Advanced search


Search results        Search results      Copy URL to E-Mail

Safety and Feasibility of Osteopathic Manipulative Treatment (OMT) in Addressing Plagiocephaly
Wolf, K. J. [1]
Martone, J. [1]
Varrasso, E. [1]
Belsky, J. A. [7]

Journal: Journal of Osteopathic Medicine Date: 2025/12, 125(12):Pages: A684–686. doi: Subito , type of study: crossover study


Keywords:

adverse events [44]
cross sectional study [826]
infants [201]
OMT [3746]
osteopathic manipulative treatment [3766]
pediatrics [527]
plagiocephaly [53]

Abstract:

Context: 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 other cranial structures, including the 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 prevalence since its implementation6. We are conducting a two-arm, randomized crossover clinical trial looking at the benefit of osteopathic manipulative treatment (OMT) versus the standard of care of repositioning in the management of DP/PP. This abstract focuses on an interim analysis of the safety and feasibility data to date of the larger study. Objective: The objective of this interim analysis is to examine how safe and feasible OMT is for the treatment of PP/DP in infants enrolled between 0-4 months of age? Methods: This interim analysis considers safety and feasibility data collected from families who are taking part in the randomized crossover trial. Key outcomes being examined are OMT 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 conducted with the caregivers of participants also after the OMT intervention. All family satisfaction data were collected and analyzed by external consultants who deidentified the data before sharing the results with the research team. A total of 94 participants have been recruited, meaning a pre-screening survey was requested. Participants are referred by local healthcare providers or self-referred. A total of 58 participants have met eligibility criteria and have been enrolled. Inclusion criteria: under 5 months at the time of enrollment, diagnosis of DP/PP, and ability (for parent) to read and write in English or Spanish. An infant is ineligible if they were born: preterm (before 37 weeks), with genetic syndromes, craniofacial defects/deformities, brachycephaly/scaphocephaly, hypotonia, hypertonia, craniosynostosis, head trauma or other neurological illnesses, can’t attend 10 in-person visits, have had prior treatment for plagiocephaly, or 3+ treatments for a concern other than plagiocephaly. Enrolled participants are randomly assigned to treatment with OMT or standard of care based on a computer-generated algorithm. Those in the treatment group receive OMT once per week for 8 weeks with two cranial measurements at each visit, directly before treatment and immediately following OMT. Those in the standard of care group perform exercises at home consistent with the current standard of care for plagiocephaly in this age group and come for 2 measurement visits (in week 1 and week 8). Physicians treat each patient’s unique structural exam findings using multiple OMT modalities, often focusing on osteopathic cranial manipulative medicine (OCMM). Descriptive statistics have been performed on the data for this interim analysis. This study is significant in the field of osteopathic medicine as it has the potential to be an alternative treatment to helmet therapy with potential for significant cost savings for the families and the larger healthcare system. Additionally, the pragmatic treatments performed in the study are in line with osteopathic philosophy and practice. The pre- and post-OMT measurements demonstrate the impact of OMT and that the treatment benefits are not explicitly due to placebo. The longitudinal outcomes monitored in the study aim to show the benefit of early intervention on existing somatic dysfunction and how this may have a more significant impact on children’s health and development. The safety and family satisfaction data will help reduce concerns about seeking OMT for pediatric patients. Results: Preliminary results suggest that OMT has a favorable safety profile and is a feasible option for families in management of DP/PP. Among the 37 participants who have completed the intervention portion of the study thus far, there is 100% compliance. This includes 10 visits total per participant: 8 OMT 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 benefits. Parents have highlighted how important OMT has been as an alternative to helmets, which were suggested as a treatment option for many families. Eighteen out of 42 families (43%) responded to the feedback survey at the conclusion of treatment. Of those 18, 100% reported that they believed OMT improved their baby’s head shape and 100% of parents stated they felt safe during treatment. In addition to improved head shape, parents identified many other benefits including improved breast/chestfeeding, bottle feeding, neck movement, and a reduction in fussiness, among others. No concerns were raised and the only barrier to treatment was the time to travel to appointments, which was mentioned by only one family. A total of 355 treatment visits have been conducted on 48 patients in the study. Complications have only been identified for 48 of those visits (14%). The main complication noted by parents is fussiness/irritability following OMT which typically resolves within a few hours. No parents have expressed that the complications are bothersome or a deterrent to continuing OMT. These findings reinforce the positive perceptions of OMT’s effectiveness and safety. 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.

Search results      Copy URL to E-Mail

 
 
 






  • Impressum • Legal notice • Datenschutz •


ostlib.de/data_avzetpmgcyrjsbdnfwxu



Supported by

OSTLIB recommends