Table 1.
Procedure and evaluation times of the trial
| Visit | Baseline | 1 month | 3 months | 6 months |
|---|---|---|---|---|
| Visit number |
1 |
2 |
3 |
4 |
|
Recruitment & Clinical assessment | ||||
| Signing of informed consent |
X |
|
|
|
| Diagnosis |
X |
|
|
|
| Inclusion/exclusion criteria |
X |
|
|
|
| Sociodemographic variables |
X |
|
|
|
| Pain assessed with sphygmomanometer |
X |
X |
X |
X |
| Pain assessed with Analogue Visual Scale |
X |
X |
X |
X |
| Cognitive function (assessed with MEC) |
X |
X |
X |
X |
| Global function (evaluated by FIQ) |
X |
X |
X |
X |
| Anxiety and depression (assessed with HADS) |
X |
X |
X |
X |
| Quality of life (assessed by EuroQol 5D) |
X |
X |
X |
X |
| Clinical Global Impression (CGI) |
X |
X |
X |
X |
|
Neuroimage assessment | ||||
| Magnetic resonance spectroscopy |
X |
|
|
X |
|
Safety assessments | ||||
| Adverse events |
|
X |
X |
X |
|
Other study procedures | ||||
| Delivery of the research drug |
X |
X |
X |
|
| Inventory of drug taken back and used |
|
X |
X |
X |
| Concomitant pharmacological treatment | X | X | X | X |