SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain

Inclusion criteria

• Skeletally mature patients age 25 - 70 years, inclusive
• Chronic lower back pain for at least six (6) months
• Failure to respond to at least six (6) months of non-operative conservative management. The minimum requirement is as follows:

• Analgesic therapy (minimum of 2 weeks) and a minimum of 4 weeks of NSAID therapy
• Supervised exercise program(minimum of 12 sessions)
• Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
• Baseline Visual Analog Scale (VAS) of at least 4cm on a 10cm scale
• The following test indicating that the vertebral body is the source of pain:

1.MRI showing Type 1 or Type II Modic changes at least one vertebral endplate, at one or more levels from L3 to S1

• Understands the local language and is willing and able to follow the requirements of the protocol
• Understands the informed consent and signs the institutional review board/ independent ethics committee (IRB/IEC) approved informed consent form

Exclusion criteria

• Radicular pain by history or evidence of pain or neurological deficit in a dermatomal zone at or below the medial thigh.
• Previous surgery performed on the lumbar spine
• History of symptomatic spinal stenosis
• History of osteoporotic or tumor-related vertebral body compression fracture
• History of vertebral cancer or spinal metastasis
• History of spinal infection
• Metabolic bone disease (e.g. osteogenesis imperfecta)
• BMI ≥40
• Osteoporosis, defined as T score <-2.5
• Any radiographic evidence of other important back pathology, such as:

• Nerve root compression or severe effacement of the thecal sac that correlates with radicular pain or muscle weakness
• Disc extrusion or disc protrusion >5mm
• Facet arthrosis or facet effusion at any lumbar level that correlates with clinical evidence of facet mediated low back pain
• Spondylolisthesis 2mm or greater at any level
• Spondylolysis at any level
• MRI evidence of Modic changes, Type I or Type II at greater than 3 vertebral bodies.
• Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
• Demonstrates 3 or more Waddell's signs of Inorganic Behavior
• Any evidence of current systemic infection
• Uncorrected bleeding diathesis
• Any neurologic problem that prevents early mobilization after surgery or interferes with assessment of ODI
• Contraindication to MRI or patients who have allergies to the components of the Intracept device
• Pregnant, lactating or plan to become pregnant in next year
• Diabetes requiring daily insulin
• Current use of steroid therapy, with the exception of inhalation steroids for asthma
• Evidence of mental instability or uncontrolled depression; patients requiring anti-depressants or anti-psychotics within 3 months of enrollment are not eligible; patients with a Beck Depression Score of greater than 24 are not eligible
• Receiving Workmen's Compensation
• Currently involved in litigation regarding back pain/injury or financial incentive to remain impaired
• Any medical condition that impairs follow-up
• Contraindications to the proposed anesthetic protocol.
• Evidence of substance abuse; patients using prescribed extended release narcotics are not eligible (e.g. fentanyl patch,MS contin, oxycontin)
• Known to require at the time of screening and/or randomization, additional surgery to the lumbar spinal region within six months
• Being treated with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
• Has a life expectancy of less than 1 year
• Has active implantable devices, such as cardiac pacemakers, spinal cord stimulators, etc.
• Is a prisoner