Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis

Study Overview
=================
Brief Summary
-----------------
the aim of our study is to compare effectiveness (satisfaction) and duration of pain relief between patients receiving the conventional thermal radiofrequency on the genicular nerves alone vs patients who will receive the conventional method plus alcohol neurolysis of the targeted nerves.

Official Title
-----------------
Comparative Study Between Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis for Treatment of Symptomatic Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: genicular nerve ablation by thermal radiofrequency
* Procedure: genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders. Age between 60-70 years. ASA 1,2 & 3 physical status. x ray imaging confirming the osteoarthritis and unwell or not candidate for knee replacement surgery Exclusion Criteria: Neurological disorders.(previous cerebrovascular stroke , neuropathy , or weakness ) coagulopathy ( plt < 50000, INR > 1.7 ) Infection at or near the injection site. presence of pacemaker or defibrillator 5 - Acute knee injury. 6- age < 60 or >70 years

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>The patients are placed in supine position with knee preparation using an iodine-based product and drape in a sterile manner Then the ground pad of the radio frequency machine will be placed in the other leg (we used the Neurotherm NT1100 re generator) All the patients will be monitored by ECG, noninvasive blood pressure and pulse oximetry The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves ( superior medial genicular, superior lateral genicular and the inferior medial genicular nerves ). this group will receive radio frequency alone . | Procedure: genicular nerve ablation by thermal radiofrequency<br>* radio-frequency will be done using the Neurotherm NT1100 re-generator. The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves ( superior medial genicular, superior lateral genicular and the inferior medial genicular nerves ) . A confirmation of the targeted sites is done under fluoroscopy in both A-P and lateral views then a motor stimulation will be done to ensure no undesirable motor response followed by lidocaine 1 % injection and placing of the radiofrequency cables and ablation was done at 80 degrees for 90 seconds . The procedure will be repeated 3 times at different levels in the lateral view separated by 0,5 cm to ensure successful targeting. Then remove the needles.<br>|
| Experimental: study group<br>this group will pass through the all steps but after the radiofrequency is done at each level a 1 ml of 70% alcohol will be injected making a total of 3 ml injection to each nerve. | Procedure: genicular nerve ablation by thermal radiofrequency<br>* radio-frequency will be done using the Neurotherm NT1100 re-generator. The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves ( superior medial genicular, superior lateral genicular and the inferior medial genicular nerves ) . A confirmation of the targeted sites is done under fluoroscopy in both A-P and lateral views then a motor stimulation will be done to ensure no undesirable motor response followed by lidocaine 1 % injection and placing of the radiofrequency cables and ablation was done at 80 degrees for 90 seconds . The procedure will be repeated 3 times at different levels in the lateral view separated by 0,5 cm to ensure successful targeting. Then remove the needles.<br>Procedure: genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis<br>* radio-frequency will be done using the Neurotherm NT1100 re-generator. The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves of the knee. A confirmation of the targeted sites is done under fluoroscopy in both A-P and lateral views then a motor stimulation will be done to ensure no undesirable motor response followed by lidocaine 1 % injection and placing of the radio-frequency cables and ablation was done at 80 degrees for 90 seconds . The procedure will be repeated 3 times at different levels in the lateral view. After the radiofrequency is done at each level a 1 ml of 70% alcohol will be injected making a total of 3 ml injection to each nerve Then remove the needles.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief after 1 month | evaluating degree of pain relief after knee genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis using numeric pain rating scale ( 11 number score scale where 0 indicates no pain and 10 indicates worst pain imaginable )after 1 month. | 1 month |