Multisystem Spinal Cord Stimulation Trialing: A Single Center, Retrospective, Observational Study

Abstract

Background Spinal cord stimulation is a well‐established modality for the treatment of chronic intractable pain. The safety and efficacy of various stimulation therapy designs have been demonstrated in multiple randomized controlled studies, oftentimes comparing an investigational device to an existing commercial therapy. In the real‐world setting, data are lacking regarding selection of spinal cord stimulation (SCS) therapy, as waveform, pulse trains, and programming are not interchangeable among the devices. The purpose of this study is to help dissect a methodology for a patient centric multisystem trialing. Methods We conducted a single center, retrospective, open label observational chart review. Between June 2017 and June 2019, 83 patients underwent SCS trials. Devices from four commercially available systems were trialed. Patients were given the opportunity to trial up to three systems. If the patient reported 50% or more pain relief/functional improvement with the trial, they were able to choose which system they liked best and proceed with implantation. Results There were 82% (68/83) of patients who proceeded to permanent implant, with 72 patients electing to trial more than one stimulation paradigm. Of those, 62 trialed 2 SCS systems, whereas 11 trialed 3. During the SCS trials, loss of efficacy due to lead migration was 1.2% (1/83) and no infections occurred. The average pain score measured on the numeric pain rating scale (NRS), improved from 6.8 at baseline to 2.9 after implantation. Conclusions Multisystem trialing is safe and effective in providing patients increased exposure to multiple commercially available SCS systems.

Role of patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain: a comprehensive narrative review

“…Among two other studies reporting on trial-related infections, minor infection was noted in 6%119 and 1.3% 143. Lead migration and unintended stimulation were noted by two studies 9 118…”

“…Retrospective studies comparing the two approaches noted no differences in trial success rate, but differences in complications noted later in this section 9 119. In a recent study, Buchanan et al trialed multiple systems from different manufacturers to be used in sequence (3–5 days) during the trial period and noted that a majority preferred to be tested with two different systems and among 81% trial responders, 48% chose the first system 118…”

“…We included 41 studies,7 9 113–151 with 13 of them specifically evaluating trial outcomes or its predictors or trial-related parameters9 113 118–123 127 137 138 143 147 150 (table 4). The remaining studies evaluated predictors of therapy response related to non-pain characteristics.…”

Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain

“…Recent developments in the field allow different types of stimulation, and the ability to check for responses to different waveforms/technologies during the trial phase 111. If a patient demonstrates an indeterminate response with one type of waveform, adapting the inserted leads to use a different type of stimulation or a different technology without the need for another trial procedure is considered in clinical practice 112. However, there is limited literature to indicate the benefits achieved, in terms of improving trial success rate and subsequent long-term therapy.…”

Spinal Cord Stimulation for Failed Back Surgery Syndrome: to Trial or Not to Trial?

“…Therefore, trialing patients with multiple waveforms might become highly relevant. 3 Although SCS relieves pain in a cost-effective way, 29 SCS trials may raise healthcare costs in some cases or could even exceed cost-effectiveness 14 due to a higher infection rate, repeated surgery, and potential second trials if patients are reconsidered to undergo SCS therapy. 12,34 The overall evidence for the use of SCS trials is incomplete.…”