Clinical Trial Finder

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)

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.

Arms

Experimental: NSSD

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.

Sham Comparator: Sham NSSD

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.

Interventions

Device: - NSSD

A robotically-controlled distractive force is applied to the lower back to produce decompression of the spinal column.

Device: - Sham NSSD

A robotically-controlled distractive force (lower than the intervention) is applied to tension the belt and create a sense of decompression without producing decompression of the spinal column.