Contact information
Type
Scientific
Primary contact
Dr Andreas Goebel
ORCID ID
Contact details
Pain Management Department
National Hospital for Neurology & Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
+44 (0)7855310956
andreasgoebel@rocketmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0263177713
Study information
Scientific title
Randomised, double blinded, placebo controlled crossover trial to assess the clinical response to intravenous immunoglobulin inpatients with complex regional pain syndrome (CRPS), and to ascertain pathogenic serum factors
Acronym
Study hypothesis
To assess if intravenous immunoglobulin (IVIG) is more effective than saline in relieving pain from complex regional pain syndrome (CRPS), and to ascertain pathogenic serum factors in patients versus healthy controls.
Ethics approval
Research Ethics of the National Hospital for Neurology and Neurosurgery gave approval on the 6th April 2005 (ref: 06/044)
Study design
Randomised double blinded placebo controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Complex regional pain syndrome (CRPS)
Intervention
1. Intravenous immunoglobulin (0.5 g/kg)
2. Placebo
Patients were given an infusion of one of the above on two consecutive days, then crossed-over to the other arm for one infusion given on two consecutive days, no less than 28 days after the original infusion. Follow up: 3 months.
Intervention type
Drug
Phase
Not Applicable
Drug names
Immunoglobulin
Primary outcome measures
The average numeric rating scale pain value from day four to day 18 after infusions compared between IVIG and saline
Secondary outcome measures
1. The number of patients who found either treatment more effective
2. The global impression of change values between day four to day 18 after infusions compared between IVIG and saline
Overall trial start date
01/11/2005
Overall trial end date
01/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. 16 patients from Pain Management aged 16 years and older, male and female
2. CRPS of between 6 and 30 months duration
3. Numeric rating scale pain score greater than 4
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16
Participant exclusion criteria
1. Pregnant or lactating women
2. IgA deficiency
Recruitment start date
01/11/2005
Recruitment end date
01/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Pain Management Department
London
WC1N 3BG
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University College London Hospitals NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University College London Hospitals (UCLH) Trustees (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20124231
Publication citations
-
Results
Goebel A, Baranowski A, Maurer K, Ghiai A, McCabe C, Ambler G, Intravenous immunoglobulin treatment of the complex regional pain syndrome: a randomized trial., Ann. Intern. Med., 2010, 152, 3, 152-158, doi: 10.7326/0003-4819-152-3-201002020-00006.