Francesca Galiano
|
20/09/2022 - Last update 28/12/2022

Margherita Gasperini, Nicola Vanacore, Luca Massimi, Stefano Consolo, Cristina Haass, Maria E. Scapillati, Marco Petracca | Year 2021

Effects of osteopathic approach in infants with deformational plagiocephaly, an outcome research study

Pathology:

Plagiocephaly

Type of study:

Outcome study

Date of publication of the study’:

2021/Nov/10

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Purpose of the study

  • Objective: to evaluate the effects and safety of OMT on deformational plagiocephaly at 12-month follow-up and parental satisfaction
  • Measured outcomes:
    • Primary: oblique diameter difference index (ODDI) in case of unilateral deformational plagiocephaly and cranial proportional index (CPI) in case of brachycephaly (bilateral deformational plagiocephaly) through plagiocephalometry
    • Secondary: ear deviation index (EDI) using plagiocephalometry, OMT safety through questionnaire and parental satisfaction through Likert scale

Participants

  • Number: 37 infants (19 female and 14 male, mean age 16.6 weeks)
  • Criteria of inclusion: infants under 6 months of corrected age (the age the infants would have if they had been born at the end of the gestational period), seen in a private pediatric osteopathic clinic, with deformational plagiocephaly and assessed with plagiocephalometry.
  • Criteria of exclusion: presence of syndromic and metabolic pathologies, craniosynostosis, congenital malformations of the cranial bones, brain fractures, minor or major neurological deficits, congenital muscle torticollis, contraindications to OMT; children undergoing physiotherapy or cranial orthosis.
  • Groups of study: 1 group
    • Group 1: OMT and postural indications, 37 infants
      • 6 infants with gestational age of 34-36 weeks and 31 infants of 37-41 weeks
      • 35 children with unilateral plagiocephaly, of which 21 right-sided
        • 2 infants did not present at the follow-up at the end of the study
        • 18 infant with mild severity, 8 severe, 7 very severe
      • 18 infants with brachycephaly
        • 10 infants with light severity, 5 severe, 3 very severe
      • 21 with both

Interventions and evaluations

  • Evaluation at baseline and at 12 months of corrected age using plagiocephalometry
    • in particular, the ODDI, CPI and EDI indices were used
  • Evaluation of OMT safety through a questionnaire created on the basis of questionnaires use to assess adverse reactions to drugs
    • the questionnaire was given to the parents at the beginning of the study and returned at 12 months of corrected age
  • Evaluation of parental satisfaction through Likert scale made of 7 questions concerning the environment of the treatment, the duration, the number of sessions, costs and general satisfaction with scores ranging from 1 to 4
    • the satisfaction questionnaire was given to parents at the beginning of the study and it was returned at 12 months of corrected age
  • At baseline, collection of the following data: medical history during pregnancy, delivery and health status of the infant, reason of the consultation and physical evaluation
  • OMT sessions with postural indication until the corrected age of 9 months based on the history and clinical situation of the child and on the availabilities of their parents
    • about, 2-12 OMT sessions of 30-45 minutes, each one with separate postural indications to be followed from 1 to 6 weeks, for a total period spanning from 1 to 8 months
  • OMT: complete evaluation to detect somatic dysfunctions, clinical reasoning and application of gentle and personalized techniques to resolve the somatic dysfunctions found
    • approaches used: functional method, facilitated deformational release, facilitated oscillatory release, myofascial release, fascial unwinding, visceral manipulation, cranial osteopathy, balanced ligamentous tension, balanced membranous tension, V-spread
  • Postural indications: teaching parents how to position the child’s head during sleep, how to give various stimuli to improve the child’s motor development and indications on tummy time (belly-down playing) according to the American Academy of Pediatrics guidelines
  • OMT performed by an osteopath with experience in the pediatric field and evaluations carried out by a pediatric physiotherapist expert in plagiocephalometry

Results

  • Primary outcomes: OMT favored a statistically significant reduction of the ODDI and CPI indices at 12 months of corrected age. As a result, 25 out of 33 children with unilateral plagiocephaly and 18 out of 18 children with brachycephaly had their problems resolved: only 8 children remained with a moderate unilateral plagiocephaly. Therefore, at 12 months, none of the children presented severe or very severe plagiocephaly.
  • Secondary outcomes: OMT favored a statistically significant decrease of the EDI index at 12 months of corrected age. As a consequence, 17 out of 22 infants with altered EDI resolved their situation, 4 remained with a mild asymmetry and 1 with a severe asymmetry. With regard to parental satisfaction, 4 negative evaluations and 256 positive evaluations were reported. There were no adverse events nor, at the time of follow-up, any pathologies associated with plagiocephaly.

Discussion

OMT showed to be able to act positively on cranial conformation in the case of deformational plagiocephaly. The results obtained through ODDI and CPI indices indicate that the cranial vault and base have undergone a remodeling of their shape. These results, together with the lack of adverse effects, are particularly important considering that deformational plagiocephaly, although benign as a condition, can promote postural, visual, auditory, occlusal, cognitive and neuromotor problems.

OMT might have acted thanks to the correction of the somatic dysfunctions (in particular, in this case, of the intraosseous dysfunctions) and, therefore, reinstating a tissue mobility that allowed the correct cranial remodeling, thus positively affecting development. Furthermore, OMT could also have acted by rebalancing the neurologic function, because in deformational plagiocephaly there often seems to be a state of sensitization. However, studies are needed to try to compare OMT and postural indications alone and OMT with the addition of postural indications to better understand the importance of the two interventions used. Finally, studies are needed comparing different types of treatment to each others, to evaluate possible placebo effects

The review of Osteopedia

By Marco Chiera

Strengths:good introduction description of plagiocephaly and of possible usefulness of OMT; good description of interventions and measurements; use of a simple type of evaluation, non-invasive, little costly and clinically valid; execution of OMT as personalized according to the different infants’ needs; good discussion of the results, also compared to past studies.

Limits:since children were recruited in a private clinic and there is no control group, the placebo effect, also mediated by parents (placebo by proxy) potentially predisposed to osteopathy, should not be excluded; inability to assess how much the OMT or the postural indications affected the results.

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