Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatme… (NCT02260869) | Clinical Trial Compass
TerminatedNot Applicable
Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain
Stopped: Due to financial constraints, sponsor could not complete the study.
United States79 participantsStarted 2015-01
Plain-language summary
This is a single center randomized controlled trial. Approximately 102 patients will be randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar radiofrequency ablation. Patients with chronic knee pain, with moderate to severe osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed conservative therapy will be screened for the study.
Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic guided single diagnostic block of the geniculate nerves (superior medial, superior lateral, and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).
Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4, 12, 24 and 52 weeks.
Outcome measures will be: Visual analogue scale (VAS) both while at rest and during ambulation, Oxford knee scores, WOMAC, and global perceived effect.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who have given their written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them.
* Female patients who are not pregnant and do not plan to become pregnant during the study. Females of child bearing potential must provide a negative pregnancy test provided by the study physician and must be using reliable contraception and must continue to use reliable contraception until study completion at 52 weeks. Non-childbearing potential is defined as postmenopausal for at least 2 years or surgical sterilization or hysterectomy at least 3 months before study start.
* Must be older than 18 years old..
* Must have chronic knee pain for at least 6 months.
* Must have radiologic evidence of OA of the knee, grade 2-4 based on the Kellgreen-Lawrence scale.
* Persistent pain despite the use of conservative treatment (physical therapy, oral analgesic, steroid injections).
* Must have a VAS score of at least 5 with ambulation.
* Subjects must be on a stable dose of pain medication regimen for at least 2 months.
* Greater than or equal to 50% improvement from blocks in target knee for duration of the anesthetic.
Exclusion Criteria:
* Knee pain must not be acute.
* Previous total knee replacement.
* Evidence of connective tissue disease.
* Patients who have a BMI greater than 40.
* Evidence of serious neurological or psychiatric disorders.
* Current opi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.