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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 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.

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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.

Interventions

  • DEVICE NSSD
  • DEVICE Sham NSSD

Study Locations (2)

California

  • Stanford University - Stanford

Florida

  • University of South Florida - Tampa

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2025-01-07
Est. Completion 2026-08-31
Phase NA

Sponsor

University of South Florida

252 total trials

What the Registry Record Tells You About NCT06525896

The ClinicalTrials.gov registry entry for NCT06525896 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (92% lower). The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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