Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation

Condition(s) studied

Investigational drug(s) / intervention(s)

Lever Positioning Manipulation: 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 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. 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.

Eligibility

Primary outcome measure(s)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Trial sites (2)

More The Third Affiliated hospital of Zhejiang Chinese Medical University trials in China

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