How Should we Use Multicolumn Spinal Cord Stimulation to Optimize Back Pain Spatial Neural Targeting? A Prospective, Multicenter, Randomized, Double-Blind, Controlled Trial (ESTIMET Study)

Finite Mixture Models Based on Pain Intensity, Functional Disability and Psychological Distress Composite Assessment Allow to Identify Two Distinct Classes of Persistent Spinal Pain Syndrome after Surgery Patients Related to Their Quality of Life

“…The vast majority of comparative pain research works are based on primary outcomes focused on pain reduction scores (VAS or NPRS). Regarding spinal cord stimulation; as an example; national and international guidelines recommend permanent implantation of neurostimulation devices based on a 30% or a 50% pain decrease during the trial period [36][37][38]; but this can only reflect an angle of pain assessment prism [39;40]. Harmful consequences of focusing exclusively on pain intensity have been observed by Ballantyne and Sullivan [30]; who contended that the multimodal pain management approaches proposed to chronic pain patients should include behavioral and physical-rehabilitation; which cannot be adequately evaluated using only pain intensity measures [41].…”

Machine Learning Algorithms Provide Greater Prediction of Response to Scs Than Lead Screening Trial: A Predictive AI-Based Multicenter Study

“…The first study is ESTIMET [18], which is a multicenter randomized controlled trial, including 115 PSPS-T2 patients eligible for SCS and implanted with surgical multicolumn SCS paddle lead, in 12 French centers with a 1-year follow-up. The study details are available at https://clinicaltrials.gov/ct2/show/NCT01628237.…”

“…The primary objective of this study was to compare the efficacy of multicolumn SCS programming to the efficacy of monocolumn SCS programming. As part of the ESTIMET study, all subjects provided informed consent and enrolled following ethical committee approval (CPP-Ouest III) [18]. The study population consisted of PSPS-T2 patients with refractory pain, eligible to SCS according to the French guidelines for SCS selection and implantation.…”

“…With a legitimate determination to bring some medico-economic rationale to technological evolution, health care systems provide strict rules of SCS implantation since its initial diffusion; following international recommendations, a lead trial must be performed and validated before any permanent device implantation [16][17][18][19]. In addition, SCS lead trialing is intended to potentially optimize neural structure spatial targeting, as some implanters choose to perform intra-operative table testing and/or deliberate temporary trial to optimize lead placement, and to reimplant the same patient later permanently, when test results are positive [20].…”

“…However, recent clinical data highlight some major limitations of this approach: -First, one can observe a lack of homogeneity among practices, making comparisons and recommendations regarding lead trialing very difficult: a patient can be trialed with a surgical lead (requiring an invasive approach) vs a percutaneous trial, where one, two or three percutaneous lead(s) are placed in the spinal canal, under local sedation or general anesthesia [14,18]; he can be trialed from 3 to 28 days, depending on healthcare systems [22], which is responsible for significant differences in terms of lead trial complication rates [14]; during the trial, patients can test one, a few, or hundreds of programs [18], which might affect lead trial outcome, depending on the clinical expertise of the implanting team and trial duration. Ultimately, lead trialing could create a bias since the trial cannot be blinded except in paresthesia-free techniques at the price of strict protocols, which cannot be standardized among practices, centers and countries, except for research purposes.…”