Table 2

Schedule of outcome assessments for GaPP2

PhaseRun-inBaseline, randomisation and treatment dispensedTitrationTreatmentEnd of study and unblindingTaper
Duration (weeks)−4 to −101–45–1213–1617–19
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.