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

Autor:	Wallace MS; University of California, San Diego, San Diego, CA, 92093, USA., North JM; Carolinas Pain Institute & the Center for Clinical Research, Winston-Salem, NC, 27103, USA., Phillips GM; Pacific Sports & Spine, Eugene, OR, 97401, USA., Calodney AK; Precision Spine Care, Tyler, TX, 75701, USA., Scowcroft JA; Pain Management Associates, Lee's Summit, MO, 64086, USA., Popat-Lewis BU; Michigan Pain Consultants, Big Rapids, MI, 49307, USA., Lee JM; Evergreen Health Medical Group, Kirkland, WA, 98034, USA., Washabaugh EP 3rd; Michigan Pain Specialists, Ypsilanti, MI, 48198, USA., Paez J; South Lake Pain Institute, Clermont, FL, 34711, USA., Bolash RB; Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA., Noles J; Spine & Pain Specialists, Shreveport, LA, 71105, USA., Atallah J; The Toledo Clinic, Toledo, OH, 43606, USA., Shah B; Carolinas Pain Center, Huntersville, NC, 28078, USA., Ahadian FM; University of California, San Diego, San Diego, CA, 92093, USA., Trainor DM; The Denver Spine & Pain Institute, Denver, CO, 80033, USA., Chen L; Boston Scientific Neuromodulation, Valencia, CA, 91355, USA., Jain R; Boston Scientific Neuromodulation, Valencia, CA, 91355, USA.
Jazyk:	angličtina
Zdroj:	Pain management [Pain Manag] 2023 Mar; Vol. 13 (3), pp. 171-184. Date of Electronic Publication: 2023 Mar 03.
DOI:	10.2217/pmt-2022-0101
Abstrakt:	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).
Databáze:	MEDLINE
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