Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nonsynostotic Plagiocephaly
- Sponsor
- PRIOLO CLAUDIO
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
PRIOLO CLAUDIO
Paediatrician
A.O.U. Città della Salute e della Scienza
Eligibility Criteria
Inclusion Criteria
- •Infants with NSP, ODDI score of 104% or more.
- •To be at term corrected age if born prematurely.
Exclusion Criteria
- •Synostotic Plagiocephaly
- •Infant who underwent an osteopathic manipulative treatment before the enrolment
- •Dysmorphisms
- •Syndromes
- •Congenital Muscular Torcicolis
- •Cerebral Palsy
Outcomes
Primary Outcomes
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
Time Frame: 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
Time Frame: 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 Outcomes
- 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.)
- Adverse Event(From first treatment (1 week post-baseline) up to end of treatment course (3 months).)