Study procedure | Enrollment | Randomization | Screening test | Implant | 1 montha | 3 monthsb | 6 monthsb | 9 monthsb | 12 monthsb | 18 monthsb | 24 monthsb | Unscheduled | Early discontinuec |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Time window (days) | -90 to 0 | 0 | 0 to 57 | 3 to 60 | 10 to 67 | 68 to 137 | 138 to 228 | 229 to 319 | 320 to 455 | 456 to 637 | 638 to 789 | NA | NA |
Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Demographics (age, gender) | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Inclusion/exclusion criteria | X | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Pain location | X | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Pain diary (complete prior to visit) | Â | X | Â | Â | X | X | X | X | X | X | X | Â | X |
OMM treatment plan | Â | X | Â | Â | X | X | X | X | X | X | X | Â | Â |
Questionnaires (ODI, SF-36, EQ-5Dd, Pittsburgh Sleep Quality Index, employment status, pain and/or paresthesia map) | Â | X | Â | Â | Â | X | X | X | X | X | X | Â | X |
Randomization assignment | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Neuropathic pain (DN4) | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
PGIC, Patient satisfaction with therapy | Â | Â | Â | Â | Â | X | X | X | X | X | X | Â | X |
Nondrug pain treatment and other healthcare use assessment | Â | X | X | X | X | X | X | X | X | X | X | Â | X |
Payer information (US only) | X | Â | Â | Â | Â | Â | Â | Â | X | Â | X | Â | Â |
Medication assessment | Â | X | X | X | X | X | X | X | X | X | X | Â | X |
Event assessmentd | Â | X | X | X | X | X | X | X | X | X | X | X | X |
Screening test assessment | Â | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Implant information | Â | Â | X | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Request for change in randomized therapy | Â | Â | Â | Â | Â | Â | X | X | X | X | X | X e | Â |
SCS therapy thresholds | Â | Â | Â | Â | Â | Â | X | Â | Â | Â | Â | Â | Â |
Device interrogation (initial and final) | Â | Â | Â | X f | X | X | X | X | X | X | X | X | X |