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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
NPS 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