Cryoneurolysis for Facet Mediated Chronic Low Back Pain

Status Completed

Clinical Trial Summary

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06016127
Study type	Interventional
Source	Medical Pain Management Services, PLLC
Contact
Status	Completed
Phase	N/A
Start date	June 18, 2022
Completion date	October 23, 2023

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