Table 1 Summary of procedures performed per visit

Describe study to potential subject

X

Obtain informed consent

X

Collect demographics and medical history

X

Verify eligibility criteria

X

X

Physical examination

X

X

X

X

X

Placement of device

X

Pain Scale (VAS)

X

X

X

X

X

Carolinas Comfort Scale™

X

X

X

X

EQ-5D

X

X

X

X

Collect Adverse Events

X

X

X

X

X

Collect pain medications

X

X