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Cerritelli F.,C.O.ME. Collaboration | Ginevri L.,Accademia Italiana Osteopatia Tradizionale | Messi G.,Accademia Italiana Osteopatia Tradizionale | Caprari E.,Accademia Italiana Osteopatia Tradizionale | And 6 more authors.
Complementary Therapies in Medicine

Objective: To assess the effectiveness of OMT on chronic migraineurs using HIT-6 questionnaire, drug consumption, days of migraine, pain intensity and functional disability. Design: 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. Interventions: 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. Main outcome measures: 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. © 2015 Elsevier Ltd. Source

Cerritelli F.,C.O.ME. Collaboration | Cicchitti L.,C.O.ME. Collaboration | Martelli M.,C.O.ME. Collaboration | Barlafante G.,Accademia Italiana Osteopatia Tradizionale | And 8 more authors.

Background: Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. Methods/design: A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. Discussion: The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy of a specific technique or a pre-determined protocol. © Cerritelli et al.; licensee BioMed Central. Source

Cerritelli F.,Center For Osteopathic Medicine Come Collaboration | Pizzolorusso G.,Accademia Italiana Osteopatia Tradizionale | Renzetti C.,Accademia Italiana Osteopatia Tradizionale | Cozzolino V.,Accademia Italiana Osteopatia Tradizionale | And 15 more authors.

Background: Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods: The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results: A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions: Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. © 2015 Cerritelli et al. Source

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