Status:
WITHDRAWN
Intravenous Immunoglobulins in Complex-regional Pain Syndrome
Lead Sponsor:
University of Giessen
Conditions:
Complex Regional Pain Syndrome Type 1
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 func...
Eligibility Criteria
Inclusion
- CRPS 1 (according to the IASP criteria) between 6 weeks and 6 months after diagnosis
- skin temperature of the affected side equal or higher than on non-affected side
- no change of the analgetic or co-analgetic medication within the last 10 days
Exclusion
- Immunosuppressive or immunomodulatory treatment within the last three months
- CRPS previously treated with sympathetic block, lidocaine patch, local DMSO, spinal cord stimulation, intrathecal drug administration
- Known immune-mediated neuropathy (CIDP, MMN, MADSAM)
- Selective IgA-deficiency
- Severe heart disease
- Tumour disease in the last 5 years
- Allergy against Gamunex 10%
- Chronic renal disease Vaccination with live vaccine within the last three months
- Member of another clinical trial within the last 3 months
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00949065
Start Date
August 1 2009
End Date
February 15 2011
Last Update
July 15 2021
Active Locations (1)
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1
Hospital of the Justus-Liebig-University
Giessen, Hesse, Germany, 35392