Intravenous Immunoglobulins in Complex-regional Pain Syndrome

Complex Regional Pain Syndrome Type 1 Clinical Trial

— PAINLESS  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00949065
• Other study ID #: 2007-007794-23
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 2009
• Est. completion date: February 15, 2011

Study information

• Verified date: July 2021
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome Type 1
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Biological:
• intravenous immunoglobulins
0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks

Locations

Country	Name	City	State
Germany	Hospital of the Justus-Liebig-University	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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):246-251. doi: 10.1016/j.pain.2009.03.009. Epub 2009 Apr 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in impairment Level SumScore (ISS)		after 0,3,6,9 months
Secondary	Pain disability score		0,3,6,9 months
Secondary	Quality of life (SF-36)		0,3,6,9 months
Secondary	Titer of surface-binding neuronal autoantibodies in the serum		0,3,6,9 months
Secondary	Serum concentration of B-cell activating factors BAFF, APRIL		0,3,6,9 months