1. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial
- Author
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Mark S Wallace, James M North, Gregory M Phillips, Aaron K Calodney, James A Scowcroft, Bindu U Popat-Lewis, Jennifer M Lee, Edward P Washabaugh, Julio Paez, Robert B Bolash, John Noles, Joseph Atallah, Binit Shah, Farshad M Ahadian, Drew M Trainor, Lilly Chen, and Roshini Jain
- Subjects
General Medicine - 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 Clinical Trial Registration: NCT03689920 ( ClinicalTrials.gov ), Combining Mechanisms for Better Outcomes (COMBO)
- Published
- 2023
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