Visit | S | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
---|---|---|---|---|---|---|---|---|---|
Week | 1 | 2 | 3 | 4 | |||||
Informed consent | ● | ||||||||
Demographic characteristics | ● | ||||||||
Vital signs | ● | ● | ● | ● | ● | ● | ● | ● | ● |
Blood test | ● | ● | |||||||
Medical history | ● | ||||||||
Inclusion/Exclusion criteria | ● | ||||||||
Conformity assessment | ● | ||||||||
Treatment expectancy questionnaire | ● | ||||||||
Random allocation | ● | ||||||||
Treatment | ● | ● | ● | ● | ● | ● | ● | ● | |
Prescription of rescue medicine | ● | ||||||||
PI-NRS | ● | ● | ● | ● | ● | ● | ● | ● | |
NDI | ● | ● | |||||||
CROM | ● | ● | |||||||
HRV | ● | ● | |||||||
Perceived stress scale | ● | ● | |||||||
EQ-5D | ● | ● | |||||||
PGIC | ● | ||||||||
Pressure pain threshold | ● | ● | |||||||
Consumption of rescue medicine | ● | ||||||||
Days of restricted activity | ● | ● | |||||||
Blinding test | ● | ● | |||||||
Safety assessment | ● | ● | ● | ● | ● | ● | ● | ● |