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.
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