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.
Any patient with knee osteoarthritis receiving knee RFA.
Stable pain medications for past 1 month.
Able to speak English.
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.
Parallel
Radiofrequency ablation - 3-target technique
Procedure/SurgeryX-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.
Radiofrequency ablation - 6-target technique
Procedure/SurgeryX-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.
Nature of adverse events
The types of adverse events occurring while participants are in the study will be reviewed.
Frequency of adverse events
defined by the number of adverse events a participant experiences while participating in the study
Recruitment rate
Average number of participants enrolled per month during the recruitment period.
Retention and Attrition Rates
proportion of participants retained and the proportion lost to follow-up at each scheduled follow-up timepoint
Change in functional outcomes
Measured by the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, a patient-reported questionnaire assessing pain, stiffness, and physical function. Total scores range from 0 to 96, with higher scores indicating worse symptoms and greater functional limitation.
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
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.
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Lawson Research Institute of St. Joseph's
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor institution
Western University
Collaborator
St. Joseph's Health Care London
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
