NCT04803149

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

A Prospective, Multi-center, Randomized, Single-Blind Clinical Trial Comparing COOLIEF* Cooled Radiofrequency to Conventional Radiofrequency Ablation of the Medial Branch Nerves in the Management of Chronic Facetogenic Low Back Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Avanos Medical · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center, randomized, single-blind comparison study examining the outcomes of subjects with chronic axial low back pain that originates in the lumbar facet joints undergoing a procedure to create a radiofrequency lesion in the medial branch nerves with either Cooled Radiofrequency Ablation (CRFA) or Conventional (Standard) Radiofrequency Ablation (SRFA). Approximately 188 participants from approximately 15 sites will be enrolled into this study, with subjects undergoing either CRFA or SRFA in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-treatment, with the primary endpoint being completed at month 6. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-23
• Primary completion: 2023-01-01
• Completion: 2023-07-01
• First posted: 2021-03-17
• Last updated: 2022-06-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study