Dorsal column stimulator trial2/9/2024 The watch also was used to collect sleep quality scores and continuously recorded daily physical activity via the accelerometer. During the commercial trial and investigational phase, daily patient-reported NRS pain intensity scores (overall, back, leg) were collected in the at-home setting via the electronic watch at prescheduled 12-hour intervals participants also logged notable increases or decreases in pain. To assess real-world pain relief, electronic watches were provided at the time of enrollment. In-office NRS pain intensity and percent pain relief (PPR) were assessed for in-office visit 1 (capturing commercial trial) and in-office visits 2 and 3 (capturing investigational phase) for overall, leg, and back pain. Pain intensity was collected in two settings: 1) in-office via questionnaires administered during study visits and 2) at-home via electronic watches and written diaries. Throughout the 11-to-12–day investigational phase, remote follow-up included daily phone calls to adjust stimulation according to a predefined dosing protocol. Upon meeting washout criteria, multiphase SCS (therapy A or B) was initiated remotely. During the washout period, participants were aware that stimulation was turned off but were not informed that return of pain intensity to baseline levels was required to proceed to the investigational phase. Participants then entered a two-to-three–day washout period without any stimulation, during which pain intensity was required to increase to within 2 NRS points of baseline to proceed to activation of multiphase stimulation participants who did not return to within 2 NRS points of baseline were excluded for washout failure. During this visit, the investigational EPG was tested and programmed according to the participants’ randomly assigned multiphase therapy, but stimulation was not enabled. Commercial Trial Phase ProceduresĪt in-office visit 1 (end of commercial trial phase), eligible participants who experienced a successful trial had their commercial EPG disconnected and existing leads connected to the investigational EPG. A study design diagram can be found in Supplementary Data Figure S1. During the investigational phase, participants received their randomly assigned multiphase therapy (A: approximately 600–1500 Hz or B: approximately 300–600 Hz) for 11 or 12 days, depending on the duration of washout. The second was an investigational phase, which followed a two-to-three–day washout period designed to mitigate therapeutic carryover effects from the commercial trial. The first was a commercial SCS screening trial, which typically lasted five to seven days and was carried out according to standard routine of investigators at each clinical site. After enrollment and baseline assessments, participants underwent two consecutive SCS trial phases. At the enrollment visit, participants completed baseline assessments and were provided an electronic watch (CamNTech LTD, Cambridge, UK) and written diaries for collecting patient-reported outcomes (watch and diary) and physical activity data (watch) throughout the study. Randomization and MaskingĬonsenting patients identified by the investigators from their general patient populations were assessed for eligibility on the basis of study inclusion and exclusion criteria. 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. 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.
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