Table 1

Inclusion and exclusion criteria: Listing of the inclusion and exclusion criteria for the study are noted below

Inclusion criteriaExclusion criteria
  • 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

  • BDI, Beck Depression Index; BMI, body mass index; ODI, Oswestry Disability Index; VAS, Visual Analog Scale.