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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Knee Osteoarthritis
• Intervention / Treatment: Procedure: Monopolar radiofrequency ablation; Procedure: Bipolar radiofrequency ablation

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherif A Mousa, MD; Phone Number: 00201001637298; Email: S_abdomousa@yahoo.com
• Study Contact Backup: Name: Ola T Abd El-Dayem, MD; Phone Number: 00201202811110; Email: Olataha2007@yahoo.com

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Recruiting
      • Mansoura University
      • Contact: Sherif A Mousa, MD; Phone Number: 00201001637298; Email: S_abdomousa@yahoo.com
      • Contact: Ola T Abd El-Dayem, MD; Phone Number: 00201202811110; Email: Olataha2007@yahoo.com
      • Principal Investigator: Sayed M Emam, MD
      • Sub-Investigator: Hanaa M Mohamad, MSec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monopolar radiofrequency ablation; Patients will receive ultrasound-guided monopolar radiofrequency ablation	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.
Active Comparator: Bipolar radiofrequency ablation; Patients will receive ultrasound-guided bipolar radiofrequency ablation	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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
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	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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Sherif A Mousa, MD, Professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MD.19.03.152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study protocol Statistical analysis plan Informed consent form
• IPD Sharing Time Frame: data will be available at the end of study
• IPD Sharing Access Criteria: data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement

Drug and device information, study documents

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