Clinial Application of Park et al.(The Knee 27 (2020) 1577-1584)'s Study

Pulsed Radiofrequency Ablation to the Modified Ablation Points for Chronic Knee Pain Due to Osteoarthritis: Preliminary Prospective Randomized Controlled Study

The goal of this study was to perform pulsed radiofrequency ablation with a modified target suggested in the cadaver study by Park et al. (The Knee 27 (2020) 1577-1584) on knee osteoarthritis patients, and to evaluate the effect of reducing the frequency of intravascular injection and reducing pain.

Study Overview

• Status: Withdrawn
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: pulsed radiofrequency ablation to modifined points group; Procedure: pulsed radiofrequency ablation to conventional points group

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. chronic knee pain that does not respond to conservative treatment (physiotherapy, oral analgesic, steroid intra-articular injection, Hyruan injection) for more than 6 months
2. A score of 6 or higher (out of 10) on the target knee's numerical rating scale
3. Knee osteoarthritis 1-4 confirmed in knee X ray within 6 months of study enrollment

Exclusion Criteria:

1. Systemic inflammatory diseases such as rheumatic diseases
2. uncontrolled diabetes
3. malignant tumor
4. If the target knee has a previous surgical history (arthroscopy, arthroscopy, autologous or allograft osteochondral transplantation and autologous cartilage cell transplantation, osteotomy, arthritis surgery)
5. Patients with lidocaine and contrast agent allergy
6. history of nerve block in the target knee within 2 weeks
7. Body mass index over 40 kg/m2
8. bleeding disorder
9. Pregnant/lactating women
10. Inability to understand informed consent and respond to research questionnaires due to cognitive impairment
11. Unable to read consent form (e.g. illiterate, foreigner, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pulsed radiofrequency ablation to modified points group; pulsed radiofrequency ablation aimed at the adjusted target point of Park et al. under C-arm guidance	Procedure: pulsed radiofrequency ablation to modifined points group; Point 1 place 10mm higher than the boundary between Femur's medial epicondyle and shaft. The 2nd point is targeted 20mm above the patella. Point 3 is targeted 10mm above the femur lateral epicondyle and shaft boundary. At point 4, find the boundary position between the tibia epicondyle and the shaft in the AP view and move it superolateral by 10 mm to target the central part of the medial shaft of the tibia and perform the main touch. Point 5 targets the center of the fibular head.
Active Comparator: pulsed radiofrequency ablation to conventional points group; pulsed radiofrequency ablation aimed at conventional target point under C-arm guidance	Procedure: pulsed radiofrequency ablation to conventional points group; Under AP view X-ray fluoroscopy, enter the cannula into the tunnel view until reaching the bone, reaching the border of the shaft and epicondyle, then stop the cannula tip at the anterior 2/3 junction in the lateral view. A total of three target points are the boundary position between the femur medial epicondyle and the shaft, the boundary position between the femur lateral epicondyle and the shaft, and the boundary position between the tibia meidal epiconcyle and the shaft. Subsequent procedure will be proceed same as Arm 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate at which vascular uptake is confirmed when the first contrast agent is given after the needle is positioned at the target point	Whether vascular uptake is confirmed on the x-ray image is a binary response.	during the ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric rating score	A score of 0 indicates no pain and a score of 10 indicates maximum pain.	Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
functional status	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints	Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
quality of life	Q-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys.	Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
medication	The Medication Quantification Scale (MQS) is an instrument with potential clinical and research applications for quantifying medication regimen use in chronic pain populations.	Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

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: 3-2021-0432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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