Non-surgical Spinal Decompression Therapy and Outcomes

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

Interventions

DEVICE

Sham NSSD

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.

DEVICE

NSSD

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

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• U.S. Army Medical Research and Development Command

  collaborator FED

• University of South Florida

  lead OTHER

Principal Investigators

• Nathan D Schilaty, DC, PhD · University of South Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-07

Primary Completion

2026-08-31

Completion

2026-10-31

FDA Device

Yes

Countries

• United States

Study Locations