Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

Conditions
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Nonsynostotic Plagiocephaly

Intervention / Treatment
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* Other: Osteopathic manipulative therapy (OMTh)
* Other: Light Touch Therapy (LTT)
* Other: Repositioning therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic manipulative therapy<br>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. | Other: Osteopathic manipulative therapy (OMTh)<br>* The Osteopathic Manipulative Therapy includes evaluation and treatment. The evaluation considers the pelvic girdle and lower limb, thorax abdominal area, pectoral girdle and upper limbs, cervical and upper thoracic area, cranial vault, cranial base and viscero cranium. The treatment is based on balanced ligamentous tension technique, myofascial release, visceral manipulation, and balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 minutes of evaluation and 30 minutes of treatment.<br>Other: Repositioning therapy<br>* It consists of strategies that guide the parents to position the baby back to sleep, by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant's head is placed.<br>|
| Sham Comparator: Light Touch Therapy<br>Repositioning Therapy plus Light Touch Therapy (LTT) Participants to the LTT group receive the LTT protocol at the same date of the OMTh group. | Other: Light Touch Therapy (LTT)<br>* The LTT is consistent with the OMT during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body, moving the hands every few seconds, and by flattening and softening the surface of the hands to minimize focal areas of force.<br>Other: Repositioning therapy<br>* It consists of strategies that guide the parents to position the baby back to sleep, by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant's head is placed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% 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. | Baseline and 3 months | 
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 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 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome. | Follow-up at 1 year of age | 
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% 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. | At 3 months | 
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 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. | Follow-up at one year of age | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positional Plagiocephaly, Deformational Plagiocephaly,