RESUMO
OBJECTIVE: The article aims to study the safety and effectiveness of dorsal root ganglion (DRG) stimulation with a new device in the treatment of chronic pain. DESIGN: This is a prospective, single-arm, pilot study. SETTING: Four clinical centers were used as setting for this study. PATIENTS: Ten (10) patients with chronic intractable pain of the trunk and/or limbs were included. INTERVENTION: A trial period of DRG stimulation was studied. Two to four leads, each with four electrical contacts, were inserted using a minimally invasive epidural approach and steered toward the lateral epidural space, near the DRG. Leads were attached to an external trial stimulator and stimulation therapy was provided for three to seven days. OUTCOME MEASURES: Pain reduction using a visual analog scale, subject and physician-rated improvement, adverse event (AE) rates, device programming settings, and medication utilization was evaluated at baseline and at prospective follow-up time points during stimulation. RESULTS: On average, there was a 70% reduction in pain following stimulation (p = 0.0007). Eight of the nine patients experienced a clinically meaningful (>30%) reduction in pain, and seven of the nine reduced their pain medication utilization. Pain relief in specific anatomical regions such as the leg, back, and foot was also observed. No device-related AEs were reported. CONCLUSIONS: These initial results suggest that stimulation of the DRG can reduce pain in those patients suffering from chronic pain. DRG stimulation may offer several potential benefits over other neuromodulation techniques, including the ability to target difficult-to-reach anatomies such as the low back and foot.
