Intravenous Immunoglobulins in Complex-regional Pain Syndrome

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

Detailed Description
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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.

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

Conditions
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Complex Regional Pain Syndrome Type 1

Intervention / Treatment
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* Biological: intravenous immunoglobulins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous immunoglobulins (IvIg)<br>3 x 0.36-0.44g/Kg IvIg every 4 weeks, then 3 months washing out, then 3x NaCl 0.9% every 4 weeks | Biological: intravenous immunoglobulins<br>* 0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks<br>* Other names: Gamunex 10%;|
| Placebo Comparator: NaCl 0.9%<br>NaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks | Biological: intravenous immunoglobulins<br>* 0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks<br>* Other names: Gamunex 10%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in impairment Level SumScore (ISS) |  | after 0,3,6,9 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complex regional pain syndrome, sympathetic reflex dystrophy, intravenous immunoglobulins, autoimmune disease