Osteoarthritis, Knee
Conditions
Keywords
radiofrequency ablation, radiofrequency, needle insertion, knee pain, pain management
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.
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
PROCEDURERadiofrequency 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.
PROCEDURERadiofrequency 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.
Sponsors
Lawson Research Institute of St. Joseph's
Western University
St. Joseph's Health Care London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nature of adverse events | up to 12 months | The types of adverse events occurring while participants are in the study will be reviewed. |
| Frequency of adverse events | up to 12 months | defined by the number of adverse events a participant experiences while participating in the study |
| Recruitment rate | During enrolment period | Average number of participants enrolled per month during the recruitment period. |
| Retention and Attrition Rates | 3, 6, 9, and 12 months post-procedure | proportion of participants retained and the proportion lost to follow-up at each scheduled follow-up timepoint |
| Questionnaire Completion Rate | Baseline, 3, 6, 9, and 12 months post-procedure | completion rates for the Patient Numeric Rating Scale (PNRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires at each scheduled study timepoint. |
| Procedural efficiency | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional outcomes | Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure on the following questionnaires. | 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 | Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure | 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 | baseline, 3 months, 6 months, 9 months and 12 months post procedure | Measured by the pain numeric rating scale (PNRS), where 0 indicates no pain, and 10 indicates worst imaginable pain. |
Contacts
CONTACTMelissa Calleja, MSc
CONTACTArden Lawson, MSc
STUDY_CHAIREldon Loh, MD
Lawson Health Research Institute of St. Joseph's
PRINCIPAL_INVESTIGATORJohn Tran, PhD
Lawson Health Research Institute of St. Joseph's
Outcome results
None listed