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

Abstract

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.