Combination Therapy with Simultaneous Delivery of Spinal Cord Stimulation Modalities: COMBO Randomized Controlled Trial
Mark S. Wallace, James North, Gregory M Phillips, Aaron Calodney, James Scowcroft, Bindu U Popat-Lewis, Jennifer M Lee, Edward P. Washabaugh, Julio Paez, Robert Bolash, John Noles, Joseph Atallah, Binit Shah, Farshad Ahadian, Drew M Trainor, Lilly Chen, Roshini Jain
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 ≥6 months). Primary end point was the proportion with ≥50% pain reduction without increased opioids at the 3-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 outcomes improvement 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)