Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain

(Lumbar CvS Trial)

Recruiting at 9 trial locations

Overseen By William Keck

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Avanos Medical

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Arthritis, Neurologic signs, Scoliosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate procedure

79 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

David Provenzano

Principal Investigator

Pain Diagnostics and Interventional Care

Eligibility Criteria

Inclusion Criteria

You are experiencing moderate to severe pain, with a score of 6 or higher on a pain scale from 0 to 10.

You have chronic low back pain for at least 3 months that is caused by a specific condition in your lower back joints. You have tried different non-surgical treatments like exercise, pain relief medication, and activity modification but haven't gotten enough relief.

If you take certain types of pain medication, such as Neurontin or Cymbalta, you must have been taking the same amount for at least 6 weeks before the study. You cannot change your dosage during the study without permission from the study doctor.

Exclusion Criteria

Your body has physical differences that would make it difficult to follow the study's procedures.

You have a medical condition that weakens your immune system and it is not under control.

You have severe narrowing in your spine that is causing nerve-related pain or difficulty walking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Cooled Radiofrequency Ablation (CRFA) or Conventional Radiofrequency Ablation (SRFA) to manage chronic facetogenic low back pain

Immediate procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary endpoint at 6 months and continued monitoring up to 12 months

12 months

Treatment Details

Interventions

• COOLIEF* Cooled Radiofrequency Probe
• Standard Radiofrequency Probe

Participant Groups

Group I: Cooled Radiofrequency Experimental Treatment 1 Intervention

Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain

Group II: Conventional Radiofrequency Active Control 1 Intervention

Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain

Who Is Running the Clinical Trial?

Avanos Medical

Lead Sponsor

Trials

9

Recruited

1,900+

References

1. United States pubmed.ncbi.nlm.nih.gov

Reliability assessment of a cooled intraesophageal balloon to prevent thermal injury during RF cardiac ablation: an agar phantom study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Discrepancies between catheter tip and tissue temperature in cooled-tip ablation: relevance to guiding left atrial ablation. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Internally gas-cooled radiofrequency applicators as an alternative to conventional radiofrequency and microwave ablation devices: an in vivo comparison. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Convective cooling effect on cooled-tip catheter compared to large-tip catheter radiofrequency ablation. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Radiofrequency interstitial tissue ablation: wet electrode. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Micro MRI of the mouse brain using a novel 400 MHz cryogenic quadrature RF probe. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Performance of a 200-MHz cryogenic RF probe designed for MRI and MRS of the murine brain. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Self-compensated standing wave probe for characterization of radio-frequency plasmas. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

A hybrid probe system for quantifying plasma parameters in a 13.56 MHz capacitive coupled magnetized plasma. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Active compensation of rf-pulse transients. [2009]