Non-surgical Spinal Decompression Therapy and Outcomes
NCT Number: NCT06525896
Acronym: RESTORE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain|Herniation, Disc|Sciatic Radiculopathy|Intervertebral Disc Stenosis of Neural Canal|Intervertebral Disc Injury
Interventions: DEVICE: NSSD|DEVICE: Sham NSSD
Sponsor: University of South Florida
Collaborators: Stanford University|U.S. Army Medical Research and Development Command
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-31
Locations: Stanford University, Stanford, California, 94305-2004, United States|University of South Florida, Tampa, Florida, 33613, United States

Summary:
This project will determine the clinical utility of non-surgical spine decompression for chronic low back pain (LBP). LBP is one of the highest incidence medical conditions that contributes to disability, decreased activities of daily living, decreased quality of life, and inability to work. LBP affects ≈70-85% of people during their lifetime, with ≈20% becoming chronic by age 20-59 years. Many current LBP therapeutics have detrimental long-term effects, undesired side effects, are invasive procedures with low success rates, and do not fare better than conservative care. Further, many chronic musculoskeletal pain patients do not respond to surgery, and many develop dependence on opioids.

This project will implement a small-scale double-blinded, randomized proof-of-concept clinical trial to gather biomechanical and MRI data that will objectively determine the effectiveness of non-surgical spinal decompression (NSSD) over a 12-week longitudinal timeframe. The potential to provide a non-invasive alternative to chronic LBP via NSSD is innovative and addresses the pressing need for safer, more effective pain management options with fewer negative sequelae. NSSD has the potential to greatly improve lives, offering a new paradigm for chronic pain management.

Primary Outcome Measures: Lumbar Spine Magnetic Resonance Imaging (MRI), 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., Baseline, Pre-Intervention; Immediately after intervention|3D Motion Capture, 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., Baseline, Pre-Intervention; Immediately after intervention|Surface Electromyography, Lumbar neuromotor activation will be assessed with EMG collection (2 kHz) on bilateral musculature, specifically the erector spinae, quadratus lumborum, and gluteus maximus muscles., Baseline, Pre-Intervention; Immediately after intervention|Myotonometer, 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., Baseline, Pre-Intervention; Immediately after intervention|Sensorimotor Reflex (H-Reflex), 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., Baseline, Pre-Intervention; Immediately after intervention
Secondary Outcome Measures: DVPRS 2.0, A pain assessment tool that utilizes a numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions matched to pain levels. Higher scores correlate with increased pain., Baseline, Pre-Intervention; Throughout trial (approximately 3x/week); Immediately after intervention|PROMIS Physical Function, A test that measures how well patients with musculoskeletal disorders can perform activities of daily living. High scores correlated with increased function., Baseline, Pre-Intervention; Immediately after intervention|PROMIS Pain Interference, A scale measures how much pain limits a person's ability to participate in physical, mental, cognitive, emotional, recreational, and social activities. Lower scores correlate with increased interference of pain in daily activities., Baseline, Pre-Intervention; Immediately after intervention|Oswestry Disability Index, A patient-reported questionnaire for disability associated with the low back that analyzes 10 items. A higher total score correlates with higher disability., Baseline, Pre-Intervention; Immediately after intervention|Central Sensitization Inventory, A self-report tool that helps identify patients who may have central sensitization or central sensitivity syndromes. A higher score correlates with higher central sensitization., Baseline, Pre-Intervention; Immediately after intervention