Clinical response to intravenous immunoglobulin inpatients with complex regional pain syndrome (CRPS)
| ISRCTN | ISRCTN63918259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63918259 |
| Protocol serial number | N0263177713 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | University College London Hospitals NHS Foundation Trust (UK), University College London Hospitals (UCLH) Trustees (UK), NHS R&D Support Funding (UK) |
- 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 |
|---|---|
| andreasgoebel@rocketmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blinded placebo controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Immunoglobulin |
| Primary outcome measure(s) |
The average numeric rating scale pain value from day four to day 18 after infusions compared between IVIG and saline |
| Key secondary outcome measure(s) |
1. The number of patients who found either treatment more effective |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Pain Management Department
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/02/2010 | Yes | No |
