Intravenous Immunoglobulins in Complex-regional Pain Syndrome

Prospective, Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Effect of Intravenous Immunoglobulins on Complex Regional Pain Syndrome (CRPS, M. Sudeck)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00949065

Acronym

PAINLESS

Enrollment

Registered

2009-07-30

Start date

2009-08-31

Completion date

2011-02-15

Last updated

2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome Type 1

Keywords

complex regional pain syndrome, sympathetic reflex dystrophy, intravenous immunoglobulins, autoimmune disease

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.

Interventions

BIOLOGICALintravenous immunoglobulins

0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026