Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study

Abstract

IntroductionLow back pain is the leading cause of disability worldwide, with sacroiliac joint pain comprising up to 30% of cases of axial lower back pain. Conservative therapies provide only modest relief. Although placebo-controlled trials show efficacy for sacral lateral branch cooled radiofrequency ablation, there are no comparative effectiveness studies.MethodsIn this randomized, multicenter comparative effectiveness study, 210 patients with clinically suspected sacroiliac joint pain who obtained short-term benefit from diagnostic sacroiliac joint injections and prognostic lateral branch blocks were randomly assigned to receive cooled radiofrequency ablation of the L5 dorsal ramus and S1–S3 lateral branches or standard medical management consisting of pharmacotherapy, injections and integrative therapies. The primary outcome measure was mean reduction in low back pain score on a 0–10 Numeric Rating Scale at 3 months. Secondary outcomes included measures of quality of life and function.Results3 months post-treatment, the mean Numeric Rating Scale pain score for the cooled radiofrequency ablation group was 3.8±2.4 (mean reduction 2.5±2.5) compared with 5.9±1.7 (mean reduction 0.4±1.7) in the standard medical management group (p<0.0001). 52.3% of subjects in the cooled radiofrequency ablation group experienced>2 points or 30% pain relief and were deemed responders versus 4.3% of standard medical management patients (p<0.0001). Comparable improvements favoring cooled radiofrequency ablation were noted in Oswestry Disability Index score (mean 29.7±15.2 vs 41.5+13.6; p<0.0001) and quality of life (mean EuroQoL-5 score 0.68±0.22 vs 0.47±0.29; p<0.0001).ConclusionsIn patients with sacroiliac joint pain, cooled radiofrequency ablation provided statistically superior improvements across the spectrum of patient outcomes compared with standard medical management.Trial registration numberNCT03601949.

Cooled Radiofrequency Treatment for Radicular Pain Related to Lumbar Disc Herniation

“…Considering this, CRT emerges as a therapeutic option with greater effectiveness and a lower risk of severe adverse effects. This technique has been shown to offer statistically superior improvements across the spectrum of patients with chronic sacroiliac joint pain [29], intercostal neuralgia, knee osteoarthritis, discogenic lower back pain [30], and other painful conditions compared to standard medical management. Generally, the improvement of pain by CRT is obtained by ablating the nerves that give rise to the unpleasant sensation.…”

5. Sacroiliac joint pain

“…The efficacy of RFA treatments of the SI joint is demonstrated by numerous observational, [88][89][90] retrospective, [91][92][93] and randomized controlled studies. 58,[94][95][96][97][98][99][100] However, the selection criteria, definitions of success, RFA techniques (conventional monopolar, bipolar, multielectrode combination mono-and bipolar, and monopolar cooled), and parameters (ie, temperature, duration, and location of RFA treatment), and imaging techniques (fluoroscopy, CT, ultrasound) have varied widely between studies.…”

“…At the 3-month primary endpoint, 47% of patients in the RFA group experienced a positive outcome, defined as ≥50% reduction in average pain coupled with significant improvement in either the SF-36 bodily pain score or functional capacity measured by Oswestry disability index, versus 12% in the control group. In their most recent multi-center randomized controlled study involving 210 patients who responded with short-term relief to SI joint injections and experienced significant benefit with prognostic lateral branch blocks, Cohen et al 100 reported the superiority of the cooled RFA over standard medical management, with 52% of patients in the RFA group experiencing a positive categorical outcome at the 3-month endpoint versus only 4% in the control group.…”

“…Some, but not all randomized trials have used prognostic lumbar dorsal rami and sacral lateral branch blocks as predictive tools before RFA. 58,94,100 For the lateral rami of S1-S3, the image intensifier may need to be angled cephalad so that it is perpendicular to the posterior foramina, the targets for the finder needles. For S1, further angling the image intensifier ipslaterally often improves visualization of the posterior opening.…”