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1050 Review Article

Osteopathic Manipulative Treatment in Pediatric


and Neonatal Patients and Disorders: Clinical
Considerations and Updated Review of the
Existing Literature
Donatella Bagagiolo, DO1 Alessia Didio, DO1 Marco Sbarbaro, DO1 Claudio Giuseppe Priolo, MD2
Tiziana Borro, MPH2 Daniele Farina, MD2

1 Research Department, Scuola Superiore di Osteopatia Italiana, Address for correspondence Donatella Bagagiolo, DO, Research
Torino, Italy Department, Scuola Superiore di Osteopatia Italiana, Piazza Bernini,
2 Division of Neonatology and NICU, Sant’Anna Hospital, Azienda 12, 10143 Torino, Italy (e-mail: donatella.bagagiolo@libero.it).
Ospedaliera Regina Margherita Sant’Anna, Torino, Italy

Am J Perinatol 2016;33:1050–1054.

Abstract Osteopathic medicine is a form of complementary and alternative medicine. Osteo-


pathic practitioners treat patients of all ages: according to the Osteopathic International

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Alliance’s 2012 survey, about one-third of all treated patients are aged between 31 and
50 years and nearly a quarter (23.4%) are pediatric patients, with 8.7% of them being
younger than 2 years. In 2013 a systematic review evaluated the effectiveness of
osteopathic manipulative treatment (OMT) in pediatric patients with different underly-
ing disorders, but due to the paucity and low methodological quality of the primary
studies the results were inconclusive. The aim of this review is therefore to update the
evidence concerning OMT in perinatal and pediatric disorders and to assess its clinical
impact. Most published studies favor OMT, but the generally small sample sizes in these
Keywords studies cannot support ultimate conclusions about the efficacy of osteopathic therapy
► osteopathic in pediatric age. In turn, clinical trials of OMT in premature infants might represent an
manipulative important step in the osteopathic research because they can address both cost-
treatment effectiveness issues, and an innovative, multidisciplinary approach to the management
► pediatric of specific pediatric diseases cared for by the same, common health care system. The
► preterm available studies in neonatal settings provide evidence that OMT is effective in reducing
► positional the hospital length of stay of the treated infants, therefore, suggesting that robust cost-
plagiocephaly effectiveness analyses should be included in the future clinical trials’ design to establish
► infantile colic new possible OMT-shared strategies within the health care services provided to
► cost-effectiveness newborns.

Osteopathic medicine is a form of complementary and alter- an array of many types of manipulative techniques, with
native medicine, an approach that incorporates medical and the aim to solve somatic dysfunction (the International
scientific knowledge to apply a range of manual techniques Classification of Diseases, Tenth Revision, Clinical Modifi-
for assessment, diagnosis, and treatment.1,2 cation Diagnosis Code M99.00–09) defined as impaired or
One important component of osteopathic health care is altered function of related components of the somatic
osteopathic manipulative treatment (OMT), which refers to system: skeletal, arthrodial, and myofascial structures,

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OMT in Pediatric and Neonatal Patients and Disorders Bagagiolo et al. 1051

and their related vascular, lymphatic, and neural Cerritelli et al randomized 110 preterm infants in two
elements.3 groups: 55 who underwent OMT and 55 who underwent
Osteopathic practitioners treat patients of all ages; accord- standard pediatric care.15 Osteopathic service was provided
ing to the Osteopathic International Alliance 2012 survey, twice a week until patients reached the stability of the
about one-third of all patients were between 31 and 50 years physiological condition (maintenance of body heat at room
of age and nearly a quarter (23.4%) were pediatric patients, temperature, coordinated sucking, swallowing, and breathing
with 8.7% of them being younger than 2 years.2 while feeding). The findings showed that there was a signifi-
A single study has described and detailed the character- cant association between OMT and LOS reduction with a
istics of the pediatric population and their use of OMT in the mean difference between treated and control group of 5.9
United States. This retrospective analysis reported a total of mean days less (standard deviation:  3.869; p < 0.01). Cost
407 patients who received 1,500 visits: their age profile analysis considering the entire study period estimates a net
showed that almost half (46%) of the children were younger saving using ordinary least square of €139,044.30 (range:
than 5 years. Diagnoses covered a wide variety of common €93,237.19–184,851.00).
pediatric conditions; of note, up to 43.5% of the patients were Another trial was conducted by Pizzolorusso et al. Several
referred to OMT for nonmusculoskeletal diagnoses (head- 110 preterm infants were randomized to receive either OMT
ache, otitis media, asthma, upper respiratory infection, feed- or routine pediatric care. Here again, the OMT group showed
ing problem, gastrointestinal disorders).4 shorter hospital stay (2.03 mean days; p < 0.01) compared
This retrospective study is in accordance with the litera- with the control group. Cost analysis showed that OMT
ture, where the impact of OMT in respiratory dysfunction, significantly provided a net saving of €740 per newborn
cerebral palsy, deformational plagiocephaly (DP), and recur- per LOS.14
rent acute otitis media is consistently reported.5–8 In 2013, a In 2015 a multicenter, randomized controlled trial (RCT)
systematic review has evaluated the effectiveness of OMT in enrolled 695 preterm newborns between 29 and 37 weeks

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several pediatric conditions, but due to the paucity and low gestational age from three different public NICUs. The infants
methodological quality of the primary studies, the results were randomly assigned to either OMT group (n ¼ 352) or a
appeared inconclusive.9 control group (conventional care; n ¼ 343). There was a
After that publication, though, a few studies assessed the statistically significant reduction in LOS, this last being 13.8
effect of OMT in preterm children—aiming at assessing the mean days for the OMT group versus 17.5 mean days for the
impact of OMT on medical outcomes such as the length of stay control group, respectively (p < 0.001). At multivariate anal-
(LOS), feeding, and gastrointestinal function. ysis, a reduction of the LOS of 3.9 mean days was shown and
The present review aims at updating the evidence con- retained statistical significance (p < 0.01). Concerning the
cerning OMT in perinatal and pediatric conditions, and its costs per infant, the study reported a significant difference
clinical impact. between the OMT and control group equal to €1,586.01
savings (p < 0.001).13
The effect of OMT on gastrointestinal function and LOS
Osteopathic Manipulative Treatment in
were investigated through a prospective, nonrandomized,
Different Pediatric and Infant Conditions: An
cohort study in 350 consecutively born neonates. Of them,
Overview
188 were assigned to standard care, while 162 received
Preterm Infants routine care plus OMT. Multivariate logistic regression re-
Prematurity is defined by the World Health Organization ported OMT to be independently associated with a 55%
when childbirths occur before 37 completed weeks of gesta- reduction of gastrointestinal symptoms. Similarly, an inde-
tion. According to estimates, 14.9 million babies are born pendent effect of OMT was seen on LOS, which was reduced by
preterm every year.10 more than 75% in the study group.16
Complications of preterm birth are the single largest direct Premature newborns and infants need to have a successful
cause of neonatal death, responsible for 35% of the world’s 3.1 transition from gavage to nipple feeding using breast or bottle
million yearly deaths, and the second most common cause of before discharge from the hospital. Delayed acquisition of
deaths after pneumonia in infancy. Preterm infants need to these skills may result in prolonged hospital stay till such a
attain medical stability, physiological maturity, including competency is achieved. In a case report study, two twin girls,
adequate temperature control, cessation of apnea, and bra- born at 25 weeks þ6 days of gestational age, were provided
dycardia and feeding behavior before discharge from the with OMT sessions due to nipple feeding dysfunction.17 The
hospital can be deemed appropriate and safe.11 two twin infants had been already proposed for surgical
The economic costs of preterm birth are important in terms placement of gastrostomy tubes due to their inability to
of the immediate neonatal intensive care unit (NICU) admis- take all feedings by nipple suction. Nonetheless, a series of
sion and stay, and of the ongoing long-term complex health evaluations and OMT sessions were performed before surger-
needs. LOS is one of the major clinical outcomes to assess and ies were scheduled, and these treatments improved consid-
rate the effectiveness of interventions in NICU settings.12,13 erably the infants’ ability to feed by nipple suction, so that
With regard to this parameter, OMT has been documented surgeries could be postponed and ultimately the two infants
effective in reducing LOS in a limited number of clinical could be safely discharged home when they were 43 1/7 weeks
trials.13–15 gestational age old.

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1052 OMT in Pediatric and Neonatal Patients and Disorders Bagagiolo et al.

Infant Conditions Other Than Prematurity: Early assessment and diagnosis of nonsynostotic deforma-
Miscellaneous tion is an essential part of management not only for the shape
Another case report study described a newborn, 12 days old, of the skull, but also for possible clinical significant differ-
with severe bilateral congenital talipes equinovarus. He was ences in gross motor development, such as sitting up, rolling
treated with two short-leg serial casting in combination with back to side, crawling, neck muscle dysfunction, and low or
four OMT, with restoring of the mobility and correction of the variable tone.27–29 An association between DP and mandibu-
deformities of both the lower limbs.18 lar asymmetry has been observed. This deformity seems to be
The positive effects of OMT reported so far cannot be secondary to rotation of the cranial base and anterior dis-
confirmed so far in constipation and difficult meconium placement of the temporomandibular joint not resulting from
evacuation, a condition that is critical for achieving and primary mandibular deformity.30 Therapeutic decisions and
maintaining good oral feeding tolerance and adequate gas- DP managements may vary according to the severity of DP
trointestinal function. A prospective, randomized pilot trial and the timing of treatment. Studies suggest that earlier
was performed in a single NICU to evaluate the effects of interventions are more effective than later treatment.31–33
visceral osteopathic manipulative on the velocity to complete The effect of OMT in DP is documented in a pilot study that
meconium excretion and on improving feeding tolerance. reveals a 50% mean reduction in asymmetry in 12 infants who
Some 41 infants with birthweight < 1,500 g and gestational undergo a course of four osteopathic treatments (60 minutes
age < 32 weeks were assigned to an OMT group (n ¼ 21) and each) scheduled 15 days apart (  4 days).8
to control group (n ¼ 20). The results showed no significant
differences between the two groups in terms of passage of
Discussion
last meconium. Time to full enteral feedings was 8 days longer
in the intervention group, with a median of 34 days, than in Here, we reviewed the scientific evidence supporting the use
the control group was 26 days, which was significant.19 of OMT in several infant/pediatric medical and osteoarticular

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conditions. Most available studies show favorable evidence
Infantile Colics supporting OMT, but the small sample sizes cannot vouch for
Infantile colics are a common cause of paroxysmal abdominal an ultimate, statistically significant efficacy of osteopathic
pains, occurring frequently in infants in the first 3 months of therapy.8,17–20
life and affecting up to 40% of them.20 Etiological factors OMT clinical trials in preterm neonates may represent an
include an incomplete lactose absorption, cow’s milk intoler- important step in osteopathic research because they may
ance, familiar and genetic factors, intestinal microflora dis- address both cost-effectiveness issues and sustainability in
turbances, as well as dietary insults. Stress factors in terms of cooperation within different services of the health
pregnancy, childbirth, and inadequate postnatal care may care system.13–15
also be important determinants in the development in infan- These studies, evidence that OMT is effective in reducing
tile colics. The effect of OMT was investigated through a LOS in preterm infants in NICU. In a multicenter RCT, the net
controlled prospective study: 28 infants between 1 and saving associated with reduced LOS was about €1,600 per
12 weeks of age were randomized to either cranial osteo- newborn, determining an overall net saving for the whole
pathic manipulation or no treatment. Results showed a NICU of more than €500,000 during the 14-month study
significant reduction between weeks 1 and 4 in crying times period.13 Consistent with the results from the previous
(hours/24 hours) (p < 0.001), recorded by the parents single-NICU studies, the three available RCTs report different
through the compilation of a daily diary, where parents extents of reduction in LOS, clearly secondary to the different
recorded the times spent in crying, sleeping, and being populations enrolled in the three different studies—as an
held/rocked.21 example, one multicenter trial included both low-birth-
weight infants as well as moderate and late preterm infants,
Plagiocephaly whereas the two other RCTs enrolled moderate and late
DP is a nonsynostotic deformation of the head that results preterm newborn only.
from external forces that mold the skull in the 1st year of the To date, the only RCT showing no favorable results of infant
life.22,23 OMT was performed to evaluate the effect of visceral osteo-
DP may be detected in up to one of five infants during the pathic manipulative practices on meconium excretion.19 Two
first 2 months of life. aspects must be underlined: first, the small sample size may
Risk factors for DP include prematurity, prolonged labor, have prevented the detection of significant effects; second,
unusual birth position, assisted delivery, twins, first-born and most importantly, the visceral osteopathic treatment
child, neck problems, maternal age (> 35 years), and male performed in that trial followed a protocol that was adapted
sex.24,25 The prevalence of DP is related to the age of infants, from an original protocol of visceral OMT in adults—thus
and changed over time after the educational campaign “Back possibly not fully suitable for preterm infants.
to Sleep”—being now estimated to occur in 16% of the infants A recent study proposed the development of a specific
aged 6 weeks, 19.7% at 4 months, 6.8% at 1 year, and 3.3% at model to apply as evaluation and treatment for the osteo-
2 years of age.22,26 pathic care to fit the specific preterm and term infants’
Of note, 4 months is the critical age for the development of needs.34 In this context, the visceral approach was not in
DP.22 direct contact with the organ. The authors assume that a

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OMT in Pediatric and Neonatal Patients and Disorders Bagagiolo et al. 1053

direct approach in newborns could be dangerous because of 4 Lund G, Carreiro JE. Characteristics of pediatric patients seen in
their fragile condition as the small size of infant anatomy medical school-based osteopathic manipulative medicine clinics.
makes osteopathic practitioners unable to perform tradition- J Am Osteopath Assoc 2010;110(7):376–380
5 Duncan B, McDonough-Means S, Worden K, Schnyer R, Andrews J,
al approaches. In addition, when considering the medical
Meaney FJ. Effectiveness of osteopathy in the cranial field and
semiotics there is no examination that allows a direct and myofascial release versus acupuncture as complementary treat-
specific palpation of the visceral structure. ment for children with spastic cerebral palsy: a pilot study. J Am
Further studies concerning osteopathic treatment in in- Osteopath Assoc 2008;108(10):559–570
fants with meconium evacuation-related disorders are re- 6 Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic
manipulative treatment on pediatric patients with asthma:
quired, as well as the development and assessment of
a randomized controlled trial. J Am Osteopath Assoc 2005;
different protocols specifically considering the peculiar phys-
105(1):7–12
iological conditions of these unique patients. 7 Wahl RA, Aldous MB, Worden KA, Grant KL. Echinacea purpurea
As for safety, no adverse events were ever reported in the and osteopathic manipulative treatment in children with recur-
studies on osteopathic treatments in infants, with these rent otitis media: a randomized controlled trial. BMC Complement
management approaches being generally well tolerated. Altern Med 2008;8:56
8 Lessard S, Gagnon I, Trottier N. Exploring the impact of osteopathic
treatment on cranial asymmetries associated with nonsynostotic
Conclusion plagiocephaly in infants. Complement Ther Clin Pract 2011;17(4):
193–198
The above summarized updated evidence on the role and 9 Posadzki P, Lee MS, Ernst E. Osteopathic manipulative treatment
indications of OMT in neonatal and infant age provides data for pediatric conditions: a systematic review. Pediatrics 2013;
supporting the feasibility of OMT practices in several infant 132(1):140–152
10 Blencowe H, Cousens S, Chou D, et al; Born Too Soon Preterm Birth
and pediatric conditions.
Action Group. Born too soon: the global epidemiology of 15
Nonetheless, there is a clear need for adequately designed million preterm births. Reprod Health 2013;10(Suppl 1):S2

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cost-effectiveness studies, with the aim to unveil the impor- 11 Cerritelli F, Pizzolorusso G, Renzetti C, et al. Effectiveness of
tance of a formal integration of osteopathic treatment strate- osteopathic manipulative treatment in neonatal intensive care
gies within the framework of the neonatal standard of care units: protocol for a multicentre randomised clinical trial. BMJ
Open 2013;3(2):e002187
provided by national health care systems.
12 Petrou S, Khan K. Economic costs associated with moderate and
New, important data in this area are expected to emerge in
late preterm birth: primary and secondary evidence. Semin Fetal
the next years, thus covering the current knowledge gap in this Neonatal Med 2012;17(3):170–178
area, and hence marking a potentially valuable step forward 13 Cerritelli F, Pizzolorusso G, Renzetti C, et al. A multicenter,
toward full adoption of such strategies in the nurseries.35,36 randomized, controlled trial of osteopathic manipulative treat-
ment on preterms. PLoS ONE 2015;10(5):e0127370
14 Pizzolorusso G, Cerritelli F, Accorsi A, et al. The effect of optimally
timed osteopathic manipulative treatment on length of hospital
Conflict of Interest stay in moderate and late preterm infants: results from a RCT. Evid
None. Based Complement Alternat Med 2014;2014:243539
15 Cerritelli F, Pizzolorusso G, Ciardelli F, et al. Effect of osteopathic
manipulative treatment on length of stay in a population of
Acknowledgments preterm infants: a randomized controlled trial. BMC Pediatr
2013;13:65
The authors would like to thank Dr. Paolo Manzoni for
16 Pizzolorusso G, Turi P, Barlafante G, et al. Effect of osteopathic
critically reviewing this article and Silvia Daccò for her manipulative treatment on gastrointestinal function and length of
helpful advice and suggestions. stay of preterm infants: an exploratory study. Chiropr Man Therap
2011;19(1):15
17 Lund GC, Edwards G, Medlin B, Keller D, Beck B, Carreiro JE.
Osteopathic manipulative treatment for the treatment of hospi-
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