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

Primary Purpose

Chronic Knee Osteoarthritis

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Monopolar radiofrequency ablation

Bipolar radiofrequency ablation

About this trial

This is an interventional treatment trial for Chronic Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monopolar radiofrequency ablation

Bipolar radiofrequency ablation

Arm Description

Patients will receive ultrasound-guided monopolar radiofrequency ablation

Patients will receive ultrasound-guided bipolar radiofrequency ablation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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

Changes in doses of rescue analgesics

The incidence of numbness

The incidence of paresthesia

The incidence of motor weakness

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

Full Information

NCT ID

NCT04112264

First Posted

September 25, 2019

Last Updated

October 7, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04112264

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 4, 2020 (Actual)

Primary Completion Date

April 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Monopolar radiofrequency ablation

Arm Type

Experimental

Arm Description

Patients will receive ultrasound-guided monopolar radiofrequency ablation

Arm Title

Bipolar radiofrequency ablation

Arm Type

Active Comparator

Arm Description

Patients will receive ultrasound-guided bipolar radiofrequency ablation

Intervention Type

Procedure

Intervention Name(s)

Monopolar radiofrequency ablation

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Bipolar radiofrequency ablation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Osteoarthritis pain

Description

Time Frame

basal value, at 1, 4, 12, 24 weeks post procedure

Secondary Outcome Measure Information:

Title

Oxford Knee Score

Description

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.

Time Frame

basal value, at 1, 4, 12, 24 weeks post procedure

Title

The procedure time

Description

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.

Time Frame

from the start of advancement of the cannula to end of procedure.

Title

Patient satisfaction score

Description

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

Time Frame

up to 24 weeks post procedure

Title

Changes in doses of rescue analgesics

Time Frame

up to 24 weeks post procedure

Title

The incidence of numbness

Time Frame

up to 24 weeks post procedure

Title

The incidence of paresthesia

Time Frame

up to 24 weeks post procedure

Title

The incidence of motor weakness

Time Frame

up to 24 weeks post procedure

Title

the proportion of successful responders

Description

the proportion of successful responders with a reduction of at least 50% of median VAS score and no increase from baseline OKS

Time Frame

up to 24 weeks post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherif A Mousa, MD

Phone

00201001637298

S_abdomousa@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ola T Abd El-Dayem, MD

Phone

00201202811110

Olataha2007@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sherif A Mousa, MD

Organizational Affiliation

Professor of Anesthesia and Surgical Intensive Care

Official's Role

Study Chair

Facility Information:

Facility Name

Mansoura University

City

Mansourah

State/Province

ZIP/Postal Code

050

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherif A Mousa, MD

Phone

00201001637298

S_abdomousa@yahoo.com

First Name & Middle Initial & Last Name & Degree

Ola T Abd El-Dayem, MD

Phone

00201202811110

Olataha2007@yahoo.com

First Name & Middle Initial & Last Name & Degree

Sayed M Emam, MD

First Name & Middle Initial & Last Name & Degree

Hanaa M Mohamad, MSec

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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