Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain

INCLUSION CRITERIA

• Age ≥ 21 years
• Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
• History of chronic knee pain for longer than 6 months unresponsive to conservative treatments (PT, oral analgesics, intra-articular injections with steroids and/or viscosupplementation)
• Positive response (defined as a decrease in numeric pain scores of at least 50%) to a geniculate nerve block of the index knee
• Pain on NRS ≥ 6 on a 10 point scale for the index knee
• Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 12 months for the index knee
• Oxford Knee Score group at Baseline of ≤ 35 indicating moderate to severe OA in the index knee
• If the patient is taking an opioid or other morphine equivalent medication, the dose must be considered clinically stable (defined as 40.
• Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a lesion of up to 14 mm in diameter to limit the risk of skin burns.
• Pending or active compensation claim, litigation or disability remuneration (secondary gain) related to knee.
• Pregnant or intent of becoming pregnant during the study period.
• Chronic pain associated with significant psychosocial dysfunction.
• Beck's Depression Index score of > 22 (indicates clinically depressed state).
• Allergies to any of the medications to be used during the procedure.
• Systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved).
• History of uncontrolled coagulopathy, ongoing coagulation treatment or unexplained or uncontrollable bleeding that is uncorrectable.
• Identifiable anatomical variability that would materially alter the procedure as described in the protocol.
• Within the preceding 2 years, subject has suffered from active narcotic addiction, substance or alcohol abuse.
• Current prescribed opioid medications equivalent to greater than 60 morphine equivalent daily opioid dose.
• Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
• Subject currently implanted with pacemaker or defibrillator.
• Participating in another clinical trial/investigation within 30 days prior to signing informed consent.
• Subject unwilling or unable to comply with follow up schedule or protocol requirements.