Andreas Goebel, MD, PhD; Andrew Baranowski, MD; Konrad Maurer, MD; Artemis Ghiai, RGN; Candy McCabe, PhD; Gareth Ambler, PhD
Acknowledgment: The authors thank the participating patients; referring colleagues; Professor Guenter Sprotte for contributions to the study design; Dr. Kahled Ayazi, Dr. Adam Woo, Mrs. Allison MacKenzie, and Dr. Brigitte Brandner for organizational support; Professor Gavin Giovannoni for providing safety advice to the trial; the staff of the Pain Management Centre and clinical laboratory at Queen Square for generous support; and Dr. Geoffrey Schott and Professor Angela Vincent for important suggestions to the manuscript.
Grant Support: By the Association of Anaesthetists of Great Britain and Ireland, the University College London Hospitals Trustees, and CSL-Behring (drugs and contribution to general expenses). This work was undertaken at University College London Hospitals/University College London, which received a proportion of funding from the Department of Health's National Institute for Health Research Biomedical Research Centres funding scheme. The sponsor under International Conference of Harmonisation Good Clinical Practice standards was University College London Hospitals/University College London.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-1292.
Reproducible Research Statement:Study protocol, statistical code, and data set: Not available.
Requests for Single Reprints: Andreas Goebel, MD, PhD, Pain Research Institute, University of Liverpool, Clinical Sciences Building, University Hospital Aintree, Liverpool L9 7AL, United Kingdom; e-mail, email@example.com.
Current Author Addresses: Dr. Goebel: Pain Research Institute, University of Liverpool, Clinical Sciences Building, University Hospital Aintree, Liverpool L9 7AL, United Kingdom.
Dr. Baranowski and Mrs. Ghiai: Pain Management Centre, The National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG, United Kingdom.
Dr. Maurer: Institute of Anesthesiology, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland.
Dr. McCabe: The National Hospital for Rheumatic Diseases, Upper Borough Walls, Bath BA1 1RL, United Kingdom.
Dr. Ambler: Joint University College London Hospitals/University College London Biomedical Research Unit, Ground Floor, Rosenheim Wing, 25 Grafton Way, London WC1E 6DB, United Kingdom.
Author Contributions: Conception and design: A. Goebel, A. Baranowski, A. Ghiai, G. Ambler.
Analysis and interpretation of the data: A. Goebel, K. Maurer, A. Ghiai, G. Ambler.
Drafting of the article: A. Goebel, A. Baranowski, K. Maurer, A. Ghiai, C. McCabe, G. Ambler.
Critical revision of the article for important intellectual content: A. Goebel, A. Baranowski, K. Maurer, A. Ghiai, G. Ambler.
Final approval of the article: A. Goebel, A. Baranowski, K. Maurer, A. Ghiai, C. McCabe, G. Ambler.
Provision of study materials or patients: A. Goebel, A. Baranowski, C. McCabe.
Statistical expertise: G. Ambler.
Obtaining of funding: A. Goebel.
Administrative, technical, or logistic support: A. Goebel, A. Baranowski, K. Maurer, A. Ghiai, C. McCabe.
Collection and assembly of data: A. Goebel, K. Maurer, A. Ghiai.
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;152:152-158. doi: 10.7326/0003-4819-152-3-201002020-00006
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Published: Ann Intern Med. 2010;152(3):152-158.
Treatment of long-standing complex regional pain syndrome (CRPS) is empirical and often of limited efficacy. Preliminary data suggest that the immune system is involved in sustaining this condition and that treatment with low-dose intravenous immunoglobulin (IVIG) may substantially reduce pain in some patients.
To evaluate the efficacy of IVIG in patients with longstanding CRPS under randomized, controlled conditions.
A randomized, double-blind, placebo-controlled crossover trial. (National Research Registry number: N0263177713; International Standard Randomised Controlled Trial Number Registry: 63918259)
University College London Hospitals Pain Management Centre.
Persons who had pain intensity greater than 4 on an 11-point (0 to 10) numerical rating scale and had CRPS for 6 to 30 months that was refractory to standard treatment.
IVIG, 0.5 g/kg, and normal saline in separate treatments, divided by a washout period of at least 28 days.
The primary outcome was pain intensity 6 to 19 days after the initial treatment and the crossover treatment.
13 eligible participants were randomly assigned between November 2005 and May 2008; 12 completed the trial. The average pain intensity was 1.55 units lower after IVIG treatment than after saline (95% CI, 1.29 to 1.82; PÂ < 0.001). In 3 patients, pain intensity after IVIG was less than after saline by 50% or more. No serious adverse reactions were reported.
The trial was small, and recruitment bias and chance variation could have influenced results and their interpretation.
IVIG, 0.5 g/kg, can reduce pain in refractory CRPS. Studies are required to determine the best immunoglobulin dose, the duration of effect, and when repeated treatments are needed.
Association of Anaesthetists of Great Britain and Ireland, University College London Hospitals Charity, and CSL-Behring.
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