A Phase 4 interventional study of 6% aqueous phenol and MethylPREDNISolone 40 MG in Osteoarthritis, Knee and Chronic Knee Pain, sponsored by University of Manitoba. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by University of Manitoba · Phase 4, Interventional, and Treatment
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
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 40 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Manitoba is the lead sponsor of 554 studies on the registry; 88 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves
Drug: 6% aqueous phenol · Drug: Intraarticular Knee Placebo
Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline
Drug: MethylPREDNISolone 40 MG · Drug: Genicular Nerve Placebo
1.5 mL of aqueous phenol will be injected at each target genicular nerve under ultrasound guidance
40 mg of methylprednisolone diluted in 5 mL of 0.9% normal saline will be injected inside the knee joint capsule under ultrasound guidance
Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance
Also known as: 0.9% normal saline
1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance
Also known as: 0.9% normal saline
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)
Time frame: 3 months
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)
Time frame: baseline, 1 month, 6 months
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)
Time frame: 1 months, 3 months, 6 months
Brief Pain Inventory Score (BPI)
Functional activity measurement using the Brief Pain Inventory (short form)
Time frame: baseline, 1 month, 3 months, 6 months
WOMAC index
The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)
Time frame: 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
Time frame: from injection up to 1 month after intervention
No study locations are listed for this record.
Plan to share: No
Start is estimated for Oct 2023; primary completion for Jan 2024, 3 months later.
Of 84 non-industry phase 4 interventional studies under Osteoarthritis, Knee, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 3 months is below that.
Counting every sponsor, half of 94 studies reached it within 20 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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