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

NCT ID: NCT06000709

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2024-07-31

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

Conditions

Osteoarthritis, Knee; Chronic Knee Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

6% aqueous phenol

Intervention Type: DRUG

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

Intraarticular Knee Placebo

Intervention Type: DRUG

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

Ultrasound-guided Intraarticular Steroid Injection

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

Group Type: ACTIVE_COMPARATOR

MethylPREDNISolone 40 MG

Intervention Type: 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

Genicular Nerve Placebo

Intervention Type: DRUG

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

Interventions

6% aqueous phenol

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

Intervention Type: 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

Intervention Type: DRUG

Intraarticular Knee Placebo

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

Intervention Type: DRUG

Genicular Nerve Placebo

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

Intervention Type: DRUG

Other Intervention Names

0.9% normal saline; 0.9% normal saline

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Javier Webar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Javier Webar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Central Contacts

Javier Webar, MD

Role: CONTACT

javier.webar@umanitoba.ca

2047873018

Sebastian Layera, MD

Role: CONTACT

layerars@myumanitoba.ca

2047873018

References

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.

Reference Type: BACKGROUND

PMID: 29514315 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33277760 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22124002 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29095245 (View on PubMed)

Other Identifiers

HS25899

Identifier Type: -

Identifier Source: org_study_id