Non-surgical Spinal Decompression Therapy and Outcomes

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Low Back Pain, Herniation, Disc, Sciatic Radiculopathy, Intervertebral Disc Stenosis of Neural Canal, Intervertebral Disc Injury

In brief

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.

Key facts

Study ID

NCT06525896

Run by

University of South Florida

People needed

42

Starts

2025-01-07

Expected to finish

2026-10-31

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Stanford University — Stanford, California, United States
• University of South Florida — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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