Table 1 Study schedule
Screening | V1 (day 1) | V2 (after trial) | V3 (3 months ± 30 days) | V4 (6 months ± 30 days) | V5 (12 months ± 60 days) | Time expenditure (min.) | |
|---|---|---|---|---|---|---|---|
NRS (0–10) (1 item) | x | x | x | x | x | x | 6 × 10 60 |
ODI (10 items) | x | x | x | x | 4 × 20 80 | ||
SF-36 (36 items) | x | x | x | x | 4 × 30 120 | ||
ADS-K | x | x | x | x | 4 × 30 120 | ||
Patient satisfaction with pain relief (0–10) (1 item) | x | x | x | x | 4 × 10 40 | ||
PSQI (24 items) | x | x | x | x | 4 × 20 80 | ||
Neurological status (50 items) | x | x | x | x | x | 5 × 30 150 | |
IPG-data (15 items) | x | x | x | x | 4 × 30 120 |