Clinical trial NCT00949065: Intravenous Immunoglobulins in Complex-regional Pain Syndrome
Official title: Prospective, Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Effect of Intravenous Immunoglobulins on Complex Regional Pain Syndrome (CRPS, M. Sudeck)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Complex Regional Pain Syndrome Type 1
Keywords: complex regional pain syndrome
sympathetic reflex dystrophy
intravenous immunoglobulins
autoimmune disease
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in impairment Level SumScore (ISS)
timeFrame: after 0,3,6,9 months
Secondary outcomes:
measure: Pain disability score
timeFrame: 0,3,6,9 months
measure: Quality of life (SF-36)
timeFrame: 0,3,6,9 months
measure: Titer of surface-binding neuronal autoantibodies in the serum
timeFrame: 0,3,6,9 months
measure: Serum concentration of B-cell activating factors BAFF, APRIL
timeFrame: 0,3,6,9 months
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Hospital of the Justus-Liebig-University
state: Hessen
Study officials:
References:
citation: 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.
citation: 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.