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

BDI-II Beck Depression Inventory BDI-II, OD12.1a Oswestry Disability Index 2.1a, PCS Pain Catastrophizing Scale, PGIC Patient Global Impression of Change, SF-36v2 ^TM Short-form 36 Health Survey, SF-MPQ-2 Short-Form McGill Pain Questionnaire version 2