Efficacy of Ultrasound-Guided Genicular Nerve Radiofrequency Ablation Therapy

ConditionGonarthrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorBengu Turemenogullari

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 30-75

Chronic knee pain that lasts at least 6 months

Radiographic confirmation of osteoarthritis: Presence of Grade 3 or 4 radiographic changes characterized by significant narrowing in the medial space of the tibiofemoral joint according to the Kellgren-Lawrence classification system

Knee pain >40 mm when performing one of the two movements that cause the most severe pain (sitting to standing or going up and down stairs) according to 100 mm VAS

Disqualifiers

Presence of systemic inflammatory disease such as rheumatoid arthritis

Previous RFA treatment to the knee or hyaluronic acid or steroid injection to the knee within the last 3 months

History of previous knee surgery

Clinically significant structural abnormalities other than osteoarthritis that may lead to chronic knee pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • 2-point Radiofrequency Ablation

    Procedure/Surgery

    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.

  • 3-point Radiofrequency Ablation

    Procedure/Surgery

    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.

  • 5-point Radiofrequency Ablation

    Procedure/Surgery

    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.

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Radiofrequency Ablation Targeting Two Genicular NervesActive comparator 1 intervention
Group B: Radiofrequency Ablation Targeting Three Genicular NervesActive comparator 1 intervention
Group C: Radiofrequency Ablation Targeting Five Genicular NervesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cybex 770, Humac Norm Dynamometer (CSMI, Stoughton, MA, USA): Isokinetic muscle strength of the quadriceps and hamstring muscles

Cybex 770, Humac Norm dynamometer (CSMI, Stoughton, MA, USA) will be used to measure the isokinetic muscle strength of the quadriceps and hamstring muscles. During the test, while the knee joint moves from 90 degrees to 0 degrees, 5 maximum contraction repetitions are provided at an angular speed of 60/sec for muscle strength and 15 maximum repetitions of contraction at an angular speed of 180/sec are provided for muscle endurance.10-second rest period is left between repetitions.The preparation set is applied before the test.Afterwards, there is a 2-minute rest period before starting the test.Isokinetic knee extensor and flexor mean peak torque is determined and It is standardized according to body weight(Peak torque/body weight:Newton-metre/kg).Higher values in peak torque indicate better levels of muscle strength and endurance.

Time frame
baseline, 1st month and 3rd month
2

HUBER 360 Evolution Device (LPG, Valence, France)

HUBER 360 Evolution device will be used in balance-coordination evoluation.The patient will be placed on a multi-axis platform and 4 different tests will be applied.

Time frame
baseline, 1st month and 3rd month
3

Cybex 770, Humac Norm dynamometer (CSMI, Stoughton, MA, USA): Proprioception of the knee joint

A Cybex 770, Humac Norm dynamometer (CSMI, Stoughton, MA, USA) will be used to measure proprioception of the knee joint. During the test, participants will be blindfolded to eliminate visual input. Initially, for the preparation set, the participants' knee joint will be passively flexed from 90 degrees to 45 degrees and they will be provided with an understanding of the test angle. During the test, the device will enter isokinetic con/con mode and the participant will be able to actively move the knee. When the participant moves the knee to the test angle, the value will be recorded and the absolute angular error, i.e. the difference between the recorded angle and the target angle (45 degrees), will be determined. The test will be repeated 3 times and the values will be averaged.The farther the measured value is from the target value, the more impaired proprioception is.

Time frame
baseline, 1st month and 3rd month

Secondary outcomes

1

Romberg Test

Stability: The movement of the patient's center of pressure will be measured with a test inspired by the Romberg test, performed on two feet for 50 seconds with both eyes open and closed.This test evaluates static balance, muscle fatigue, and visual effects. In this test, the normal values of the stability coefficient are between 1.11 and 6.77.Values measured outside this range indicate a deterioration in stability.

Time frame
baseline, 1st month and 3rd month
2

Single Leg Test

Single leg test: The balance test on one leg is applied for a maximum of 30 seconds.The right and left side imbalance, that is, the inequality in laterality that affects static balance, determines the risk of falling.The single leg test will be applied to the healthy and diseased sides, and length and area values will be obtained with the test.High length and area values indicate poor balance.

Time frame
baseline, 1st month and 3rd month
3

Walking

This test, which performs stato-dynamic analysis with a vertical ramp for 50 seconds with the arms extended, is inspired by the Fukuda test.It shows the number of steps and is related to walking speed.A minimum of 80 steps must be taken for the test to be evaluated.A high number of steps taken in a fixed time period indicates that the walking speed is at a good level.

Time frame
baseline, 1st month and 3rd month
4

Coordination

It is a test that evaluates the patient's capacity to coordinate movements.During the test, the patient must maintain a constant force in an unstable environment and as quickly as possible.Thus, the capacity to manage multiple tasks simultaneously is evaluated.There are 30 different levels in the test, and the level the patient reaches is determined by the time spent in this process.The difficulty level increases as the level progresses, thus indicating better coordination.

Time frame
baseline, 1st month and 3rd month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bengu Turemenogullari

Lead sponsor

Ankara Etlik City Hospital

Sponsor institution