Non-surgical Spinal Decompression Therapy and Outcomes
Active, not recruitingNot applicableNCT06525896
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Research on Effectiveness of Non-surgical Spinal Decompression Therapy and Outcomes With Radiographic Evaluation
- Conditions
- Low Back Pain
- Herniation, Disc
- Sciatic Radiculopathy
- Intervertebral Disc Stenosis of Neural Canal
- Intervertebral Disc Injury
- Interventions
- Device: NSSD
- Device: Sham NSSD
- Sponsor
- University of South Florida
- Collaborators
- Stanford University; U.S. Army Medical Research and Development Command
- Start date
- 2025-01-07
- Primary completion
- 2026-08-31
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: \- Diagnosis of chronic LBP for a minimum of 3 months caused by pathological intervertebral disc, degenerative disc disease, posterior facet syndrome, and/or sciatica. Exclusion Criteria: * 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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06525896