Ultrasound-guided Radiofrequency Ablation of the Genicular Nerve Versus Physical Therapy for Chronic Knee Osteoarthritis

Study Overview
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Brief Summary
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The aim of this study is to compare the effects of conventional physiotherapy methods with ultrasound-guided radiofrequency ablation of the genicular nerve on pain and functional status in patients with stage 2-3 chronic knee osteoarthritis.

Detailed Description
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Patients diagnosed with Chronic Knee Osteoarthritis according to the American College of Rheumatology criteria, and with radiological osteoarthritis at Kellgren-Lawrence grades 2 and 3, within the age range of 45-70, and meeting the study criteria will be included in the study. After providing information about the procedures to be performed and potential risks to the patients, if they give their written informed consent, treatment methods will be applied to the patients. Eligible patients will be divided into two groups. In one group, Radiofrequency Ablation of the Genicular Nerve under Ultrasound Guidance will be performed, while the other group will receive physical therapy.

Official Title
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Comparison of the Effectiveness of Physical Therapy With Ultrasound-Guided Radiofrequency Ablation of the Genicular Nerve in Patients With Chronic Knee Osteoarthritis

Conditions
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Chronic Knee Osteoarthritis

Intervention / Treatment
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* Other: radiofrequency ablation
* Other: physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: VAS ≥ 5 To be aged between 45 and 70 years old Patients diagnosed with chronic knee osteoarthritis using the American College of Rheumatology criteria and having radiological osteoarthritis of Kellgren-Lawrence grade 2 and 3 Cognitive functions being intact Being willing to participate in the study and signing the consent forms Exclusion Criteria: Having received physical therapy for chronic knee osteoarthritis in the last 6 months Having received glucocorticoid or hyaluronic acid injections in the last 6 months Having taken oral glucosamine Undergoing knee surgery Having current neurological or mental disorders History of pacemaker usage Presence of local infections or sepsis Progressive neurological deficit Presence of oncological diseases Hemorrhagic diathesis or anticoagulation Uncontrolled diabetes or other serious internal comorbidities Allergy to medications or materials used Pregnancy Lack of cooperation Not willing to participate in the study.

Ages Eligible for Study
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Minimum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-guided radiofrequency ablation of the genicular nerve in chronic knee osteoarthritis<br>A total of 34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve. | Other: radiofrequency ablation<br>* 34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve.<br>|
| Active Comparator: physical therapy for chronic knee osteoarthritis<br>Thirty-four patients with chronic knee osteoarthritis meeting the criteria will receive 10 sessions of physical therapy. | Other: physical therapy<br>* 34 patients with chronic knee osteoarthritis meeting the criteria will undergo 10 sessions of physical therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Scale. The Visual Analog Scale (VAS) is evaluated on a scale ranging from no pain to worst possible pain. The value of 0 (zero) indicates no pain, while the value of 10 (ten) indicates the most severe pain imaginable. | Before treatment (initial), after 2 weeks and 12 weeks changes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Questionnaire. The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) test is a disease-specific, valid, and reliable measure for osteoarthritis, comprising 24 questions in three subcategories: pain, stiffness, and physical function. Each question is scored using the Likert scale as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. Scores for each section are calculated independently, and the total score ranges from 0 to 100. Higher scores indicate an increase in pain and stiffness, as well as a deterioration in physical function. | Before treatment (initial), after 2 weeks and 12 weeks changes | 
| The 6-minute walk test (6MWT) | The 6MWT is an assessment to measure the distance a person is capable of walking on a flat, hard surface in 6 minutes. It is a useful test to measure the response of all the bodily systems that a person uses while exercising. | Before treatment (initial), after 2 weeks and 12 weeks changes | 
| EuroQol scale (EQ-5D-3L) | Questionnaire. The EuroQol (EQ) scale, developed by the EuroQol Group, is a general tool for measuring overall quality of life. The EQ-5D-3L (3-level version) is a widely used scale for assessing health status. The EQ-5D-3L consists of two main components: the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). In the first component, the EQ-5D descriptive system, health status is evaluated in five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression. Each dimension has three levels: 1=No problems, 2=Moderate problems, and 3=Severe problems. Combinations derived from these five dimensions create an index score to express individuals' overall health status. The second component is the visual analog scale (EQ VAS), where the patient self-assesses their health on a vertical visual analog scale with endpoints labeled 'Best imaginable health state=100' and 'Worst imaginable health state=0'. | Before treatment (initial), after 2 weeks and 12 weeks changes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, genicular nerve block, Ultrasound, radiofrequency, Chronic pain