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

NCT04803149 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-06-30

No results posted yet for this study

Summary

This study is being conducted to assess the relative effectiveness of radiofrequency neurotomy in subjects with chronic axial low back pain originating in the lumbar facet joints using the COOLIEF\* Cooled Radiofrequency Probe as compared to the same procedure conducted using a Standard Radiofrequency Probe.

Conditions

  • Chronic Low-back Pain

Interventions

DEVICE

Cooled Radiofrequency

Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

DEVICE

Conventional Radiofrequency

Delivery of energy to ablate sensory nerves via standard or conventional radiofrequency probe

Sponsors & Collaborators

  • Avanos Medical

    lead OTHER

Principal Investigators

  • David Provenzano · Pain Diagnostics and Interventional Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2023-01-31
Completion
2023-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803149 on ClinicalTrials.gov