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Intravenous Immunoglobulins in Complex-regional Pain Syndrome (PAINLESS)

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ClinicalTrials.gov Identifier: NCT00949065
Recruitment Status : Unknown
Verified July 2009 by University of Giessen.
Recruitment status was:  Not yet recruiting
First Posted : July 30, 2009
Last Update Posted : July 30, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Type 1 Biological: intravenous immunoglobulins Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Rhophylac
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Intravenous immunoglobulins (IvIg)
3 x 0.36-0.44g/Kg IvIg every 4 weeks, then 3 months washing out, then 3x NaCl 0.9% every 4 weeks
Biological: intravenous immunoglobulins
0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks
Other Name: Gamunex 10%
Placebo Comparator: NaCl 0.9%
NaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks
Biological: intravenous immunoglobulins
0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks
Other Name: Gamunex 10%


Outcome Measures

Primary Outcome Measures :
  1. Change in impairment Level SumScore (ISS) [ Time Frame: after 0,3,6,9 months ]

Secondary Outcome Measures :
  1. Pain disability score [ Time Frame: 0,3,6,9 months ]
  2. Quality of life (SF-36) [ Time Frame: 0,3,6,9 months ]
  3. Titer of surface-binding neuronal autoantibodies in the serum [ Time Frame: 0,3,6,9 months ]
  4. Serum concentration of B-cell activating factors BAFF, APRIL [ Time Frame: 0,3,6,9 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949065


Contacts
Contact: Franz Blaes, MD +49-641-99(0) ext 45357 franz.blaes@neuro.med.uni-giessen.de
Contact: Marlene Tschernatsch, MD +49-641-99(0) ext 45400 marlene.tschernatsch@neuro.med.uni-giessen.de

Locations
Germany
Hospital of the Justus-Liebig-University Not yet recruiting
Giessen, Hessen, Germany, 35392
Principal Investigator: Marlene Tschernatsch, MD         
Sponsors and Collaborators
University of Giessen
More Information

Publications:
Responsible Party: Franz Blaes, MD, Dept. of Neurology, Justus-Liebig-University, Am Steg 14, 35392 Giessen, Germany
ClinicalTrials.gov Identifier: NCT00949065     History of Changes
Other Study ID Numbers: 2007-007794-23
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009

Keywords provided by University of Giessen:
complex regional pain syndrome
sympathetic reflex dystrophy
intravenous immunoglobulins
autoimmune disease

Additional relevant MeSH terms:
Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs