P3.222: Safety and Feasibility of Osteopathic Manipulative Treatment (OMT) in Addressing Plagiocephaly

Background: Deformational/positional plagiocephaly (DP/PP) is described as an asymmetrical flattening of the cranium due to sustained external pressure. This cranial deformation can arise pre- or postnatally1. The newborn infant has unique cranial anatomy which is critical for birth, but leaves them vulnerable to DP/PP. DP/PP creates asymmetric flattening usually of the occipital bone which leads to compensatory shifts of anterior structures, including orbits and middle ear2. One clinical trial reported plagiocephaly in 205 out of 440 total infants between 7 to 12 weeks of age – totaling an incidence of ~46.6%3–5. Also contributing to significantly increased numbers of referrals for evaluation and treatment of DP/PP has been the “Back to Sleep” campaign which has led to a 600% increase in prevalence6.



We are conducting a two-arm, randomized cross-over clinical trial7 looking at the benefit of osteopathic manipulative treatment (OMT) in the management of DP/PP versus the standard of care of repositioning. This interim analysis examines the following question: “How safe and feasible is OMT for the treatment of PP/DP in infants enrolled between 0-4 months of age?”

Methods: Key outcomes being examined are study safety and feasibility. Safety is assessed by tabulating and describing adverse events as reported by families and the medical team. Feasibility outcomes, such as adherence to OMT are tabulated and family satisfaction summarized descriptively. Family satisfaction was examined through a feedback survey sent upon completion of the 8-week OMT intervention and focus groups which were conducted with the caregivers of participants also after completion of the OMT intervention. All family satisfaction data were collected and analyzed by consultants unknown to the families and who deidentified the data before sharing the results with the research team.

Results: Preliminary results suggest that OMT has a favorable safety profile and is a feasible option for families in management of DP/PP. Among those who have completed the study, there is 100% compliance. This includes 10 visits total per participant: 8 OMT visits and 2 measurement visits. No serious adverse events have occurred, showing OMT is safe and well-tolerated by infants. Parents who have completed the OMT visits are satisfied with treatment and have identified multiple secondary results, such as improved feeding, fussiness, reflux, and sleep. Parents have highlighted how important OMT has been as an alternative to helmets, which were suggested as a treatment option to many families.

Conclusion: The results of our safety and feasibility analysis show OMT has a favorable treatment profile for infants with DP/PP and yields secondary benefits. OMT should be considered for families who are seeking a low-cost, non-invasive treatment option for management of DP/PP.