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Am J Perinatol 2022; 39(S 01): S52-S62
DOI: 10.1055/s-0042-1758723
Original Article

A Randomized Controlled Trial of Osteopathic Manipulative Therapy to Reduce Cranial Asymmetries in Young Infants with Nonsynostotic Plagiocephaly

Donatella Bagagiolo
1   Department of Research, Scuola Superiore di Osteopatia Italiana, Turin, Italy
,
Claudio G. Priolo
2   Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin, Italy
,
Elena M. Favre
1   Department of Research, Scuola Superiore di Osteopatia Italiana, Turin, Italy
,
Antonella Pangallo
1   Department of Research, Scuola Superiore di Osteopatia Italiana, Turin, Italy
,
Alessia Didio
1   Department of Research, Scuola Superiore di Osteopatia Italiana, Turin, Italy
,
Marco Sbarbaro
1   Department of Research, Scuola Superiore di Osteopatia Italiana, Turin, Italy
,
Tiziana Borro
2   Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin, Italy
,
Silvia Daccò
3   Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
4   Department of Clinical Neurosciences, Villa San Benedetto Menni Hospital, Hermanas Hospitalarias, Albese con Cassano, Como, Italy
,
Paolo Manzoni
2   Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin, Italy
5   Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Ponderano, Italy
,
Daniele Farina
2   Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin, Italy
› Author Affiliations
Funding None.
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Abstract

Objective This study aimed to compare the efficacy of osteopathic manipulative therapy (OMTh) versus light touch therapy (LTT) in reducing cranial asymmetries in infants with nonsynostotic plagiocephaly (NSP).

Study Design A prospective, parallel-group, single-center, LTT-controlled randomized clinical trial was conducted in the Department of Neonatology of Sant'Anna Hospital in Turin, Italy, from September 6, 2016 to February 20, 2020. We enrolled infants of 1 to 6 months of age with NSP, who were then randomly assigned to the study group (repositioning therapy plus six sessions of OMTh) or the control group (repositioning therapy plus six sessions of LTT). The outcome was the reduction of the oblique diameter difference index (ODDI) score <104%, which was assessed at the end of the intervention protocol (at 3 months) and at 1 year of age.

Results A total of 96 infants were randomized, 48 in the OMTh group and 48 in the LTT group, with mean ages of 3.1 versus 3.2 months, and baseline ODDI score of 110.2 versus 108.7%. In the OMTh group, a significant reduction of the ODDI score <104%, compared with the LTT group, was observed in the intension-to-treat (ITT) and per-protocol (PP) analyses. The ITT analysis revealed an ODDI score <104% in the OMTh group at 3 months (risk difference: 0.41; 95% confidence interval [CI]: 0.25–0.53; p < 0.001) and at the follow-up at 1 year of age (risk difference: 0.47; 95% CI: 0.31–0.64; p < 0.001). The PP analysis at 3 months reported a risk difference of 0.44 (95% CI: 0.27–0.60; p < 0.001), and at 1 year of age, a risk difference of 0.54 (95% CI: 0.36–0.72; p < 0.001).

Conclusion In infants with NSP, a course of six OMTh sessions significantly reduced cranial asymmetries at both the 3-month and 1-year follow-up assessments, compared with LTT. This study is registered with ClinicalTrial.gov (identifier: NCT03970395; www.clinicaltrials.gov ).

Key Points

  • OMTh plus repositioning therapy significantly decreased the risk and severity of NSP compared with LTT.

  • OMTh reduced mild and moderate cranial asymmetries.

  • The role of OMTh in severe cranial asymmetries should be investigated in a multicenter trial.

Keywords

osteopathic manipulative treatment - nonsynostotic plagiocephaly - deformational plagiocephaly - infant - randomized controlled trial - osteopathic manipulative therapy - neonatology

Data Availability

Datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.


Authors' Contributions

Conceived and designed the study: D.B., E.M.F., A.P., A.D., M.S., S.D., T.B., G.C.P., and D.F. Performed the study-related activities: E.M.F., A.P., A.D., C.G.P., and T.B. Analyzed the data: S.D. Wrote the paper: D.B., P.M., E.M.F., A.P., A.D., S.D., M.S., T.B., G.C.P., and D.F.


Supplementary Material



Publication History

Received: 29 July 2022

Accepted: 21 September 2022

Article published online:
30 November 2022

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