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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980338
• Other study ID #: knee genicular nerve ablation
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2023
• Est. completion date: November 2023

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: Lydia E Zakhary, MD
• Phone: 00201222555128
• Email: lydia_zakhary[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: November 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• genicular nerve ablation by thermal radiofrequency
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.
• genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis
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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Dass RM, Kim E, Kim HK, Lee JY, Lee HJ, Rhee SJ. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain. 2019 Jul 1;32(3):223-227. doi: 10.3344/kjp.2019.32.3.223. — View Citation

Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26. — View Citation

Liu J, Wang T, Zhu ZH. Efficacy and safety of radiofrequency treatment for improving knee pain and function in knee osteoarthritis: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Jan 15;17(1):21. doi: 10.1186/s13018-021-02906-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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