Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
NCT07914842, Not applicable, Not yet recruiting, The Third Affiliated hospital of Zhejiang Chinese Medical University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation | ClinicalTrials.gov |
| NCT number | NCT07914842 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University | ClinicalTrials.gov |
| Conditions | Lumbar Disc Herniation | ClinicalTrials.gov |
| Interventions | Lever Positioning Manipulation | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Cortical Surface-Based Mean-Normalized Amplitude of Low-Frequency Fluctuations | 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. | ClinicalTrials.gov |
| Primary | Change in Cortical Surface-Based Regional Homogeneity | 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. | ClinicalTrials.gov |
| Primary | Change in Cortical Surface-Based Global Functional Connectivity Density | 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. | ClinicalTrials.gov |
| Primary | Change in Cortical Surface-Based Seed-to-Vertex Functional Connectivity | 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. | ClinicalTrials.gov |
| Primary | Change in Cortical Region-to-Region Functional Connectivity | 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. | ClinicalTrials.gov |
| Primary | Change in Within-Network and Between-Network Cortical Functional Connectivity | 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. | ClinicalTrials.gov |
| Primary | Change in Cortical Functional Connectivity Gradient Scores | 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. | ClinicalTrials.gov |
| Primary | Change in Cortical Functional Gradient Eccentricity | 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. | ClinicalTrials.gov |
| Secondary | Change in Pain Intensity Measured by the Visual Analog Scale (VAS) | Baseline before treatment and week 4 after the first treatment session in participants with LDH. | 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. | ClinicalTrials.gov |
| Secondary | Change in Lumbar Function Measured by the Japanese Orthopaedic Association (JOA) Score | Baseline before treatment and week 4 after the first treatment session in participants with LDH. | 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. | ClinicalTrials.gov |
| Secondary | Change in Disability Measured by the Oswestry Disability Index (ODI) | Baseline before treatment and week 4 after the first treatment session in participants with LDH. | 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. | ClinicalTrials.gov |
| Secondary | Change in Anxiety Symptoms Measured by the Zung Self-Rating Anxiety Scale (SAS) | Baseline before treatment and week 4 after the first treatment session in participants with LDH. | 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. | ClinicalTrials.gov |
| Secondary | Change in Depressive Symptoms Measured by the Zung Self-Rating Depression Scale (SDS) | Baseline before treatment and week 4 after the first treatment session in participants with LDH. | 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. | ClinicalTrials.gov |
| Other | Incidence of Adverse Events | From the first treatment session through the end of the 4-week intervention. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
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Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
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Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
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Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)