Non-surgical Spinal Decompression Therapy and Outcomes

NCT06525896 | Recruiting DMC FDA Device

• 1 other identifier: STUDY007409: NSSD-RESTORE
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Low Back Pain; Herniation, Disc; Sciatic Radiculopathy; Intervertebral Disc Stenosis of Neural Canal; Intervertebral Disc Injury

Keywords

decompression; non-surgical; spine; low back; pain; traction; vertebral axial decompression; spinal traction; stretch; spinal decompression therapy; non-surgical spinal decompression; lumbar; lumbar decompression; back pain treatment; herniated disc therapy; degenerative disc disease treatment; non-invasive spine therapy; chronic back pain relief; Intervertebral Disc Displacement; back pain; lumbar vertebrae; physical therapy modalities; musculoskeletal manipulations; rehabilitation; therapeutics

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• DVPRS 2.0

  Baseline, Pre-Intervention; Throughout trial (approximately 3x/week); Immediately after intervention, 6 months after intervention

• PROMIS Physical Function

  Baseline, Pre-Intervention; Immediately after intervention, , 6 months after intervention

• PROMIS Pain Interference

  Baseline, Pre-Intervention; Immediately after intervention, , 6 months after intervention

• Oswestry Disability Index

  Baseline, Pre-Intervention; Immediately after intervention, 6 months after intervention

• Central Sensitization Inventory

  Baseline, Pre-Intervention; Immediately after intervention, 6 months after intervention

Study Arms (2)

NSSD

EXPERIMENTAL

This group will receive non-surgical spinal decompression (20x over 6-8 weeks). Non-surgical spinal decompression is performed by securing the pelvis in a brace and stabilizing the upper torso. The decompression device provides an inferior force along a vector targeting the level of pathology by pulling on the pelvic brace. This causes a comfortable decompression of the spine.

Device: NSSD

Sham NSSD

SHAM COMPARATOR

This group will receive sham non-surgical spinal decompression (20x over 6-8 weeks). Sham non-surgical spinal decompression is performed by securing the pelvis in a brace and stabilizing the upper torso. The decompression device provides an inferior force along a vector targeting the level of pathology by pulling on the pelvic brace, but at a force that does not cause decompression of the spine. This is not perceivable by the participant.

Device: Sham NSSD

Interventions

NSSD DEVICE

A robotically-controlled distractive force is applied to the lower back to produce decompression of the spinal column.

Also known as: Vertebral Axial Decompression, Traction

NSSD

Sham NSSD DEVICE

A robotically-controlled distractive force (lower than the intervention) is applied to tension the belt and create a sense of decompression without producing decompression of the spinal column.

Also known as: Vertebral Axial Decompression, Traction

Sham NSSD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosis of chronic LBP for a minimum of 3 months caused by pathological intervertebral disc, degenerative disc disease, posterior facet syndrome, and/or sciatica.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of South Florida: lead
• Stanford University: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305-2004, United States

ACTIVE NOT RECRUITING

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

Related Publications (5)

• Ramos G, Martin W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg. 1994 Sep;81(3):350-3. doi: 10.3171/jns.1994.81.3.0350.

  PMID: 8057141 BACKGROUND

• Ramos G. Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen. Neurol Res. 2004 Apr;26(3):320-4. doi: 10.1179/016164104225014030.

  PMID: 15142327 BACKGROUND

• Gose EE, Naguszewski WK, Naguszewski RK. Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: an outcome study. Neurol Res. 1998 Apr;20(3):186-90. doi: 10.1080/01616412.1998.11740504.

  PMID: 9583577 BACKGROUND

• Macario A, Richmond C, Auster M, Pergolizzi JV. Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective chart review. Pain Pract. 2008 Jan-Feb;8(1):11-7. doi: 10.1111/j.1533-2500.2007.00167.x.

  PMID: 18211590 BACKGROUND

• Karimi N, Akbarov P, Rahnama L. Effects of segmental traction therapy on lumbar disc herniation in patients with acute low back pain measured by magnetic resonance imaging: A single arm clinical trial. J Back Musculoskelet Rehabil. 2017;30(2):247-253. doi: 10.3233/BMR-160741.

  PMID: 27636836 BACKGROUND

Related Links

• DRX9000 510(k) approval

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Displacement; Pain; Back Pain

Interventions

Traction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Nathan D Schilaty, DC, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan D Schilaty, DC, PhD

CONTACT

(813) 974-1377; MCOM-SchilatyNeubacLab@usf.edu

Lauren Luginsland, PhD

CONTACT

813-974-1112; MCOM-SchilatyNeubacLab@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 29, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)