Efficacy of Ultrasound-Guided Genicular Nerve Radiofrequency Ablation Therapy

Official title

Ultrasound-Guided Genicular Nerve Radiofrequency Ablation Therapy: Effectiveness of 5 Nerve Protocols Versus 3 Nerve and 2 Nerve Protocols - A Prospective Randomized Controlled Study

Overview

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.

Detailed description

Our aim in this study is; to investigate the superiority and long-term effectiveness of radiofrequency ablation therapy applied with 5 nerves, 3 nerves and 2 nerves on fall risk, balance, proprioception, chronic pain and symptoms in knee osteoarthritis.

Radiofrequency ablation therapy; it is effective in chronic pain by causing nerve damage. Application of radiofrequency ablation therapy on chronic knee pain with different protocols has been reported in the literature with different results.

In the literature, it has been shown that the 5-nerve protocol versus the 3-nerve protocol with the radiofrequency ablation method reduces pain and provides functional improvement in patients with chronic knee osteoarthritis. In another study in the literature, functional and physical performance was examined with a 3-nerve protocol in the same patient group without a control group and was found effective.

To our knowledge, there is no study in the literature evaluating the effectiveness of radiofrequency ablation therapy on fall risk, balance and proprioception after applying different protocols in knee osteoarthritis.

There are few studies in the literature regarding radiofrequency ablation treatment procedures for knee osteoarthritis. In line with this information, it is obvious that more studies are needed on the radiofrequency ablation method. Although this method has been shown to be effective and popular in recent years, since it is an invasive procedure, another aim of ours is to reveal what is the least intervention that will give the most effective results for patients.

Diagnostic genicular nerve block: It will be performed by injecting lidocaine (%2, 2 cc) into the superıor lateral (SL), superıor medial (SM) and inferior medial (IM) branches of the genicular nerve passing through the periosteal areas connecting the femoral shaft to the bilateral epicondyles and the tibia shaft to the medial epicondyle.

All patients who meet the study eligibility criteria will undergo a diagnostic genicular nerve block before the procedure, and patients with a decrease in VAS (visual analog scale) of more than 50 percent for more than 24 hours will be considered for the RFA procedure. Injection will be performed under ultrasound guidance using a 12 Mhz linear array transducer probe (GE Logiq P9, GE Healthcare, Boston, MA).

The patients are randomly divided into 3 groups with the help of a computer-based randomization program. One group will be treated with the RFA method for 2 nerves (SM, IM), the other group will be treated with 3 nerves (SM, SL, IM), and the other group will be treated with a single treatment session for 5 nerves (SM, SL, IM, Rekurrent fibular nerve-RFN, Infrapatellar branch of saphenous nerve-IPBSN).

Before the RFA procedure, all participants will be anesthetized with 1 cc %1 lidocaine under sterile conditions, in a supine position, with a pillow placed under the popliteal fossa, and the skin and subcutaneous tissues on the surface of the targeted nerves.

RFA application sites will be determined by finding the arteries between the shaft and epicondyles of the femur and tibia with the help of Color Doppler Ultrasound. The infrapatellar branch of the saphenous nerve (IPBSN) will be confirmed by Doppler Ultrasound of the artery of the nerve 4 cm medial to the apex of the patella and tibial tubercle. Recurrent fibular nerve (RFN) will be confirmed by Doppler Ultrasound of the nerve artery along the caudate line of Gerdy's tubercle, 1 cm below the tuberosity tibia. For the 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. The RFA process will be applied to the existing nerves via a generator (TOP Lesion Generator TLG-20, MPS Medical Product Service GmbH, Germany) at 42 C, as pulse RFA for 120 seconds.

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.

For participants who will not be injected at more than 2 points, the same procedure will be applied without activating the generator in order to ensure that the participants remain blind to group allocation and only 2 cc % 0,9 NaCl will be injected into the treatment points. After the procedure, patients will be advised to continue their current medication and exercise therapy. Patients will not receive other pain treatments such as physical therapy, knee re-RFA treatment, intra-articular hyaluronic acid, steroid or similar injection treatments for 3 months.

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 rele
• 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
• 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

Primary outcome measures

• Cybex 770, Humac Norm Dynamometer (CSMI, Stoughton, MA, USA): Isokinetic muscle strength of the quadriceps and hamstring muscles [Time frame: baseline, 1st month and 3rd month]
• HUBER 360 Evolution Device (LPG, Valence, France) [Time frame: baseline, 1st month and 3rd month]
• Cybex 770, Humac Norm dynamometer (CSMI, Stoughton, MA, USA): Proprioception of the knee joint [Time frame: baseline, 1st month and 3rd month]

Secondary outcome measures (8)

• Romberg Test [Time frame: baseline, 1st month and 3rd month]
• Single Leg Test [Time frame: baseline, 1st month and 3rd month]
• Walking [Time frame: baseline, 1st month and 3rd month]
• Coordination [Time frame: baseline, 1st month and 3rd month]
• Berg-Balance Test [Time frame: baseline, 1st month and 3rd month]
• International Falls Efficacy Scale (FES-1) [Time frame: baseline, 1st month and 3rd month]
• WOMAC Osteoarthritis Index [Time frame: baseline, 1st month and 3rd month]
• SF-12 (Short Form-12) [Time frame: baseline, 1st month and 3rd month]

Eligibility criteria

Inclusion criteria

• 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

• 50% reduction in VAS with diagnostic genicular nerve block

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara Etlik City Hospital, Physical Medicine and Rehabilitation — Ankara

Publications

• Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5. PMID 20305774
• 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. PMID 23705060
• 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. PMID 20103404
• 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. PMID 24321442
• 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. PMID 21055873
• 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. PMID 31578561
• 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. PMID 34308957
• 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. PMID 36869680

Identifiers

NCT: NCT06914960 · Genicular nerve RF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗