SCIG in CRPS over 12 months

• Research type

  Research Study

• Full title

  An open study to compare the efficacy of immunoglobulin administered subcutaneoulsy (SCIG) with current best practice in patients with Complex Regional Pain Syndrome (CRPS)

• IRAS ID

  22602

• Sponsor organisation

  The Walton Centre for Neurology and Neurosurgery NHS Trust

• Eudract number

  2009-015242-30

• ISRCTN Number

  In progress

• Research summary

  Complex Regional Pain Syndrome (CRPS) is a severe neuropathic limb pain syndrome. A recent study found a single application of low dose (0.5g/kg) intravenous immunoglobulin (IVIG) to be significantly more effective for pain relief than saline. The aim of this proposed study is to determine whether this effect can be sustained over a longer period of time when immunoglobulin is given repeatedly and to establish whether it can have a meaningful effect on patients?? quality of life. Using a prospective, open case-control design, four patients who previously reported a beneficial response to a single IVIG dose will receive immune modulation treatment with a subcutaneous preparation of immunoglobulins (SCIG) alongside best medical care (BMC) for one year. They will be matched with a control group of eight patients on age, gender and disease characteristics who will receive BMC only. The objectives are firstly to ascertain the efficacy of SCIG in patients who had pain relief after a single dose treatment. Secondly to assess, using Quantitative Sensory Testing (QST), whether and how much evoked pain is reduced and sensory thresholds normalized following SCIG therapy, thirdly to assess the effectiveness of immunoglobulin treatment when delivered in home application over one year using measures of function, quality of life and return to work, fourthly to elucidate via qualitative interviews whether and to what extent appropriate cognitive, behavioural and work related support measures designed to maximize effectiveness are indicated, fifthly to compare the efficacy and effectiveness of this treatment with the efficacy and effectiveness of BMC in the matched patient group, and finally to calculate a QALY (Quality adjusted life years) estimate for this treatment. We expect that this trial can provide a basis for future trials of IVIG or SCIG therapy both in CRPS, and also in other refractory neuropathic pain syndromes.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0714/47

• Date of REC Opinion

  5 Oct 2009

• REC opinion

  Favourable Opinion