Table 1 Study flow-chart
|
Visit 1 baseline |
Visit 2 1 month |
Visit 3 3 months |
Visit 4 6 months |
Visit 5 12 months | |
|---|---|---|---|---|---|
| Data | |||||
| Medical history | X | ||||
| Informed consent | X | ||||
| Demographic data | X | ||||
| Inclusion criteria | X | ||||
| Adverse events | X | X | X | X | |
| Concomitant medication | X | X | X | X | |
| Treatment compliance | X | X | X | X | |
| Physical examination | X | X | X | ||
| MRI (1) | X | ||||
| Laboratory assays | X | X | X | X | X |
| IGF-1 levels (2) | X | X | X | X | X |
| Insulin tolerance secretion test (3) | X | ||||
| Tender points evaluation | X | X | X | X | X |
| Fibromyalgia Impact questionnaire | X | X | X | X | X |
| EuroQol EQ-5D + VAS | X | X | X | X | X |
| Rehabilitation | X | X | X | X | X |
| Psychological assistance | X | X | X | X | X |