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

NCT06000709 | Unknown Phase 4

• 1 other identifier: HS25899
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee; Chronic Knee Pain

Keywords

Phenol; Injections, Intra-Articular; Steroids; Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months

Secondary Outcomes (5)

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

  baseline, 1 month, 6 months

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

  1 months, 3 months, 6 months

• Brief Pain Inventory Score (BPI)

  baseline, 1 month, 3 months, 6 months

• WOMAC index

  baseline, 1 month, 3 months, 6 months

• Incidence of adverse events

  from injection up to 1 month after intervention

Study Arms (2)

Ultrasound-guided Genicular Nerve Phenol Neurolysis

EXPERIMENTAL

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

Drug: 6% aqueous phenol; Drug: Intraarticular Knee Placebo

Ultrasound-guided Intraarticular Steroid Injection

ACTIVE COMPARATOR

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

Drug: MethylPREDNISolone 40 MG; Drug: Genicular Nerve Placebo

Interventions

6% aqueous phenol DRUG

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

Ultrasound-guided Genicular Nerve Phenol Neurolysis

MethylPREDNISolone 40 MG DRUG

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

Ultrasound-guided Intraarticular Steroid Injection

Intraarticular Knee Placebo DRUG

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

Also known as: 0.9% normal saline

Ultrasound-guided Genicular Nerve Phenol Neurolysis

Genicular Nerve Placebo DRUG

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

Also known as: 0.9% normal saline

Ultrasound-guided Intraarticular Steroid Injection

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Related Publications (4)

• Walega DR, McCormick ZL. Chemical Neurolysis of the Genicular Nerves for Chronic Knee Pain: Reviving an Old Dog and an Old Trick. Pain Med. 2018 Sep 1;19(9):1882-1884. doi: 10.1093/pm/pny023. No abstract available.

  PMID: 29514315 BACKGROUND

• Risso RC, Ferraro LHC, Nouer Frederico T, Peng PWH, Luzo MV, Debieux P, Sakata RK. Chemical Ablation of Genicular Nerve with Phenol for Pain Relief in Patients with Knee Osteoarthritis: A Prospective Study. Pain Pract. 2021 Apr;21(4):438-444. doi: 10.1111/papr.12972. Epub 2020 Dec 29.

  PMID: 33277760 BACKGROUND

• Park Y, Lee SC, Nam HS, Lee J, Nam SH. Comparison of sonographically guided intra-articular injections at 3 different sites of the knee. J Ultrasound Med. 2011 Dec;30(12):1669-76. doi: 10.7863/jum.2011.30.12.1669.

  PMID: 22124002 BACKGROUND

• Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.

  PMID: 29095245 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Methylprednisolone; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Javier Webar, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Webar, MD

CONTACT

2047873018; javier.webar@umanitoba.ca

Sebastian Layera, MD

CONTACT

2047873018; layerars@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: October 20, 2023
• Primary Completion: January 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share