Ultrasound-guided Monopolar Versus Bipolar Radiofrequency Ablation for Genicular Nerves in Chronic Knee Osteoarthritis

Study Overview
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Brief Summary
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Radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation. This technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. Ultrasound-guided RF genicular ablation yielded both significant reductions in knee pain and improvements in functional capacity.

Detailed Description
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The aim of this study is to compare between ultrasound guided monopolar and bipolar radiofrequency ablation in chronic knee osteoarthritis. Osteoarthritis of knee joint is one of the most common disease conditions with advanced age and leads to considerable morbidity in terms of pain, stiffness, limitation in functions, disturbance in sleep and psychological disturbance A diagnostic genicular nerve block (GNB) with local anesthetic is performed before RF genicular ablation, and a successful response to GNB is considered to indicate the need for RF genicular ablation

Official Title
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Effect of Monopolar Radiofrequency Ablation for Genicular Nerves Compared to Bipolar Radiofrequency Ablation Using Ultrasound in Treating Chronic Knee Osteoarthritis

Conditions
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Chronic Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Monopolar radiofrequency ablation
* Procedure: Bipolar radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiologic tibiofemoral Osteoarthritis (Kellgren-Lawrence grade 2-4). Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids. Patients refused surgery. Exclusion Criteria: Patient refusal. Prior knee surgery. Acute knee pain. Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months. Connective tissue diseases that affected the knee. Anticoagulant medication use. Local skin infection and sepsis at the site of intervention

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monopolar radiofrequency ablation<br>Patients will receive ultrasound-guided monopolar radiofrequency ablation | Procedure: Monopolar radiofrequency ablation<br>* a radiofrequency cannula is advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia along the area of knee joint supplied by that respected genicular nerve by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.<br>|
| Active Comparator: Bipolar radiofrequency ablation<br>Patients will receive ultrasound-guided bipolar radiofrequency ablation | Procedure: Bipolar radiofrequency ablation<br>* Two radiofrequency cannula are advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoarthritis pain | The mean changes from baseline levels of osteoarthritis pain using visual analogue scale used to measure pain intensity. It is 10 cm scale where 0 cm represent no pain and 10 cm represent the worst pain ever | basal value, at 1, 4, 12, 24 weeks post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score | A specific score to assess the functional changes in the knee using Oxford Knee Score (OKS). The scores are 12-item questionnaires ranging from 12-60, with 12 representing the optimal outcome. | basal value, at 1, 4, 12, 24 weeks post procedure | 
| The procedure time | The procedure time taken by each mode of radiofrequency from the start of advancement of the cannula under US guidance to the end of the procedure. | from the start of advancement of the cannula to end of procedure. | 
| Patient satisfaction score | Patient satisfaction score with treatment which is scored from 1 to 10. A score of 1-4 was considered dissatisfied, 5-8 was satisfied, and 9 or 10 was very satisfied | up to 24 weeks post procedure | 
| Changes in doses of rescue analgesics |  | up to 24 weeks post procedure | 
| The incidence of numbness |  | up to 24 weeks post procedure | 
| The incidence of paresthesia |  | up to 24 weeks post procedure | 
| The incidence of motor weakness |  | up to 24 weeks post procedure | 
| the proportion of successful responders | the proportion of successful responders with a reduction of at least 50% of median VAS score and no increase from baseline OKS | up to 24 weeks post procedure |