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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: genicular nerve ablation by thermal radiofrequency; Procedure: genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis

• Registration Number: NCT05980338
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-17
• Status Verified: 2023-07
• Study First Submitted: 2023-07-08
• Study First Submitted QC: 2023-07-29
• Last Update Submitted: 2023-07-29
• Study First Posted: 2023-08-08
• Last Update Posted: 2023-08-08
• Primary Completion: 2023-09
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Both genders.
2. Age between 60-70 years.
3. ASA 1,2 & 3 physical status.
4. x ray imaging confirming the osteoarthritis and unwell or not candidate for knee replacement surgery

Exclusion Criteria

1. Neurological disorders.(previous cerebrovascular stroke , neuropathy , or weakness )
2. coagulopathy ( plt < 50000, INR > 1.7 )
3. Infection at or near the injection site.
4. presence of pacemaker or defibrillator 5 - Acute knee injury.

6- age < 60 or >70 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	genicular nerve ablation by thermal radiofrequency	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 .
study group	genicular nerve ablation by thermal radiofrequency	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.
study group	genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis	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.

Primary Outcome Measures

Name	Time	Method
pain relief after 1 month	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.

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt