Table 2.
Study timeline. V0 to V14 represent the succesive patient visits for the purposes of this study. V0 is the inclusion visit (see heading « Visit Schedule»), V1–V6 represent the first phase; V7 is the evaluation after the first phase and cross-over, V8–V13 are the second phase visits and finally V14 is the final visit
| Study duration | Screening | Pre-inclusion | Inclusion V0 | Treatment (each month + / − 1 week) | V14 EOS | ||
|---|---|---|---|---|---|---|---|
| V1-V2-V3-V4-V5-V6 | V7 (cross over) | V8-V9-V10-V11-V12-V13 | |||||
| Inclusion / non-inclusion criteria | ✓ | ||||||
| Informed consent if positive test | ✓ | ||||||
| Randomization | ✓ | ||||||
| Pump implantation | ✓ | ||||||
| Clinical data | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| VAS Pain* | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| MINI | ✓ | ✓ | ✓ | ||||
| SF12 | ✓ | ✓ | ✓ | ||||
| McNair, HADS, BRIEF-A, PCS questionnaire | ✓ | ✓ | ✓ | ||||
| CSSRS questionnaire | ✓ | ✓ | |||||
| Treatment compliance/ medical events | ✓ | ✓ | ✓ | ✓ | |||
| Adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |