NCT06016127

Cryoneurolysis for Facet Mediated Chronic Low Back Pain

A Single-center, Randomized, Pilot Study to Assess Iovera° Lumbar Medial Branch Cryoneurolysis vs Lumbar Radiofrequency Ablation for Facet Mediated Chronic Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medical Pain Management Services, PLLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº medial branch cryoneurolysis or radiofrequency ablation.

Detailed description

This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº medial branch cryoneurolysis or radiofrequency ablation. This study is designed to determine if a full efficacy RCT can be successfully conducted using the procedures and protocols described in the current pilot study protocol, or if protocol modifications are necessary before moving forward with a full efficacy RCT. Furthermore, the study will assess the feasibility of the outcome measurements employed, construct a foundation for sample size calculation, and the acceptability/practicality of conducting the full efficacy RCT. Randomization to treatment groups according to the randomization assignment will be performed on the day of treatment. The treatment groups are: * Group 1: subjects will receive iovera° cryoneurolysis to the medial branch nerves of the lumbar spine * Group 2: subjects will receive RFA to the medial branch nerves of the lumbar spine

Conditions

• Low Back Pain
• Facet Joint Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-18
• Primary completion: 2023-10-23
• Completion: 2023-10-23
• First posted: 2023-08-29
• Last updated: 2024-12-06
• Results posted: 2024-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study