Complex Regional Pain Syndrome Type 1Phase 3PAINLESSNCT00949065
Intravenous Immunoglobulins in Complex-regional Pain Syndrome
A Phase 3 study testing intravenous immunoglobulins in people with Complex Regional Pain Syndrome Type 1, run by University of Giessen at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether intravenous immunoglobulins are effective in the treatment of complex-regional pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type 1
- What is being tested?
- intravenous immunoglobulins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to 15 Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
The purpose of this study is to determine whether intravenous immunoglobulins are effective in the treatment of complex-regional pain syndrome.
Read the 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.
- Conditions
- Complex Regional Pain Syndrome Type 1
- Being tested
- intravenous immunoglobulins
- Keywords
- complex regional pain syndrome, sympathetic reflex dystrophy, intravenous immunoglobulins, autoimmune disease
- Medical subject headings
- Complex Regional Pain Syndromes, Reflex Sympathetic Dystrophy, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous immunoglobulinsBiological
Also called Gamunex 10%
0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intravenous immunoglobulins (IvIg) | Active comparator | 3 x 0.36-0.44g/Kg IvIg every 4 weeks, then 3 months washing out, then 3x NaCl 0.9% every 4 weeks Receives: Biological: intravenous immunoglobulins |
| NaCl 0.9% | Placebo comparator | NaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks Receives: Biological: intravenous immunoglobulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in impairment Level SumScore (ISS)
Measured: after 0,3,6,9 months
Secondary outcomes (4)
Pain disability score
Measured: 0,3,6,9 months
Quality of life (SF-36)
Measured: 0,3,6,9 months
Titer of surface-binding neuronal autoantibodies in the serum
Measured: 0,3,6,9 months
Serum concentration of B-cell activating factors BAFF, APRIL
Measured: 0,3,6,9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completion15 Feb 2011
Why it stopped: No more interest to follow this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marlene Tschernatsch, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949065
- Sponsor's protocol ID
- 2007-007794-23
- Acronym
- PAINLESS
- Status last verified
- Jul 2021
- First submitted
- 29 Jul 2009
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19375222Goebel 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.
PubMed 15732112
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00949065
- Acronym / sponsor ID
- PAINLESS / 2007-007794-23
- Conditions
- Complex Regional Pain Syndrome Type 1
- Keywords
- complex regional pain syndrome, sympathetic reflex dystrophy, intravenous immunoglobulins, autoimmune disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No more interest to follow this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- Aug 2009 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- 15 Feb 2011 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous immunoglobulins (IvIg) | Active comparator | Biological: intravenous immunoglobulins3 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% | Placebo comparator | Biological: intravenous immunoglobulinsNaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous immunoglobulinsAlso: Gamunex 10%0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks | Biological | Intravenous immunoglobulins (IvIg), NaCl 0.9% |
Primary outcome
Change in impairment Level SumScore (ISS)
Time frame: after 0,3,6,9 months
4 secondary outcomes
Pain disability score
Time frame: 0,3,6,9 months
Quality of life (SF-36)
Time frame: 0,3,6,9 months
Titer of surface-binding neuronal autoantibodies in the serum
Time frame: 0,3,6,9 months
Serum concentration of B-cell activating factors BAFF, APRIL
Time frame: 0,3,6,9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Background: PubMed 19375222Kohr 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.
- Background: PubMed 15732112Goebel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intravenous immunoglobulins in people with Complex Regional Pain Syndrome Type 1, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in impairment Level SumScore (ISS) (time frame: after 0,3,6,9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00949065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.