Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Phase: NA
Conditions: Nonsynostotic Plagiocephaly
Sponsor: PRIOLO CLAUDIO

 
 
 
 
 
 
 
 
 
 
 
Effectiveness of Osteopathic Manipulative Therapy 
in Nonsynostotic Plagiocephaly. Protocol of randomized controlled trial. 
 
ID: NCT03970395 
 
 
 
 
 
May 19, 2019 
 
 
 
 
 
 

Osteopathic manipulative therapy in NonSynostotic Plagiocephaly. A randomised Controlled Trial.  
 
Nonsynostotic Plagiocephaly (NSP) is a non-synostotic deformation of the head that results from 
external forces that mould the skull in the 1st year of the life. (1) NSP may be detected in up to one 
of five infants during the first two months of life. (2) Risk factors associated with NSP include 
prematurity, prolonged labour, unusual birth position, assisted delivery, twins, first-born child, 
limited neck rotation or preference in head position, maternal age (older) and male gender.(3)(4) The 
prevalence of NSP is related to the age of infants, and changed over time after the educational “Back 
to Sleep” 1994 campaign, for reducing the incidence of sudden infant death syndrome (SIDS) (5). 
Prior to 1992, the incidence of NSP was estimated at 1 in 300 infants. (1). After the recommendation 
was estimated an increase of incidence of NSP that varies with different definitions and measuring 
methods. Ballardini et al. (6) reported on 283 infants examined with Argenta’s assessment tool, 37,8% 
with DP at 8-12 weeks. Mawji et al. (7)estimated the incidence of NSP in infants at 7 to 12 weeks of 
age to be 46,6% using the Argenta’s tool. Van Vlimmerer et al. evidenced on 380 infants an increased 
from 6,1% at birth to 22,1% at 7 weeks, with the plagiocephalometry assessment tool.(8). By two 
years of age, the point prevalence of positional plagiocephaly may be as low as 3.3% (3). Of note, 
four months seems to be the critical age for the development of NSP. (8) 
Previously, NSP was considered merely a cosmetic problem (9)(10), but it causes parental worried 
and can require costly and lengthy management (11). Moreover, evidence has increased for a possible 
association, between developmental delay and deformational plagiocephaly. (12) Speltz et al. (11) 
found a clinically significant differences in gross motor development, infants with DP scored lower 
on items such as sitting up, rolling back to side, and crawling. Cabrera -Martos et al. (13) reported in 
children aged 3-5 years with history of non-synostotic plagiocephaly present significant differences 
in thoracic mobility and a muscle shortening of trunk and lower limb muscles.  
In the first instance, assessment and diagnosis of NSP is based on a clinical examination from the 
anterior, posterior and vertex positions, look for symmetry of cheeks, eyes, and ear.(1) Visual 
assessment proposed by Argenta is an excellent way of communicating and explaining to parents the 
shape of a baby’s head(13). In addition, accurate and consistent measurements of some transcranial 
diameters, head circumference, cranial width and length. DP is generally defined as including the 
presence of one or more of the following: a cranial vault asymmetry (CVA), of 3 mm or more, a 
Trans-cranial Vault Asymmetry (TCVA) (14) (15) of 4mm or more and an Oblique Diameter 
Difference Index (ODDI) score of 104% or more (16). Many tools are available for the clinical 
diagnosis and management of DP, including anthropometric calipers, plagiocephalometry, moulding 
device, digital devices with software analysis, and 3D scanning device (1)(17) (18). 

Plagiocephalometry has been identified as an accurate, cost-effective, non-invasive method with a 
good intraclass correlation. The ODDI score being the most clinically relevant measure. (19)  
Intervention strategies are depending on degree of NSP, age of infant and compliance to the therapy 
(1) Evidence reports that timing of treatment is generally consistent in suggesting that earlier 
treatment is more effective than later treatment.  Common management’s include repositioning and 
physical therapies that have a high rate of reducing NSP (9). For moderate persistent or severe NSP 
that are not responsive to conservative management strategies, helmet therapy can be used by the age 
of 5-6 months (1)(20).  
Others option for the treatment of NSP are the CAM therapy. Osteopathic manipulative medicine is 
a form of manual therapy used to diagnose and treat somatic dysfunction, normalize the structure-
function relationship and promote the body’s own self-healing mechanism (21). Osteopathic 
manipulative medicine is commonly used as an adjunctive medical approach in the treatment of 
patients, including paediatric patients in different age categories, for a variety of conditions (22). The 
treatment component of osteopathic manipulative medicine is osteopathic manipulative therapy 
(OMTh) manipulative care provided by foreign-trained osteopaths), an array of many types of 
manipulative technique (23), considered safe and effective, used for many paediatric disorders, such 
as torticollis, neck pain, scoliosis, asthma, constipation and otitis. (24) (25) In NSP, the only pilot 
study shows an average reduction of 50% asymmetry in 12 infants who have undergone four 
osteopathic treatments. (16). 
Therefore, the potential benefit of OMT in NSP requires studies with a larger population and, for the 
first time, in a randomized controlled trial. In the current study will test the hypothesis that a course 
of six osteopathic manipulative therapy will reduce the cranial asymmetries compared to Light Touch 
Therapy (LTT).  
The objective of this study will be to assess the effectiveness of OMTh in reducing cranial 
asymmetries in neonates with Nonsynostotic plagiocephaly from 1 to 6 months of age in addition to 
repositioning therapy, compared to LTT. 
 
 

Methods 
Study design and setting 
A randomized (1:1 ratio) placebo-controlled, parallel group study will be performed at the 
Department of Neonatology of Sant’Anna Hospital in Turin from September 2016 to February 2020. 
The trial was approved by the ethical commitee of Città della Salute e della Scienza of Turin 
(0074260) and registered on www.ClinicalTrials.gov (identifier: NTC NCT03970395). 
 
Population  
Eligible participants will be infants between one and six months of age at first assessment, with 
Nonsynostotic plagiocephaly assessed using the Oblique Diameter Difference Index (ODDI) score of 
104% or more, at term corrected age if born prematurely. Infants with synostotic plagiocephaly, 
infants who undergo an osteopathic manipulation before the enrolment, congenital muscular 
torticollis, dysmorphism, syndromes or cerebral palsy will be excluded. Written informed consent 
from parents or guardians will be obtain prior to the study enrolment of infants.  
Randomization and blinding  
Infants will be randomly assigned to either OMT group or Light Touch Therapy (LTT) groups using 
simple randomization procedures (computerized random number generator www.random.org) with a 
1:1 allocation, that will be prepared in advance by an independent biostatistician. The allocation 
sequence will be concealed from paediatrician enrolling and assessing participants in sequentially 
numbered, opaque, sealed envelopes. Whereas parents or guardians’ infants will be unaware of the 
allocated arm for the entire duration of the study. Outcome assessors, physical therapist, 
neonatology’s staff will be kept blinded to the allocation. Two osteopaths in charge of osteopathic 
manipulative therapy and light touch therapy will be unaware of the outcome and clinical assessment 
but will not blinded to group assignment. The statistical analysis will be performed by a biostatistician 
who is not involved in the clinical allocation and management of patients.  
Measures  
During the first assessment, will be collected data about the obstetrical, perinatal and postnatal 
information: gender, age, age for preterm: term equivalent age (TEA), gestational age, birthweight, 
head circumference, presentation at birth, delivery, mother’s first pregnancy, multiple birth, feeding, 
sleeping, daytime position, mother’s age and father’s age. Data will be retrieved by a paediatrician 
who will be blinded to group assignment.  
The primary outcome will be an improvement in cranial asymmetries from baseline at 3 months and 
at 1 year of age, defined as a reduction of  ODDI score < 104%. (9) The category of DP is defined by 
reference to the following score: ³104 <108 mild  NSP, ³ 108<112 moderate NSP, ³ 112 severe 
NSP.(19)  

The ODDI score will be carried out by plagiocephalometry a strip of thermoplastic material that is 
located at the widest transverse circumference around the head of the infant. The score will be 
calculated as the longest oblique diameter divided by the shortest oblique diameter multiplied by 
100%. Assessments will be performed by an osteopath blinded to group allocation and to clinical 
information.  
Adverse events 
Symptoms such as irritability that may occur after the osteopathic manipulative therapy or light touch 
therapy will be reported from first treatment up to the end of the course of care, at 3 months.  
Arms and Interventions  
Both groups will receive repositioning therapy that will be administered to the parents or guardians 
during the first visit. In addiction the two groups, OMTh and LTT will receive six interventions, first 
at baseline, second at 1 week, the third at 3 weeks, and then three more at 3 weeks.  
OMTh  
Osteopathic manipulative therapy requires an assessment phase to identify the area in which somatic 
dysfunctions are present in order to be treated with a specific osteopathic approach and technique. 
The assessment includes the pelvic girdle and lower limb, thorax abdominal area, pectoral girdle and 
upper limbs, cervical and upper thoracic area, cranial vault, cranial base and visceral cranium. The 
treatment consists of balanced ligamentous tension technique, myofascial release, visceral 
manipulation, and balanced membranous tension technique. The OMTh will last 45 minutes, 
including 15 minutes of assessment and 30 minutes of treatment.  
OMTh and LTT will be performed by two registered osteopaths with a specific background in 
paediatric field.  
 
Light Touch Therapy 
The LTT is consistent with the OMTh during the phase of assessment. Treatment retains the same 
areas used for osteopathic manipulation, but avoids prolonged touch in any area of the body, moving 
the hands every few seconds, flattens and softens the surface of the hands to minimize focal areas of 
force.(26)  
Repositioning Therapy  
The repositioning therapy will be performed by a paediatric physical therapist, with specific neonatal 
experience. The repositioning therapy consists of strategies that guide parents or guardians to position 
the neonate “back to sleep”, by alternating head position, the use of tummy time while supervised, 
and infants will spend limited time in car seats or other devices that facilitate supine positions. In 
active counter-positioning the parents or guardians will be encouraged to put some toys on the side 
of the head where neck rotation is limited.(1)  

Statistical analysis plan 
This trial represents the first study involving only infants with ODDI score ³ 104%. We considered that 
Osteopathic Manipulative Therapy reduced, NSP by at least 30% compared to the control group - Light Touch 
Therapy at the end of three-month intervention. We needed 45 infants, for each group, to give 80% power to 
detect a significant difference between the two groups, corresponding to a 30% of reduction of absolute risk, 
at the end of the intervention, with a type 1 error of 5%.  
We conducted the analysis of baseline clinical characteristics according to intention-to-treat (ITT) using last 
observation carried forward (LOCF) imputation technique and, by per-protocol (PP) analysis of infants 
receiving 100% of three-month intervention. Continuous variables were analysed with means and standard 
deviation and discrete variables with counts and percentages. Intervention effect was presented as change in 
prevalence of mild NSP in the intervention and control group, defines as ODDI score <104% from baseline to 
three-month and at one year of age. Relative Risk (RRs) and 95% confidence intervals (CI), absolute risk 
reductions were calculated.  
Thereafter to study the independent effect of OMTh on primary outcome we carried out a multiple regression 
model considering age start and end of intervention, sex, delivery and presentation at birth. Data were analysed 
using the software STATA/IC version 15.1 for Mac (Stata Corp LLC, USA). 
 
 
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