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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• \- Diagnosis of chronic LBP for a minimum of 3 months caused by pathological intervertebral disc, degenerative disc disease, posterior facet syndrome, and/or sciatica.

Locations
United States
California
Stanford University
ACTIVE_NOT_RECRUITING
Stanford
Florida
University of South Florida
RECRUITING
Tampa
Contact Information
Primary
Nathan D Schilaty, DC, PhD
MCOM-SchilatyNeubacLab@usf.edu
(813) 974-1377
Backup
Lauren Luginsland, PhD
MCOM-SchilatyNeubacLab@usf.edu
813-974-1112
Time Frame
Start Date: 2025-01-07
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 42
Treatments
Experimental: NSSD
This group will receive non-surgical spinal decompression (20x over 6-8 weeks). Non-surgical spinal decompression is performed by securing the pelvis in a brace and stabilizing the upper torso. The decompression device provides an inferior force along a vector targeting the level of pathology by pulling on the pelvic brace. This causes a comfortable decompression of the spine.
Sham_comparator: Sham NSSD
This group will receive sham non-surgical spinal decompression (20x over 6-8 weeks). Sham non-surgical spinal decompression is performed by securing the pelvis in a brace and stabilizing the upper torso. The decompression device provides an inferior force along a vector targeting the level of pathology by pulling on the pelvic brace, but at a force that does not cause decompression of the spine. This is not perceivable by the participant.
Related Therapeutic Areas
Sponsors
Leads: University of South Florida
Collaborators: Stanford University, U.S. Army Medical Research and Development Command

This content was sourced from clinicaltrials.gov