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

NCT ID: NCT05447624

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2022-10-02

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Radiofrequency Ablation; Genicular Nerve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients undergoing ablation of two of the genicular nerve branches

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation of genicular nerves

Intervention Type: PROCEDURE

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.

Patients undergoing ablation of three of the genicular nerve branches

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation of genicular nerves

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Marmara University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

092021654

Identifier Type: -

Identifier Source: org_study_id