Conventional (Simplicity III) and Cooled (SInergy) Radiofrequency for Sacroiliac Joint Denervation: One-Year Retrospective Study Comparing Two Devices

Abstract

Objective: To compare two radiofrequency (RF) devices, Simplicity III (conventional RF), and SInergy (cooled RF), which are specifically designed to denervate the sacroiliac joint (SIJ).

Design: Retrospective observational study.

Setting: Italian National Health Service Public Hospital.

Subjects: Forty-three patients with SIJ-derived pain refractory to conservative treatment; 21 and 22 patients, respectively, received Simplicity III or SInergy to denervate the SIJ.

Methods: Mean numerical rating scale (NRS) and Oswestry Disability Index (ODI) scores were determined for each study group up to 12 months postprocedure. Secondary outcomes included the average amount of time required to complete each RF procedure and the adverse events associated with each technique.

Results: Average SInergy group NRS and ODI scores were consistently less than those in the Simplicity III cohort at each post-RF denervation follow-up, and such differences were statistically significant at six and 12 months. The Simplicity III procedure was completed approximately 2.5 times faster than the SInergy procedure, and one minor adverse event was reported in the SInergy group.

Conclusions: The study results suggest that SInergy safely afforded patients with greater and more durable analgesia and disability relief than Simplicity III for SIJ-derived pain. The Simplicity III procedure may be more conducive than SInergy for bilateral procedures and for patients who have limited tolerance to be in an RF procedure-required prone position. Randomized controlled trials are needed to confirm the implication made in this study that SInergy is the preferred RF denervation option for treating SIJ-derived pain and the disability associated with it.

Keywords: Disability; Low Back Pain; Pain; Radiofrequency; Sacroiliac Joint; Sacroiliac Joint Syndrome (SIJS).