title: Report of a preliminary discontinued double-blind, randomized, placebo-controlled trial of the anti-TNF-α chimeric monoclonal antibody infliximab in complex regional pain syndrome.
abstract: OBJECTIVE
  Inflammation appears to play a role in CRPS as, for example, cytokines (like TNF-α) are involved in the affected limb. The ongoing inflammation is probably responsible for the central sensitization that sometimes occurs in CRPS. Thus, early start of a TNF-α antagonist may counteract inflammation, thereby preventing rest damage and leading to recovery of the disease.
  
  
  METHODS
  Patients (n = 13) were randomly assigned to infliximab 5 mg/kg or placebo, both administered at week 0, 2, and 6.
  
  
  METHODS
  The aim was to confirm a reduction in clinical signs of regional inflammation (based on total impairment level sumscore: ISS) after systemic administration of infliximab. Also, levels of mediators in the fluid of induced blisters were examined in relation to normalization and improvement in quality of life.
  
  
  RESULTS
  Six patients received infliximab and 7, placebo. There was no significant change in total ISS score between the two groups. Similarly, no significant difference in change in cytokine levels was found between infliximab compared with placebo. However, there was a trend toward a greater reduction of TNF-α in the intervention group compared with the placebo group. A subscale of the EuroQol (ie EuroQol VAS) revealed significant decrease in health status in the intervention group compared with the placebo group.
  
  
  CONCLUSIONS
  This study was terminated before the required number of participants had been reached for sufficient statistical power. Nevertheless, a trend was found toward an effect of infliximab on the initially high TNF-α concentration.
authors.affiliation: Erasmus MC, Center for Pain Medicine, Rotterdam, The Netherlands.
authors.forename: Maaike
authors.initials: M
authors.lastname: Dirckx
authors.forename: George
authors.initials: G
authors.lastname: Groeneweg
authors.forename: Feikje
authors.initials: F
authors.lastname: Wesseldijk
authors.forename: Dirk L
authors.initials: DL
authors.lastname: Stronks
authors.forename: Frank J P M
authors.initials: FJ
authors.lastname: Huygen
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D020918:Complex Regional Pain Syndromes / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D011788:Quality of Life; D016059:Range of Motion, Articular / Q000187:drug effects; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000032:analysis / Q000037:antagonists & inhibitors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: TNF-alpha; anti-inflammatory agents; anti-tumor necrosis factor; complex regional pain syndromes; infliximab