Clinical trial NCT06000709: Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections
Official title: Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Chronic Knee Pain
Keywords: Phenol
Injections, Intra-Articular
Steroids
Nerve Block
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Pain scores (Numeric Rating Scale) at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months
timeFrame: baseline, 1 month, 6 months
measure: Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)
timeFrame: 1 months, 3 months, 6 months
measure: Brief Pain Inventory Score (BPI)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: WOMAC index
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Incidence of adverse events
timeFrame: from injection up to 1 month after intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Javier Webar, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.