Comparing ultrasound and fluoroscopy for knee pain treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of cooled radiofrequency ablation (cRFA) of the geniculate nerves in patients with knee osteoarthritis using two different guidance methods: fluoroscopy and ultrasound. The study will enroll patients who have not responded to conventional treatments and will assess outcomes such as pain levels and functional improvement. Participants will be randomized into two groups, receiving either ultrasound or fluoroscopic guidance for their cRFA treatment. The trial will also explore additional measures, including biomarkers related to inflammation and cartilage health.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Rochester
  Rochester, New York, United States Recruiting
• UC Davis Health
  Sacramento, California, United States Not yet recruiting

Study contacts

• Principal investigator: Daniel Herman, MD — University of California, Davis
• Study coordinator: Daniel Herman, MD
• Email: dcherman@ucdavis.edu
• Phone: 916-734-6805

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.