The PERK Study: Predicting and Evaluating Response to Knee RFA Using fNIRS

NCT07835269 | Not Yet Recruiting

• 1 other identifier: PERK01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Conditions

Osteo Arthritis of the Knee; Pain

Keywords

Pain Management; Osteoarthritis; fNIRS; Genicular Nerve Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1-hr post-GNRFA and 3-month post-GNRF

Other Outcomes (2)

• Pain and Pain-related Disability

  Baseline, GNRFA Procedure, 3-month post-GNRFA, 6-month post-GNRFA, 9-month post-GNRFA, and 12-month post-GNRFA

• Psychological

  Baseline, GNRFA procedure, 3-month post-GNRFA, 6-month post-GNRFA, 9-month post-GNRFA, 12-month post-GNRFA

Study Arms (1)

Intervention: Genicular Nerve Radiofrequency Ablation

EXPERIMENTAL

All participants will receive the study interventions and assessments.

Procedure: Radiofrequency ablation alone; Diagnostic Test: Genicular Nerve Block

Interventions

Radiofrequency ablation alone PROCEDURE

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.

Also known as: Genicular Nerve Radiofrequency Ablation

Intervention: Genicular Nerve Radiofrequency Ablation

Genicular Nerve Block DIAGNOSTIC_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.

Intervention: Genicular Nerve Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Have osteoarthritis in either knee

You may not qualify if:

• Limited English proficiency or lack of capacity to consent (per clinical judgement)
• Scheduled for knee arthroplasty within next 6 months

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Hospital London

London, Ontario, Canada

Location

MeSH Terms

Conditions

Pain; Agnosia; Osteoarthritis

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Eldon Loh, MD

  Lawson Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eldon Loh, MD

CONTACT

519-685-4080; Eldon.Loh@sjhc.london.on.ca

Melissa Calleja, MSc

CONTACT

519-646-6100; Melissa.Calleja@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 22, 2026

Record last verified: 2026-08

Locations

CA (1)