Standard Versus Novel RFA for Chronic Knee Pain in Osteoarthritis

NCT07674082 | Not Yet Recruiting

• 1 other identifier: JTNRFA001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

radiofrequency ablation; radiofrequency; needle insertion; knee pain; pain management

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Change in functional outcomes

  Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure on the following questionnaires.

• Average time to return to <50% pain relief

  Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure

• Average time to return to baseline pain level

  baseline, 3 months, 6 months, 9 months and 12 months post procedure

Study Arms (2)

Traditional RFA

ACTIVE COMPARATOR

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

Novel RFA

ACTIVE COMPARATOR

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

Interventions

Radiofrequency ablation - 3-target technique PROCEDURE

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.

Traditional RFA

Radiofrequency ablation - 6-target technique PROCEDURE

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.

Novel RFA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lawson Research Institute of St. Joseph's: lead
• Western University: collaborator
• St. Joseph's Health Care London: collaborator

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 41060031 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eldon Loh, MD

  Lawson Health Research Institute of St. Joseph's

  STUDY CHAIR

• John Tran, PhD

  Lawson Health Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Calleja, MSc

CONTACT

519-646-6100; melissa.calleja@sjhc.london.on.ca

Arden Lawson, MSc

CONTACT

519-646-6100; arden.lawson@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 29, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): August 20, 2028
• Study Completion (Estimated): August 20, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share