiving no intervention. Clinical recruitment and treatment will be conducted at the Third Affiliated Hospital of Zhejiang Chinese Medical University. MRI will be acquired at Zhejiang Hospital in Hangzhou. Group membership is based on disease status. The target is 30 participants completing the required assessments in each group. Participants who withdraw will be replaced as needed; all enrolled participants, withdrawals and replacements will be accounted for in cumulative enrollment and participant flow. The anticipated enrollment estimate will be updated as replacement recruitment requires.
Participants with LDH will receive lever positioning manipulation three times weekly for 4 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. Outcome assessors will be masked to group assignment; participants and treating practitioners will not be masked. Concomitant medications and therapies will be managed according to the approved protocol.
Participants with LDH will undergo MRI and clinical assessments at baseline before treatment and at week 4 after the first treatment session. Healthy controls will undergo baseline MRI and general eligibility assessments only; they will not receive treatment or complete the patient clinical outcome scales. No additional routine follow-up is planned after the week-4 assessment.
Cortical surface-based resting-state MRI analyses will evaluate eight primary outcome groups: amplitude of low-frequency fluctuations, regional homogeneity, global functional connectivity density, seed-to-vertex functional connectivity, region-to-region functional connectivity, within-network and between-network connectivity, functional connectivity gradient scores, and functional gradient eccentricity. The primary imaging comparison is within-participant change from baseline to week 4 in the LDH group. Healthy controls provide a baseline reference only.
Clinical outcomes will assess pain with the Visual Analog Scale, neurological and functional status with the Japanese Orthopaedic Association score, disability with the Oswestry Disability Index, anxiety symptoms with the Chinese-language Zung Self-Rating Anxiety Scale, and depressive symptoms with the Chinese-language Zung Self-Rating Depression Scale.
Adverse events and vital signs will be assessed at each treatment session throughout the 4-week treatment period. Adverse events will be recorded regardless of causal relationship, and severity and relationship to the intervention will be assessed. Serious adverse events will be reported according to institutional requirements. Prespecified quality-control and statistical procedures will account for the multiple imaging outcome families and missing observations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This nonrandomized study will include an LDH group receiving lever positioning manipulation for 4 weeks and a healthy control group receiving no intervention. Group membership is based on disease status. The target is 30 participants completing the required assessments in each group. Participants who withdraw will be replaced as needed, and cumulative enrollment will include withdrawals and replacement participants. LDH participants undergo MRI at baseline and week 4; healthy controls undergo MRI at baseline only.
| Arm | Type | Receives |
|---|---|---|
| Lumbar Disc Herniation (LDH) | Experimental | Procedure: Lever Positioning ManipulationParticipants with lumbar disc herniation receive lever positioning manipulation three times weekly for 4 weeks, approximately 20 minutes per session. Clinical outcome scales and MRI are obtained before treatment and at week 4 after the first session. The target is 30 participants completing the required assessments; withdrawals will be replaced as needed and included in cumulative enrollment. |
| Healthy Controls (HC) | No intervention | –Age- and sex-matched healthy controls undergo baseline eligibility assessment and MRI only, without study intervention or patient clinical outcome scales. The target is 30 participants completing the baseline assessment. Withdrawals before completion will be replaced as needed and included in cumulative enrollment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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 score greater than 4 and Japanese Orthopaedic Association score less than 15.
- No use of analgesics, neurotrophic drugs, or sedatives within 1 month before enrollment.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lever Positioning ManipulationDelivered to participants with LDH by an experienced rehabilitation practitioner three times weekly for 4 weeks, approximately 20 minutes per session. 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 or surgery | Lumbar Disc Herniation (LDH) |
Primary outcome
Change in Cortical Surface-Based Mean-Normalized Amplitude of Low-Frequency Fluctuations
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Resting-state functional MRI will assess the amplitude of low-frequency blood oxygen level-dependent (BOLD) fluctuations on the cortical surface. Mean-normalized ALFF in the 0.01-0.08 Hz band will be calculated relative to the mean cortical ALFF. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
Change in Cortical Surface-Based Regional Homogeneity
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Regional homogeneity will be calculated as Kendall's coefficient of concordance between the BOLD time series at each cortical vertex and its one-ring surface neighbors. Scores range from 0 to 1, with higher values indicating greater local temporal concordance. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
Change in Cortical Surface-Based Global Functional Connectivity Density
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Global functional connectivity density will be quantified as the proportion of other cortical vertices whose BOLD time series have a Pearson correlation greater than 0.6 with each vertex. Self-connections will be excluded. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
Change in Cortical Surface-Based Seed-to-Vertex Functional Connectivity
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Left and right insular cortex seeds will be defined using independent anatomical labels. Seed-to-vertex functional connectivity will be calculated using Pearson correlation followed by Fisher z transformation. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
Change in Cortical Region-to-Region Functional Connectivity
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Cortical regions will be defined using the Schaefer 400-region parcellation. Region-to-region functional connectivity will be calculated using Pearson correlation between regional BOLD time series followed by Fisher z transformation. Changes in unique region-pair connectivity values from baseline to week 4 will be assessed in participants with LDH.
Change in Within-Network and Between-Network Cortical Functional Connectivity
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Using the seven Yeo networks, within-network and between-network connectivity will be quantified as mean Fisher-z-transformed region-to-region connectivity. The measures include seven within-network and 21 between-network values. Within-participant changes from baseline to week 4 will be assessed in participants with LDH.
Change in Cortical Functional Connectivity Gradient Scores
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
The first three cortical functional connectivity gradients will be estimated from regional connectivity profiles using diffusion-map embedding and aligned to a fixed independent reference. Regional gradient coordinates will be reported in arbitrary units. Within-participant changes from baseline to week 4 will be assessed in participants with LDH.
Change in Cortical Functional Gradient Eccentricity
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Functional gradient eccentricity will be calculated as each cortical region's Euclidean distance from the centroid of all regions in the space of the first three aligned functional gradients. Values will be reported in arbitrary units. Within-participant change from baseline to week 4 will be assessed in participants with LDH.
5 secondary outcomes
Change in Pain Intensity Measured by the Visual Analog Scale (VAS)
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Lumbar Function Measured by the Japanese Orthopaedic Association (JOA) Score
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Disability Measured by the Oswestry Disability Index (ODI)
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Anxiety Symptoms Measured by the Zung Self-Rating Anxiety Scale (SAS)
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Change in Depressive Symptoms Measured by the Zung Self-Rating Depression Scale (SDS)
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of de-identified individual participant data has not yet been made.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lijiang Lv principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lever Positioning Manipulation in people with Lumbar Disc Herniation, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lijiang Lv (+86-18958107858, lvlijiang0288@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cortical Surface-Based Mean-Normalized Amplitude of Low-Frequency Fluctuations (time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.