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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

Summary

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.

Eligible Conditions
  • Chronic Lower Back Pain

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 6 Months
Secondary study objectives
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
+1 more
Other study objectives
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
The mean change in SF-36 Physical Functioning (PF) score from baseline to the 12-month visit
+2 more

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

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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
~18 spots leftby Sep 2025
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