Condition category
Signs and Symptoms
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
25/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes