Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique

Study Overview
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Brief Summary
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The study is designed to evaluate and compare the efficacy of three needles approach as a new technique in radiofrequency neurotomy of genicular nerve versus the traditional single needle approach as a treatment of advanced knee osteoarthritic pain. Primary outcome: Pain intensity via the visual analogue score (VAS). Function and pain via the Oxford Knee Score. Evaluated after 6 months of the procedure Secondary outcome: Failure rate. Incidence of any complication. Total analgesic requirement during the period of follow up.

Official Title
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Three Needles Approach... A New Technique of Genicular Nerve Radio-frequency Ablation for Pain Relief in Advanced Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Radiation: Radio-frequency ablation of genicular nerves


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- Age 35-85 years old 2- Patients with stage 3 or higher OA-related radiological changes based on Kellgren-Lawrence (K/L) rating scale 3- Knee pain for at least 3 months 4-Patients are clinically unresponsive to conservative treatment modalities (physical therapy and rehabilitation practices, orally administered analgesics and anti-inflammatory drugs). Exclusion Criteria: 1- Patients with other causes of pain as radiculopathy, neurological disorders or intermittent claudication. 2- Previous knee trauma. 3- Previous knee surgery. 4- Patients received intra-articular injection during the previous three months. 5- Acute knee pain. 6- Crystal arthropathy. 7- Joint effusion. 8- Serious neurological or psychiatric disorders. 9- On anticoagulant medication. 10- Any other connective tissue disorder that affects the knee joint. 11- skin infection at the site of injection. 12-patient refusal.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Three needles group<br> | Radiation: Radio-frequency ablation of genicular nerves<br>* Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis<br>|
| Active Comparator: Single needle group<br> | Radiation: Radio-frequency ablation of genicular nerves<br>* Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue score | Pain intensity via the visual analogue score (VAS). | 6 months after the procedure | 
| Oxford knee score | Follow up of pain and function via the Oxford knee score | 6 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rate | Persistence of pain after the procedure | 6 months after the procedure | 
| Incidence of complication | Any infection, heamatoma | 6 months after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genicular nerve radio-frequency ablation