Andreas Goebel1*, Corresponding author Email: andreas.goebel@liv.ac.uk
Nicholas Shenker2 Email: Nicholas.shenker@addenbrookes.nhs.uk
Nick Padfield3 Email: n.padfield@btconnect.com
Karim Shoukrey4 Email: drshoukrey@yahoo.com
Candida McCabe5 Email: candy.mccabe@rnhrd.nhs.uk
Mick Serpell6 Email: Michael.Serpell@glasgow.ac.uk
Mark Sanders7Email: mark.sanders@nnuh.nhs.uk
Caroline Murphy8 Email: caroline.murphy@kcl.ac.uk
Amaka Ejibe8 Email: Ekwujuru.ejibe@kcl.ac.uk
Holly Milligan1 Email: h.milligan@liverpool.ac.uk
Joanna Kelly8 Email: joanna.kelly@kcl.ac.uk
Gareth Ambler9 Email: g.ambler@ucl.ac.uk
1 The University of Liverpool, Brownlow Hill, L69 7ZX Liverpool, UK
2 Addenbrookes Hospital, Hills Road, CB2 0QQ Cambridge, UK
3 Guy’s and St Thomas’ NHS Trust, Westminster Bridge Rd, SE1 7EH London, UK
4 University Hospital of Leicester NHS Trust, Gwendolen Road, LE5 9PW Leicester, UK
5 RNHRD and University West of England, Upper Borough Walls, BA1 1RL Bristol, UK
6 Gartnavel General Hospital, Great Western Road, G12 0YN Glasgow, UK
7 Norfolk and Norwich University NHS Trust, Colney Lane, NR4 7UY Norwich, UK
8 King’s Clinical Trials Unit at KHP, De Crespigny Park, SE5 8AF London, UK
9 University College London, Gower Street, WC1E 6BT London, UK
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/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).
Full study protocol can be read online for FREE Low-dose intravenous immunoglobulin treatment for complex regional pain syndrome (LIPS): study protocol for a randomized controlled trial
hope-over-pain.org 
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