Osteoarthritis, KneeNCT07674082
Standard Versus Novel RFA for Chronic Knee Pain in Osteoarthritis
A study testing Radiofrequency ablation - 3-target technique and Radiofrequency ablation - 6-target technique in people with Osteoarthritis, Knee, run by Lawson Research Institute of St. Joseph's.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Radiofrequency ablation - 3-target technique and Radiofrequency ablation - 6-target technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 20 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient with knee osteoarthritis receiving knee RFA.
- Stable pain medications for past 1 month.
- Able to speak English.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Radiofrequency ablation - 3-target technique, Radiofrequency ablation - 6-target technique
- Keywords
- radiofrequency ablation, radiofrequency, needle insertion, knee pain, pain management
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation - 3-target techniqueProcedure or surgery
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.
Radiofrequency ablation - 6-target techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Radiofrequency ablation - 6-target technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature of adverse events
The types of adverse events occurring while participants are in the study will be reviewed.
Measured: up to 12 months
Frequency of adverse events
defined by the number of adverse events a participant experiences while participating in the study
Measured: up to 12 months
Recruitment rate
Average number of participants enrolled per month during the recruitment period.
Measured: During enrolment period
Retention and Attrition Rates
proportion of participants retained and the proportion lost to follow-up at each scheduled follow-up timepoint
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: baseline, 3 months, 6 months, 9 months and 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Aug 2028 (estimated)
- Study completion20 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, St. Joseph's Health Care London
- Responsible party
- Principal investigator, John Tran, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Eldon Loh, MD, Study chair, Lawson Health Research Institute of St. Joseph'sJohn Tran, PhD, Principal investigator, Lawson Health Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674082
- Sponsor's protocol ID
- JTNRFA001
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 41060031
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study Comparing Standard and Novel Radiofrequency Ablation Protocols for Chronic Knee Pain in Osteoarthritis
- ClinicalTrials.gov ID
- NCT07674082
- Acronym / sponsor ID
- JTNRFA001
- Conditions
- Osteoarthritis, Knee
- Keywords
- radiofrequency ablation, radiofrequency, needle insertion, knee pain, pain management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University, St. Joseph's Health Care London
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 20 Aug 2028 (estimated)
- Study completion
- 20 Aug 2029 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional RFA | Active comparator | Procedure: Radiofrequency ablation - 3-target techniqueParticipants randomized to this arm will receive the standard 3-target knee RFA protocol as part of their standard clinical care. |
| Novel RFA | Active comparator | Procedure: Radiofrequency ablation - 6-target techniqueParticipants randomized to this arm will receive the 6-target knee RFA protocol as part of their standard clinical care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient with knee osteoarthritis receiving knee RFA.
- Stable pain medications for past 1 month.
- Able to speak English.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation - 3-target techniqueX-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 or surgery | Traditional RFA |
| Radiofrequency ablation - 6-target techniqueX-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. | Procedure or surgery | Novel RFA |
Primary outcome
Nature of adverse events
Time frame: up to 12 months
The types of adverse events occurring while participants are in the study will be reviewed.
Frequency of adverse events
Time frame: up to 12 months
defined by the number of adverse events a participant experiences while participating in the study
Recruitment rate
Time frame: During enrolment period
Average number of participants enrolled per month during the recruitment period.
Retention and Attrition Rates
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- BackgroundJulious, 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: PubMed 41060031Tran 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eldon Loh, MD study chair
Lawson Health Research Institute of St. Joseph's
John Tran, PhD principal investigator
Lawson Health Research Institute of St. Joseph's
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation - 3-target technique and Radiofrequency ablation - 6-target technique in people with Osteoarthritis, Knee, run by Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Calleja, MSc (519-646-6100 ext. 42208, melissa.calleja@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature of adverse events (time frame: up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07674082, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.