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Goebel A, Bisla J, Carganillo R, et al. A randomised placebo-controlled Phase III multicentre trial: low-dose intravenous immunoglobulin treatment for long-standing complex regional pain syndrome (LIPS trial). Southampton (UK): NIHR Journals Library; 2017 Nov. (Efficacy and Mechanism Evaluation, No. 4.5.)

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A randomised placebo-controlled Phase III multicentre trial: low-dose intravenous immunoglobulin treatment for long-standing complex regional pain syndrome (LIPS trial).

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Appendix 3Research diagnostic criteria (the ‘Budapest Criteria’) for complex regional pain syndrome

General definition of the syndrome

Complex regional pain syndrome describes an array of painful conditions that are characterised by a continuing (spontaneous and/or evoked) regional pain that is seemingly disproportionate in time or degree to the usual course of any known trauma or other lesion. The pain is regional (not in a specific nerve territory or dermatome) and usually has a distal predominance of abnormal sensory, motor, sudomotor, vasomotor, and/or trophic findings. The syndrome shows variable progression over time.

To make the clinical diagnosis, the following criteria must be met:

  • Continuing pain, which is disproportionate to any inciting event.
  • Must report at least one symptom in all four of the following categories:
    • sensory – reports of hyperaesthesia and/or allodynia
    • vasomotor – reports of temperature asymmetry and/or skin colour changes and/or skin colour asymmetry
    • sudomotor/oedema – reports of oedema and/or sweating changes and/or sweating asymmetry
    • motor/trophic – reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
  • Must display at least one sign at time of evaluation in two or more of the following categories:
    • sensory – evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or temperature sensation and/or deep somatic pressure and/or joint movement)
    • vasomotor – evidence of temperature asymmetry (> 1 °C) and/or skin colour changes and/or asymmetry
    • sudomotor/oedema – evidence of oedema and/or sweating changes and/or sweating asymmetry
    • motor/trophic – evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
  • There is no other diagnosis that better explains the signs and symptoms.
Copyright © Queen’s Printer and Controller of HMSO 2017. This work was produced by Goebel et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK464482

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