A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus… (NCT07214844) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
United States110 participantsStarted 2026-04-16
Plain-language summary
A research study is being conducted to compare two treatments for long-term low back pain:
* One uses the iovera° system, which applies cold to certain nerves in the lower back.
* The other is the standard treatment called radiofrequency ablation, which uses heat.
The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit)
. Neurogenic claudication Prior lumbar spinal fusion surgery at the intended treatment levels
. Cryoglobulinemia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares two procedures — the Iovera cryoneurolysis device and radiofrequency ablation — for my chronic low back pain; can you explain how each one works on the medial branch nerves and which approach you think might be more appropriate for my specific situation?
2Since this study is listed as Phase NA, meaning it's comparing two already-used procedures rather than testing a brand-new experimental treatment, what does that mean for what we already know about the safety and effectiveness of each option?
3The trial is measuring pain relief using a numeric rating scale — can you help me understand what a meaningful improvement in that score would actually look like in terms of my day-to-day life, and how long that relief might last with each procedure?
4Before considering this trial, should I try any standard treatments first, or have I already exhausted the options that would typically come before either cryoneurolysis or radiofrequency ablation?
5What would the practical demands of participating in this study look like for me — how many visits would be required, and are there any restrictions or follow-up commitments I should plan around?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.