Week | Screening (baseline) | 1 | Â | 2 | Â | 3 | Â | 4 | Â | 5 | 7 | 9 | 12 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
Informed consent | o | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Demographic characteristics, Medical history | o | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Inclusion/Exclusion criteria | o | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Blood test | o | Â | Â | Â | Â | Â | Â | Â | Â | o | Â | Â | o |
MRI | o | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | o |
Credibility and Expectancy Questionnaire | o | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Blinding test | Â | Â | Â | o | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Randomization | Â | o | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Treatment | Â | o | o | o | o | o | o | o | o | Â | Â | Â | Â |
Education program | Â | o | Â | o | Â | o | Â | o | Â | o | o | o | o |
NRS | o | o | o | o | o | o | o | o | o | o | o | o | o |
VAS | Â | o | Â | o | Â | o | Â | o | Â | o | o | o | o |
ODI | Â | o | Â | o | Â | o | Â | o | Â | o | o | o | o |
Physical examination | Â | o | Â | o | Â | o | Â | o | Â | o | o | o | o |
SF-36 | Â | o | Â | Â | Â | Â | Â | Â | Â | o | o | Â | o |
EQ-5D | Â | o | Â | Â | Â | Â | Â | Â | Â | o | o | Â | o |
PGIC | Â | Â | Â | Â | Â | Â | Â | Â | Â | o | o | Â | o |
Safety assessment | Â | o | o | o | o | o | o | o | o | o | o | o | o |
Use of medication | Â | o | o | o | o | o | o | o | o | o | o | o | o |