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NCT02260869 · ClinicalTrials.gov registry record · NA
Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain
A NA study, sponsored by Millennium Pain Center.
- Terminated
- Registry status
- NA
- Development phase
- 79
- Enrollment target
NCT02260869: Clinical Trial NA study, sponsored by Millennium Pain Center.
NCT02260869 is a NA study that was terminated before completion, run by Millennium Pain Center. The registered enrollment target is 79 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02260869, a NA study, was terminated before completion, sponsored by Millennium Pain Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
Study 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.
Primary Outcome
A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level. Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable. A negative change in VAS means a reduction in pain level after 24-weeks of treatment.
Interventions
- PROCEDURE Genicular nerve radiofrequency ablation
- DEVICE Pain Management Radiofrequency Kit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2015-01 |
| Est. Completion | 2019-06-26 |
| Phase | NA |
Why NCT02260869 stopped before completion
NCT02260869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Genicular nerve radiofrequency ablation is the first listed.
NCT02260869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02260869 about?
NCT02260869 is a clinical study titled "Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain". 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 Kellgre...
What is the current status of trial NCT02260869?
This trial is currently terminated. It is a NA study. The enrollment target is 79 participants. The study started on 2015-01. Estimated completion is 2019-06-26.
What interventions are being tested in trial NCT02260869?
The interventions under investigation include: Genicular nerve radiofrequency ablation (PROCEDURE), Pain Management Radiofrequency Kit (DEVICE).
Who is sponsoring clinical trial NCT02260869?
This trial is sponsored by Millennium Pain Center, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02260869's enrollment target sits among peer trials
79 1060th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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