gms | German Medical Science

Objective: Dorsal root ganglion (DRG) stimulation provides treatment with high levels of dermatomal specificity and can provide advantages compared to conventional spinal cord stimulation (SCS). The purpose of this study is to evaluate the real-world clinical outcomes of DRG stimulation for the treatment of chronic neuropathic pain.

Methods: This prospective, single-arm, single-center, post-market study included 33 consented subjects. Clinical indications were varied and were comprised of those diagnosed with: peripheral nerve injury (n=17), failed back surgery syndrome (n=6), complex regional pain syndrome (n=3), post-amputation pain (n=1), peripheral polyneuropathies (n=1), radicular pain (n=1) and other (n=4). A total of 27 subjects met inclusion criteria: chronic pain for at least 6 mo, failed conservative treatments, and a baseline VAS of 6. Clinical endpoints included pain relief (VAS), quality of life (EQ-5D), mood profile (POMS), physical functioning (BPI), and subject satisfaction. Outcomes data were made at the 1-week post-implant and 1, 3, 6, and 12-mo FUs.

Results: Of the 27 subjects who proceeded external trial, 15 reported optimal pain relief (­50%), a response rate of 55.5%. For the responder subjects, average pain ratings were decreased from 8.3 (SD 1.3) at baseline to 1.7 (SD 1.7) at the 1-week FU and 2.4 (SD 2.2) at the 12-mo FU. In the 8 subjects available at the 12-mo FU, 6 (75%) had maintained greater than 50% pain reduction. Corresponding improvements in pain severity, pain interference, and total mood disturbance measures were also discovered at the 12-mo FU.

Conclusion: This study suggests that DRG neurostimulation therapy can provide multi-modal clinical benefits for patients with chronic neuropathic pain. Substantial and prolonged pain relief can be achieved over a period of 12 mo across a diverse population of chronic pain etiologies. Additional prospective studies are needed to further inform the patient.