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Intravenous Immunoglobulins in Complex-regional Pain Syndrome (PAINLESS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Giessen.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT00949065
First received: July 29, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Complex Regional Pain Syndrome Type 1
 Biological: intravenous immunoglobulins
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Change in impairment Level SumScore (ISS) [ Time Frame: after 0,3,6,9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain disability score [ Time Frame: 0,3,6,9 months ] [ Designated as safety issue: No ]
  • Quality of life (SF-36) [ Time Frame: 0,3,6,9 months ] [ Designated as safety issue: No ]
  • Titer of surface-binding neuronal autoantibodies in the serum [ Time Frame: 0,3,6,9 months ] [ Designated as safety issue: No ]
  • Serum concentration of B-cell activating factors BAFF, APRIL [ Time Frame: 0,3,6,9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: August 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 29, 2009
Last Updated: July 29, 2009
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Somatoform Disorders
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013