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

University of Manitoba

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Knee Pain; Osteoarthritis, Knee

Treatments: Drug: 6% aqueous phenol; Drug: MethylPREDNISolone 40 MG; Drug: Intraarticular Knee Placebo; Drug: Genicular Nerve Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06000709

HS25899

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

Ultrasound-guided Genicular Nerve Phenol Neurolysis

Experimental group

Description:

One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves

Treatment:

Drug: Intraarticular Knee Placebo

Drug: 6% aqueous phenol

Ultrasound-guided Intraarticular Steroid Injection

Active Comparator group

Description:

Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline

Treatment:

Drug: MethylPREDNISolone 40 MG

Drug: Genicular Nerve Placebo