Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain

Exclusion Criteria

• •1. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause pain.
• •2. Focal neurologic signs or symptoms.
• •3. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher spondylolisthesis at an affected joint or adjacent level, or significant lumbar scoliosis (sagittal vertical axis angle \>5 degrees or Cobb Angle \>10 degrees).
• •4. Suspected mechanical instability based on flexion/extension and/or films at the proposed treatment levels
• •5. History of prior lumbar fusion or previous lumbar back surgery at the intended treatment levels.
• •6. Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy.
• •7. Radiologic evidence of a symptomatic herniated disc or nerve root impingement.
• •8. Symptomatic moderate or severe foramina or central canal stenosis demonstrating radicular symptoms or neurogenic claudication.
• •9. Evidence of neuropathic pain affecting the lower back.
• •10. Intra-articular steroid injection at target levels within 90 days from randomization.
• •11. Platelet rich plasma (PRP) or stem cells at target levels within 180 days from randomization.
• •12. Prior lumbar radiofrequency neurotomy of the L3/L4, L4/L5 medial branches and/or L5/S1dorsal ramus.
• •13. Body mass index (BMI) \> 40 kg/m2
• •14. Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the risk of skin burns.
• •15. Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved).
• •16. Pending or active compensation claim, litigation, or disability remuneration (e.g. disability, worker's compensation, auto injury in litigation or pending litigation).
• •17. Pregnant, nursing or intent of becoming pregnant during the study period
• •18. Chronic pain associated with significant psychosocial dysfunction.
• •19. Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator.
• •20. Allergies to any of the medications to be used during the procedures
• •21. History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable.
• •22. Identifiable anatomical variability that would materially alter the procedure as described in the protocol.
• •23. Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse.
• •24. Current prescribed opioid medications greater than 50 morphine equivalent daily opioid dose.
• •25. Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.).
• •26. Subject currently implanted with pacemaker, stimulator or defibrillator.
• •27. Participating in another clinical trial/investigation which included therapeutic treatment within 30 days prior to signing informed consent.
• •28. Subject unwilling or unable to comply with follow up schedule, protocol requirements or procedures.