Study visit | Visit 1 | Phone call | Visit 2 |
---|---|---|---|
Day 0 | Day 0 + 7 days, 14 days, 21 days (interval 1 day) | Day 28 | |
Clinical interviews | |||
Informed consent | × | ||
Inclusion and exclusion criteria | × | ||
Clinical examination: diagnosis of fibromyalgia | × | ||
Measures | |||
Numeric pain rating scale | × | × | |
Assessment of pain threshold to a thermal stimulus | × | × | |
Test-stimulus intensity ‘pain 60/stimulus’ | × | × | |
Conditioned pain modulation test | × | × | |
Cantab® tests | × | × | |
Treatment | |||
Randomization: delivery of therapeutic units | × | ||
Reporting of adverse events and concomitant treatments | × | × | × |
Treatment compliance | × | × | |
Reporting of adverse events and concomitant treatments | × | × | × |
Return of therapeutic units | × |