Skeletally mature patients with chronic (≥6 months) isolated lumbar back pain, who had not responded to at least 6 months of non-operative management Type 1 or type 2 Modic changes at one or more vertebral body for levels L3-S1 Minimum Oswestry Disability Index (ODI) of 30 points (100-point scale) Minimum Visual Analog Scale (VAS) of 4 cm on a 10 cm scale Ability to provide informed consent, read and complete questionnaires
| MRI evidence of Modic at levels other than lumbar level 3 to sacral level 1 (L3-S1) Radicular pain (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression in imaging) Previous lumbar spine surgery (discectomy/laminectomy allowed if >6 months prior to baseline and radicular pain resolved) Symptomatic spinal stenosis (defined as the presence of neurogenic claudication and confirmed by imaging) Metabolic bone disease, spine fragility fracture history, or trauma/compression fracture, or spinal cancer Spine infection, active systemic infection, bleeding diathesis Radiographic evidence of other pain etiology Disc extrusion or protrusion >5 mm Spondylolisthesis >2 mm at any level Spondylolysis at any level Facet arthrosis/effusion correlated with clinically suspected facet-mediated low back pain Beck Depression Inventory (BDI) >24 or 3 or >Waddell’s signs Compensated injury or litigation Currently taking extended-release narcotics with addiction behaviors Body mass index (BMI) >40 Bedbound or neurological condition that prevents early mobility or any medical condition that impairs follow-up Contraindication to MRI, allergies to components of the device, or active implantable devices, pregnant or lactating
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