Chronic Knee Pain, Osteoarthritis, Knee
Conditions
Keywords
Phenol, Injections, Intra-Articular, Steroids, Nerve Block
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
Interventions
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
DRUGIntraarticular Knee Placebo
Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance
DRUGGenicular Nerve Placebo
1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores (Numeric Rating Scale) at 3 months | 3 months | Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months | baseline, 1 month, 6 months | Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain) |
| Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS) | 1 months, 3 months, 6 months | Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain) |
| Brief Pain Inventory Score (BPI) | baseline, 1 month, 3 months, 6 months | Functional activity measurement using the Brief Pain Inventory (short form) |
| WOMAC index | baseline, 1 month, 3 months, 6 months | The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall) |
| Incidence of adverse events | from injection up to 1 month after intervention | Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection |
Contacts
Primary ContactJavier Webar, MD
Backup ContactSebastian Layera, MD
Outcome results
None listed