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Completed

NCT Number: NCT03970395

Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

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.

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Key information

Conditions

Nonsynostotic Plagiocephaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Plagiocephaly Plagiocephaly, Nonsynostotic

Age range

1 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Universitaria Città della Salute e della Scienza.

Torino, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic manipulative therapy (OMTh)

Other

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.

Light Touch Therapy (LTT)

Other

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.

Repositioning therapy

Other

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.

Primary outcomes

  1. Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months

    Time frame: Baseline and 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.

  2. 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 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Cranial Proportion Index (CPI)

    Time frame: 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.

  2. Adverse Event

    Time frame: 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

Sponsors and collaborators

Lead sponsor

PRIOLO CLAUDIO

Other

Collaborators

  • Scuola Superiore di Osteopatia Italiana

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 31, 2019
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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