Francesca Galiano
|
11/09/2023 - Last update 10/11/2023

Ramon Cases-Solé, David Varillas-Delgado, Marta Astals-Vizcaino, Óscar García-Algar | Year 2022

Efficacy and Feasibility of an Osteopathic Intervention for Neurocognitive and Behavioral Symptoms Usually Associated With Fetal Alcohol Spectrum Disorder

Pathology:

Fetal Alcohol Syndrome-FAS

Type of study:

Pilot randomized controlled trial

Date of publication of the study’:

2022/Mar/15

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Purpose of the study

  • Objective: to evaluate the feasibility and effectiveness of OMT on neurocognitive and behavioral symptoms in fetal alcohol spectrum disorders, and validate the use of OMT for future studies
  • Measured outcomes:
    • Assessment of the percentage of children who completed all OMT sessions and showed significant changes on the scales of the Neuropsychological Maturity Questionnaire for Children (Cumanin®)

Participants

  • Numbers: 32 children (15 female and 17 male)
  • Criteria of inclusion: children (from 3 to 6 years of age) without a diagnosis of fetal alcohol spectrum disorder, but with symptoms normally present in this condition detected by neuropsychological evaluation and referred by osteopathic schools or centers; attentional and behavioral problems according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); reduced levels of attention (score below the 50th percentile on the Cumanin® measuring test)
  • Criteria of exclusion: diagnosis of ADHD, other neurological, genetic or metabolic disorders; medication treatmentsp at the time of the study; having received OMT in the 12 months prior to the study
  • Groups of study: 2 groups obtained by randomization
    • Group 1: Standard of Care with OMT, 16 children (6 female and 10 male, mean age 54.75 months
    • Group 2: Standard of Care, 16 children (9 female and 7 male, mean age 48.81 months)

Interventions and evaluations

  • Assessment at the beginning and end of the study of neurocognitive development (attention, iconic memory, spatial structuring, and visual perception) using Cumanin®
  • Assessment of the percentage of children who completed all OMT sessions and showed significant changes on the Cumanin® scales
  • 3 biweekly OMT sessions of 50 minutes (at the first visit) and 30 minutes (at the next two visits)
  • OMT: history, standardized assessment using SOAP, search for somatic dysfunctions according to the TART standard, and treatment of all somatic dysfunctions
    • Techniques applied: balanced ligamentous tension, balanced membranous tension, osteopathy of the cranial area and facilitated positional release
  • Standard of care: personalized support for school learning according to guidelines on educational interventions for children with neurocognitive and behavioral symptoms
  • OMT performed by a pediatric osteopath
  • Neuropsychological tests administered by a certified psychologist

Results

Primary outcomes: all children completed the OMT.
At the end of the study, the control group showed a statistically significant worsening in the attention and spatial structuring scales, while the OMT group showed a statistically significant improvement in the attention and iconic memory scales and a statistically significant worsening in the spatial structuring and visual perception scales.

Comparing the groups, the OMT group showed a statistically significant improvement in the attention and iconic memory scales compared with the control group, and also showed a statistically significant worsening in the lower spatial structuring scale compared with the control group.

Secondary outcomes: the visits had an average duration of: 16 minutes for history taking, 10 minutes for evaluation, and 10 minutes for treatment. On average, somatic dysfunctions were found mainly at the level of the skull (30.0%), diaphragm (17.1%) and cervical area (12.8%); while there were about 4 somatic dysfunctions per participant at the beginning of the study, there were only 1.5 of them by the end of it.
Osteopathic techniques were used with the following frequencies: balanced ligamentous tension (61.4%), balanced membranous tension and osteopathy of the cranial area (30.0%), facilitated positional release (8.6%).
No major side effects or adverse events were reported.

Discussion

OMT was shown to be a feasible intervention in children with neurocognitive and behavioral symptoms typical of fetal alcohol spectrum disorders. Indeed, it promoted an improvement in attention and iconic memory and promoted a minor decrease in spatial structuring abilities.

One reason for these findings may lie in the role that the somatosensory system plays in perceptual and cognitive development: consequently, somatic dysfunctions, by altering the somatosensory system, may also affect the neurocognitive development. Since these are in fact young children, OMT could promote neuroplasticity events, but more research is needed to better clarify the mechanisms of action of OMT in this context.

Further studies are needed because this study had a small sample size and a short duration, but also because there is a lack of research on the usefulness of OMT not only in case of fetal alcohol spectrum disorders in particular, but also in case of neurodevelopmental disorders in general. The relevance of such studies resides also in the impact neurodevelopmental disorders may have on growth and future educational levels.

The absence of adverse effects may have been due to the mildness of the OMT approach compared to other therapies, as well as the preparation and experience of the practitioner. In addition, families with children with behavioral or cognitive problems tend to seek out effective therapies, which may have influenced the lack of drop-outs.

A limitation of the study was the lack of a sham treatment group so as to rule out possible placebo effects, as well as the use of a questionnaire (Cumanin®) specific to the Spanish population and, therefore, not usable in studies on other populations.

The review of Osteopedia

By Marco Chiera

Strengths: area of special interest, as the child’s neurocognitive development lays the foundation for all future health; individualized treatment; good discussion of the role OMT can play in these conditions and the needs for further studies coming from the children themselves and from their families.

Limits: children with symptoms usually present in fetal alcohol spectrum disorders were evaluated, but not children diagnosed with fetal alcohol spectrum disorders; not very linear presentation of the data; very sketchy presentation of results; unclear concept of “major adverse events,” which should be given more importance given that this is a feasibility study (with a specific purpose to find out about possible adverse effects); lack of follow-up.

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