title: Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial.
abstract: OBJECTIVE
  To assess the effectiveness of OMT on chronic migraineurs using HIT-6 questionnaire, drug consumption, days of migraine, pain intensity and functional disability.
  
  
  METHODS
  3-Armed randomized controlled trial setting: all patients admitted in the Department of Neurology of Ancona's United Hospitals, Italy, with a diagnosis of migraine and without chronic illness, were considered eligible for the study.
  
  
  METHODS
  Patients were randomly divided into three groups: (1) OMT+medication therapy, (2) sham+medication therapy and (3) medication therapy only. Patients received 8 treatments in a study period of 6 months.
  
  
  METHODS
  Changing from baseline HIT-6 score.
  
  
  RESULTS
  105 subjects were included. At the end of the study, ANOVA showed that OMT significantly reduced HIT-6 score (mean change scores OMT-conventional care: -8.74; 95% confidence interval (CI) -12.96 to -4.52; p<0.001 and OMT-sham: -6.62; 95% CI -10.85 to -2.41; p<0.001), drug consumption (OMT-sham: RR=0.22, 95% CI 0.11-0.40; OMT-control: RR=0.20, 95% CI 0.10-0.36), days of migraine (OMT-conventional care: M=-21.06; 95% CI -23.19 to -18.92; p<0.001 and OMT-sham: -17.43; 95% CI -19.57 to -15.29; p<0.001), pain intensity (OMT-sham: RR=0.42, 95% CI 0.24-0.69; OMT-control: RR=0.31, 95% CI 0.19-0.49) and functional disability (p<0.001).
  
  
  CONCLUSIONS
  These findings suggest that OMT may be considered a valid procedure for the management of migraineurs. The present trial was registered on www.ClinicalTrials.gov (identifier: NCT01851148).
authors.affiliation: Clinical-based Human Research Department, C.O.ME. Collaboration, Pescara, Italy; Research Department, Accademia Italiana Osteopatia Tradizionale, Pescara, Italy. Electronic address: francesco.cerritelli@gmail.com.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cerritelli
authors.affiliation: Research Department, Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Liana
authors.initials: L
authors.lastname: Ginevri
authors.affiliation: Research Department, Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Messi
authors.affiliation: Research Department, Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Caprari
authors.affiliation: Research Department, Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Di Vincenzo
authors.affiliation: Research Department, Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Renzetti
authors.affiliation: Research Department, Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Cozzolino
authors.affiliation: Research Department, Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Gina
authors.initials: G
authors.lastname: Barlafante
authors.affiliation: Neurological Clinic, Marche Polytechnic University, Ancona, Italy.
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Foschi
authors.affiliation: Neurological Clinic, Marche Polytechnic University, Ancona, Italy.
authors.forename: Leandro
authors.initials: L
authors.lastname: Provinciali
mesh_terms: D000328:Adult; D002908:Chronic Disease; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D026301:Manipulation, Osteopathic / Q000379:methods*; D008881:Migraine Disorders / Q000453:epidemiology / Q000628:therapy*; D010919:Placebos; D011795:Surveys and Questionnaires
chemical_list: D010919:Placebos
keywords: Disability; Drug; HIT-6; Headache; Osteopathic manipulative treatment; Pain; Sham therapy