Post-polio Syndrome
Conditions
Brief summary
Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.
Interventions
BIOLOGICALintravenous immunoglobulins
One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days
BIOLOGICALSaline solution
Placebo
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* a history of acute poliomyelitis * increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis * a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi
Exclusion criteria
* clinically relevant systemic disease * malignancy * hypothyroidism * diabetes mellitus not fully controlled by medical therapy * medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome * conditions associated with prolonged coagulation time * serum IgA deficiency * previous allergic reaction to IVIG * body-mass index greater than 30 * immune-modulating treatments other than IVIG within the preceding 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SF-36 physical component | Baseline; 2 and 4 months after treatment |
Outcome results
None listed