Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain (NCT04145011) | Clinical Trial Compass
CompletedNot Applicable
Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain
United States153 participantsStarted 2019-10-04
Plain-language summary
This study is being performed to assess the relative effectiveness of genicular nerve ablation with the COOLIEF\* Cooled Radiofrequency probe to manage moderate to severe knee pain in patients with osteoarthritis (OA) of the knee when compared to radiofrequency ablation using a Standard Radiofrequency probe.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Age ≥ 21 years
✓. Able to understand and personally sign and date the informed consent form
✓. Able to complete outcome measures
✓. Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
✓. Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs \[NSAIDs\])
✓. Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
✓. Pain on NRS ≥ 6 on an 11-point scale for the index knee
✓. Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) grade 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
Exclusion criteria
✕. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic inflammatory condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause knee pain
✕. Evidence of neuropathic pain affecting the index knee
. Intra-articular steroid injection into the index knee within 90 days from randomization
✕. Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
✕. Prior radiofrequency ablation of the genicular nerves of the index knee
✕. Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
✕. Clinically significant ligamentous laxity of the index knee