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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06000709
Other study ID # HS25899
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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