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

A Prospective Randomized, Double-blind, Controlled Investigation Evaluating the Intracept Intraosseous Nerve Ablation System for the Reduction of Pain in Patients With Chronic Axial Low Back Pain

To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component.

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:

  1. Nerve root compression or severe effacement of the thecal sac that correlates with radicular pain or muscle weakness
  2. Disc extrusion or disc protrusion >5mm
  3. Facet arthrosis or facet effusion at any lumbar level that correlates with clinical evidence of facet mediated low back pain
  4. Spondylolisthesis 2mm or greater at any level
  5. 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