Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

Not Applicable

Completed

Interventions: Other: Osteopathic manipulative therapy (OMTh)
Other: Light Touch Therapy (LTT)
Other: Repositioning therapy

Brief Summary: The aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.

Detailed Description: Nonsynostotic plagiocephaly (NSP) is defined as the deformation of the head resulting from external forces that mould the skull during the first months of life.

Four months seems to be a critical age for the development of NSP, but many positional head shape deformities may improve with time.

Early assessment and diagnosis is important not only for the shape of the skull, but also for possible clinical significant differences in gross motor development.

In paediatric conditions the effect of osteopathic manipulative treatment is documented in systematic reviews; in NSP the only study, which is a pilot, reveals an average reduction of 50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Osteopathic manipulative therapy	Osteopathic manipulative therapy (OMTh)	Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). Osteopathic Manipulative Therapy. Participant OMT group receive 6 OMTh in 3 months, as follows: first at baseline, the second after 1 week, the third after 3 weeks, and then once every 3 weeks for three more visits.
Light Touch Therapy	Light Touch Therapy (LTT)	Repositioning Therapy plus Light Touch Therapy (LTT) Participants to the LTT group receive the LTT protocol at the same date of the OMTh group.
Light Touch Therapy	Repositioning therapy	Repositioning Therapy plus Light Touch Therapy (LTT) Participants to the LTT group receive the LTT protocol at the same date of the OMTh group.
Osteopathic manipulative therapy	Repositioning therapy	Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). Osteopathic Manipulative Therapy. Participant OMT group receive 6 OMTh in 3 months, as follows: first at baseline, the second after 1 week, the third after 3 weeks, and then once every 3 weeks for three more visits.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.	Follow-up at one year of age	The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of Nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score \>=104\<108 MILD Nonsynostotic Plagiocephaly ODDI score \>=108\<112 MODERATE Nonsynostotic Plagiocephaly ODDI score \>= 112 SEVERE Nonsynostotic Plagiocephaly Higher score means a worse outcome.
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months	At 3 months	The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score \>=104 Nonsynostotic Plagiocephaly ODDI score \<104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Cranial Proportion Index (CPI)	The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.	Change of the width and length diameter measured with Plagiocephalometry.
Adverse Event	From first treatment (1 week post-baseline) up to end of treatment course (3 months).	Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy

Locations (1): Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Universitaria Città della Salute e della Scienza.
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Torino, Italy