NCT06935539

Cryoneurolysis vs Radiofrequency Ablation for Chronic Sacroiliac Joint Pain

A Prospective, Single-center, Open-label, Pilot Randomized Controlled Study Evaluating the Clinical Effectiveness of Lateral Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Sacroiliac Joint Pain

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

Summary

This is a single-center, randomized, open-label, pilot study in adult subjects with chronic sacroiliac joint (SIJ) pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation.

Detailed description

This is a single-center, randomized, pilot study in adult subjects with chronic SIJ pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation (RFA). This study is designed to evaluate the clinical effectiveness of iovera° cryoneurolysis in adult subjects with chronic SIJ pain. 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 an efficacy randomized controlled trial (RCT). Randomization to treatment groups according to the randomization assignment will be performed on the day of treatment.

Conditions

• Chronic Sacroiliac Joint Pain

Interventions

Type	Name	Description
DEVICE	Cryoneurolysis	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 "STT21180STIM" Smart Tip will be used in this study.
DEVICE	Radiofrequency ablation	Radiofrequency ablation is a minimally invasive procedure that uses heat at the lumbosacral spine to destroy the target spinal nerves.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2025-04-20
• Last updated: 2025-04-20

Regulatory

• FDA-regulated device study