Table 2 Study visits and associated assessments
Visit | Assessments |
|---|---|
Enrollment and screening | • Pain history and demographics • BDI-II • Pain Location Form • Medications • Provide subject with the 7-day Pain Diary for the baseline evaluation |
Baseline evaluation | • 7-day Pain Diary returned • SF-MPQ-2 • ODI2.1a • SF-36v2TM • PCS • Medications |
Trial system implantation | • 7-day Pain Diary returned • Medications |
End of trial visit (4–8 days after trial system implantation) | • Medications • End-of-trial physician assessment |
System implantation | • Medications • Physician’s record surgical summary for the procedure, including any complications |
Randomization/activation | • Medications • Participant programming record |
Control phase follow-up visits (Occurring at 6, 12, 18, and 24 weeks after randomization) | • 7-day Pain Diary returned • SF-MPQ-2 • ODI2.1a • SF-36v2TM • PCS • Medications • Paresthesia mapping • Self-evaluation |
End of control phase (Assessments occurring at the 24-week visit, in addition to those described above) | • PGIC • Patient preference |
Open-label phase follow-up visits (Occurring every 6 months for up to 2 years) | • 7-day Pain Diary returned • SF-MPQ-2 • ODI2.1a • SF-36v2TM • PCS • Medications • Paresthesia mapping • Self-evaluation |