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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.
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BMC Musculoskeletal Disorders

ISSN: 1471-2474

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