Clinical Trial: Intravenous Immunoglobulins in Complex-regional Pain Syndrome

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective, Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Effect of Intravenous Immunoglobulins on Complex Regional Pain Syndrome (CRP

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

Detailed Summary: 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.
Sponsor: University of Giessen

Current Primary Outcome: Change in impairment Level SumScore (ISS) [ Time Frame: after 0,3,6,9 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain disability score [ Time Frame: 0,3,6,9 months ]
  • Quality of life (SF-36) [ Time Frame: 0,3,6,9 months ]
  • Titer of surface-binding neuronal autoantibodies in the serum [ Time Frame: 0,3,6,9 months ]
  • Serum concentration of B-cell activating factors BAFF, APRIL [ Time Frame: 0,3,6,9 months ]


Original Secondary Outcome: Same as current

Information By: University of Giessen

Dates:
Date Received: July 29, 2009
Date Started: August 2009
Date Completion: April 2011
Last Updated: July 29, 2009
Last Verified: July 2009