Intravenous Immunoglobulins in Complex-regional Pain Syndrome

Condition(s) targeted: Complex Regional Pain Syndrome Type 1

Intervention: intravenous immunoglobulins (Biological)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: University of Giessen

Overall contact:
Franz Blaes, MD, Phone: +49-641-99(0), Ext: 45357, Email: franz.blaes@neuro.med.uni-giessen.de

The purpose of this study is to determine whether intravenous immunoglobulins are effective in the treatment of 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in impairment Level SumScore (ISS)

Secondary outcome:

Pain disability score

Quality of life (SF-36)

Titer of surface-binding neuronal autoantibodies in the serum

Serum concentration of B-cell activating factors BAFF, APRIL

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Franz Blaes, MD, Phone: +49-641-99(0), Ext: 45357, Email: franz.blaes@neuro.med.uni-giessen.de

Hospital of the Justus-Liebig-University, Giessen, Hessen 35392, Germany; Not yet recruiting
Marlene Tschernatsch, MD, Principal Investigator

Related publications:

Kohr D, Tschernatsch M, Schmitz K, Singh P, Kaps M, Schäfer KH, Diener M, Mathies J, Matz O, Kummer W, Maihöfner 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):246-51. 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.

Starting date: August 2009
Last updated: July 29, 2009