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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old

Have osteoarthritis in either knee

Disqualifiers

Limited English proficiency or lack of capacity to consent (per clinical judgement)

Scheduled for knee arthroplasty within next 6 months

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiofrequency ablation alone

    Procedure/Surgery

    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

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Intervention: Genicular Nerve Radiofrequency AblationExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

1

Pain and Pain-related Disability

The numeric rating scale (NRS), the Western Ontario McMaster Osteoarthritis Index (WOMAC), a Body Diagram, and the Multidimensional Symptom Index will be used to quantify pain and functional response to GNRFA.

Time frame
Baseline, GNRFA Procedure, 3-month post-GNRFA, 6-month post-GNRFA, 9-month post-GNRFA, and 12-month post-GNRFA
2

Psychological

The Patient Health Questionnaire-9 (PHQ-9) will be used to assess changes in mood over time.

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

Sponsors and contacts

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