NCT06525896

Non-surgical Spinal Decompression Therapy and Outcomes

Research on Effectiveness of Non-surgical Spinal Decompression Therapy and Outcomes With Radiographic Evaluation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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: Participants will be randomized to either non-surgical spinal decompression (20 treatments) or placebo (20 treatments). Participants will not be able to choose the treatment. The participant nor the investigators will know which treatment you are receiving. If a participant receives the placebo treatment, once they are unblinded, they will be able to receive non-surgical spinal decompression should they elect to do so. Pre-intervention Assessments: Assessments prior to intervention will include 1) 3D motion capture performing functional tasks, 2) electromyography of the lower back and legs, 3) myotonometer tonometry, 4) range of motion, and 5) Sensorimotor reflex measurement. In addition, the participant will complete online questionnaires that include the Defense Veterans Pain Rating Scale 2.0, PROMIS Pain Interference, PROMIS Physical Function, Central Sensitization Inventory, and the Oswestry Disability Index. Post-intervention Assessments: Assessments after intervention will include 1) 3D motion capture performing functional tasks, 2) electromyography of the lower back and legs, 3) myotonometer tonometry, 4) range of motion, and 5) Sensorimotor reflex measurement. In addition, the participant will complete online questionnaires that include the Defense Veterans Pain Rating Scale 2.0, PROMIS Pain Interference, PROMIS Physical Function, Central Sensitization Inventory, and the Oswestry Disability Index.

Conditions

• Low Back Pain
• Herniation, Disc
• Sciatic Radiculopathy
• Intervertebral Disc Stenosis of Neural Canal
• Intervertebral Disc Injury

Interventions

Type	Name	Description
DEVICE	NSSD	A robotically-controlled distractive force is applied to the lower back to produce decompression of the spinal column.
DEVICE	Sham 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.

Timeline

• Start date: 2025-01-07
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2024-07-29
• Last updated: 2025-07-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study