title: Low-dose intravenous immunoglobulin treatment for complex regional pain syndrome (LIPS): study protocol for a randomized controlled trial.
abstract: 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
  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.
  
  
  BACKGROUND
  ISRCTN42179756 (Registered 28 June 13).
authors.affiliation: The University of Liverpool, Brownlow Hill, L69 7ZX Liverpool, UK. andreas.goebel@liv.ac.uk.
authors.forename: Andreas
authors.initials: A
authors.lastname: Goebel
authors.forename: Nicholas
authors.initials: N
authors.lastname: Shenker
authors.forename: Nick
authors.initials: N
authors.lastname: Padfield
authors.forename: Karim
authors.initials: K
authors.lastname: Shoukrey
authors.forename: Candida
authors.initials: C
authors.lastname: McCabe
authors.forename: Mick
authors.initials: M
authors.lastname: Serpell
authors.forename: Mark
authors.initials: M
authors.lastname: Sanders
authors.forename: Caroline
authors.initials: C
authors.lastname: Murphy
authors.forename: Amaka
authors.initials: A
authors.lastname: Ejibe
authors.forename: Holly
authors.initials: H
authors.lastname: Milligan
authors.forename: Joanna
authors.initials: J
authors.lastname: Kelly
authors.forename: Gareth
authors.initials: G
authors.lastname: Ambler
mesh_terms: D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D020918:Complex Regional Pain Syndromes / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D010147:Pain Measurement; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000700:Analgesics; D016756:Immunoglobulins, Intravenous