Clinical trial NCT03970395: Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Official title: Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonsynostotic Plagiocephaly
Keywords: Positional Plagiocephaly, Deformational Plagiocephaly,
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: Scuola Superiore di Osteopatia Italiana
First posted: 2019-05-31
Enrollment: 96
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months
timeFrame: Baseline and 3 months
measure: Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
timeFrame: Follow-up at 1 year of age
measure: Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months
timeFrame: At 3 months
measure: Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
timeFrame: Follow-up at one year of age
Secondary outcomes:
measure: Cranial Proportion Index (CPI)
timeFrame: The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.
measure: Adverse Event
timeFrame: From first treatment (1 week post-baseline) up to end of treatment course (3 months).
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Universitaria Città della Salute e della Scienza.
Study officials:
affiliation: Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy
name: Claudio G Priolo, Medical
role: STUDY_DIRECTOR
affiliation: Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy
name: Daniele Farina, Medical
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers GF. Deformational plagiocephaly, brachycephaly, and scaphocephaly. Part I: terminology, diagnosis, and etiopathogenesis. J Craniofac Surg. 2011 Jan;22(1):9-16. doi: 10.1097/SCS.0b013e3181f6c313.
citation: Rogers GF. Deformational plagiocephaly, brachycephaly, and scaphocephaly. Part II: prevention and treatment. J Craniofac Surg. 2011 Jan;22(1):17-23. doi: 10.1097/SCS.0b013e3181f6c342.
citation: Lennartsson F. Developing guidelines for child health care nurses to prevent nonsynostotic plagiocephaly: searching for the evidence. J Pediatr Nurs. 2011 Aug;26(4):348-58. doi: 10.1016/j.pedn.2010.07.003. Epub 2010 Sep 25.
citation: Lessard S, Gagnon I, Trottier N. Exploring the impact of osteopathic treatment on cranial asymmetries associated with nonsynostotic plagiocephaly in infants. Complement Ther Clin Pract. 2011 Nov;17(4):193-8. doi: 10.1016/j.ctcp.2011.02.001. Epub 2011 Mar 5.
citation: van Vlimmeren LA, Takken T, van Adrichem LN, van der Graaf Y, Helders PJ, Engelbert RH. Plagiocephalometry: a non-invasive method to quantify asymmetry of the skull; a reliability study. Eur J Pediatr. 2006 Mar;165(3):149-57. doi: 10.1007/s00431-005-0011-1. Epub 2005 Oct 7.