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

NCT05980338 | Unknown

• 1 other identifier: knee genicular nerve ablation
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control group

ACTIVE COMPARATOR

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

study group

EXPERIMENTAL

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; Procedure: genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis

Interventions

genicular nerve ablation by thermal radiofrequency PROCEDURE

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.

control group; study group

genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis PROCEDURE

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.

study group

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• age \< 60 or \>70 years

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 31333900 BACKGROUND

• 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.

  PMID: 35033150 BACKGROUND

• 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.

  PMID: 31257831 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Lydia E Zakhary, MD

CONTACT

00201222555128; lydia_zakhary@med.asu.edu.eg

samuel H Daniel, MD

CONTACT

00201224394897

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: August 8, 2023
• Study Start: June 17, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-07

Locations

EG (1)