Cooled radiofrequency ablation vs. standard medical management for chronic sacroiliac joint pain

Monday, March 6, 2023

3:27 PM – 3:36 PM

Location: 227ABC

Presenting Author(s)

Douglas Beall, MD

Chief of Radiology Services
Clinical Radiology of Oklahoma

Disclosure information not submitted.

Author/Co-author(s)

SC

Steve Cohen Cohen, MD

Professor of Anesthesiology
Johns Hopkins Schools of Medicine and Public Health
LK

Leo Kapural, MD

Anesthesiology
The Center for Clinical Research
LK

Lynn Kohan, MD

Professor of Anesthesiology
University of Virginia
SL

Sean Li, MD

Anesthesiology
Premier Pain Centers

Purpose:

Low back pain (LBP) is one of the leading causes of physician visits and disability in the United States, with a lifetime prevalence rate ranging between 60 and 80% (1). It is estimated that up to 30% of chronic LBP originates from the sacroiliac joint (SIJ) (2).

Materials and Methods:

This study was registered in ClinicalTrials.gov (NCT03601949) on July 26, 2018. Eligible participants were randomized in 1:1 ratio by at each site to receive either CRFA (treatment group) or physician prescribed SMM (control group). Blinded outcome assessors conducted all follow-up visits. The primary endpoint was at 3 months, with follow-up visits performed up to 12 months from treatment. Subjects in the SMM group were permitted to cross-over (XO) and received CRFA at the 3-month timepoint, provided that they requalified for the study.

Endpoints measured included NRS pain scores, PGIC, ODI, SF-36, and (EQ-5D-5L).

Responders were defined as participants who had a > 30% decrease in average daily NRS pain score (OR a 2-point decrease in NRS) coupled with a PGIC score >.

Results:

The previously reported primary 3-month endpoint found that CRFA was superior to SMM in the management of chronic SIJ pain.

At the 12-month timepoint, subjects within the CRFA cohort reported a mean NRS decrease of 2.7 (±2.5) and the XO cohort reported a mean NRS decrease of 2.6 (±2.8) (Table 1).

57.4% of subjects in the original CRFA cohort were deemed responders at the 12-month timepoint, compared to 55.6% of subject in the XO cohort.

With respect to PGIC, at the 12-month timepoint, 67.2% of subjects in the CRFA cohort reported being ‘improved’, compared with 65.1% of subject in the XO cohort.

Other endpoints (ODI, SF-36 and EQ-5D-5L) also demonstrate clinically significant improvements for patients in the original CRFA cohort as well as the XO cohort.

Conclusion:

CRFA treatment resulted in statistically significant, clinically meaningful, and durable improvements in both the original CRFA cohort as well as the XO cohort 12 months following a single CRFA treatment. Given the difficulty of managing SIJ pain, and the lack of effective, minimally-invasive treatment options, CRFA appears to provide clinical benefit and durability for this patient population.