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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05980338
Enrollment
52
Registered
2023-08-08
Start date
2023-06-17
Completion date
2023-11-30
Last updated
2023-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

PROCEDUREgenicular 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.

PROCEDUREgenicular 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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain relief after 1 month1 monthevaluating 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.

Countries

Egypt

Contacts

Primary ContactLydia E Zakhary, MD
lydia_zakhary@med.asu.edu.eg00201222555128
Backup Contactsamuel H Daniel, MD
00201224394897

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026