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

Sponsor

University of Manitoba (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06000709

Collaborator

(none)

Enrollment

Arms

11.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Chronic Knee Pain	Drug: 6% aqueous phenol Drug: MethylPREDNISolone 40 MG Drug: Intraarticular Knee Placebo Drug: Genicular Nerve Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

Anticipated Study Start Date :

Aug 28, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound-guided Genicular Nerve Phenol Neurolysis One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves	Drug: 6% aqueous phenol 1.5 mL of aqueous phenol will be injected at each target genicular nerve under ultrasound guidance Drug: Intraarticular Knee Placebo Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance Other Names: 0.9% normal saline
Active Comparator: Ultrasound-guided Intraarticular Steroid Injection Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline	Drug: MethylPREDNISolone 40 MG 40 mg of methylprednisolone diluted in 5 mL of 0.9% normal saline will be injected inside the knee joint capsule under ultrasound guidance Drug: Genicular Nerve Placebo 1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance Other Names: 0.9% normal saline

Arm

Intervention/Treatment

Experimental: Ultrasound-guided Genicular Nerve Phenol Neurolysis

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

Drug: 6% aqueous phenol

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

Drug: Intraarticular Knee Placebo

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

Other Names:

0.9% normal saline

Active Comparator: Ultrasound-guided Intraarticular Steroid Injection

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

Drug: MethylPREDNISolone 40 MG

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

Drug: Genicular Nerve Placebo

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

Other Names:

0.9% normal saline

Outcome Measures

Primary Outcome Measures

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

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)
Brief Pain Inventory Score (BPI) [baseline, 1 month, 3 months, 6 months]
Functional activity measurement using the Brief Pain Inventory (short form)
WOMAC index [baseline, 1 month, 3 months, 6 months]
The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.