Comparing Guidance Methods for Cooled Radiofrequency Ablation in Knee Osteoarthritis
This study is comparing two ways to guide a procedure called cooled radiofrequency ablation (cRFA) for knee osteoarthritis. cRFA is a treatment that uses heat to block pain signals from nerves around the knee. Typically, doctors use X-rays (fluoroscopy) to guide this procedure, but this study is looking at whether using ultrasound guidance might be more accurate because it can show nerves and blood vessels more clearly. You may be able to join if you are between 35 and 99 years old, have knee osteoarthritis that hasn't improved with other treatments, and experience significant knee pain. The study will measure success by looking at your pain levels and how well you can move and function, over a period of up to 24 months. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 90 participants. Participants will be randomly assigned to receive cRFA with either fluoroscopic or ultrasound guidance.
- What's involved
- You would undergo the cRFA procedure, which involves numbing the skin and soft tissues around your knee. Your pain and function will be measured at various times for up to 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 24 months after the procedure to assess pain and function.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
At a glance
Conditions
NCT04472702
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
UC Davis Health
Sacramento, Californiastudy coordinator listed
Not yet recruiting
University of Rochester
Rochester, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Daniel Herman, MD · PRINCIPAL_INVESTIGATOR · University of California, Davis
Who to contact
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Inclusion
Exclusion
What this trial measures
- Numeric Pain Rating ScaleBaseline up to 24 months
The objective is to rate patient's reported pain. The NPRS asks for a number between zero and ten that fits best to the subject's pain intensity, with zero as "no pain at all" and ten representing "the worst pain ever possible". It has a similar minimal clinically significant difference (20%) as the visual analog scale and can be administered via a phone interview.
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)Baseline up to 24 months
The objective is to measure the patient's reported functional status.The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores
- PROMIS - DepressionBaseline up to 24 months
The objective is to measure items relevant to the subject's mood, views of self, and engagement. The test version 8b has good responsiveness with a minimally important difference range of 3-3.1 in adults with knee OA.
- PROMIS - Pain InterferenceBaseline up to 24 months
The objective is to measure the consequences of pain on the subject's life with a minimally important difference range of 2.35 to 2.4