Long‐Term Effectiveness and Safety of Dorsal Root Ganglion Stimulation for Persistent Spinal Pain Syndrome: Results From an Expanded Prospective Registry

INTRODUCTION: Persistent spinal pain syndrome (PSPS) with predominant low-back pain (LBP) is difficult to manage when conservative and surgical treatments fail. Dorsal root ganglion stimulation (DRG-S) offers segmental, focal neuromodulation that may be particularly suited for managing axial LBP, yet long-term evidence from real-world practice remains limited. This study evaluated the effectiveness, safety, and impact on medication use of bilateral T12 DRG-S in patients with intractable LBP, using prospectively collected registry data. METHODS: Of 33 consecutive patients with chronic LBP assessed for DRG-S, 20 underwent trial stimulation after multidisciplinary evaluation. Eighteen (90%) proceeded to permanent implantation following ≥ 50% pain reduction during trial. Patients were followed via a digital platform at 3, 6, 12, and 24 months. Outcomes included pain intensity (NRS), quality of life (PROMIS-29), pain catastrophizing (PCS), satisfaction, medication use, and adverse events. Statistical comparisons were made between baseline and follow-up time points using paired tests. RESULTS: Pain intensity decreased substantially and significantly across all follow-up assessments: mean NRS declined from 8.0 ± 1.8 at baseline to 3.6 ± 1.6 at 3 months, 3.2 ± 1.8 at 6 months, 3.6 ± 1.7 at 12 months, and 2.9 ± 1.6 at 24 months (all p < 0.001). At 24 months, 100% of patients achieved ≥ 30% pain reduction and 70% achieved ≥ 50% reduction. Patient-reported outcomes demonstrated broad improvements. PROMIS-29 domains showed significant gains in physical function, pain interference, fatigue, and sleep disturbance, with consistent improvements also observed in anxiety and depression. Pain catastrophizing (PCS) scores decreased markedly, with total scores reduced by 47%-62% across follow-ups (all p < 0.001), reflecting improvements across helplessness, magnification, and rumination subdomains. Medication use declined over time. Mean opioid dose fell from 27 mg/day at baseline to 11.25 mg/day at 1 year and 4.44 mg/day at 2 years (p = 0.019 and 0.011, respectively). Paracetamol use also decreased significantly, whereas gabapentinoid use remained variable. Seven hardware-related complications were recorded (lead migration n = 3, lead fracture/damage n = 4), all successfully managed with revision surgery. Kaplan-Meier analysis estimated mean time to complication at 1080 days. Two patients discontinued therapy (EOT), both for reasons unrelated to device failure. CONCLUSIONS: In this prospective registry, bilateral T12 DRG-S provided durable reduction in pain intensity, improved physical, psychosocial, and cognitive outcomes, and facilitated meaningful opioid-sparing effects over 2 years. Complications were limited to correctable hardware issues, and therapy discontinuation was rare. Although larger multicentre studies are warranted, these findings add important real-world evidence supporting DRG-S as a valuable therapeutic option for refractory axial LBP.