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

Condition(s) studied

Investigational drug(s) / intervention(s)

Radiofrequency ablation alone: 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 Block: 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 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. Are baseline brain activation patterns measured using fNIRS associated with clinically meaningful treatment responses to GNRFA?
2. 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

Eligibility

Primary outcome measure(s)

• Cortical Activation Measures — 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.

Trial sites (1)

More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Canada

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