RECRUITING

Non-surgical Spinal Decompression Therapy and Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-01-07
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06525896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Known serious spinal pathology (e.g., vertebral fracture, tumor, osteoporosis)
  2. * Evidence of central nervous system involvement of pain
  3. * Other chronic pain conditions
  4. * Pregnancy
  5. * Spinal fusion
  6. * Inability to comply with treatment schedule
  7. * Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)

Contacts and Locations

Study Contact

Nathan D Schilaty, DC, PhD
CONTACT
(813) 974-1377
MCOM-SchilatyNeubacLab@usf.edu
Lauren Luginsland, PhD
CONTACT
813-974-1377
MCOM-SchilatyNeubacLab@usf.edu

Principal Investigator

Nathan D Schilaty, DC, PhD
PRINCIPAL_INVESTIGATOR
University of South Florida

Study Locations (Sites)

Stanford University
Stanford, California, 94305-2004
United States
University of South Florida
Tampa, Florida, 33620
United States

Collaborators and Investigators

Sponsor: University of South Florida

  • Nathan D Schilaty, DC, PhD, PRINCIPAL_INVESTIGATOR, University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-07
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2025-01-07
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • decompression
  • non-surgical
  • spine
  • low back
  • pain
  • traction
  • vertebral axial decompression
  • spinal traction
  • stretch
  • spinal decompression therapy
  • non-surgical spinal decompression
  • lumbar
  • lumbar decompression
  • back pain treatment
  • herniated disc therapy
  • degenerative disc disease treatment
  • non-invasive spine therapy
  • chronic back pain relief
  • Intervertebral Disc Displacement
  • back pain
  • lumbar vertebrae
  • physical therapy modalities
  • musculoskeletal manipulations
  • rehabilitation
  • therapeutics

Additional Relevant MeSH Terms

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