Osteopathic treatment shows safety in infants with plagiocephaly

Osteopathic manipulative treatment (OMT) was feasible and well-tolerated among infants with positional plagiocephaly (PP), with no serious adverse events reported in an interim analysis of an ongoing randomized clinical trial presented at the American Academy of Pediatrics (AAP) 2026 National Conference & Exhibition in San Diego, California.^1,2

The analysis, “Safety and Feasibility of Osteopathic Manipulative Treatment (OMT) in Addressing Plagiocephaly,” included 67 families who completed the study. Investigators reported 100% adherence to the protocol, which included 8 OMT visits and 2 measurement visits per participant.

"Families of infants with plagiocephaly often want treatment options that are gentle and non-invasive,” Kimberly Wolf, DO, FAAP, FACOP, FAAPO, NABBLM-C, said in a press release. “Our study demonstrates that osteopathic manipulative treatment is safe, well-accepted by families, and provides additional benefits for the baby’s health.”

Evaluating OMT for positional plagiocephaly

PP is characterized by asymmetric flattening of an infant's skull associated with sustained external pressure. Flattening commonly affects the occipital region and may be accompanied by compensatory changes to anterior structures.

Current management can include repositioning strategies, such as supervised tummy time, physical therapy when appropriate, and helmet therapy for selected infants with persistent or more severe skull deformation.

The investigators are conducting the OPT-IN trial, a 2-arm, randomized crossover clinical trial comparing OMT with standard-of-care repositioning for PP. Infants were enrolled between birth and 4 months of age.

The current interim analysis focused specifically on safety and feasibility rather than comparative treatment efficacy. Safety was evaluated by documenting adverse events reported by families and the medical team. Investigators assessed feasibility through adherence to OMT and collected information on family satisfaction after completion of the 8-week intervention.

Family feedback was obtained through a survey and caregiver focus groups. Consultants who were unknown to participating families collected and analyzed the satisfaction data and deidentified the information before sharing results with investigators.

No serious adverse events reported

All 67 families who completed the study attended the 10 required visits, resulting in 100% adherence. No serious adverse events were reported. Concurrent symptoms, including fussiness, were described as mild, not bothersome to families, and resolving quickly.

Parents also reported improvements in feeding, fussiness, reflux, and sleep during the intervention. These outcomes were based on caregiver feedback, however, and the interim abstract did not report controlled comparisons establishing that OMT caused these changes.

“A flat head is a common reason parents bring their infants to the pediatrician in the first few months of life — yet until now, families have had strikingly few choices for treatment,” Wolf said. “Our research team wanted to know if there we could help close that gap — finding an option that works with the baby's own body to help improve the head’s shape and addresses the root causes behind the flat head.”

Parents also described OMT as an alternative to helmet therapy, which investigators said had been suggested as a treatment option to many participating families.

Although the press release described improvement in head shape, the interim abstract presented at the meeting focused on safety, feasibility, adherence, and caregiver feedback and did not provide comparative head-shape measurements demonstrating efficacy.

Additional findings from the OPT-IN trial will be needed to determine how OMT compares with repositioning for improving PP and whether the secondary benefits reported by caregivers differ between treatment groups.

References

1. American Academy of Pediatrics.Hands-on treatment studied as option in treating baby flat head syndrome. Eurekalert. October 2, 2026. Accessed October 2, 2026. https://www.eurekalert.org/news-releases/1145253?

2. Kaur S. Safety and feasibility of osteopathic manipulative treatment (OMT) in addressing plagiocephaly. Abstract presented at: American Academy of Pediatrics 2026 National Conference & Exhibition; October 2-6, 2026; San Diego, CA