title: Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial.
abstract: BACKGROUND
  The prevalence of fibromyalgia increases worldwide and is characterized by widespread and chronic pain. Treatment is difficult and includes both drug and non-drug approaches. Milnacipran, an antidepressant, is used for fibromyalgia, with a possible beneficial effect on central pain modulation. Our hypothesis is that the efficacy of milnacipran in fibromyalgia depends on the performance of pain inhibitory controls.
  
  
  METHODS
  A randomized, double blind, clinical trial (NCT01747044) with two parallel groups, in 48 women with fibromyalgia, is planned in the Clinical Pharmacology Center, University Hospital, Clermont-Ferrand, France. Conditioned pain modulation (estimated with thermal stimuli using a numeric pain rating scale), the primary endpoint measure, is evaluated before and one month after treatment with milnacipran or placebo. Secondary outcome measures include the predictability of pain descending pathways performance for milnacipran efficacy, tolerance and cognitive function. Data analysis is performed using mixed models; the tests are two-sided, with a type I error set at alpha = 0.05. Not only will this trial allow estimation of the beneficial effect of milnacipran on pain and on descending pain pathways but it will also evaluate whether the performance of this modulatory system could be predictive of its efficacy in alleviating pain.
  
  
  CONCLUSIONS
  This method would allow clinicians to take a pro-active attitude by performing a rapid psychophysical test before starting milnacipran treatment and would avoid unnecessary prescription while preventing therapeutic failure in patients who often face this recurrent problem.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01747044 .
authors: CHU de Clermont-Ferrand, Inserm CIC 1405, Centre de Pharmacologie Clinique, F-63003, Clermont-Ferrand, France. nmacian@chu-clermontferrand.fr.
authors: Nicolas
authors: N
authors: Macian
authors: CHU de Clermont-Ferrand, Délégation Recherche Clinique & Innovation - Villa annexe IFSI, 58 Rue Montalembert, F-63003, Clermont-Ferrand, France. bpereira@chu-clermontferrand.fr.
authors: Bruno
authors: B
authors: Pereira
authors: CHU de Clermont-Ferrand, Inserm CIC 1405, Centre de Pharmacologie Clinique, F-63003, Clermont-Ferrand, France. c_shinjo@chu-clermontferrand.fr.
authors: Coralie
authors: C
authors: Shinjo
authors: CHU de Clermont-Ferrand, Inserm CIC 1405, Centre de Pharmacologie Clinique, F-63003, Clermont-Ferrand, France. cdubray@chu-clermontferrand.fr.|Clermont Université, Université d'Auvergne, Pharmacologie Fondamentale et Clinique de la Douleur, Laboratoire de Pharmacologie, Facultés de Médecine/Pharmacie, F-63000, Clermont-Ferrand, France. cdubray@chu-clermontferrand.fr.|Inserm, U1107 Neuro-Dol, F-63001, Clermont-Ferrand, France. cdubray@chu-clermontferrand.fr.
authors: Claude
authors: C
authors: Dubray
authors: CHU de Clermont-Ferrand, Inserm CIC 1405, Centre de Pharmacologie Clinique, F-63003, Clermont-Ferrand, France. gisele.pickering@udamail.fr.|Clermont Université, Université d'Auvergne, Pharmacologie Fondamentale et Clinique de la Douleur, Laboratoire de Pharmacologie, Facultés de Médecine/Pharmacie, F-63000, Clermont-Ferrand, France. gisele.pickering@udamail.fr.|Inserm, U1107 Neuro-Dol, F-63001, Clermont-Ferrand, France. gisele.pickering@udamail.fr.
authors: Gisèle
authors: G
authors: Pickering
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D003521:Cyclopropanes / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy* / Q000503:physiopathology; D005602:France; D006785:Hospitals, University; D006801:Humans; D000078764:Milnacipran; D009433:Neural Inhibition / Q000187:drug effects; D010146:Pain / Q000188:drug therapy* / Q000503:physiopathology; D059408:Pain Management; D010147:Pain Measurement; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D003521:Cyclopropanes; D000078764:Milnacipran; D017367:Selective Serotonin Reuptake Inhibitors