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Intravenous Immunoglobulins in Complex-regional Pain Syndrome (PAINLESS)

Primary Purpose

Complex Regional Pain Syndrome Type 1

Status
Withdrawn
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
intravenous immunoglobulins
Sponsored by
University of Giessen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome Type 1 focused on measuring complex regional pain syndrome, sympathetic reflex dystrophy, intravenous immunoglobulins, autoimmune disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the Justus-Liebig-University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intravenous immunoglobulins (IvIg)

NaCl 0.9%

Arm Description

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%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks

Outcomes

Primary Outcome Measures

Change in impairment Level SumScore (ISS)

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2009
Last Updated
July 8, 2021
Sponsor
University of Giessen
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1. Study Identification

Unique Protocol Identification Number
NCT00949065
Brief Title
Intravenous Immunoglobulins in Complex-regional Pain Syndrome
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No more interest to follow this study
Study Start Date
August 2009 (Actual)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 15, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Giessen

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome Type 1
Keywords
complex regional pain syndrome, sympathetic reflex dystrophy, intravenous immunoglobulins, autoimmune disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous immunoglobulins (IvIg)
Arm Type
Active Comparator
Arm Description
3 x 0.36-0.44g/Kg IvIg every 4 weeks, then 3 months washing out, then 3x NaCl 0.9% every 4 weeks
Arm Title
NaCl 0.9%
Arm Type
Placebo Comparator
Arm Description
NaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks
Intervention Type
Biological
Intervention Name(s)
intravenous immunoglobulins
Other Intervention Name(s)
Gamunex 10%
Intervention Description
0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks
Primary Outcome Measure Information:
Title
Change in impairment Level SumScore (ISS)
Time Frame
after 0,3,6,9 months
Secondary Outcome Measure Information:
Title
Pain disability score
Time Frame
0,3,6,9 months
Title
Quality of life (SF-36)
Time Frame
0,3,6,9 months
Title
Titer of surface-binding neuronal autoantibodies in the serum
Time Frame
0,3,6,9 months
Title
Serum concentration of B-cell activating factors BAFF, APRIL
Time Frame
0,3,6,9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital of the Justus-Liebig-University
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19375222
Citation
Kohr D, Tschernatsch M, Schmitz K, Singh P, Kaps M, Schafer KH, Diener M, Mathies J, Matz O, Kummer W, Maihofner 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.
Results Reference
background
PubMed Identifier
15732112
Citation
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. doi: 10.1002/ana.20400. No abstract available.
Results Reference
background

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Intravenous Immunoglobulins in Complex-regional Pain Syndrome

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