Comparing ultrasound and fluoroscopy for knee pain treatment
Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
This study tests whether using ultrasound or fluoroscopy to guide a knee pain treatment can help people with knee osteoarthritis feel less pain and improve their function when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 35 Years to 99 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 2 sites (Sacramento, California and 1 other locations) |
| Trial ID | NCT04472702 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with knee osteoarthritis who have not found relief from standard treatments and have a Kellgren-Lawrence score of 2-4.
Not a fit: Patients under 35 years old, those with a BMI over 40, or individuals who have previously undergone knee radiofrequency ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and functional outcomes for patients with knee osteoarthritis.
How similar studies have performed: While there are few studies directly comparing these two guidance methods, the approach of using ultrasound for nerve targeting is gaining interest and may offer advantages over traditional methods.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Sacramento, California and 1 other locations
- UC Davis Health — Sacramento, California, United States (Not_yet_recruiting)
- University of Rochester — Rochester, New York, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.