No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
35 – 99
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
University of California, Davis · Other
Who this trial is looking for
This trial is looking for patients with knee osteoarthritis to compare two ways of guiding a treatment that may help relieve pain. Participants will receive cooled radiofrequency ablation targeting nerves around the knee.
Are You a Good Fit for This Trial?
Rules you outRheumatoid arthritisPsoriatic arthritis
You may be able to join if
I have been diagnosed with knee osteoarthritis.
I am experiencing knee pain of at least four out of ten.
I have tried common treatments for at least three months without relief.
I have a Kellgren-Lawrence score of two to four.
I am at least 35 years old.
I can understand and speak English.
I need treatment on my most painful knee.
You may not be able to join if
I weigh more than 40 on the body mass index scale.
I have had previous knee joint replacement surgery.
I have active infections at the treatment site.
I have had a radiofrequency ablation procedure for my knee before.
I am unable to walk independently.
I have a pacemaker or similar device.
I have an unstable medical or psychiatric condition.
I cannot provide my own consent, like having dementia.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical guidance of choice, but uses bony landmarks to target these nerves which have variable positions around the knee. Alternatively, ultrasound allows for targeting based on visualization of bony landmarks, the nerves, and th…
Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical guidance of choice, but uses bony landmarks to target these nerves which have variable positions around the knee. Alternatively, ultrasound allows for targeting based on visualization of bony landmarks, the nerves, and their accompanying vascular structures, and thus may offer greater accuracy. However, there are few studies which directly compare the clinical efficacy of these two guidance options. This study will compare these two options.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 1\) patients of either gender with primary knee OA of one or both knees fulfilling the diagnostic criteria for knee OA by the American College of Rheumatology,
* 2\) Kellgren-Lawrence score of two to four,
* 3\) reported NPRS pain intensity of at least four on most or all days…
Inclusion Criteria:
* 1\) patients of either gender with primary knee OA of one or both knees fulfilling the diagnostic criteria for knee OA by the American College of Rheumatology,
* 2\) Kellgren-Lawrence score of two to four,
* 3\) reported NPRS pain intensity of at least four on most or all days of the past week
* 4\) pain resistant to conventional treatments which may include but is not limited to medications (e.g. acetaminophen, oral or topical non-steroidal anti-inflammatory drugs, opioids), physical therapy, and intra-articular injections (e.g. corticosteroids, hyaluronic acid, platelet-rich-plasma) for at least 3 months. In the case of bilateral knee OA, the most symptomatic knee will be treated and studied.
Exclusion Criteria:
* 1\) age \<35 years,
* 2\) non-English speaking patients,
* 3\) body mass index greater than 40,
* 4\) previous radiofrequency ablation procedure for the knee,
* 5\) active systemic or local infections at the site of needle/cRFA probe placement,
* 6\) previous knee joint replacement surgery,
* 7\) autoimmune or inflammatory cause of knee arthritis such as rheumatoid or psoriatic arthritis,
* 8\) non-ambulatory patients,
* 9\) patients who are unable to provide their own consent (e.g. dementia),
* 10\) unstable medical or psychiatric illness,
* 11\) patients with pacemakers, spinal cord stimulators, deep brain stimulators, or similar devices,
* 12\) patients seeking care as a part of workman's compensation or have litigation pending
* 13\) a negative response to diagnostic geniculate nerve lidocaine injections.
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