Schedule of outcome assessments for GaPP2
Phase | Run-in | Baseline, randomisation and treatment dispensed | Titration | Treatment | End of study and unblinding | Taper | |||||||
Duration (weeks) | −4 to −1 | 0 | 1–4 | 5–12 | 13–16 | 17–19 | |||||||
Weekly worst and average NRS | x | x | x | x | x | x | x | x | |||||
SF-12 | X | X | |||||||||||
BPI | X | X | |||||||||||
PCS | X | X | |||||||||||
SAQ | X | X | |||||||||||
BFI | X | X | |||||||||||
GHQ | X | X | |||||||||||
WPAIQ | X | X | |||||||||||
PainDETECT | X | X | |||||||||||
PUF | X | ||||||||||||
Adverse events | X | X | X | X | X | ||||||||
Permitted/concomitant medication | X | X | X | X | X | ||||||||
Adherence or discontinuation | X | X | X | X |
BFI, Brief Fatigue Inventory; BPI, Brief Pain Inventory; GHQ, General Health Questionnaire; NRS, Numerical Rating Scale; PCS, Pain Catastrophising Scale; PUF, Pelvic Pain and Urinary/Frequency Patient Symptom Scale; SAQ, Sexual Activity Questionnaire; SF-12, 12-Item Short-Form Health Survey; WPAIQ, Work and Productivity Activity Impairment Questionnaire.