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Table 1 Study flow chart (except laboratory assessments)

From: Intravenous immunoglobulin therapy for small fiber neuropathy: study protocol for a randomized controlled trial

 

Screening

Treatment phase

End of Treatment

Follow-up5

Assessment/Evaluation

- 10 days (Day -10 to Day 0)

Week 0 Baseline/ Day 1

Completion of baseline infusion

(Day 2, 3 or 4)3

3-6 Days after completion of baseline infusion4

Week 3,6,9

(± 3 days)

Week 12

(± 3 days)

Month 4, 5, 6

Informed Consent

X

      

Medical History/physical examination

X

      

Nerve Conduction Studies

X

      

Skin biopsy and QST

X

      

Laboratory Assessments

(see Table 2)

X

X

X

X

X

X

 

PI-NRS

X

   

X

X

X

PGIC

    

X

X

X

SFN-SIQ

X

   

X

X

X

NPS

X

   

X

X

X

SFN-RODS

X

   

X

X

X

Pain relief

    

X

X

X

Sleep quality

X

   

X

X

X

SF-36

X

   

X

X

X

Study Medication Infusion1

 

X

  

X

  

Vital Signs2

 

X

  

X

X

 

Concomitant Medication

X

X

X

X

X

X

X

Adverse Events

X

X

X

X

X

X

X

  1. 1 Medications given over 2 consecutive days at baseline and over 1 day every 3 weeks thereafter. Treatment is allowed to be prolonged up to 4 or 2 days respectively for reasons of tolerability
  2. 2 Vital signs (blood pressure and heart rate) to be taken right before infusion, 30 minutes after starting infusion, and immediately after infusion completed
  3. 3 Visit to be conducted after completion of entire baseline infusion (Day 2, 3, or 4 depending on duration of baseline infusion)
  4. 4 Visit to be conducted 3-6 days after completion of the baseline infusion, not 3-5 days after baseline/Day 1 infusion began
  5. 5 The follow-up period will be performed by standardized telephone call interviews
  6. QST = quantitative sensory testing, PI-NRS = pain intensity numerical rating scale, PGIC = patients’ global impression of change, RT-SFN-SIQ = Rasch-transformed small fiber neuropathy symptoms inventory questionnaire, NPS = neuropathic pain scale, SFN-RODS = small fiber neuropathy Rasch-built overall disability outcome scale, SF-36 = short form 36 health survey