Cryoneurolysis for Facet Mediated Chronic Low Back Pain

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 18, 2022

Primary Completion Date

October 23, 2023

Study Completion Date

October 23, 2023

Conditions
Low Back PainFacet Joint Pain
Interventions
DEVICE

iovera system

"The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The 190 Smart Tip will be used in this study."

DEVICE

Radiofrequency ablation

The RFA system consists of a Cosman, G4 Generator. The needles used are 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman, is placed on the upper thigh for each procedure and connected to the G4 Generator.

Trial Locations (1)

12866

The Albany & Saratoga Centers For Pain Management, Saratoga Springs

Sponsors
All Listed Sponsors
collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

lead

Medical Pain Management Services, PLLC

OTHER