Intravenous Immunoglobulins in Complex-regional Pain Syndrome (PAINLESS)

University of Giessen

Status and phase: Withdrawn; Phase 3

Conditions: Complex Regional Pain Syndrome Type 1

Treatments: Biological: intravenous immunoglobulins

Study type: Interventional

Funder types: Other

Identifiers

NCT00949065

2007-007794-23

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Intravenous immunoglobulins (IvIg)

Active Comparator group

Description:

3 x 0.36-0.44g/Kg IvIg every 4 weeks, then 3 months washing out, then 3x NaCl 0.9% every 4 weeks

Treatment:

Biological: intravenous immunoglobulins

NaCl 0.9%

Placebo Comparator group

Description:

NaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks

Treatment:

Biological: intravenous immunoglobulins