Efficacy of Ultrasound-Guided Genicular Nerve Radiofrequency Ablation Therapy

Summary

The main symptom of knee osteoarthritis, which occurs after damage to the joint cartilage with age, is pain, but this symptom often becomes chronic. Current conservative treatments have moderate effects on chronic knee pain and their use is limited due to the risk of side effects. In addition to pain, patients also experience other symptoms.

As a result of the osteoarthritis process, prorioception in the knee is impaired with a decrease in mechanoreceptors, resulting in loss of balance and an increase in the risk of falling.

Conditions

• Gonarthrosis

Interventions

PROCEDURE

2-point Radiofrequency Ablation

For the radiofrequency ablation (RFA) procedure, a 10 cm long, 22 gauge RF cannula with a 10 mm active tip (Model SC-K, Top Neuropole, MPS Medical Product Service GmbH, Germany) will be used. In order to increase the accuracy of the location determined by ultrasound, sensory stimulation will be applied at a frequency of 50 Hz and with a threshold value lower than 0.6 volts. In order to prevent the motor nerves from being affected, the absence of lower extremity muscle fasciculations in the relevant area will be confirmed with 2 volt stimulation at 2 Hz frequency. Patients in 2 nerve groups (SM and IM) will undergo 2-point RFA at 42°C using a 120-second pulse RFA generator (TOP Lesion Generator TLG-20, MPS Medical Product Service GmbH, Germany). To address any discomfort that may occur after the procedure, a total of 2 cc of betamethasone (5 mg+2 mg/1 cc) and %2 lidocaine (1 cc) will be injected into the points where RFA is applied, after aspiration.

PROCEDURE

3-point Radiofrequency Ablation

Description: For the radiofrequency ablation (RFA) procedure, a 10 cm long, 22 gauge RF cannula with a 10 mm active tip (Model SC-K, Top Neuropole, MPS Medical Product Service GmbH, Germany) will be used. In order to increase the accuracy of the location determined by ultrasound, sensory stimulation will be applied at a frequency of 50 Hz and with a threshold value lower than 0.6 volts. In order to prevent the motor nerves from being affected, the absence of lower extremity muscle fasciculations in the relevant area will be confirmed with 2 volt stimulation at 2 Hz frequency. 3-point RFA will be applied to patients in 3 nerve groups (SM, SL and IM) using a generator (TOP Lesion Generator TLG-20, MPS Medical Product Service GmbH, Germany) in the form of 120-second pulse RFA at 42°C. To address any discomfort that may occur after the procedure, a total of 2 cc of betamethasone (5 mg+2 mg/1 cc) and %2 lidocaine (1cc) will be injected into the points where RFA is applied, after aspiration.

PROCEDURE

5-point Radiofrequency Ablation

Description: For the radiofrequency ablation (RFA) procedure, a 10 cm long, 22 gauge RF cannula with a 10 mm active tip (Model SC-K, Top Neuropole, MPS Medical Product Service GmbH, Germany) will be used. In order to increase the accuracy of the location determined by ultrasound, sensory stimulation will be applied at a frequency of 50 Hz and with a threshold value lower than 0.6 volts. In order to prevent the motor nerves from being affected, the absence of lower extremity muscle fasciculations in the relevant area will be confirmed with 2 volt stimulation at 2 Hz frequency. 5-point RFA will be applied to patients in 5 nerve groups (SM, SL and IM, recurrent fibular nerve-RFN, infrapatellar branch of saphenous nerve-IPBSN) via same generator in the form of 120-second pulse RFA at 42°C. To address any discomfort that may occur after the procedure, a total of 2cc of betamethasone (5mg+2mg/1cc) and %2 lidocaine (1cc) will be injected into the points where RFA is applied, after aspiration.

Sponsors & Collaborators

• Bengu Turemenogullari

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-15

Primary Completion

2026-08-31

Completion

2026-12-31

Countries

• Turkey (Türkiye)

Study Locations