Ti | T0 | T1 | T2 | T3 | T4 | T5 | T6 | T7 | T8 | |
---|---|---|---|---|---|---|---|---|---|---|
Incl | Tx | 3d | 7d | 14di | 14d | 4w | 6w | 3 m | 6 m | |
Informed consent | x | |||||||||
Baseline data | x | |||||||||
Patient diary * | x | x | x | x | x | |||||
Brief Pain Inventory | x | x | x | x | x | |||||
Assessment of adverse events (by telephone) | x | x | x | x | x | x | x | x | ||
Quality of life questionnaires ** | x | x | x | x | x | x | x | |||
Anxiety and depression in patient/partner/caregiver (HADS + EDIZ) | x | x | x | x | x | x | x | |||
Patient Global Impression of Change score | x | x | x | x | x | x | x | |||
CT and/or MRI *** | x | x | x |