Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial.

Abstract

Aim: The Combining Mechanisms for Better Outcomes randomized controlled trial assessed the effectiveness of various spinal cord stimulation (SCS) modalities for chronic pain. Specifically, combination therapy (simultaneous use of customized sub-perception field and paresthesia-based SCS) versus monotherapy (paresthesia-based SCS) was evaluated. Methods: Participants were prospectively enrolled (key inclusion criterion: chronic pain for ≥6months). Primary end point was theproportion with ≥50% pain reduction without increased opioids at the3 month follow-up. Patients were followed for 2 years. Results: The primary end point was met (n=89; p<0.0001) in 88% of patients in the combination-therapy arm (n=36/41) and 71% in the monotherapy arm (n=34/48). Responder rates at 1 and 2 years (with available SCS modalities) were 84% and 85%, respectively. Sustained functional outcomesimprovement was observed out to 2 years. Conclusion: SCS-based combination therapy can improve outcomes in patients with chronic pain. Clinical Trial Registration: NCT03689920 (ClinicalTrials.gov), Combining Mechanisms for Better Outcomes (COMBO).