A pragmatic randomized prospective trial of cooled radiofrequency ablation of the medial branch nerves versus facet joint injection of corticosteroid for the treatment of lumbar facet syndrome: 12 month outcomes

Abstract Background Lumbar medial branch radiofrequency ablation (LRFA) and intraarticular facet steroid injections (FJI) are commonly performed for recalcitrant facet joint-mediated pain. However, no study has compared clinical outcomes of the two treatments in patients selected using dual medial branch blocks (MBBs) with an 80% relief threshold. Objective Compare the effectiveness of cooled LRFA (C-LRFA) to FIJ as assessed by pain and functional improvements. Design Prospective randomized comparative trial. Methods Patients with dual MBB-confirmed facet joint-mediated pain were randomized to receive C-LRFA or FIJ. Outcomes were assessed at 1, 3, 6, and 12 months. The primary outcome was ≥50% improvement in numerical pain rating scale (NPRS) score at 3 months. Secondary outcomes included ≥30% Oswestry Disability Index (ODI) improvement and Patient Global Impression of Chance (PGIC) ≥6 points, among others. Data were analyzed using contingency tables and mixed-effects logistic regression models. Results Of 1128 patients screened, 32 met eligibility criteria, were randomized, and received their allocated study treatment. In total, 20 (62.5%) and 12 (37.5%) participants received C-LRFA and FIJ, respectively. In the C-LRFA group, 70% (95% CI 48–85), 55% (95% CI 34–74), and 45% (95% CI 26–66) of participants met the NPRS responder definition, compared to 25% (95%CI 9–53), 25% (95% CI 9–53), and 17% (95% CI 5–45) in the FJI group at 3, 6, and 12 months, respectively (P = .014 at 3 months). The PGIC responder proportion was higher in the C-LRFA compared to FJI group at 3 and 6 months (P < .05). Conclusions C-LRFA demonstrated superior success rates compared to FJI across pain and functional outcome domains. Trial registration details ClinicalTrials.gov (NCT03614793); August 3, 2018.