Research on Effectiveness of Non-surgical Spinal Decompression Therapy and Outcomes With Radiographic Evaluation
University of South Florida
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.
Description
Participants who consent to the study will undergo a comprehensive baseline assessment. Baseline: During this visit, the patient will receive a chiropractic physician examination that will include reflexes, myotome, dermatome, and orthopedic assessments. If the examination provides evidence of an intervertebral disc pathology and/or sciatica, the patient will be referred to an MRI assessment to confirm diagnosis for standard of care. Based on these assessments, the research team will determine if the participant meets the initial criteria to continue with participation. Randomization: Partic…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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)
Interventions
- DeviceNSSD
A robotically-controlled distractive force is applied to the lower back to produce decompression of the spinal column.
- DeviceSham NSSD
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)
- Stanford UniversityStanford, California
- University of South FloridaTampa, Florida