Efficacy of Ultrasound-Guided Genicular Nerve Radiofrequency Ablation Therapy

NCT06914960 | Recruiting

• 1 other identifier: Genicular nerve RF
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gonarthrosis; genicular nerve; radiofrequency; ablation; proprioception; balance; risk of falling; chronic pain

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline, 1st month and 3rd month

• 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.

  baseline, 1st month and 3rd month

• 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.

  baseline, 1st month and 3rd month

Secondary Outcomes (8)

• Romberg Test

  baseline, 1st month and 3rd month

• Single Leg Test

  baseline, 1st month and 3rd month

• Walking

  baseline, 1st month and 3rd month

• Coordination

  baseline, 1st month and 3rd month

• Berg-Balance Test

  baseline, 1st month and 3rd month

Study Arms (3)

Radiofrequency Ablation Targeting Two Genicular Nerves

ACTIVE COMPARATOR

2 nerve radiofrequency ablation: Superior Medial (SM) and Inferior Medial (IM) branches. A group of patients will receive a single treatment session using the Radiofrequency Ablation method for 2 nerves, Superior Medial (SM) and Inferior Medial (IM).

Procedure: 2-point Radiofrequency Ablation

Radiofrequency Ablation Targeting Three Genicular Nerves

ACTIVE COMPARATOR

3 nerve radiofrequency ablation: Superior Medial (SM), Superıor Lateral (SL) and Inferior Medial (IM) branches. A group of patients will receive a single treatment session using the Radiofrequency Ablation method for 3 nerves, Superior Medial (SM), Superior Lateral (SL) and Inferior Medial (IM).

Procedure: 3-point Radiofrequency Ablation

Radiofrequency Ablation Targeting Five Genicular Nerves

ACTIVE COMPARATOR

5 nerve radiofrequency ablation: Superior Medial (SM), Superıor Lateral (SL), Inferior Medial(IM), Rekurren Fibular Nerve (RFN) and İnfrapatellar Branch of Saphenous Nerve (IPBSN). Another group of patients will receive a single treatment session with Radiofrequency Ablation for 5 nerves: Superior Medial (SM), Superior Lateral (SL), Inferior Medial (IM), Recurrent Fibular Nerve (RFN) and Infrapatellar Branch of Saphenous Nerve (IPBSN).

Procedure: 5-point Radiofrequency Ablation

Interventions

2-point Radiofrequency Ablation PROCEDURE

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.

Radiofrequency Ablation Targeting Two Genicular Nerves

3-point Radiofrequency Ablation PROCEDURE

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.

Radiofrequency Ablation Targeting Three Genicular Nerves

5-point Radiofrequency Ablation PROCEDURE

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.

Radiofrequency Ablation Targeting Five Genicular Nerves

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % reduction in VAS with diagnostic genicular nerve block

You may not qualify if:

• 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
• Having undergone physical therapy to the knee in the last 6 months or a history of knee trauma
• Application of other pain treatments
• Body-Mass İndex \<18 and \>40 kg/m2
• Pregnancy
• Presence of uncontrolled serious illness (cancer, diabetes, etc.), infection, psychiatric disorder, coagulation disorder

Sponsors & Collaborators

• Bengu Turemenogullari: lead

Study Sites (1)

Ankara Etlik City Hospital, Physical Medicine and Rehabilitation

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (18)

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• Crawford DC, Miller LE, Block JE. Conservative management of symptomatic knee osteoarthritis: a flawed strategy? Orthop Rev (Pavia). 2013 Feb 22;5(1):e2. doi: 10.4081/or.2013.e2. Print 2013 Feb 22.

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• Williams SB, Brand CA, Hill KD, Hunt SB, Moran H. Feasibility and outcomes of a home-based exercise program on improving balance and gait stability in women with lower-limb osteoarthritis or rheumatoid arthritis: a pilot study. Arch Phys Med Rehabil. 2010 Jan;91(1):106-14. doi: 10.1016/j.apmr.2009.08.150.

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• Chang AH, Lee SJ, Zhao H, Ren Y, Zhang LQ. Impaired varus-valgus proprioception and neuromuscular stabilization in medial knee osteoarthritis. J Biomech. 2014 Jan 22;47(2):360-6. doi: 10.1016/j.jbiomech.2013.11.024. Epub 2013 Nov 25.

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• Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.

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• Ajrawat P, Radomski L, Bhatia A, Peng P, Nath N, Gandhi R. Radiofrequency Procedures for the Treatment of Symptomatic Knee Osteoarthritis: A Systematic Review. Pain Med. 2020 Feb 1;21(2):333-348. doi: 10.1093/pm/pnz241.

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• Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.

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• Guven Kose S, Kirac Unal Z, Kose HC, Celikel F, Akkaya OT. Ultrasound-guided genicular nerve radiofrequency treatment: prospective randomized comparative trial of a 3-nerve protocol versus a 5-nerve protocol. Pain Med. 2023 Jul 5;24(7):758-767. doi: 10.1093/pm/pnad025.

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• Chang YW, Tzeng IS, Lee KC, Kao MC. Functional Outcomes and Physical Performance of Knee Osteoarthritis Patients After Ultrasound-Guided Genicular Nerve Radiofrequency Ablation. Pain Med. 2022 Feb 1;23(2):352-361. doi: 10.1093/pm/pnab280.

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• Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006.

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• Ulus Y, Durmus D, Akyol Y, Terzi Y, Bilgici A, Kuru O. Reliability and validity of the Turkish version of the Falls Efficacy Scale International (FES-I) in community-dwelling older persons. Arch Gerontol Geriatr. 2012 May-Jun;54(3):429-33. doi: 10.1016/j.archger.2011.06.010. Epub 2011 Aug 9.

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• Thomsen MG, Latifi R, Kallemose T, Husted H, Troelsen A. Does knee awareness differ between different knee arthroplasty prostheses? A matched, case-control, cross-sectional study. BMC Musculoskelet Disord. 2016 Apr 1;17:141. doi: 10.1186/s12891-016-1001-3.

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• Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.

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• Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.

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• Cankurtaran D, Karaahmet OZ, Yildiz SY, Eksioglu E, Dulgeroglu D, Unlu E. Comparing the effectiveness of ultrasound guided versus blind genicular nerve block on pain, muscle strength with isokinetic device, physical function and quality of life in chronic knee osteoarthritis: a prospective randomized controlled study. Korean J Pain. 2020 Jul 1;33(3):258-266. doi: 10.3344/kjp.2020.33.3.258.

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MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bengu Turemenogullari

CONTACT

+905072848966; drbenguturemen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients and care provider, the physician performing the assessment and the physiotherapist treating the patient will be blind to what procedure is being performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: April 7, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

TU (1)