Non-surgical Spinal Decompression Therapy and Outcomes

Last updated: February 19, 2025
Sponsor: University of South Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Radiculopathy

Chronic Pain

Treatment

NSSD

Sham NSSD

Clinical Study ID

NCT06525896
STUDY007409: NSSD-RESTORE
  • Ages 18-65
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of chronic LBP for a minimum of 3 months caused by pathologicalintervertebral disc, degenerative disc disease, posterior facet syndrome, and/orsciatica.

Exclusion

Exclusion Criteria:

  • Known serious spinal pathology (e.g., vertebral fracture, tumor, osteoporosis)

  • Evidence of central nervous system involvement of pain

  • Other chronic pain conditions

  • Pregnancy

  • Spinal fusion

  • Inability to comply with treatment schedule

  • Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: NSSD
Phase:
Study Start date:
January 07, 2025
Estimated Completion Date:
August 31, 2026

Study Description

Participants who consent to the study will undergo a comprehensive baseline assessment.

Baseline: During this visit, the patient will receive a chiropractic physician examination that will include reflexes, myotome, dermatome, and orthopedic assessments. If the examination provides evidence of an intervertebral disc pathology and/or sciatica, the patient will be referred to an MRI assessment to confirm diagnosis for standard of care. Based on these assessments, the research team will determine if the participant meets the initial criteria to continue with participation.

Randomization: Participants will be randomized to either non-surgical spinal decompression (20 treatments) or placebo (20 treatments). Participants will not be able to choose the treatment. The participant nor the investigators will know which treatment you are receiving. If a participant receives the placebo treatment, once they are unblinded, they will be able to receive non-surgical spinal decompression should they elect to do so.

Pre-intervention Assessments: Assessments prior to intervention will include 1) 3D motion capture performing functional tasks, 2) electromyography of the lower back and legs, 3) myotonometer tonometry, 4) range of motion, and 5) Sensorimotor reflex measurement. In addition, the participant will complete online questionnaires that include the Defense Veterans Pain Rating Scale 2.0, PROMIS Pain Interference, PROMIS Physical Function, Central Sensitization Inventory, and the Oswestry Disability Index.

Post-intervention Assessments: Assessments after intervention will include 1) 3D motion capture performing functional tasks, 2) electromyography of the lower back and legs, 3) myotonometer tonometry, 4) range of motion, and 5) Sensorimotor reflex measurement. In addition, the participant will complete online questionnaires that include the Defense Veterans Pain Rating Scale 2.0, PROMIS Pain Interference, PROMIS Physical Function, Central Sensitization Inventory, and the Oswestry Disability Index.

Connect with a study center

  • Stanford University

    Stanford, California 94305-2004
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33620
    United States

    Active - Recruiting

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