Background and Aims In this study, we will report prospectively-collected outcomes from a multicenter, international study of patients treated with Radiofrequency Ablation (RFA) for management of chronic pain.
Methods RAPID (ClinicalTrials.gov: NCT04673032) is an international, prospective, multicenter, observational outcomes study of up to 1500 patients using a commercially-approved radiofrequency ablation system (Boston Scientific, Marlborough, MA), as indicated per local directions for use, for chronic pain. Key data and clinical assessments will include demographic characteristics, pain diagnosis, baseline (and post-treatment) pain scores, percent pain relief, patient global impression of change, change in disability, change in use of opioid medications, and occurrence of adverse events. Study participants will be evaluated out to 24 months. This study was approved by Institutional Review Board (IRB) for each site and is registered at Clinicaltrials.gov: NCT04673032.
Results To date, 104 subjects (mean age = 60.5 ± 12.7 years) have been enrolled. Of the 100 subjects that completed their procedure, 74 and 56 subjects reached their 1- and 3-months post-procedure visit. In addition, at 1-and 3-months post-procedure, a mean targeted pain score of 2.9 and 2.6 (0–10 scale) were reported, respectively. Seventy-seven percent of subjects reported ≥50% targeted pain relief at 1-month (75% at 3 months). Updated data will be presented.
Conclusions The data collected from this multi-national, prospectively-enrolled clinical investigation aims to offer a substantial bulk of real-world evidence regarding the use of RFA as a beneficial strategy for use in the treatment of chronic pain.
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