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Radiofrequency Ablation

Cooled Radiofrequency for Chronic Lower Back Pain (Lumbar CvS Trial)

N/A
Waitlist Available
Led By David Provenzano
Research Sponsored by Avanos Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Lumbar CvS Trial Summary

This trial is comparing two types of radiofrequency probes to see which is more effective in treating chronic low back pain originating from the lumbar facet joints.

Eligible Conditions
  • Chronic Lower Back Pain

Lumbar CvS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects experiencing adverse events through 6-months
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 6 Months
Secondary outcome measures
The mean change in EQ-5D-5L score from baseline to the 6-month visit
The mean change in Oswestry Disability Index (ODI) score from baseline to the 6-month visit
The mean change in SF-36 Physical Functioning (PF) score from baseline to the 6-month visit
+2 more
Other outcome measures
Proportion of subjects experiencing adverse events through 12 months
The mean change in EQ-5D-5L score from baseline to the 12-month visit
The mean change in Oswestry Disability Index (ODI) score from baseline to the 12-month visit
+4 more

Lumbar CvS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cooled RadiofrequencyExperimental Treatment1 Intervention
Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Group II: Conventional RadiofrequencyActive Control1 Intervention
Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cooled Radiofrequency
2019
N/A
~490

Find a Location

Who is running the clinical trial?

Avanos MedicalLead Sponsor
8 Previous Clinical Trials
1,819 Total Patients Enrolled
David ProvenzanoPrincipal InvestigatorPain Diagnostics and Interventional Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being accepted for participation in this clinical trial?

"According to the information available on clinicaltrials.gov, this trial has completed recruitment. This particular study was posted on February 23rd, 2021 and was most recently updated on June 28th, 2022. Although this study is no longer recruiting, there are 353 other trials that are still looking for participants."

Answered by AI

Where is this clinical trial being conducted?

"Presently, there are 10 hospitals conducting this trial. In addition to Bloomington, Washington and New Orleans, there are also test centres in 10 other locations. To cut down on travel, it is best to try and select a site near to you."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Washington
Louisiana
How old are they?
18 - 65
65+
What site did they apply to?
Ochsner Baptist Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Ochsner Baptist Medical Center: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain
2021. "Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04803149.
All > Low Back Pain > Back Pain
~19 spots leftby Apr 2025
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