Standard Versus Novel RFA for Chronic Knee Pain in Osteoarthritis

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Nature of adverse events [Time frame: up to 12 months]
• Frequency of adverse events [Time frame: up to 12 months]
• Recruitment rate [Time frame: During enrolment period]
• Retention and Attrition Rates [Time frame: 3, 6, 9, and 12 months post-procedure]
• Questionnaire Completion Rate [Time frame: Baseline, 3, 6, 9, and 12 months post-procedure]
• Procedural efficiency [Time frame: Baseline]

Secondary outcome measures (3)

• Change in functional outcomes [Time frame: Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure on the following questionnaires.]
• Average time to return to <50% pain relief [Time frame: Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure]
• Average time to return to baseline pain level [Time frame: baseline, 3 months, 6 months, 9 months and 12 months post procedure]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 41060031

Identifiers

NCT: NCT07674082 · JTNRFA001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗