Ultrasound-guided Monopolar Versus Bipolar Radiofrequency Ablation for Genicular Nerves in Chronic Knee Osteoarthritis

Chronic Knee Osteoarthritis Clinical Trial

Official title:

Effect of Monopolar Radiofrequency Ablation for Genicular Nerves Compared to Bipolar Radiofrequency Ablation Using Ultrasound in Treating Chronic Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04112264
• Other study ID #: MD.19.03.152
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2020
• Source: Mansoura University
• Contact: Sherif A Mousa, MD
• Phone: 00201001637298
• Email: S_abdomousa[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation.

This technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. Ultrasound-guided RF genicular ablation yielded both significant reductions in knee pain and improvements in functional capacity.

Description:

The aim of this study is to compare between ultrasound guided monopolar and bipolar radiofrequency ablation in chronic knee osteoarthritis.

Osteoarthritis of knee joint is one of the most common disease conditions with advanced age and leads to considerable morbidity in terms of pain, stiffness, limitation in functions, disturbance in sleep and psychological disturbance

A diagnostic genicular nerve block (GNB) with local anesthetic is performed before RF genicular ablation, and a successful response to GNB is considered to indicate the need for RF genicular ablation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Radiologic tibiofemoral Osteoarthritis (Kellgren-Lawrence grade 2-4).

• Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.

• Patients refused surgery.

Exclusion Criteria:

• Patient refusal.

• Prior knee surgery.

• Acute knee pain.

• Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.

• Connective tissue diseases that affected the knee.

• Anticoagulant medication use.

• Local skin infection and sepsis at the site of intervention

Related Conditions & MeSH terms

• Chronic Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Monopolar radiofrequency ablation
a radiofrequency cannula is advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia along the area of knee joint supplied by that respected genicular nerve by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.
• Bipolar radiofrequency ablation
Two radiofrequency cannula are advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteoarthritis pain	The mean changes from baseline levels of osteoarthritis pain using visual analogue scale used to measure pain intensity. It is 10 cm scale where 0 cm represent no pain and 10 cm represent the worst pain ever	basal value, at 1, 4, 12, 24 weeks post procedure
Secondary	Oxford Knee Score	A specific score to assess the functional changes in the knee using Oxford Knee Score (OKS). The scores are 12-item questionnaires ranging from 12-60, with 12 representing the optimal outcome.	basal value, at 1, 4, 12, 24 weeks post procedure
Secondary	The procedure time	The procedure time taken by each mode of radiofrequency from the start of advancement of the cannula under US guidance to the end of the procedure.	from the start of advancement of the cannula to end of procedure.
Secondary	Patient satisfaction score	Patient satisfaction score with treatment which is scored from 1 to 10. A score of 1-4 was considered "dissatisfied," 5-8 was "satisfied," and 9 or 10 was "very satisfied	up to 24 weeks post procedure
Secondary	Changes in doses of rescue analgesics		up to 24 weeks post procedure
Secondary	The incidence of numbness		up to 24 weeks post procedure
Secondary	The incidence of paresthesia		up to 24 weeks post procedure
Secondary	The incidence of motor weakness		up to 24 weeks post procedure
Secondary	the proportion of successful responders	the proportion of successful responders with a reduction of at least 50% of median VAS score and no increase from baseline OKS	up to 24 weeks post procedure