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

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.