Clinical response to intravenous immunoglobulin inpatients with complex regional pain syndrome (CRPS)
ISRCTN | ISRCTN63918259 |
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DOI | https://doi.org/10.1186/ISRCTN63918259 |
Secondary identifying numbers | N0263177713 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 25/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andreas Goebel
Scientific
Scientific
Pain Management Department
National Hospital for Neurology & Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
Phone | +44 (0)7855310956 |
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andreasgoebel@rocketmail.com |
Study information
Study design | Randomised double blinded placebo controlled crossover trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Study objectives | 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(s) | Research Ethics of the National Hospital for Neurology and Neurosurgery gave approval on the 6th April 2005 (ref: 06/044) |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Immunoglobulin |
Primary outcome measure | 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 study start date | 01/11/2005 |
Completion date | 01/08/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 16 Years |
Sex | Both |
Target number of participants | 16 |
Key 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 |
Key exclusion criteria | 1. Pregnant or lactating women 2. IgA deficiency |
Date of first enrolment | 01/11/2005 |
Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pain Management Department
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University College London Hospitals NHS Foundation Trust (UK)
No information available
University College London Hospitals (UCLH) Trustees (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 02/02/2010 | Yes | No |