Clinical trial: Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain (NCT04145011)

Eligibility criteria:
Inclusion Criteria:

          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)

        Exclusion Criteria:

          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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment