boston scientific linear dorsal column stimulator

#Boston scientific linear dorsal column stimulator trial#

Complete inclusion and exclusion criteria can be found in Supplementary Data Table S1. After randomization, participants entered a two-to-three–day washout period during which pain intensity was required to return to baseline levels (defined as an increase to within 2 NRS points of the baseline pain score) before initiation of multiphase therapy.

#Boston scientific linear dorsal column stimulator trial#

Key exclusion criteria confirmed before randomization at the end of the commercial trial included reduction of ≤40% in overall pain intensity (NRS) from baseline no SCS trial lead positioned to cover the T8 or T9 vertebral level at the time of trial lead placement and presence of SCS trial lead migration causing inability to deliver SCS therapy.

Key exclusion criteria at the time of enrollment included morphine equivalent doses >120 mg/d documented history of substance abuse or dependency six months before baseline and immunocompromised and/or at high risk for infection. Other key inclusion criteria at the time of enrollment included the following: planned to undergo an SCS trial for the treatment of low back and/or leg pain with a commercially available SCS system and planned placement of two eight-electrode leads (or at least one 16-electrode lead), with at least one lead covering the T8 or T9 vertebral level. Patients aged ≥18 years with chronic low back and/or leg pain and baseline pain intensity (numerical rating scale, overall pain) ≥6 were included.