Intravenous Immunoglobulins in Complex-regional Pain Syndrome
NCT ID: NCT00949065
Last Updated: 2021-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2009-08-31
2011-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Intravenous immunoglobulins (IvIg)
3 x 0.36-0.44g/Kg IvIg every 4 weeks, then 3 months washing out, then 3x NaCl 0.9% every 4 weeks
intravenous immunoglobulins
0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks
NaCl 0.9%
NaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks
intravenous immunoglobulins
0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks
Interventions
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intravenous immunoglobulins
0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of Giessen
OTHER
Responsible Party
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Dr. Marlene Tschernatsch
Dr.
Locations
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Hospital of the Justus-Liebig-University
Giessen, Hesse, Germany
Countries
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References
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Kohr D, Tschernatsch M, Schmitz K, Singh P, Kaps M, Schafer KH, Diener M, Mathies J, Matz O, Kummer W, Maihofner C, Fritz T, Birklein F, Blaes F. Autoantibodies in complex regional pain syndrome bind to a differentiation-dependent neuronal surface autoantigen. Pain. 2009 Jun;143(3):246-251. doi: 10.1016/j.pain.2009.03.009. Epub 2009 Apr 16.
Goebel A, Stock M, Deacon R, Sprotte G, Vincent A. Intravenous immunoglobulin response and evidence for pathogenic antibodies in a case of complex regional pain syndrome 1. Ann Neurol. 2005 Mar;57(3):463-4. doi: 10.1002/ana.20400. No abstract available.
Other Identifiers
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2007-007794-23
Identifier Type: -
Identifier Source: org_study_id
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