Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain
(Lumbar CvS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing two methods of using heat to treat chronic lower back pain. It targets patients whose pain comes from specific joints in the lower back. The treatment works by blocking pain signals from certain nerves. For years, heat has been used for comfort and pain relief and is recommended as a first-line therapy in many clinical guidelines.
Do I need to stop taking my current medications for the trial?
You may need to keep your current pain medications stable, as the trial requires that analgesics like Neurontin (gabapentin) and Cymbalta (duloxetine) remain at a stable dosage for at least 6 weeks before the trial and not change during the study without approval.
How does the COOLIEF* Cooled Radiofrequency Probe treatment differ from other treatments?
The COOLIEF* Cooled Radiofrequency Probe treatment is unique because it uses cooled radiofrequency energy to target nerves, providing pain relief by disrupting nerve signals. This method is different from traditional treatments as it combines cooling with radiofrequency, potentially offering longer-lasting pain relief with less discomfort during the procedure.12345
What data supports the effectiveness of the treatment COOLIEF* Cooled Radiofrequency Probe, Standard Radiofrequency Probe?
Research shows that cooled radiofrequency treatments can effectively create larger tissue lesions without causing excessive heat damage, which may improve healing and reduce inflammation. This suggests that the COOLIEF* Cooled Radiofrequency Probe could be effective in treating conditions by safely targeting and destroying problematic tissue.678910
Who Is on the Research Team?
David Provenzano
Principal Investigator
Pain Diagnostics and Interventional Care
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either Cooled Radiofrequency Ablation (CRFA) or Conventional Radiofrequency Ablation (SRFA) to manage chronic facetogenic low back pain
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary endpoint at 6 months and continued monitoring up to 12 months
What Are the Treatments Tested in This Trial?
Interventions
- COOLIEF* Cooled Radiofrequency Probe
- Standard Radiofrequency Probe
Find a Clinic Near You
Who Is Running the Clinical Trial?
Avanos Medical
Lead Sponsor