Table 1 SPIRIT figure of study structure
Study period | ||||||
|---|---|---|---|---|---|---|
Timepoint | Enrolment | Implantation | Trial | 3 months | 6 months | 12 months |
Enrolment: | ||||||
Eligibility screening | X | |||||
Informed consent | X | |||||
Randomization | X | |||||
Intervention: | ||||||
Active burst neuromodulation | X | X | X | X | X | |
Passive burst neuromodulation | X | X | X | X | X | |
Open-label phase | In case of LOE | In case of LOE | In case of LOE | In case of LOE | X | |
Assessments: | ||||||
PCS | X | X | X | X | X | |
NRS | X | X | X | X | X | |
ODI | X | X | X | X | X | |
PainDETECT | X | X | X | X | X | |
PVAQ | X | X | X | X | X | |
HADS | X | X | X | X | X | |
PGIC | X | X | X | X | X | |
CPH/CPM | X | X | X | |||