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Comparing two imaging methods to guide nerve treatment for knee osteoarthritis pain

Compares x-ray and ultrasound guidance for cooled radiofrequency nerve ablation in knee osteoarthritis.

Key facts

Who runs it
University of California, Davis
Where
Rochester and Sacramento, United StatesSee the 2 sites
Trial code
Registry title
Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
Status
Recruiting
People taking part
90 people, planned
Started
2 Feb 2022
Expected to end
1 May 2027
Type of study
Interventional, 2 groups
Treatments tested
  • cRFA
Record updated
16 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with knee osteoarthritis (wear-and-tear arthritis) in one or both knees. Their pain must not have improved with usual treatments. The trial compares two ways of guiding a nerve heat treatment (cRFA): ultrasound or X-ray imaging.

Age
35 Years to 99 Years
Sex
All
Disease stage
Primary knee osteoarthritis that meets the American College of Rheumatology criteria. Kellgren-Lawrence score of 2 to 4 on X-ray. Pain score (NPRS) of at least 4 on most or all days of the past week.
Earlier treatment
Pain must have resisted usual treatments for at least 3 months. These can include medicines, physical therapy or knee injections. People cannot join if they had radiofrequency ablation of the knee or knee joint replacement before.
Biomarker or test result
People need a positive response to test numbing injections (lidocaine) of the knee nerves.

Main reasons for not taking part

  • Body mass index greater than 40
  • Arthritis caused by an autoimmune or inflammatory disease, such as rheumatoid or psoriatic arthritis
  • Active infection in the body or where the needle goes
  • Pacemaker, spinal cord stimulator, deep brain stimulator or similar device
  • Not able to walk, not able to give own consent, not English speaking, or unstable medical or mental illness

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 4) previous radiofrequency ablation procedure for the knee,
  • 6) previous knee joint replacement surgery,
  • 5) active systemic or local infections at the site of needle/cRFA probe placement,
  • 7) autoimmune or inflammatory cause of knee arthritis such as rheumatoid or psoriatic arthritis,
  • 9) patients who are unable to provide their own consent (e.g. dementia),
  • 10) unstable medical or psychiatric illness,
  • 1) age <35 years,
  • 2) non-English speaking patients,
  • 3) body mass index greater than 40,
  • 8) non-ambulatory patients,
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 35 and 99 years old?

Where in United States

  • University of RochesterRochester, United StatesContact: Katherine Rizzone, MDTaking people
  • UC Davis HealthSacramento, United StatesContact: Daniel Herman, MDNot yet recruiting

About the trial

What the trial wants 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 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.

The 2 groups in the trial

  • Subjects with knee OA using ultrasound for cRFA interventionTreatment being tested

    Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to ultrasound (N=45) cRFA treatment arm.

    Treatment: cRFA

  • Subjects with knee OA using fluoroscopy for cRFA interventionTreatment being tested

    Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to fluoroscopic (N=45) cRFA treatment arm.

    Treatment: cRFA

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
Plain-language title
Comparing two imaging methods to guide nerve treatment for knee osteoarthritis painGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT04472702, who can take part
Record updated
16 June 2026