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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Ultrasound-guided Intraarticular Steroid Injection | Active Comparator | Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6% aqueous phenol | Drug | 1.5 mL of aqueous phenol will be injected at each target genicular nerve under ultrasound guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Webar, MD | Contact | 2047873018 | javier.webar@umanitoba.ca | |
| Sebastian Layera, MD | Contact | 2047873018 | layerars@myumanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Javier Webar, MD | University of Manitoba | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29514315 | Background | 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. | |
| 33277760 | 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. |
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| 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 |
|
| Intraarticular Knee Placebo | Drug | Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance |
|
|
| Genicular Nerve Placebo | Drug | 1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance |
|
|
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 |
| Brief Pain Inventory Score (BPI) | Functional activity measurement using the Brief Pain Inventory (short form) | baseline, 1 month, 3 months, 6 months |
| WOMAC index | The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall) | baseline, 1 month, 3 months, 6 months |
| 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 |
| 22124002 | 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. |
| 29095245 | 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. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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