Low-dose Intravenous Immunoglobulin Treatment for CRPS (LIPS Trial)

• Research type

  Research Study

• Full title

  A multi-centre (UK) double-blind randomised parallel group placebo controlled trial to evaluate the efficacy, safety, and tolerability of Intravenous Immunoglobulin (IVIg) 0.5g/kg plus standard treatment, versus matched placebo plus standard treatment in patients with longstanding Complex Regional Pain Syndrome.

• IRAS ID

  102786

• Contact name

  Andreas Goebel

• Sponsor organisation

  University of Liverpool

• Eudract number

  2012-000058-73

• Research summary

  Many patients with chronic pain do not experience satisfactory pain relief with currently available treatments. This may be related to the fact that the causes for chronic pain are often not fully understood. Investigators involved in the proposed study have previously treated patients with IVIG and have reported encouraging results in a pilot randomised trial. It is now important to perform a larger randomised trial to explore this further. IVIG may provide pain relief in patients where classical treatments are not satisfactorily effective. If IVIG treatment proved effective, this study may also stimulate research on the efficacy of IVIG in other chronic pain syndromes. Patients will be asked to consent to receive two blinded infusions of IVIg or placebo three weeks apart and to complete detailed pain diaries during the study. They will also have the option to receive two further open label infusions of IVIG 3 weeks apart once the primary outcome data for the trial has been collected.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0164

• Date of REC Opinion

  6 Jun 2012

• REC opinion

  Further Information Favourable Opinion