Vincenzo Cozzolino

Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial.

BackgroundThe use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvements in several clinical outcomes. The aim of the present study is to investigate the effect of OMT on LOS in premature infants.MethodsA randomized controlled trial was conducted on preterm newborns admitted to a single NICU between 2008-2009. N=110 subjects free of medical complications and with gestational age >28 and < 38 weeks were enrolled and randomized in two groups: study group (N=55) and control group (N=55). All subjects received routine pediatric care and OMT was performed to the study group for the entire period of hospitalization. Endpoints of the study included differences in LOS and daily weight gain.ResultsResults showed a significant association between OMT and LOS reduction (mean difference between treated and control group: -5.906; 95% C.I. -7.944, -3.869; p<0.001). OMT was not associated to any change in daily weight gain.ConclusionsThe present study suggests that OMT may have an important role in the management of preterm infants hospitalization.Trial registrationClinicalTrials.gov,NCT01544257.

Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study

BackgroundOrganizational improvement of neonatal intensive care units requires strict monitoring of preterm infants, including routine assessment of physiological functions of the gastrointestinal system and optimized procedures for the definition of appropriate discharge timing.MethodsWe conducted a prospective study on the effect of osteopathic manipulative treatment in a cohort of N = 350 consecutive premature infants admitted to a neonatal intensive care unit without any major complication between 2005 and 2008. In addition to ordinary care, N = 162 subjects received osteopathic treatment. Endpoints of the study were differences between study and control groups in terms of excessive length of stay and gastrointestinal symptoms, defined as the upper quartiles in the distribution of the overall population. Statistical analysis was based on crude and adjusted odds ratios from multivariate logistic regression.ResultsBaseline characteristics were evenly distributed across treated/control groups, except for the rate of infants unable to be oral fed at admission, significantly higher among those undergoing osteopathic care (p = .03). Osteopathic treatment was significantly associated with a reduced risk of an average daily occurrence of gut symptoms per subject above .44 (OR = 0.45; 0.26-0.74). Gestational age lower or equal to 32 weeks, birth weight lower or equal to 1700 grams and no milk consumption at admission were associated with higher rates of length of stay in the unit of at least 28 days, while osteopathic treatment significantly reduced such risk (OR = 0.22;0.09-0.51).ConclusionsIn a population of premature infants, osteopathic manipulative treatment showed to reduce a high occurrence of gastrointestinal symptoms and an excessive length of stay in the NICU. Randomized control studies are needed to generalize these results to a broad population of high risk newborns.

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

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 Anconas 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. The present trial was registered on www.ClinicalTrials.gov (identifier: NCT01851148).

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

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.

Introducing an osteopathic approach into neonatology ward: the NE-O model.

BackgroundSeveral studies showed the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay in hospital, gastrointestinal problems, clubfoot complications and improving cranial asymmetry of infants affected by plagiocephaly. Despite several results obtained, there is still a lack of standardized osteopathic evaluation and treatment procedures for newborns recovered in neonatal intensive care unit (NICU). The aim of this paper is to suggest a protocol on osteopathic approach (NE-O model) in treating hospitalized newborns.MethodsThe NE-O model is composed by specific evaluation tests and treatments to tailor osteopathic method according to preterm and term infants’ needs, NICU environment, medical and paramedical assistance. This model was developed to maximize the effectiveness and the clinical use of osteopathy into NICU.ResultsThe NE-O model was adopted in 2006 to evaluate the efficacy of OMT in neonatology. Results from research showed the effectiveness of this osteopathic model in reducing preterms’ length of stay and hospital costs. Additionally the present model was demonstrated to be safe.ConclusionThe present paper defines the key steps for a rigorous and effective osteopathic approach into NICU setting, providing a scientific and methodological example of integrated medicine and complex intervention.

OA09.04. NEonatology and Osteopathy (NEO) Study: effect of OMT on preterms’ length of stay

Methods Randomized controlled trial on preterm newborns admitted in a single NICU between 2008-2009. N=101 subjects free of medical complications and with gestational age >28 and < 38 weeks were enrolled and randomized into two groups: study group (N=47) and control group (N=54). All subjects received routine pediatric care and OMT was performed to the study group for the entire period of hospitalization. Endpoints of the study included differences in LOS and daily weight gain. Statistical analyses were based on univariate tests and multivariate linear regression.

Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial

BackgroundRecent 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/designA 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.DiscussionThe 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.Trial registrationThe protocol has been registered on ClinicalTrials.gov (NCT02146677) on 20 May 2014.

Klinische Effektivität einer osteopathischen Behandlung bei Migräne

Zusammenfassung Zielsetzung Beurteilung der Effektivitat einer osteopathischen Behandlung (OMT) bei Patienten mit chronischer Migrane anhand von HIT-6-Fragebogen, Medikamenteneinnahme, Anzahl Migranetagen, Schmerzintensitat und funktioneller Beeintrachtigung. Studiendesign 3-armige randomisierte, kontrollierte Studie. Alle in der Abteilung fur Neurologie der Ospedali Riuniti di Ancona, Italien, aufgenommene Patienten mit diagnostizierter Migrane ohne weitere chronische Erkrankung galten als studiengeeignet. Interventionen Die Patienten wurden nach dem Zufallsprinzip 3 Gruppen zugeteilt: 1) OMT plus Medikamententherapie, 2) Scheinbehandlung plus Medikamententherapie und 3) nur Medikamententherapie. Die Patienten erhielten im Studienzeitraum von 6 Monaten 8 Behandlungen. Wichtigste Ergebnisparameter Abweichung vom HIT-6-Ausgangswert. Ergebnisse 105 Patienten wurden in die Studie einbezogen. Nach Abschluss der Studie zeigte die ANOVA eine erhebliche Reduktion der HIT-6-Werte durch die OMT (mittlere Anderung der Werte fur OMT vs. konventionelle Versorgung: −8,74; 95% Konfidenzintervall (KI) −12,96 bis −4,52; p Fazit Diese Ergebnisse legen nahe, OMT als ein valides Verfahren fur die Behandlung von Migranepatienten einzustufen.

426 Effect of Omt on Length of Stay and Weight Gain in a Population of Preterm Infants

Background and aims: The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. Aim of the present study is to show the effect of OMT on LOS and daily weight gain in a sample of premature infants. Methods: Randomized controlled trial on preterm newborns admitted in a single NICU between 2008- 2009. N=101 subjects free of medical complications and with gestational age >28 and < 38 weeks were enrolled and randomized in two groups: study group (N=47) and control group (N=54). All subjects received routine pediatric care and OMT was performed to the study group for the entire period of hospitalization. Endpoints of the study included differences in LOS and daily weight gain. Statistical analyses were based on univariate tests and multivariate linear regression. Results: Univariate statistical analysis showed no significant imbalances among treated and control groups in terms of main characteristics measured at admission. After adjusting for all potential confounders, multivariate analysis showed a significant association between OMT and LOS reduction (mean difference between treated and control group: -6.325 95%c.i. -8.687 - -3.962, p< 0.0001). OMT was not associated to any change in daily weight gain. Conclusions: The present study suggests that OMT plays an important role in the management of preterm infants hospitalization.