Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain

1. Age ≥ 21 years

2. Able to understand and personally sign and date the informed consent form

3. Able to complete outcome measures

4. Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)

5. Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs])

6. Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee

7. Pain on NRS ≥ 6 on an 11-point scale for the index knee

8. Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) grade 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee

9. Analgesics including membrane stabilizers such as Neurontin (gabapentin) and antidepressants for pain, such as Cymbalta (duloxetine), must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the course of the study without approval of the investigator

10. Agree to see one physician (study physician) for knee pain during the study period

11. Subjects of child bearing potential must be willing to utilize double barrier contraceptive method

12. Willingness to comply with the requirements of this protocol for the full duration of the study (24 months regardless of effect of initial therapy)

1. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic inflammatory condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause knee pain

2. Evidence of neuropathic pain affecting the index knee

3. Previous or pending lower limb amputation

4. Intra-articular steroid injection into the index knee within 90 days from randomization

5. Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization

6. Prior radiofrequency ablation of the genicular nerves of the index knee

7. Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)

8. Clinically significant ligamentous laxity of the index knee

9. Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations

10. Body mass index (BMI) > 40 kg/m2

11. 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

12. Pending or active compensation claim, litigation, or disability remuneration (secondary gain)

13. Pregnant, nursing or intent of becoming pregnant during the study period

14. Chronic pain associated with significant psychosocial dysfunction

15. Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator

16. Allergies to any of the medications to be used during the procedures

17. Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)

18. History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable

19. Identifiable anatomical variability that would materially alter the procedure as described in the protocol

20. Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse

21. Current prescribed opioid medications greater than 60 mg morphine equivalent daily opioid dose

22. Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)

23. Subject currently implanted with pacemaker, stimulator or defibrillator

24. Participating in another clinical trial/investigation which included therapeutic treatment within 30 days prior to signing informed consent

25. Subject unwilling or unable to comply with follow up schedule, protocol requirements or procedures