Genicular RFT vs Phenol Management in Patients With Knee Osteoarthritis

Knee Pain Chronic Clinical Trial

Official title:

Comparison of the Efficacy of Genicular Nerve Phenol Ablation and Radiofrequency Ablation for Pain Management in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05908942
• Other study ID #: Genicular
• Status: Active, not recruiting
• Start date: October 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study was to compare the efficacy of phenol and radiofrequency ablation for genicular nerve neurolysis in severe knee pain. The invesigators compare the efficacy of radiofrequency and phenol applications on numerical pain score and Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC) before, 1 and 3 months after the procedure. The procedures will be performed by applying radiofrequency waves and phenol to the genicular nerves under ultrasound guidance.

Description:

Ultrasound-guided genicular nerve ablation is a minimally invasive procedure that reduces or eliminates pain in patients with knee pain by destroying the nerves that transmit pain with heat or chemical drugs such as phenol. Genicular nerve ablation is an effective treatment option for patients with chronic knee pain who cannot undergo prosthesis surgery. In this method, radiofrequency waves or phenol are applied to the nerves going to the knee joint, preventing the transmission of pain signals to the brain.

The procedure is applied as follows:

Haemodynamic monitoring is provided. Superomedial genicular nerve (SMGS), superolateral genicular nerve (SLGS), inferomedial genicular nerve (IMGS) are the nerves to be blocked. The 8-12 Hz linear ultrasound probe is first placed superomedial to the knee and the SMGS and genicular artery are visualised at the junction of the shaft and condyle of the femur. The skin is locally anaesthetised with 2% lidocaine (2 cc) and the needle is inserted in plane with the ultrasound probe. For radiofrequency ablation The cannula placed close to the nerve is connected to the radiofrequency generator with the help of cables. At the tip of the needle, 2% lidocaine (1 cc) is administered and the nerve is heated by applying radiofrequency current. Ablation is performed at 80 °C for 1 minute. This procedure is repeated for other genicular nerves. For phenol ablation, 1 mL of 7% phenol solution is applied to cause neurolysis with the help of a needle placed close to the nerve. Phenol provides ablation by denaturing the proteins in the structure of the nerve.

Patients will be evaluated on NRS and WOMAC scales before, 1 and 3 months after the procedure. The evaluation will be done face to face and by telephone call.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: June 30, 2023
• Est. primary completion date: April 1, 2023
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)

• Permanent pain for more than 6 months

• Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis

• Pain with conservative methods such as analgesics and physiotherapy treatment failure

Exclusion Criteria:

• History of intra-articular knee intervention in the last 6 months

• Cognitive impairment

• Hepatic or renal insufficiency

• Severe psychiatric illness

• Local or systemic infection

• Coagulopathy

Related Conditions & MeSH terms

• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Nerve ablation
radiofrequency and phenol ablation of the genicular nerves will be performed

Locations

Country	Name	City	State
Turkey	Diskapi Training and Research Hospital	Ankara
Turkey	Etlik City Hospital	Ankara	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating scale (NRS)	Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity.	Change from Baseline NRS at 3 months
Primary	Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC)	The WOMAC Pain score ranges from 0 to 20 with higher scores equating to greater pain with activities of daily living. The generic pain scale ranges from 0 to 10 for the OAI and 0 to 100 for MOST, with higher scores equating to greater pain	Change from Baseline WOMAC at 3 months