Early osteopathic manipulative treatment to prevent cranial positional deformities: A randomized controlled trial.

Background: Cranial positional deformities occur frequently in the first months of life.

Objective: To evaluate the effectiveness of osteopathic manipulative treatment (OMT) in preventing the onset of positional plagiocephaly and brachycephaly at 4 months in at-risk newborns.

Methods: This single-center, randomized, controlled open-label study, with blinded assessment of the endpoints, was carried out at the maternity unit of Montpellier University Hospital (France) between 2019 and 2022. Newborns aged between 3 and 10 days with at least one risk factor for cranial deformity were included and randomized into a group receiving OMT in addition to advice for the prevention of cranial deformities or a group receiving advice alone (standard care). OMT included an osteopathic assessment, osteopathic treatment, and at least one follow-up session. The primary outcome was the occurrence of plagiocephaly (cranial asymmetry index ≥106 %) or brachycephaly (cranial index ≥93 %) at 4 months after birth.

Results: The trial terminated early due to enrolment issues (56.1 % of planned recruitment). Among the 101 patients included, 35 in the OMT group and 30 in the control group completed the study and were analyzed. At 4 months, no significant difference was observed in the rates of brachycephaly (relative risk [RR] of the control group vs. OMT: 1.55, 95 % confidence interval [CI]: [0.38, 6.39], p = 0.54), or plagiocephaly (RR=1.64, 95 % CI [0.34, 8.00], p = 0.54). A trend toward more frequent cases of severe brachycephaly or plagiocephaly was observed in the control group (n = 5) compared with the OMT group (n = 1; p = 0.09). No adverse effects were reported.

Conclusions: This study did not find any significant effect of OMT on the occurrence of cranial positional deformities. However, recruitment and follow-up difficulties, partly linked to the COVID-19 pandemic, resulted in an underpowered study that does not allow definitive conclusions to be drawn on potential benefits of OMT.