Actively Recruiting
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
Eligibility Criteria
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.
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
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
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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