Study requirements | Screening | Baseline | Test stimulation implant | Permanent implant | Wound check | 1 month | 3 months | 6 months | 9 months | 12 months | 18 and 24 months | 30 and 36 months | Unscheduled | Discontinued |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Patient informed consent/patient information sheet | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Screening inclusion/exclusion criteria | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Demographics | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Physical examination | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
HCU history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
VAS (point in time measurement only) | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | X |
Back pain map | X | Â | Xa | Xa | X | X | X | X | X | X | X | X | X | X |
Paresthesia map (implanted subjects only) | Â | Â | X | Xa | X | X | X | X | X | X | X | X | X | X |
Confirmation of 7-day baseline dairy inclusion criteria | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Randomization assignment (after questionnaires) | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
HADS | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
painDETECT | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
EQ-5D | Â | X | Â | Â | Â | Â | X | X | X | X | X | X | X | X |
ODI | Â | X | Â | Â | Â | Â | X | X | X | X | X | X | Â | Â |
SF-36 | Â | X | Â | Â | Â | Â | X | X | X | X | X | X | Â | Â |
PGIC | Â | X | Â | Â | Â | Â | X | X | X | X | X | X | X | X |
Implant information | Â | Â | Xa | Xa | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Postoperative radiography | Â | Â | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Subject satisfaction | Â | Â | Â | Â | Â | Â | X | X | X | X | X | X | X | X |
7-day diary completion | Â | Â | Â | Â | Â | Â | X | X | X | X | X | X | Â | Â |
Initial and final interrogations and uploads | Â | Â | X | X | X | X | X | X | X | X | X | X | X | X |
Medication assessment | Â | X | X | X | X | X | X | X | X | X | X | X | X | X |
Protocol deviations | Â | X | X | X | X | X | X | X | X | X | X | X | X | X |
Event assessment (adverse events) | Â | X | X | X | X | X | X | X | X | X | X | X | X | X |
HCU | Â | X | X | X | X | X | X | X | X | X | X | X | X | X |