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NCT06525896 · ClinicalTrials.gov registry record · NA
Non-surgical Spinal Decompression Therapy and Outcomes
A NA study of Low Back Pain and Herniation, Disc, sponsored by University of South Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 2
- Study locations
NCT06525896: Recruiting NA study of Low Back Pain and Herniation, Disc, sponsored by University of South Florida.
NCT06525896 is a NA study of Low Back Pain and Herniation, Disc that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 42 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06525896, a NA study of Low Back Pain and Herniation, Disc, is actively recruiting participants, sponsored by University of South Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Diagnostic imaging of the lumbar spine including T1, T2, and Dixon Fat-Water images. Measures of intervertebral disc height and hydration will be extracted from each lumbar level (L1-L5). Intervertebral disc height will be measured on both T1- and T2-weighted images. The T2-weighted image will assess water signal intensity for intervertebral disc hydration. Muscle quality from the axial Dixon fat-water images will be assessed using the percentage of signal from fat (muscle fat infiltration), a m
Conditions Studied
Interventions
- DEVICE NSSD
- DEVICE Sham NSSD
Study Locations (2)
California
- Stanford University - Stanford
Florida
- University of South Florida - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2025-01-07 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What NCT06525896 shows while recruiting
NCT06525896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (92% lower).
The record links to 5 conditions, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which NSSD is the first listed.
NCT06525896 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT06525896 about?
NCT06525896 is a clinical study titled "Non-surgical Spinal Decompression Therapy and Outcomes". 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 aff...
What is the current status of trial NCT06525896?
This trial is currently recruiting. It is a NA study. The enrollment target is 42 participants. The study started on 2025-01-07. Estimated completion is 2026-08-31.
What conditions does trial NCT06525896 study?
This clinical trial studies the following conditions: Low Back Pain, Herniation, Disc, Sciatic Radiculopathy, Intervertebral Disc Stenosis of Neural Canal, Intervertebral Disc Injury.
What interventions are being tested in trial NCT06525896?
The interventions under investigation include: NSSD (DEVICE), Sham NSSD (DEVICE).
Who is sponsoring clinical trial NCT06525896?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06525896 being conducted?
This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06525896's enrollment target sits among peer trials
42 95th of 122 higher than 28 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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