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Table 3 SubQStim study: summary of data collection

From: Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial

Study requirements

Screening

Baseline

Test stimulation implant

Permanent implant

Wound check

1 month

3 months

6 months

9 months

12 months

18 and 24 months

30 and 36 months

Unscheduled

Discontinued

Patient informed consent/patient information sheet

X

             

Screening inclusion/exclusion criteria

X

             

Demographics

X

             

Physical examination

X

             

Medical history

X

             

HCU history

X

             

VAS (point in time measurement only)

X

           

X

X

Back pain map

X

 

Xa

Xa

X

X

X

X

X

X

X

X

X

X

Paresthesia map (implanted subjects only)

  

X

Xa

X

X

X

X

X

X

X

X

X

X

Confirmation of 7-day baseline dairy inclusion criteria

 

X

            

Randomization assignment (after questionnaires)

 

X

            

HADS

 

X

            

painDETECT

 

X

            

EQ-5D

 

X

    

X

X

X

X

X

X

X

X

ODI

 

X

    

X

X

X

X

X

X

  

SF-36

 

X

    

X

X

X

X

X

X

  

PGIC

 

X

    

X

X

X

X

X

X

X

X

Implant information

  

Xa

Xa

          

Postoperative radiography

   

X

          

Subject satisfaction

      

X

X

X

X

X

X

X

X

7-day diary completion

      

X

X

X

X

X

X

  

Initial and final interrogations and uploads

  

X

X

X

X

X

X

X

X

X

X

X

X

Medication assessment

 

X

X

X

X

X

X

X

X

X

X

X

X

X

Protocol deviations

 

X

X

X

X

X

X

X

X

X

X

X

X

X

Event assessment (adverse events)

 

X

X

X

X

X

X

X

X

X

X

X

X

X

HCU

 

X

X

X

X

X

X

X

X

X

X

X

X

X

  1. EQ-5D EuroQoL five dimensions, HADS Hospital Anxiety and Depression Scale, HCU healthcare utilization, ODI Oswestry Disability Index, PGIC Patient Global Impression of Change, SF-36 Short-Form 36, VAS visual analog scale. aPre-implant and post-implant as indicated; otherwise, post-implant or post-reprogramming only.