Non-surgical Spinal Decompression Therapy and Outcomes
Research on Effectiveness of Non-surgical Spinal Decompression Therapy and Outcomes With Radiographic Evaluation
University of South Florida
42 participants
Jan 7, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- \- 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 Criteria7
- 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)
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Interventions
A robotically-controlled distractive force is applied to the lower back to produce decompression of the spinal column.
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.
Locations(2)
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NCT06525896