• Complement Ther Med · Apr 2015

    Randomized Controlled Trial

    Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial.

    • Francesco Cerritelli, Liana Ginevri, Gabriella Messi, Emanuele Caprari, Marcello Di Vincenzo, Cinzia Renzetti, Vincenzo Cozzolino, Gina Barlafante, Nicoletta Foschi, and Leandro Provinciali.
    • 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.
    • Complement Ther Med. 2015 Apr 1; 23 (2): 149-56.

    ObjectiveTo assess the effectiveness of OMT on chronic migraineurs using HIT-6 questionnaire, drug consumption, days of migraine, pain intensity and functional disability.Design3-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.InterventionsPatients 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.Main Outcome MeasuresChanging from baseline HIT-6 score.Results105 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).ConclusionsThese 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).Copyright © 2015 Elsevier Ltd. All rights reserved.

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