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Table 1 Study flow-chart

From: Growth hormone as concomitant treatment in severe fibromyalgia associated with low IGF-1 serum levels. A pilot study

  Visit 1
baseline
Visit 2
1 month
Visit 3
3 months
Visit 4
6 months
Visit 5
12 months
Data      
Medical history X     
Informed consent X     
Demographic data X     
Inclusion criteria X     
Adverse events   X X X X
Concomitant medication   X X X X
Treatment compliance   X X X X
Physical examination X    X X
MRI (1) X     
Laboratory assays X X X X X
IGF-1 levels (2) X X X X X
Insulin tolerance secretion test (3) X     
Tender points evaluation X X X X X
Fibromyalgia Impact questionnaire X X X X X
EuroQol EQ-5D + VAS X X X X X
Rehabilitation X X X X X
Psychological assistance X X X X X
  1. (1) When baseline IGF-1 < 150 ng/ml to exclude pituitary lesion.
  2. (2) For patient inclusion and r-hGH dose adjustment.
  3. (3) When IGF-1 < 150 ng/ml.