Radiofrequency Ablation of Genicular Nerves for Advanced Osteoarthrosis of the Knee Joint 1 Year Follow-up.

Study Overview
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Brief Summary
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Pharmacological treatment of pain due to osteoarthritis of the knee often proves to be inadequate and/or cause intolerable side effects. Arthroplasty of the knee may offer a solution, but waiting lists may be long or certain patients may not be apt for a surgical intervention. Therefore an alternative pain treatment that is effective and has little side effects allowing to offer pain relief to those difficult to manage patients would be an added value in the therapeutic options. We studies the short and long-term effects of radio frequency treatment of the genicular nerves in patients with severe pain due to osteoarthritis of the knee.

Detailed Description
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Radio frequency treatment (RF) of the genicular nerves was found to be effective in a randomized controlled trial. Because of the blinding patients were allowed to continue pre-intervention pharmacological treatment, which may have interfered with the outcome. The short follow-up (12 weeks) does not allow drawing conclusion on the duration of the effect. We aimed at assessing the pain reducing effect of RF of the genicular nerves and the duration of the effect.

Official Title
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Analgesic Effect and Functional Improvement Caused by Radiofrequency Ablation of Genicular Nerves in Patients With Advanced Osteoarthrosis of the Knee Joint Until 1 Year Following Treatment

Conditions
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Painful Osteoarthritis of the Knee

Intervention / Treatment
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* Procedure: RF treatment
* Radiation: radiofrequency ablation
* Device: ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients suffering from pain caused by osteoarthrosis of the knee joint osteoarthrosis of the knee joint (grade 3-4 according to the Kellgren Lawrence classification) pain of moderate to severe intensity (VAS≥5, on a 10-point scale) during >3 months pain resistant to conservative treatments Exclusion Criteria: acute knee pain associated with radicular neuropathy or intermittent claudication, connective tissue diseases affecting the knee, serious neurologic or psychiatric disorders, mental deterioration impeding adequate communication or collaboration, injection with steroids or hyaluronic acids during the previous 3 months, anticoagulant medications, pacemakers, and prior electro-acupuncture treatment

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RF treatment<br>Patients treated with radio frequency of the genicular nerves | Procedure: RF treatment<br>* the genicular nerves are identified with the help of landmarks, ultrasound and nerve stimulation. Once the needle is correctly placed high frequency current is passed through the probe during 90 seconds at 20 V with tip temperature put to 80°C.<br>Radiation: radiofrequency ablation<br> <br> Device: ultrasound<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Pain intensity is measured using a 10-point VAS score | 1, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global patient satisfaction | Satisfaction is scored on a 4-point Likert scale: 1 (poor), 2 (average), 3 (good) and 4 (very good) | 1,6 and 12 months | 
| Improvement of quality of life | evaluated using the Western Ontario and MacMaster Universities Index of Osteoarthrosis (WOMAC) | 1,6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radio frequency treatment, genicular nerves, osteoarthritis of the knee