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Table 1 PROMISE study – summary of data collection

From: Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study)

Study procedure

Enrollment

Randomization

Screening test

Implant

1 montha

3 monthsb

6 monthsb

9 monthsb

12 monthsb

18 monthsb

24 monthsb

Unscheduled

Early discontinuec

Time window (days)

-90 to 0

0

0 to 57

3 to 60

10 to 67

68 to 137

138 to 228

229 to 319

320 to 455

456 to 637

638 to 789

NA

NA

Informed consent

X

            

Demographics (age, gender)

X

            

Medical history

X

            

Inclusion/exclusion criteria

X

X

           

Pain location

X

X

           

Pain diary (complete prior to visit)

 

X

  

X

X

X

X

X

X

X

 

X

OMM treatment plan

 

X

  

X

X

X

X

X

X

X

  

Questionnaires (ODI, SF-36, EQ-5Dd, Pittsburgh Sleep Quality Index, employment status, pain and/or paresthesia map)

 

X

   

X

X

X

X

X

X

 

X

Randomization assignment

 

X

           

Neuropathic pain (DN4)

 

X

           

PGIC, Patient satisfaction with therapy

     

X

X

X

X

X

X

 

X

Nondrug pain treatment and other healthcare use assessment

 

X

X

X

X

X

X

X

X

X

X

 

X

Payer information (US only)

X

       

X

 

X

  

Medication assessment

 

X

X

X

X

X

X

X

X

X

X

 

X

Event assessmentd

 

X

X

X

X

X

X

X

X

X

X

X

X

Screening test assessment

  

X

          

Implant information

  

X

X

         

Request for change in randomized therapy

      

X

X

X

X

X

X e

 

SCS therapy thresholds

      

X

      

Device interrogation (initial and final)

   

X f

X

X

X

X

X

X

X

X

X

  1. DN4, Douleur neuropathique en 4 questions; ODI, Oswestry Disability Index; OMM, optimal medical management; PGIC, Patient Global Impression of Change; SF-36, Short-Form 36; SCS, spinal cord stimulation.
  2. aFor subjects randomized to SCS, the 1-month visit should occur a minimum of 7 days after implant (or screening test if the test was unsuccessful).
  3. bVisits should occur within the window but at least 2 weeks after the previous visit.
  4. cEarly discontinuation, collect data if possible.
  5. dWhen possible, collect additional EuroQoL (EQ-5D) at time of event if device-related event requiring surgical intervention or hospitalization occurred.
  6. eOnly after 6 months.
  7. fNo initial interrogation at implant, final only.