Intravenous Immunoglobulins in Complex-regional Pain Syndrome

University of Giessen

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Complex Regional Pain Syndrome Type 1

Interventions

intravenous immunoglobulinsBIOLOGICAL

0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital of the Justus-Liebig-University

Giessen, Hesse, Germany

Outcomes

Primary Outcomes

Change in impairment Level SumScore (ISS)

Time frame: after 0,3,6,9 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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