title: Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine.
abstract: BACKGROUND
  Migraine is a chronic neurologic disease that can severely affect the patient's quality of life. Although in recent years many randomised studies have been carried out to investigate the effectiveness of acupuncture as a treatment for migraine, it remains a controversial issue. Our aim is to determine whether acupuncture, applied under real conditions of clinical practice in the area of primary healthcare, is more effective than conventional treatment.
  
  
  METHODS
  The design consists of a pragmatic multi-centre, three-armed randomised controlled trial, complemented with an economic evaluation of the results achieved, comparing the effectiveness of verum acupuncture with sham acupuncture, and with a control group receiving normal care only. Patients eligible for inclusion will be those presenting in general practice with migraine and for whom their General Practitioner (GP) is considering referral for acupuncture. Sampling will be by consecutive selection, and by randomised allocation to the three branches of the study, in a centralised way following a 1:1:1 distribution (verum acupuncture; sham acupuncture; conventional treatment). Secondly, one patient in three will be randomly selected from each of the acupuncture (verum or sham) groups for a brain perfusion study (by single photon emission tomography). The treatment with verum acupuncture will consist of 8 treatment sessions, once a week, at points selected individually by the acupuncturist. The sham acupuncture group will receive 8 sessions, one per week, with treatment being applied at non-acupuncture points in the dorsal and lumbar regions, using the minimal puncture technique. The control group will be given conventional treatment, as will the other two groups.
  
  
  CONCLUSIONS
  This trial will contribute to available evidence on acupuncture for the treatment of migraine. The primary endpoint is the difference in the number of days with migraine among the three groups, between the baseline period (the 4 weeks prior to the start of treatment) and the period from weeks 9 to 12. As a secondary aspect, we shall record the index of laterality and the percentage of change in the mean count per pixel in each region of interest measured by the brain perfusion tomography, performed on a subsample of the patients within the real and sham acupuncture groups.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN98703707.
authors.affiliation: Pain Treatment Unit, Primary Care Center, Dos Hermanas, Spain. jorgef.vas.sspa@juntadeandalucia.es.
authors.forename: Jorge
authors.initials: J
authors.lastname: Vas
authors.forename: Angel
authors.initials: A
authors.lastname: Rebollo
authors.forename: Emilio
authors.initials: E
authors.lastname: Perea-Milla
authors.forename: Camila
authors.initials: C
authors.lastname: Méndez
authors.forename: Carlos Ramos
authors.initials: CR
authors.lastname: Font
authors.forename: Manuel
authors.initials: M
authors.lastname: Gómez-Río
authors.forename: Manuel
authors.initials: M
authors.lastname: Martín-Avila
authors.forename: Justo
authors.initials: J
authors.lastname: Carbrera-Iboleón
authors.forename: M Dolores
authors.initials: MD
authors.lastname: Caballero
authors.forename: M Angeles
authors.initials: MA
authors.lastname: Olmos
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Aguilar
authors.forename: Vicente
authors.initials: V
authors.lastname: Faus
authors.forename: Francisco
authors.initials: F
authors.lastname: Martos
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods*; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000628:therapy*; D015990:Placebo Effect; D011320:Primary Health Care / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D013030:Spain; D016896:Treatment Outcome