Assessment | Enrollment | Trial and permanent phase (SCS only) | Follow-up phase | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit | Consent | Entry criteria | Baseline assessment | Trial implant | End of trial | Permanent implant | Device activation | 1-month visit | 3-month visit | 6-month visit | 9-month visit | 12-month visit | 18-month visit | 24-month visit |
Informed consent | X | |||||||||||||
Medication usage | X | X | X | X | X | X | X | X | X | X | X | X | X | |
Health-care utilization | X | X | X | X | X | X | X | X | ||||||
Pain assessment (VAS) | X | X | X | X | X | X | X | X | X | X | ||||
Weight | X | X | X | X | X | X | ||||||||
Neuropathic pain assessment (DN4) | X | X | X | X | X | X | X | |||||||
Modified Neuropathy Symptom Score (NSS) | X | X | X | X | X | X | X | |||||||
Brief Pain Inventory (BPI-DPN) | X | X | X | X | X | X | X | X | ||||||
Pain experience (SF-MPQ-2) | X | X | X | X | X | |||||||||
Diabetes quality of Life (DQOL) | X | X | X | X | X | |||||||||
Quality of life assessment (EQ-5D-5L) | X | X | X | X | X | |||||||||
Pain and sleep assessment (PSQ-3) | X | X | X | X | X | X | X | X | ||||||
Patient Global Impression of Change (PGIC) | X | X | X | X | ||||||||||
Clinical Global Impression of Change (CGIC) | X | X | X | X | ||||||||||
Global Assessment of functioning (GAF) | X | X | X | X | X | X | X | X | ||||||
Six-minute walk test (6MWT) | X | X | X | X | ||||||||||
Hemoglobin A1c | X | X | X | X | X | X | ||||||||
Subject satisfaction | X | X | X | X | ||||||||||
Neurological assessment | X | X | X | X | X | X | ||||||||
Work status and disability | X | X | X | X | ||||||||||
Adverse event monitoring | X | X | X | X | X | X | X | X | X | X | X | X | X | |
Wound assessment | X | X | X | X | X | X | X | X | X |