NCT06525896

Non-surgical Spinal Decompression Therapy and Outcomes

Active, Not Recruiting
NAAges 18–65InterventionalTreatment
University of South Florida
~42 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:NSSDSham NSSD

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lumbar Spine Magnetic Resonance Imaging (MRI)
Measured over Baseline, Pre-Intervention; Immediately after intervention
+4 more outcomes measured
Low Back Pain
Herniation, Disc
Sciatic Radiculopathy
Intervertebral Disc Stenosis of Neural Canal
Intervertebral Disc Injury
2 sites across 2 states
California1
Florida1
  • Nathan D Schilaty, DC, PhD · PRINCIPAL_INVESTIGATOR · University of South Florida

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

Known serious spinal pathology (e.g., vertebral fracture, tumor, osteoporosis)
Evidence of central nervous system involvement of pain
Other chronic pain conditions
Pregnancy
Spinal fusion
Inability to comply with treatment schedule
Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)
  • Lumbar Spine Magnetic Resonance Imaging (MRI)Baseline, Pre-Intervention; Immediately after intervention

    Diagnostic imaging of the lumbar spine including T1, T2, and Dixon Fat-Water images. Measures of intervertebral disc height and hydration will be extracted from each lumbar level (L1-L5). Intervertebral disc height will be measured on both T1- and T2-weighted images. The T2-weighted image will assess water signal intensity for intervertebral disc hydration. Muscle quality from the axial Dixon fat-water images will be assessed using the percentage of signal from fat (muscle fat infiltration), a measure of muscle quality. Muscle quality will be assessed in the left and right multifidi, erector spinae, quadratus lumborum, and psoas major muscles.

  • 3D Motion CaptureBaseline, Pre-Intervention; Immediately after intervention

    A markerless motion capture system will measure kinetics and kinematics of functional tasks. Variables of interest include joint angles, limb symmetry, ground reaction forces, double- and single-leg stance percentages, and anticipatory postural acceleration. Tasks include 1) isometric chest raise, 2) tandem balance, 3) sit-to-stand, 4) timed up and go (with gait), and 5) step-up / step-down.

  • Surface ElectromyographyBaseline, Pre-Intervention; Immediately after intervention

    Lumbar neuromotor activation will be assessed with EMG collection (2 kHz) on bilateral musculature, specifically the erector spinae, quadratus lumborum, and gluteus maximus muscles.

  • MyotonometerBaseline, Pre-Intervention; Immediately after intervention

    A measure of passive stiffness of the low back muscles (erector spinae, quadratus lumborum, gluteus maximus) at rest (prone) with a MyotonPRO. The MyotonPRO utilizes oscillation accelerometry to measure five output variables of soft tissue: tone (Hz), stiffness (m/sec), elasticity, relaxation (msec), and creep.

  • Sensorimotor Reflex (H-Reflex)Baseline, Pre-Intervention; Immediately after intervention

    This electrically evoked response is analogous to a monosynaptic stretch reflex. It is used to assess functionality of the peripheral nervous system (diagnosing and monitoring peripheral neuropathies, radiculopathies, and motor neuron diseases; investigation of mechanisms of motor control, plasticity, and adaptation in response to interventions). The H-reflex is particularly valuable in evaluating the excitability of the alpha motor neurons and their synaptic inputs, which can be affected by IVD lesions. A low-intensity electrical stimulus is applied to a mixed peripheral nerve (commonly the tibial nerve) to preferentially activate the Ia afferent fibers. A Digitimer DS7R will provide an electrical stimulus to a sensory neuron. A recording electrode measures the resultant reflexive muscle response which is recorded with surface EMG from the corresponding muscle, providing timing to the sensorimotor reflex loop.