Knee Osteoarthritis Clinical Trial
Official title:
Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | October 1, 2025 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
United States | UC Davis Health | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | American Medical Society for Sports Medicine Collaborative Research Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Pain Rating Scale | 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. | Baseline up to 24 months | |
Primary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 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 |
Baseline up to 24 months | |
Primary | PROMIS - Depression | 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. | Baseline up to 24 months | |
Primary | PROMIS - Pain Interference | 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 | Baseline up to 24 months | |
Secondary | 30-Second Chair Stand Test | The objective is to determine the maximum number of chair stand repetitions possible in a 30 second period. | The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods. | |
Secondary | Stair Climb Test | The objective is to determine the time (seconds) it takes to ascend and descend a flight of stairs. | The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods. | |
Secondary | 40m Fast Paced Walk Test | The objective is to determine the time (seconds) it takes to complete a fast-paced walking task over 4x10m (total 40m). | The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods. | |
Secondary | Timed Up and Go Test48 | The objective is to determine the time (seconds) to rise from a chair, walk 3m, turn, walk back to the chair, and then sit down. | The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods. | |
Secondary | Six Minute Walk Test | The objective is to determine the maximal distance covered in a 6min period. | The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods. |
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