Osteo Arthritis of the KneePERKNCT07835269
The PERK Study: Predicting and Evaluating Response to Knee RFA Using fNIRS
A study testing Radiofrequency ablation alone and Genicular Nerve Block in people with Osteo Arthritis of the Knee and Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The goal of this clinical trial is to understand whether changes in brain activity, measured using functional near-infrared spectroscopy (fNIRS), are related to how well patients with knee osteoarthritis respond to genicular nerve radiofrequency ablation (GNRFA). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis of the Knee, Pain
- What is being tested?
- Radiofrequency ablation alone and Genicular Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Have osteoarthritis in either knee
Who cannot join
- Limited English proficiency or lack of capacity to consent (per clinical judgement)
- Scheduled for knee arthroplasty within next 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Joseph's Hospital London
London, Ontario
Melissa Calleja, MSc, 519-646-6100 ext. 42208, Melissa.Calleja@sjhc.london.on.ca
About this study
The goal of this clinical trial is to understand whether changes in brain activity, measured using functional near-infrared spectroscopy (fNIRS), are related to how well patients with knee osteoarthritis respond to genicular nerve radiofrequency ablation (GNRFA). The main questions it aims to answer are:
- Are baseline brain activation patterns measured using fNIRS associated with clinically meaningful treatment responses to GNRFA?
- What changes in brain activation patterns do we see overtime after GNRFA in those who are responders to treatments, vs. those who are non-responders?
Read more
Participants will:
- Receive a diagnostic genicular nerve (GN) block
- Receive a GNRFA if they experience at least 50% pain relief from the GN block
- Come to the clinic as baseline, approximately one week later, and then 3-months after that for assessment
- Fill out questionnaires once every 3-months for up to 12-months
Read the detailed description
The goal of this study is collect data for a larger study about using fNIRS to evaluate whether baseline and post-GNRFA cortical activation patterns are associated with clinically meaningful pain relief and improvement in pain-related disability following GNRFA in adults with knee osteoarthritis. While GNRFA is a promising treatment, clinical outcomes remain variable, limiting its widespread adoption. Pain relief following GNRFA may depend not only on anatomically optimized placement, but also on inter-individual differences in central pain processing and modulation reflected in cortical activation patterns. Currently, patient selection for GNRFA is based on response to genicular nerve (GN) blocks, which targets the peripheral sensory innervation. The ability to predict the response to GNRFA from the GN block has been inconsistent. In contrast, fNIRS is a novel, non-invasive and scalable method for assessing cortical activity associated with pain processing and movement-related function. fNIRS may therefore allow clinicians to use cortical activation patterns to select patients most likely to respond to GNRFA, and to objectively quantify response to GNRFA.
This study will have participants complete a combination of in-person visits and remote visits. In-person visits will include fNIRS assessments, questionnaires, the GN block procedure, and the GNRFA procedure if they receive at least 50% pain relief on the GN block. Remote visits will include filling out questionnaires. The questionnaires at all visits will measure pain, mood and quality of life. The primary objective is to obtain preliminary data for estimating effect sizes and informing sample size calculations for a larger study. Secondary objectives including determining whether baseline cortical activation patterns measured using fNIRS is associated with a clinically meaningful treatment response following GNRFA, and to characterize changes in fNIRS activation patterns over time post-GNRFA in responders and non-responders. The results will help determine whether fNIRS may be a feasible, non-invasive way to better select patients to receive GNRFA procedures.
- Conditions
- Osteo Arthritis of the Knee, Pain
- Being tested
- Radiofrequency ablation alone, Genicular Nerve Block
- Keywords
- Pain Management, Osteoarthritis, fNIRS, Genicular Nerve Radiofrequency Ablation
- Medical subject headings
- Pain, Agnosia, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneProcedure or surgery
Also called Genicular Nerve Radiofrequency Ablation
At the week 1 visit, under fluoroscopic guidance, electrodes are positioned at established anatomical landmarks around the knee and thermal lesions are created to disrupt the targeted sensory nerve fibres. There will be a total of six landmarks that are reached through the insertion of three needles. These landmarks are 1) superomedial a) posterior to the medial epicondyle and b) on same distal plane but anterior to the medial epicondyle, 2) superolateral c) posterior to the lateral epicondyle and d) on the same distal plane but anterior to the lateral epicondyle, and 3) Inferomedial e) junction between medial tibial condyle and tibial shaft and f) superiorly and anteriorly to this, along the medial tibial condyle.
Genicular Nerve BlockDiagnostic test
GN Blocks will be done to determine which patients will proceed to receive a GNRFA. This procedure involves an injection of local anesthetic around the sensory nerves supplying the knee joint. This serves as a diagnostic procedure to confirm that the patient may benefit from the GNRFA, which is completed as part of routine clinical practice. Participants who achieve at least 50% pain relief from the GN block for at least the duration of the local anesthetic (≥4 hours) will be considered suitable candidates for GNRFA, and will proceed within the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Genicular Nerve Radiofrequency Ablation | Experimental | All participants will receive the study interventions and assessments. Receives: Procedure: Radiofrequency ablation alone; Diagnostic Test: Genicular Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical Activation Measures
Changes from baseline, to 1hr post-GNRFA, and 3-month post-GNRFA in cortical activation measured using fNIRS will be examined as well as differences in activation patterns between responders and non-responders.
Measured: Baseline, 1-hr post-GNRFA and 3-month post-GNRF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will all follow the same procedures. For analysis, participant's will be classified as either 1) Responders or, 2) Non-Responders to the GNRFA procedure, based on the level of pain relief they experience.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eldon Loh, MD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Eldon Loh, MD, Principal investigator, Lawson Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835269
- Sponsor's protocol ID
- PERK01
- Acronym
- PERK
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PERK Study: Predicting and Evaluating Response to Knee RFA Using fNIRS
- ClinicalTrials.gov ID
- NCT07835269
- Acronym / sponsor ID
- PERK / PERK01
- Conditions
- Osteo Arthritis of the Knee, Pain
- Keywords
- Pain Management, Osteoarthritis, fNIRS, Genicular Nerve Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 Sep 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.
The goal of this clinical trial is to understand whether changes in brain activity, measured using functional near-infrared spectroscopy (fNIRS), are related to how well patients with knee osteoarthritis respond to genicular nerve radiofrequency ablation (GNRFA). The main questions it aims to answer are:
- Are baseline brain activation patterns measured using fNIRS associated with clinically meaningful treatment responses to GNRFA?
- What changes in brain activation patterns do we see overtime after GNRFA in those who are responders to treatments, vs. those who are non-responders?
Participants will:
- Receive a diagnostic genicular nerve (GN) block
- Receive a GNRFA if they experience at least 50% pain relief from the GN block
- Come to the clinic as baseline, approximately one week later, and then 3-months after that for assessment
- Fill out questionnaires once every 3-months for up to 12-months
Detailed description
The goal of this study is collect data for a larger study about using fNIRS to evaluate whether baseline and post-GNRFA cortical activation patterns are associated with clinically meaningful pain relief and improvement in pain-related disability following GNRFA in adults with knee osteoarthritis. While GNRFA is a promising treatment, clinical outcomes remain variable, limiting its widespread adoption. Pain relief following GNRFA may depend not only on anatomically optimized placement, but also on inter-individual differences in central pain processing and modulation reflected in cortical activation patterns. Currently, patient selection for GNRFA is based on response to genicular nerve (GN) blocks, which targets the peripheral sensory innervation. The ability to predict the response to GNRFA from the GN block has been inconsistent. In contrast, fNIRS is a novel, non-invasive and scalable method for assessing cortical activity associated with pain processing and movement-related function. fNIRS may therefore allow clinicians to use cortical activation patterns to select patients most likely to respond to GNRFA, and to objectively quantify response to GNRFA.
This study will have participants complete a combination of in-person visits and remote visits. In-person visits will include fNIRS assessments, questionnaires, the GN block procedure, and the GNRFA procedure if they receive at least 50% pain relief on the GN block. Remote visits will include filling out questionnaires. The questionnaires at all visits will measure pain, mood and quality of life. The primary objective is to obtain preliminary data for estimating effect sizes and informing sample size calculations for a larger study. Secondary objectives including determining whether baseline cortical activation patterns measured using fNIRS is associated with a clinically meaningful treatment response following GNRFA, and to characterize changes in fNIRS activation patterns over time post-GNRFA in responders and non-responders. The results will help determine whether fNIRS may be a feasible, non-invasive way to better select patients to receive GNRFA procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will all follow the same procedures. For analysis, participant's will be classified as either 1) Responders or, 2) Non-Responders to the GNRFA procedure, based on the level of pain relief they experience.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Genicular Nerve Radiofrequency Ablation | Experimental | Procedure: Radiofrequency ablation alone, Diagnostic Test: Genicular Nerve BlockAll participants will receive the study interventions and assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years old
- Have osteoarthritis in either knee
Key exclusion criteria (2 listed)
- Limited English proficiency or lack of capacity to consent (per clinical judgement)
- Scheduled for knee arthroplasty within next 6 months
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 aloneAlso: Genicular Nerve Radiofrequency AblationAt the week 1 visit, under fluoroscopic guidance, electrodes are positioned at established anatomical landmarks around the knee and thermal lesions are created to disrupt the targeted sensory nerve fibres. There will be a total of six landmarks that are reached through the insertion of three needles. These landmarks are 1) superomedial a) posterior to the medial epicondyle and b) on same distal plane but anterior to the medial epicondyle, 2) superolateral c) posterior to the lateral epicondyle and d) on the same distal plane but anterior to the lateral epicondyle, and 3) Inferomedial e) junction between medial tibial condyle and tibial shaft and f) superiorly and anteriorly to this, along the medial tibial condyle. | Procedure or surgery | Intervention: Genicular Nerve Radiofrequency Ablation |
| Genicular Nerve BlockGN Blocks will be done to determine which patients will proceed to receive a GNRFA. This procedure involves an injection of local anesthetic around the sensory nerves supplying the knee joint. This serves as a diagnostic procedure to confirm that the patient may benefit from the GNRFA, which is completed as part of routine clinical practice. Participants who achieve at least 50% pain relief from the GN block for at least the duration of the local anesthetic (≥4 hours) will be considered suitable candidates for GNRFA, and will proceed within the study. | Diagnostic test | Intervention: Genicular Nerve Radiofrequency Ablation |
Primary outcome
Cortical Activation Measures
Time frame: Baseline, 1-hr post-GNRFA and 3-month post-GNRF
Changes from baseline, to 1hr post-GNRFA, and 3-month post-GNRFA in cortical activation measured using fNIRS will be examined as well as differences in activation patterns between responders and non-responders.
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 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Lawson Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation alone and Genicular Nerve Block in people with Osteo Arthritis of the Knee and Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 2 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Eldon Loh, MD (519-685-4080, Eldon.Loh@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical Activation Measures (time frame: Baseline, 1-hr post-GNRFA and 3-month post-GNRF). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.