Comparing Pain Outcomes of Treatment Strategies for Osteoarthritis Knee Patients

The goal of this clinical trial is to compare two different pain relief techniques (cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injection) for patients with knee osteoarthritis (OA) over a period of 6 months. The main questions it aims to answer are:the extent of reduction of pain score and the proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment in the two treatment groups.the safety of the two treatment modalities.Participants will undergo a nerve block test to determine if they would experience pain relief from blocking of nerve signals. Responders will be randomised to receive one of the two treatments for their knee pain. Researchers will compare the pain intensity of CRFA and HA injection groups at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment using validated questionnaires.

Inclusion Criteria:Age ≥ 21 yearsAble to understand the informed consent form and provide written informed consent and able to complete outcome measuresChronic 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 kneePain on VAS ≥ 6 on an 11-point scale for the index kneeRadiologic 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 kneeAn intra-articular HA injection is indicated as an appropriate treatment optionWOMAC 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 subscaleAgree to see one physician (study physician) for knee pain during the study periodWilling to delay any surgical intervention for the index knee for the period of the study follow upWilling to comply with the requirements of this protocol for the full duration of the studyExclusion Criteria:Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee painEvidence of neuropathic pain secondary to other causes (e.g., sciatica), apart from OA knee, affecting the index kneePrevious or pending lower limb amputationIntra-articular steroid or PRP injection or Radiofrequency lesioning into the index knee within 180 days from randomizationHyaluronic acid injection, PRP injection, stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomizationPrior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)Clinically significant ligamentous laxity of the index kneeClinically 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 limitationsBody mass index (BMI) > 45 kg/m2 or < 18 kg/m2Extremely 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 burnsPending or active compensation claim, litigation, or disability remuneration (secondary gain)Pregnant, nursing or intent of becoming pregnant during the study periodChronic pain associated with significant psychosocial dysfunctionPatients 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 correctableIdentifiable anatomical variability that would materially alter the procedure as described in the protocolWithin the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuseCurrent prescribed opioid medications greater than 60 milligrams morphine equivalent daily opioid doseUncontrolled immunosuppression (e.g., AIDS, cancer, diabetes, etc.)Subject currently implanted with pacemaker, stimulator or defibrillatorParticipating in another clinical trial/investigation within 30 days prior to signing informed consentSubject unwilling or unable to comply with follow up schedule or protocol requirements