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Table 4 Participant data collection time line

From: High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN)

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

  1. Abbreviations: SCS spinal cord stimulation, VAS visual analog scale