Low-dose intravenous immunoglobulin treatment for complex regional pain syndrome
(LIPS): study protocol for a randomized controlled trial.
Author(s): Goebel A(1), Shenker N, Padfield N, Shoukrey K, McCabe C, Serpell M, Sanders M,
Murphy C, Ejibe A, Milligan H, Kelly J, Ambler G.
Affiliation(s): Author information:
(1)The University of Liverpool, Brownlow Hill, L69 7ZX Liverpool, UK.
andreas.goebel@liv.ac.uk.
Publication date & source: 2014, Trials. , 15:404
BACKGROUND: Longstanding complex regional pain syndrome (CRPS) is refractory to
treatment with established analgesic drugs in most cases, and for many patients,
alternative pain treatment approaches, such as with neuromodulation devices or
rehabilitation methods, also do not work. The development of novel, effective
treatment technologies is, therefore, important. There are preliminary data
suggesting that low-dose immunoglobulin treatment may significantly reduce pain
from longstanding CRPS.
METHODS/DESIGN: LIPS is a multicentre (United Kingdom), double-blind, randomised
parallel group, placebo-controlled trial, designed to evaluate the efficacy,
safety, and tolerability of intravenous immunoglobulin (IVIg) 0.5 g/kg plus
standard treatment, versus matched placebo plus standard treatment in 108
patients with longstanding complex regional pain syndrome. Participants with
moderate or severe CRPS of between 1 and 5 years duration will be randomly
allocated to receive IVIg 0.5 g/kg (IntratectTM 50 g/l solution for infusion) or
matching placebo administered day 1 and day 22 after randomisation, followed by
two optional doses of open-label medication on day 43 after randomisation and on
day 64 after randomisation. The primary outcome is the patients' pain intensity
in the IVIG group compared with the placebo group, between 6 and 42 days after
randomisation. The primary trial objective is to confirm the efficacy and
confidently determine the effect size of the IVIG treatment technology in this
group of patients.
TRIAL REGISTRATION: ISRCTN42179756 (Registered 28 June 13).
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