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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06000709
• Other study ID #: HS25899
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 20, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: University of Manitoba
• Contact: Javier Webar, MD
• Phone: 2047873018
• Email: javier.webar[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Knee Pain
• Osteoarthritis, Knee

Intervention

Drug:
• 6% aqueous phenol
1.5 mL of aqueous phenol will be injected at each target genicular nerve under ultrasound guidance
• 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
• Intraarticular Knee Placebo
Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance
• Genicular Nerve Placebo
1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	baseline, 1 month, 6 months
Secondary	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)	1 months, 3 months, 6 months
Secondary	Brief Pain Inventory Score (BPI)	Functional activity measurement using the Brief Pain Inventory (short form)	baseline, 1 month, 3 months, 6 months
Secondary	WOMAC index	The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)	baseline, 1 month, 3 months, 6 months
Secondary	Incidence of adverse events	Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection	from injection up to 1 month after intervention