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

University of Manitoba40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis, Knee Chronic Knee Pain

Interventions

6% aqueous phenolDRUG

1.5 mL of aqueous phenol will be injected at each target genicular nerve under ultrasound guidance

MethylPREDNISolone 40 MGDRUG

40 mg of methylprednisolone diluted in 5 mL of 0.9% normal saline will be injected inside the knee joint capsule under ultrasound guidance

Intraarticular Knee PlaceboDRUG

Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance

Genicular Nerve PlaceboDRUG

1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain scores (Numeric Rating Scale) at 3 months

Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Time frame: 3 months

Secondary Outcomes

Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months

Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Time frame: baseline, 1 month, 6 months

Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)

Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Time frame: 1 months, 3 months, 6 months

Brief Pain Inventory Score (BPI)

Functional activity measurement using the Brief Pain Inventory (short form)

Time frame: baseline, 1 month, 3 months, 6 months

WOMAC index

The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)

Time frame: baseline, 1 month, 3 months, 6 months

Incidence of adverse events

Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection

Time frame: from injection up to 1 month after intervention

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts