Non-surgical Spinal Decompression Therapy and Outcomes (RESTORE)

University of South Florida

Status: Enrolling

Conditions: Herniation, Disc; Sciatic Radiculopathy; Intervertebral Disc Stenosis of Neural Canal; Intervertebral Disc Injury; Low Back Pain

Treatments: Device: NSSD; Device: Sham NSSD

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06525896

STUDY007409: NSSD-RESTORE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

NSSD

Experimental group

Description:

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.

Treatment:

Device: NSSD

Sham NSSD

Sham Comparator group

Description:

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.

Treatment:

Device: Sham NSSD