Assessment of real-world, prospective outcomes in patients treated with lumbar radiofrequency ablation for chronic pain (RAPID).

Background: Lumbar facet joint syndrome (LFJS) is one of most common forms of chronic low back pain. Despite several decades of real-world use and a plethora of published studies, debate still exists regarding the effectiveness of Radiofrequency Ablation (RFA) as a therapy in LFJS-diagnosed patients. Objective: Here, we sought to evaluate real-world clinical outcomes in RFA-treated patients with chronic lumbar facetogenic pain participating in one of the largest studies of its kind published to date. Methods: The RAPID study (Clinicaltrials.gov identifier: NCT04673032) is an international, multicenter, prospective study of patients using a commercially-available radiofrequency ablation system for the treatment of chronic pain, provided per standard of care. Patients were assessed at pre-specified study follow-up visits (1-, 3-. 6-, 12-, and 24-months post-index procedure). Key clinical endpoint measures collected and evaluated include NRS (pain score), Oswestry Disability Index (functional disability, ODI), EQ-5D-5L (quality-of-life), and Patient Global Impression of Change (PGIC). Results: To date, 193 patients have been enrolled in this lumbar facetogenic pain patient cohort. Evaluation of pain relief amongst patients assessed out to 24-months demonstrated a mean NRS score of 3.4 (baseline NRS: 6.6, p < 0.0001). Consistent functional improvement out to 24-months was observed per an 8.6-point mean ODI score reduction (baseline ODI: 38.0, p < 0.0001). Following RFA treatment at 1-month and out to 24-months, 77.0% and 79.0% of patients were observed to be treatment responders (i.e., ≥50% pain relief), respectively. Enhanced levels in measures of quality-of-life (EQ-5D-5L) and self-reported health-related change (PGIC) were also consistently noted. Conclusions: Clinically meaningful and durable improvements in pain relief, functional disability, quality-of-life and treatment satisfaction were observed across all RAPID study follow-up visits. The results of the RAPID study provide for the potential clinical outcomes amongst selected patients with lumbar facetogenic pain within the real-world clinical setting.