Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT04472702
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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
99 Years
Study:
NCT04472702
Study Brief:
Protocol Section:
NCT04472702