An interventional study of Lever Positioning Manipulation in Lumbar Disc Herniation, sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University · Not applicable, Interventional, and Treatment
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.
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.
493 studies on the registry are indexed under Intervertebral Disc Displacement; 103 are open to participants now.
This study's planned enrollment of 60 is close to the median of 64 across 356 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →The Third Affiliated hospital of Zhejiang Chinese Medical University is the lead sponsor of 45 studies on the registry; 25 are open to participants now.
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Patients with lumbar disc herniation:
Healthy controls:
Exclusion Criteria:
Patients with LDH:
Healthy controls:
- Any condition that may affect eligibility, MRI safety, or data quality.
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.
Procedure: Lever Positioning Manipulation
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
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.
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
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.
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)
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.
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)
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.
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)
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.
Time frame: Baseline before treatment and week 4 after the first treatment session in participants with LDH.
Incidence of Adverse Events
The number and proportion of participants experiencing adverse events will be recorded throughout the 4-week treatment course. Severity and relationship to intervention will be assessed. Vital signs and treatment-related discomfort will be checked at each treatment session.
Time frame: From the first treatment session through the end of the 4-week intervention.
Plan to share: Undecided — A decision regarding the sharing of de-identified individual participant data has not yet been made.
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