Intravenous Immunoglobulins in Complex-regional Pain Syndrome

Phase 3

Withdrawn

• Conditions: Complex Regional Pain Syndrome Type 1
• Interventions: Biological: intravenous immunoglobulins

• Registration Number: NCT00949065
• Lead Sponsor: University of Giessen

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Study Start: 2009-08
• Primary Completion: 2011-01
• Study Completion: 2011-02-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intravenous immunoglobulins (IvIg)	intravenous immunoglobulins	3 x 0.36-0.44g/Kg IvIg every 4 weeks, then 3 months washing out, then 3x NaCl 0.9% every 4 weeks
NaCl 0.9%	intravenous immunoglobulins	NaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in impairment Level SumScore (ISS)	after 0,3,6,9 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital of the Justus-Liebig-University; 🇩🇪 Giessen, Hessen, Germany