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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447624
• Other study ID #: 092021654
• Status: Completed
• Phase: N/A
• Start date: January 2, 2022
• Est. completion date: October 2, 2022

Study information

• Verified date: October 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2, 2022
• Est. primary completion date: October 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Radiofrequency Ablation

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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