Standard Versus Novel RFA for Chronic Knee Pain in Osteoarthritis

A Prospective Pilot Study Comparing Standard and Novel Radiofrequency Ablation Protocols for Chronic Knee Pain in Osteoarthritis

Brief Summary

The goal of this pilot study is to evaluate the feasibility and safety of conducting a randomized comparison of two standard-of-care knee radiofrequency ablation (RFA) techniques in adults with chronic knee pain related to knee osteoarthritis.

Participants who are already scheduled to receive knee RFA as part of their standard clinical care will be randomized to receive either a standard 3-target (standard) RFA protocol or a 6-target (novel) RFA protocol. The main purpose of this pilot study is to determine whether a future larger randomized trial comparing these two RFA approaches is feasible and safe to conduct.

Participants will complete questionnaires about pain, knee function, and stiffness at baseline and at follow-up timepoints for up to 12 months after the RFA procedure. Preliminary pain relief outcomes will also be explored to help inform the design of a future definitive trial.

Participants already scheduled for a knee RFA procedure as part of their standard of care for pain related to knee osteoarthritis will answer online survey questions about their pain for up to 12 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Radiofrequency ablation - 3-target technique; Procedure: Radiofrequency ablation - 6-target technique

Detailed Description

This is a prospective, longitudinal, single-centre randomized pilot study with follow-up to 12 months. Participants scheduled to receive standard-of-care knee RFA for chronic knee pain related to osteoarthritis will be randomized through REDCap in a 1:1 manner to receive either the standard 3-target RFA protocol or the novel 6-target RFA protocol.

In usual clinical care, the RFA technique would typically be selected by the treating physician and both techniques are being done as standard of care. In this study, assignment to one of the two RFA techniques will be randomized. The RFA procedure itself will be completed as part of standard clinical care.

Study-related activities include randomization, collection of limited demographic and clinical information from the medical record, collection of procedural information, adverse event monitoring, and participant-reported outcome assessments. Outcomes will be collected at baseline before the procedure and at 3, 6, 9, and 12 months post-procedure. Follow-up may be discontinued at or after 6 months if the participant's pain returns to baseline levels or if the participant undergoes a repeat procedure.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Calleja, MSc; Phone Number: 42208 519-646-6100; Email: melissa.calleja@sjhc.london.on.ca
• Study Contact Backup: Name: Arden Lawson, MSc; Phone Number: 42570 519-646-6100; Email: arden.lawson@sjhc.london.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Any patient with knee osteoarthritis receiving knee RFA.
2. Stable pain medications for past 1 month.
3. Able to speak English.

Exclusion Criteria:

1. Scheduled for knee surgery within 6 months following RFA procedure.
2. Participating in another study that the Principal Investigator or Co-Investigators deem will interfere with the interpretation of the results.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional RFA; Participants randomized to this arm will receive the standard 3-target knee RFA protocol as part of their standard clinical care.	Procedure: Radiofrequency ablation - 3-target technique; X-ray imaging is used to guide needles that target the superior lateral, superior medial, and inferior medial genicular nerves surrounding the knee, heat is used to ablate the nerves.
Active Comparator: Novel RFA; Participants randomized to this arm will receive the 6-target knee RFA protocol as part of their standard clinical care.	Procedure: Radiofrequency ablation - 6-target technique; X-ray imaging is used to guide needle placement for radiofrequency ablation targeting the superior lateral, superior medial, and inferior medial genicular nerve regions around the knee. The 6-target protocol also includes supplementary ablation lesions at three additional target sites around the knee. These additional targets are treated by adjusting the needle angle once inserted, without requiring additional needle insertions beyond the standard approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nature of adverse events	The types of adverse events occurring while participants are in the study will be reviewed.	up to 12 months
Frequency of adverse events	defined by the number of adverse events a participant experiences while participating in the study	up to 12 months
Recruitment rate	Average number of participants enrolled per month during the recruitment period.	During enrolment period
Retention and Attrition Rates	proportion of participants retained and the proportion lost to follow-up at each scheduled follow-up timepoint	3, 6, 9, and 12 months post-procedure
Questionnaire Completion Rate	completion rates for the Patient Numeric Rating Scale (PNRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires at each scheduled study timepoint.	Baseline, 3, 6, 9, and 12 months post-procedure
Procedural efficiency	total procedure duration, measured from needle placement to final lesion completion. The 6-target protocol will be compared with the 3-target protocol to determine whether it adds no more than 20 minutes on average and remains within the 60-minute operating room threshold.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional outcomes	measured by The Western Ontario and McMaster Universities Osteoarthritis Index	Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure on the following questionnaires.
Average time to return to <50% pain relief	Measured by the pain numeric rating scale, where zero is equivalent to no pain and 10 indicates the worst possible pain	Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure
Average time to return to baseline pain level	Measured by the pain numeric rating scale (PNRS), where 0 indicates no pain, and 10 indicates worst imaginable pain.	baseline, 3 months, 6 months, 9 months and 12 months post procedure

Collaborators and Investigators

• Sponsor: Lawson Research Institute of St. Joseph's
• Collaborators: St. Joseph's Health Care London; Western University
• Investigators: Study Chair: Eldon Loh, MD, Lawson Health Research Institute of St. Joseph's; Principal Investigator: John Tran, PhD, Lawson Health Research Institute of St. Joseph's

Publications and helpful links

General Publications

• Julious, S.A. (2005), Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut. Statist., 4: 287-291. https://doi.org/10.1002/pst.185
• Tran J, McCormick ZL, Lanting BA, Lisk K, Loh E. Patient-specific knee radiofrequency ablation using contrast spread analysis and 3D anatomy knowledge: teaching Images. Pain Med. 2026 Mar 1;27(3):370-373. doi: 10.1093/pm/pnaf137. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): August 20, 2028
• Study Completion (Estimated): August 20, 2029

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: radiofrequency ablation; knee pain; pain management; radiofrequency; needle insertion
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Neurobehavioral Manifestations; Osteoarthritis; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Osteoarthritis, Knee; Agnosia
• Other Study ID Numbers: JTNRFA001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data for this study includes standard of care procedure administered, date of the procedure, and the location of the procedure can be easily found through public information on the study, increasing the risk for a privacy breach.

Drug and device information, study documents

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