Clinical response to intravenous immunoglobulin inpatients with complex regional pain syndrome (CRPS)

ISRCTN ISRCTN63918259
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

Pain Management Department
National Hospital for Neurology & Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom

Phone +44 (0)7855310956
Email andreasgoebel@rocketmail.com

Study information

Study designRandomised double blinded placebo controlled crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleRandomised, 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 objectivesTo 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) studiedComplex regional pain syndrome (CRPS)
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Immunoglobulin
Primary outcome measureThe average numeric rating scale pain value from day four to day 18 after infusions compared between IVIG and saline
Secondary outcome measures1. 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 date01/11/2005
Completion date01/08/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexBoth
Target number of participants16
Key inclusion criteria1. 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 criteria1. Pregnant or lactating women
2. IgA deficiency
Date of first enrolment01/11/2005
Date of final enrolment01/08/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Pain Management Department
London
WC1N 3BG
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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