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RECRUITING
NCT06525896
NA

Non-surgical Spinal Decompression Therapy and Outcomes

Sponsor: University of South Florida

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2025-01-07

Completion Date

2026-08-31

Last Updated

2025-07-23

Healthy Volunteers

No

Interventions

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.

Locations (2)

Stanford University

Stanford, California, United States

University of South Florida

Tampa, Florida, United States