Citations 2
Clinical utility of ECAP dosing in a real-world population delivered via EVOKE therapy: the ECAP study
Pope, Jill , Smith, Gregory L. , Goree, Johnathan , Mekhail, Nagy , Levy, Robert M. , Deer, Timothy R. , Vu, Chau , Shah, Jarna R , Costandi, Shrif , Rosen, Steven M., Bromberg, Todd A., Patel, Atish, Latif, Usman , Lad, Shivanand P. , Jameson, Jessica , Calodney, Aaron , Falowski, Steven , Smith, J. Carson , Guirguis, Maged , Boeding, Ronald B., Sprintz, Michael, Antony, Ajay, Patterson, Denis G., Laufer, Andras, Pilitsis, Julie G. , Miller, Nathan , Rosenfeld, David J. , Tate, Jordan L, Raslan, Ahmed M. , Kallewaard, Jan Willem , Leitner, Angela , Hanson, Erin, Soliday, Nicole, Petersen, Erika , Goree, Johnathan A , Mekhail, Nagy A , Costandi, Shrif J , Lam, Christopher M , Hayek, Salim , Hagedorn, Jonathan M , Kallewaard, Jan Willem , Duarte, Rui , Deer, Tim , Shah, Jarna , Rosen, Steven M, Sayed, Dawood , Lam, Christopher , Hayek, Salim M. , Hagedorn, Jonathan M. , Heros, Robert , Miller, Nathan, Tate, Jordan L, Hanson, Erin, Duarte, Rui
Regional Anesthesia & Pain Medicine | December 2, 2025 | Volume: No volume available | Issue: No issue available | Pages: rapm-2025-107051
Background The efficacy of EVOKE therapy, a closed-loop spinal cord stimulation (SCS) system, has been demonstrated in a double-blinded randomized controlled trial (RCT). RCT evidence, however, may not be generalizable to clinical practice, while limitations of real-world evidence may affect its validity. The aim of this study was to evaluate the effectiveness of EVOKE therapy in routine clinical practice employing a rigorous data collection approach. Methods The ECAP study was a prospective, multicenter, single-arm, pragmatic study that enrolled SCS candidates with chronic, intractable trunk and/or limb pain in 22 US investigational sites. PROMIS-29 questionnaire and objective neurophysiological metrics were collected, and minimal clinically important differences (MCIDs) were used to characterize baseline dysfunction and response to EVOKE therapy both at trial end and maximal analgesic effect post-implant visit. Pre-specified subgroup analyses were conducted based on diagnosis. Results EVOKE therapy observed included a dose ratio of 1.3 and neural dose accuracy of 2.8 μV. Improvements of >1 MCID were observed for all domains and improvements of ≥2 MCIDs were observed for six of the seven domains. Improvements observed at trial end were maintained or improved at post-implant visit, with statistically significant improvement in holistic MCID (MD 0.2, 95% CI 0.1 to 0.4, p=0.004), and a significantly greater proportion of patients considered holistic MCID responders (p=0.047). Subgroup analysis by diagnosis showed similar outcomes. Conclusions EVOKE therapy was associated with clinically meaningful improvements in a real-world chronic pain population across different subgroups and disease pathologies, with effects observed at trial end reproduced at post-implant visit.
Multiorganizational consensus to define guiding principles for perioperative pain management in patients with chronic pain, preoperative opioid tolerance, or substance use disorder
Dickerson, David , Mariano, Edward R. , Szokol, Joseph W., Harned, Michael , Clark, Randall M, Mueller, Jeffrey T. , Shilling, Ashley , Udoji, Mercy A. , Mukkamala, S Bobby, Doan, Lisa , Wyatt, Karla , Elkassabany, Nabil , Beck, Stacy , Wiechmann, Lisa, Chiao, Franklin, Halle, Steven G, Krishnan, Deepak G. , Cramer, John D. , Esa, Wael Ali Sakr, Muse, Iyabo O. , Baratta, Jaime L., Rosenquist, Richard W. , Gulur, Padma, Shah, Shalini , Kohan, Lynn , Robles, Jennifer, Yang, Stephen C. , Hadeed, Josef G., Schwartz, Gary , Sprintz, Michael, Urish, Kenneth L. , Walton, Ashley , Keith, Lauren, Buvanendran, Asokumar , Dickerson, David M , Muse, Iyabo O , Rosenquist, Richard , Schwenk, Eric S , Schwartz, Gary , Mariano, Edward R , Clark, Randall M., Schwalb, Jason M. , Eloy, Jean Daniel , Schwenk, Eric S. , Allen, Brian F.S. , Englesbe, Michael J. , Walton, Ashley, Keith, Lauren
Regional Anesthesia & Pain Medicine | April 25, 2023 | Volume: 49 | Issue: 10 | Pages: 716-724
Significant knowledge gaps exist in the perioperative pain management of patients with a history of chronic pain, substance use disorder, and/or opioid tolerance as highlighted in the US Health and Human Services Pain Management Best Practices Inter-Agency Task Force 2019 report. The report emphasized the challenges of caring for these populations and the need for multidisciplinary care and a comprehensive approach. Such care requires stakeholder alignment across multiple specialties and care settings. With the intention of codifying this alignment into a reliable and efficient processes, a consortium of 15 professional healthcare societies was convened in a year-long modified Delphi consensus process and summit. This process produced seven guiding principles for the perioperative care of patients with chronic pain, substance use disorder, and/or preoperative opioid tolerance. These principles provide a framework and direction for future improvement in the optimization and care of ‘complex’ patients as they undergo surgical procedures.