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

Not Applicable

• Conditions: Chronic Knee Osteoarthritis
• Interventions: Procedure: Monopolar radiofrequency ablation; Procedure: Bipolar radiofrequency ablation

• Registration Number: NCT04112264
• Lead Sponsor: Mansoura University

Brief 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.

Detailed 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Status Verified: 2020-10
• Study Start: 2020-10-04
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-04-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monopolar radiofrequency ablation	Monopolar radiofrequency ablation	Patients will receive ultrasound-guided monopolar radiofrequency ablation
Bipolar radiofrequency ablation	Bipolar radiofrequency ablation	Patients will receive ultrasound-guided bipolar radiofrequency ablation

Primary Outcome Measures

Name	Time	Method
Osteoarthritis pain	basal value, at 1, 4, 12, 24 weeks post procedure	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

Secondary Outcome Measures

Name	Time	Method
Oxford Knee Score	basal value, at 1, 4, 12, 24 weeks post procedure	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.
The procedure time	from the start of advancement of the cannula to end of procedure.	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.
Patient satisfaction score	up to 24 weeks post procedure	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
Changes in doses of rescue analgesics	up to 24 weeks post procedure
The incidence of numbness	up to 24 weeks post procedure
The incidence of paresthesia	up to 24 weeks post procedure
The incidence of motor weakness	up to 24 weeks post procedure
the proportion of successful responders	up to 24 weeks post procedure	the proportion of successful responders with a reduction of at least 50% of median VAS score and no increase from baseline OKS

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansourah, DK, Egypt