NCT00949065

Intravenous Immunoglobulins in Complex-regional Pain Syndrome

Prospective, Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Effect of Intravenous Immunoglobulins on Complex Regional Pain Syndrome (CRPS, M. Sudeck)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether intravenous immunoglobulins are effective in the treatment of complex-regional pain syndrome.

Detailed description

CRPS, a chronic pain syndrome associated with trophic disturbances is a frequent complication after limb trauma. More than one third of the CRPS will continue to chronic disease including loss of function in one limb. Some reports implicate an autoimmune pathogenesis of CRPS. Especially the finding of autoantibodies against peripheral neurons and successful treatment in single cases provide evidence for a possible successful treatment of CRPS with intravenous immunoglobulins (IvIg). Therefore IvIg may be an important anti-inflammatory treatment to prevent severe chronification of CRPS. Since IvIg is mainly effective in B-cell-mediated autoimmune diseases, autoantibodies against autonomic neurons and the concentration of B-cell activating factors BAFF and APRIL will be measured in the course of the study.

Conditions

• Complex Regional Pain Syndrome Type 1

Interventions

Type	Name	Description
BIOLOGICAL	intravenous immunoglobulins	0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-01-01
• Completion: 2011-02-15
• First posted: 2009-07-30
• Last updated: 2021-07-15

Locations

1 site across 1 country: Germany