The Effect of Radiofrequency Ablation on the Results of the Genicular Nerve Number in the Treatment of Knee Osteoarthritis

Knee osteoarthritis is a disease that increases in frequency with age and decreases the quality of life and physical activity by leading to a decrease in pain and joint range of motion. Basically, the articular cartilage is affected and clinically pain, joint stiffness, crepitation and effusion are seen. In imaging techniques applied with weight-bearing, varying degrees of joint narrowing are observed, although it is more common in the medial. Treatment options include conservative approaches such as weight loss, physical therapy, analgesics, or invasive approaches such as intra-articular injections, peripheral nerve blocks, joint-sparing surgery or total knee replacement. Surgical operation should be considered in the treatment when conservative treatments are insufficient. However, the advanced age of this patient group and the large number of comorbidities reduce the possibility of surgical operation. Although treatment cannot be cured in knee osteoarthritis, the aim of the treatment is to decrease the pain, increase the patient's quality of life and physical capacity, and slow down the progression of the disease.

Although the radiofrequency ablation (RFA) technique has been used since the 1970s, the first application area was trigeminal neuralgia. Later, its use in neck and back pain became widespread, but the first randomized controlled study on its use in knee osteoarthritis was Choi et al. Made by in 2011. The purpose of radiofrequency ablation applied to the genicular nerves that receive the sensation of the knee joint capsule is to prevent sensory transmission and reduce the sensation of pain by creating axonal damage to these nerves. Since the use of RFA in knee osteoarthritis is relatively new, studies on the development of the technique continue. Fluoroscopy device or ultrasonography can be used as imaging method to show target nerves or to place the RFA electrode in the correct localization.

The investigators hypothesis; based on the more prominent medial involvement in knee osteoarthritis, the conventional RFA procedure applied to the 3 genicular nerves (SMGN, IMGN, SLGN) is not superior to the RFA procedure applied to the medial SMGN and IMGN branches.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Radiofrequency Ablation; Genicular Nerve
• Intervention / Treatment: Procedure: Radiofrequency ablation of genicular nerves

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34899
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be over 50 years old and under 80 years old
• Symptom duration is at least 3 months
• Pre-procedure NRS score of more than 6
• Kellgren-Lawrence stage 3-4
• Failure to respond to conservative treatments
• Having given consent to participate in the study
• The patient's ability to speak and read and write Turkish

Exclusion Criteria:

• Body mass index of 41 kg/m2 or more
• Acute knee injury
• Chronic pain syndrome (fibromyalgia syndrome, chronic fatigue syndrome, etc.)
• Lumbar radicular pain
• Uncontrolled diabetes mellitus
• Presence of bleeding diathesis
• Hemodynamic instability
• Pacemaker presence
• History of septic arthritis or active local or systemic infection
• Having a history of surgery on the knee to be treated
• Intra-articular injection of the knee within 3 months
• Cognitive impairment
• Presence of genu valgus deformity
• Presence of secondary knee osteoarthritis (due to trauma, rheumatoid arthritis, systemic inflammatory diseases such as gout, kinetic chain disorder due to congenital hip dislocation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Patients undergoing ablation of two of the genicular nerve branches	Procedure: Radiofrequency ablation of genicular nerves; The RF cannula will be placed near the nerve with an in-plane technique from proximal to distal. Sensory stimulation will be performed at 50 Hz to ensure localization. The sensory threshold should be less than 0.6 V. To prevent ablation of the motor nerves, when the nerve is stimulated with 2.0 V at 2 Hz, it will be seen that there is no fasciculation in the relevant region of the lower extremity. Before starting the ablation procedure, 2 mL of 1% lidocaine solution will be injected around the nerve, after vascularity control, in order to reduce the pain and the risk of neuritis during the procedure. Then the temperature will be adjusted to 80° degrees and applied for 90 seconds and the process will be terminated.
ACTIVE_COMPARATOR: Patients undergoing ablation of three of the genicular nerve branches	Procedure: Radiofrequency ablation of genicular nerves; The RF cannula will be placed near the nerve with an in-plane technique from proximal to distal. Sensory stimulation will be performed at 50 Hz to ensure localization. The sensory threshold should be less than 0.6 V. To prevent ablation of the motor nerves, when the nerve is stimulated with 2.0 V at 2 Hz, it will be seen that there is no fasciculation in the relevant region of the lower extremity. Before starting the ablation procedure, 2 mL of 1% lidocaine solution will be injected around the nerve, after vascularity control, in order to reduce the pain and the risk of neuritis during the procedure. Then the temperature will be adjusted to 80° degrees and applied for 90 seconds and the process will be terminated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	It is a scale on which patients score their pain between 0 and 10, with 0 = "no pain" and 10 = "worst pain imaginable"	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)	WOMAC is a 24-item scale under the headings of pain, stiffness and functional activity. Patients rate the amount of strain, pain felt, and joint stiffness during daily activities between 0 and 4 (0 is the best, 4 is the worst), and the total score is between 0 and 96.	3 months
SF-36 (Short Form-36)	SF-36 is a scale in which 8 sub-parameters such as physical function, body pain, and emotional well-being are evaluated with 36 questions.	3 months
TUG (Timed Up and Go Test)	In the TUG test, the patient gets up from the chair with the command of the person performing the test, and after pressing the line drawn 3 meters on the floor with both feet before, he returns and sits on the chair. The tester measures the time elapsed between the stand up command and the patient's back contacting the chair. The patient can get support from the chair while getting up and sitting, and can rest whenever he wants, provided that he does not sit. During the test, the patient walks in the shoes he always uses and at his daily walking speed.	3 months
use of analgesic drugs	During the follow-up period, the analgesic drugs used by the patients, if any, and the information about the use of these drugs during the follow-up period will be recorded.	3 months

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2022
• Primary Completion (ACTUAL): October 2, 2022
• Study Completion (ACTUAL): October 2, 2022

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (ACTUAL): July 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; Osteoarthritis Knee; Genicular Nerve
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 092021654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No