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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)
Plain language summary
Spinal cord stimulation (SCS) is a device-based therapy for chronic pain that delivers electrical impulses to the spinal cord, disrupting pain signals to the brain. Pain relief can be achieved using different SCS techniques that use or do not use paresthesia (stimulation that produces a tingling sensation). These approaches affect patients in different ways, suggesting that different biological processes are involved in enabling pain relief. Research also suggests that better long-term results occur when patients can choose the therapy that is best for their own needs. This clinical study compared pain relief and other functional activities in those receiving combination therapy (simultaneous use of SCS that does and does not produce tingling sensation) against those receiving monotherapy (only SCS therapy producing tingling sensation) for 3 months. In the study, 88% of those receiving combination therapy and 71% with monotherapy alone reported a 50% (or greater) decrease in overall pain (the ‘responder rate’) without an increased dose of opioid drugs at 3 months after the start of therapy. This responder rate was found to be 84% at 1 year and 85% at 2 years (with all SCS therapy options available). Analysis of functional activities or disability showed that patients improved from ‘severely disabled’ at study start to ‘moderately disabled’ after 2 years, indicating that effective long-term (2 year) improvement can be achieved using SCS-based combination therapy for chronic pain.
Author contributions
Conception and design: M Wallace, L Chen and R Jain; Patient enrollment and data collection: all authors; data analysis: L Chen; manuscript preparation: M Wallace and R Jain. All authors have critically reviewed and approved the published version of the submitted manuscript.
Acknowledgments
The authors wish to express their great appreciation to D Halperin for providing substantial contribution to the writing and editing of this published manuscript, and to R Carbunaru and N Patel for their intellectual input and editorial review.
Financial & competing interests disclosure
M Wallace reports a consulting agreement from Boston Scientific; J North reports a consulting agreement with Boston Scientific; G Phillips reports a consulting agreement with Boston Scientific; A Calodney reports consultant fees or receives research support from Medtronic, Nevro, Stryker, Saluda, Nalu, Boston Scientific, Vertos, Painteq, Stimgenics, Spine BioPharma, Saol Therapeutics, Tissuetech, BioRestorative, FUSMobile and APEX Biologix; J Scowcroft reports research support from Boston Scientific, Nevro and Saluda Medical; B Popat-Lewis reports no conflicts; J Lee reports a consulting agreement with Boston Scientific; E Washabaugh III reports a consulting agreement and research funding from Boston Scientific, and research funding from Vertos; J Paez reports no conflicts; R Bolash reports a consulting agreement with AcelRx, Lilly, Medtronic, Nuvectra, Premier, Salix, TerCera, Jazz Pharmaceuticals and Pfizer; J Noles reports no conflict; J Atallah reports a consulting agreement with Boston Scientific; B Shah reports no conflicts; F Ahadian reports no conflicts; D Trainor reports a consulting agreement with Boston Scientific; L Chen reports employment with Boston Scientific; R Jain reports employment with Boston Scientific. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.
Data sharing statement
The authors certify that this manuscript reports original clinical trial data of NCT01719055. Individual and deidentified participant data will not be available. The data, analytical methods and study materials for this clinical study will be made available to other researchers in accordance with Boston Scientific’s data sharing policy (https://www.bostonscientific.com).