Introduction

While Tonic Conventional Stimulation (TCS) constitutes the basis of Spinal Cord Stimulation (SCS), studies have shown that TCS does not appear to relieve pain for more than 30-55% of Failed Back Surgery Syndrome (FBSS) patients and provokes paresthesia that can be perceived as an uncomfortable sensation for patients (1). For these reasons, new sub-paresthesia stimulation modalities were investigated such as BURST and High Frequency (HF) stimulation waveforms relegating TCS as an has-been modality (2). However, there is no evidence of the preferred patient’s modality choice between TCS, BURST and HF.

Methods/Materials

This study is a prospective, controlled, randomized, cross-over, double-blinded study. 28 FBSS patients were recruited between February 2017 and January 2020. After implantation surgery, all patients received TCS treatment for a 2-month period and were thereafter randomized in one of the 6 arms with a 1:1:1:1:1:1 ratio. Patients then received a three-month specific set of 3 combinations of the 3 different waveforms delivering each treatment modality during a 1-month period. At the end of this 3-month period, each patient selected his/her preferred stimulation modality with a follow-up period of 12 months.

Results

An intermediate analysis will be conducted after the 3-month follow-up to observe the number of waveforms used by the patients and their waveform preferences.

Discussion

Patients will choose their preferred modalities depending on daily activities.

Conclusions

The possibility offered to the patient to modify waveform modality throughout a day could be a good opportunity to manage pain with SCS.

References

(1) Verrills P, Sinclair C, Barnard A. A review of spinal cord stimulation systems for chronic pain. J Pain Res. 2016;9:481–92.

(2) Viswanath O, Urits I, Bouley E, Peck JM, Thompson W, Kaye AD. Evolving Spinal Cord Stimulation Technologies and Clinical Implications in Chronic Pain Management. Curr Pain Headache Rep. 2019;23:39.