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Table 1 Multiwave study—summary of data collection

From: Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study)

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

  1. *Phone call: 1 week prior to the planned visit (patient diary)