Study procedure | Enrollment visit | Implantation visit (inclusion) | M0 visit (randomization) | M1 | M2 | M3 | M6 | M9 | M15 |
---|---|---|---|---|---|---|---|---|---|
Patient information | x | ||||||||
Informed consent form | x | ||||||||
Inclusion and exclusion criteria | x | x | |||||||
Thoracolumbar X-rays | x | x | |||||||
Medical and surgical history (including TENS therapy) | x | ||||||||
Analgesic treatments, concomitant medications and non-drug treatments | x | x | x | x | x | x | x | x | x |
DN4 questionnaire (neuropathic pain) | x | ||||||||
N3MT (NeuroMapping Tool) pain surface, intensities, paraesthesia coverage | x | x (pre/per/post-implantation) | x | x | x | x | x | x | x |
Paraesthesia perception VAS | x (pre/post-implantation) | x | x | x | x | x | x | x | |
Global, back and leg pain VAS | x | x | x | x | x | x | x | x | x |
Patient diary (complete within 1 week prior to visit) | x | x | x | x | x | x | x | x | |
Nasal Staphylococcus aureus decolonization (2 days prior to visit till 2 days after) | x | ||||||||
Phone call* | x | x | x | x | x | x | x | x | |
EUROQOL 5-Dimensions (EQ5D) | x | x | x | x | x | x | x | x | x |
Oswestry Disability Index (ODI) | x | x | x | x | x | x | x | x | x |
Hospital Anxiety and Depression Scale (HADS) | x | x | x | x | x | x | x | x | x |
Patient Satisfaction/Patient Global Impression of Change (PGIC) | x | x | x | x | x | x | x | ||
Programming session | x | x | x | x | x | x | x | x | |
Adverse event/severe adverse event | x | x | x | x | x | x | x | x | x |