Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

Phase 4

Not yet recruiting

• Conditions: Chronic Knee Pain; Osteoarthritis, Knee
• Interventions: Drug: 6% aqueous phenol; Drug: MethylPREDNISolone 40 MG; Drug: Genicular Nerve Placebo; Drug: Intraarticular Knee Placebo

• Registration Number: NCT06000709
• Lead Sponsor: University of Manitoba

Brief Summary

Genicular nerve neurolysis (GN) constitutes a relatively novel technique, whereby different chemical compounds (i.e. alcohol, phenol) are injected in close proximity to the genicular nerves of the knee joint, with the intention to exert a neurolytic effect by denaturing proteins resulting in Wallerian degeneration distal to the lesion. Based on the preliminary evidence and considering the potential benefits of the technique, we hypothesized that ultrasound-guided genicular chemical neurolysis with phenol is superior in terms of pain relief at 3 months, when compared to intra-articular steroid (IAS) injection.

Detailed Description

This study will allow us to determine if ultrasound-guided phenol genicular neurolys is superior to intra-articular steroid injection in terms of analgesia and functional outcomes, providing a more effective and long-lasting alternative for patients with chronic knee pain secondary to osteoarthritis

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-10
• Study Start: 2023-10-20
• Primary Completion: 2024-01-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Severe knee pain for more than 6 months, defined as Numeric rating scale (NRS) score of 6 and greater, unresponsive to conservative medical treatment
• Radiological OA grade 2 to 4 (Kellgren-Lawrence scale)

Exclusion Criteria

• Previous total knee replacement on the index knee
• Prior knee radiofrequency ablation on the index knee
• Connective tissue diseases with knee involvement (e.g. rheumatoid arthritis)
• Body mass index ≥ 40 kg/m2
• Uncontrolled coagulopathy, defined as supratherapeutic dose of anticoagulation medication
• Allergy to local anesthetics
• Unstable opioid consumption, defined as an increase >10% in dosage during the last 3 months prior to recruitment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided Genicular Nerve Phenol Neurolysis	6% aqueous phenol	One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves
Ultrasound-guided Intraarticular Steroid Injection	MethylPREDNISolone 40 MG	Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline
Ultrasound-guided Intraarticular Steroid Injection	Genicular Nerve Placebo	Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline
Ultrasound-guided Genicular Nerve Phenol Neurolysis	Intraarticular Knee Placebo	One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves

Primary Outcome Measures

Name	Time	Method
Pain scores (Numeric Rating Scale) at 3 months	3 months	Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Secondary Outcome Measures

Name	Time	Method
Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months	baseline, 1 month, 6 months	Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)	1 months, 3 months, 6 months	Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
WOMAC index	baseline, 1 month, 3 months, 6 months	The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)
Brief Pain Inventory Score (BPI)	baseline, 1 month, 3 months, 6 months	Functional activity measurement using the Brief Pain Inventory (short form)
Incidence of adverse events	from injection up to 1 month after intervention	Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection