Comparing Pain Outcomes of Treatment Strategies for Osteoarthritis Knee Patients

Inclusion Criteria: Age ≥ 21 years Able to understand the informed consent form and provide written informed consent and able to complete outcome measures Chronic knee pain for longer than 3 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.) 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] etc.) Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee Pain on VAS ≥ 6 on an 11-point scale for the index knee Radiologic confirmation of arthritis (x-ray/MRI/CT) of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee An intra-articular HA injection is indicated as an appropriate treatment option WOMAC Knee Score group at baseline of Score of ≥ 2 (0 to 4 scale) on WOMAC question 1 (Pain) and a mean score of ≥ 1.5 on all five questions of the WOMAC pain subscale Agree to see one physician (study physician) for knee pain during the study period Willing to delay any surgical intervention for the index knee for the period of the study follow up Willing to comply with the requirements of this protocol for the full duration of the study Exclusion Criteria: Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain Evidence of neuropathic pain secondary to other causes (e.g., sciatica), apart from OA knee, affecting the index knee Previous or pending lower limb amputation Intra-articular steroid or PRP injection or Radiofrequency lesioning into the index knee within 180 days from randomization Hyaluronic acid injection, PRP injection, stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware) Clinically significant ligamentous laxity of the index knee 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 Body mass index (BMI) > 45 kg/m2 or < 18 kg/m2 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 Pending or active compensation claim, litigation, or disability remuneration (secondary gain) Pregnant, nursing or intent of becoming pregnant during the study period Chronic pain associated with significant psychosocial dysfunction Patients with known psychiatric history including severe mental health issues. Allergies to any of the medications to be used during the procedures, including known hypersensitivity (allergy) to hyaluronate preparations or allergies to avian or avian-derived products (including eggs, feathers, or poultry) Active joint infection or 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 that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is not correctable 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 greater than 60 milligrams morphine equivalent daily opioid dose Uncontrolled immunosuppression (e.g., AIDS, cancer, diabetes, etc.) Subject currently implanted with pacemaker, stimulator 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