Abstract
BackgroundLongstanding 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/DesignLIPS 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 registrationISRCTN42179756 (Registered 28 June 13).Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-404) contains supplementary material, which is available to authorized users.
Highlights
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, do not work
In one of the first open trials, we found that low dose intravenous immunoglobulin (IVIg)
Secondary analysis As a secondary analysis, we will calculate the proportion of patients in each arm who achieve 50% or 30% pain relief, compared to their baseline level of pain
Summary
Complex regional pain syndrome (CRPS) is a posttraumatic pain in a limb, associated with sensory, motor, autonomic, skin and bone changes [1,2]. The implication of the existing research for this trial is that the above evidence provides proof of concept for the efficacy of low-dose immunoglobulin treatment for patients with CRPS of moderate to severe pain intensity (msCRPS) in reducing pain, with an advantageous sideeffect profile. Study day 0 is defined as the day of randomisation, and a screening visit is scheduled maximally three weeks prior (day −21); patients receive blinded infusions on days 1 and 22 Thereafter, in those who decide to receive open infusion on day 43 and day 64, pain diaries will be completed daily from day 43 to day 85 and weekly for 9 weeks further to explore the duration of combined drug- and unspecific treatment effects (Additional file 1). Willingness to not start any other treatment for CRPS during the parallel part of the trial
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