Clinical trial NCT06525896: Non-surgical Spinal Decompression Therapy and Outcomes
Official title: Research on Effectiveness of Non-surgical Spinal Decompression Therapy and Outcomes With Radiographic Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Herniation, Disc
Sciatic Radiculopathy
Intervertebral Disc Stenosis of Neural Canal
Intervertebral Disc Injury
Keywords: 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
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Stanford University
name: U.S. Army Medical Research and Development Command
First posted: 2024-07-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Lumbar Spine Magnetic Resonance Imaging (MRI)
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
measure: 3D Motion Capture
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
measure: Surface Electromyography
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
measure: Myotonometer
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
measure: Sensorimotor Reflex (H-Reflex)
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
Secondary outcomes:
measure: DVPRS 2.0
timeFrame: Baseline, Pre-Intervention; Throughout trial (approximately 3x/week); Immediately after intervention
measure: PROMIS Physical Function
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
measure: PROMIS Pain Interference
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
measure: Oswestry Disability Index
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
measure: Central Sensitization Inventory
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
measure: International Physical Activity Questionnaire - Short Form
timeFrame: Baseline, Pre-Intervention; Immediately after intervention
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Nathan D Schilaty, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramos G, Martin W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg. 1994 Sep;81(3):350-3. doi: 10.3171/jns.1994.81.3.0350.
citation: Ramos G. Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen. Neurol Res. 2004 Apr;26(3):320-4. doi: 10.1179/016164104225014030.
citation: Gose EE, Naguszewski WK, Naguszewski RK. Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: an outcome study. Neurol Res. 1998 Apr;20(3):186-90. doi: 10.1080/01616412.1998.11740504.
citation: Macario A, Richmond C, Auster M, Pergolizzi JV. Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective chart review. Pain Pract. 2008 Jan-Feb;8(1):11-7. doi: 10.1111/j.1533-2500.2007.00167.x.
citation: Karimi N, Akbarov P, Rahnama L. Effects of segmental traction therapy on lumbar disc herniation in patients with acute low back pain measured by magnetic resonance imaging: A single arm clinical trial. J Back Musculoskelet Rehabil. 2017;30(2):247-253. doi: 10.3233/BMR-160741.