Comparison of Spinal Cord Stimulation, Dorsal Root Ganglion Stimulation, and Association of Both in Patients With Refractory Chronic Back and/or Lower Limb Neuropathic Pain: A Prospective, Randomized, Double-Blind, Cross-Over Trial (BOOST-DRG Study)

Neuromodulation. 2024 Nov 22:S1094-7159(24)01193-0. doi: 10.1016/j.neurom.2024.10.003. Online ahead of print.

Abstract

Objectives: Spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRGS) have individually shown efficacy in relieving pain in patients with persistent spinal pain syndrome after spinal surgery (PSPS-T2). Combining SCS and DRGS simultaneously, along with Burst stimulation programming, may enhance the responder rate of patients with PSPS-T2.

Material and methods: This study aimed to compare the pain relief (≥50%) responder rates in SCS, DRGS, and SCS+DGRS (DUAL) through a three-month randomized cross-over trial in patients with PSPS-T2. After the cross-over period, stimulation programming was switched to Burst. Secondary objectives included evaluating the clinical efficacy at three-, four-, six-, and 12-month follow-ups, assessing pain intensity, area of pain, area of paresthesia coverage, quality of life, functional disability, psychologic distress, medication intake, and the Multidimensional Clinical Response Index (MCRI).

Results: The responder rate of pain relief was similar in SCS, DRGS, and DUAL (60%, p = 0.84) at the end of the cross-over period, increasing to 80% with the ability to switch between stimulation possibilities. Burst programming did not provide additional pain relief at the four-month follow-up (p = 0.99). Clinical outcomes significantly improved until 12-month follow-up compared with baseline. Considering a clinically significant increase of 1.05 of the MCRI, all patients were responders at three-, four-, and six- month follow-up, and 80% were responders at 12 months compared with baseline.

Conclusions: The full option to stimulate different neural structures, separately or simultaneously, led to improved responder rates, allowing patients to personalize treatment. A multidimensional assessment is essential to reveal the full potential benefits of neuromodulation in patients with chronic pain.

Keywords: Composite score; DRGS; PSPS; SCS; neural targets; neuromodulation; pain area.