Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06525896

Non-surgical Spinal Decompression Therapy and Outcomes

Led by University of South Florida · Updated on 2025-07-23

42

Participants Needed

2

Research Sites

85 weeks

Total Duration

On this page

Sponsors

U

University of South Florida

Lead Sponsor

S

Stanford University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Non-surgical Spinal Decompression Therapy and Outcomes

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of chronic low back pain for at least 3 months caused by pathological intervertebral disc, degenerative disc disease, posterior facet syndrome, and/or sciatica.
Not Eligible

You will not qualify if you...

  • Known serious spinal pathology such as vertebral fracture, tumor, or 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 due to claustrophobia, pacemaker, or ferromagnetic implants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Stanford University

Stanford, California, United States, 94305-2004

Active, Not Recruiting

2

University of South Florida

Tampa, Florida, United States, 33620

Actively Recruiting

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Research Team

N

Nathan D Schilaty, DC, PhD

CONTACT

L

Lauren Luginsland, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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