AOPA questions BMJ helmet therapy study results

Anita Liberman-Lampear, MA, president of the American Orthotic and Prosthetic Association, released a letter to The New York Times citing concerns about recent study results published in BMJ that discouraged the use of a cranial helmet for standard treatment for healthy infants with moderate to severe skull deformation.

Study results suggested that helmet therapy and no treatment for the natural course of skull growth were equally effective in correcting the deformation. Researchers weighed the high prevalence of side effects and high costs associated with helmet therapy in their assessment.

In the study, researchers randomly assigned 84 infants aged 5 months to 6 months with moderate to severe skull deformation to 6 months of helmet therapy or no treatment. Participants were born after 36 weeks of gestation and had no muscular torticollis, craniosynostosis or dysmorphic features. Parents were asked to avoid any additional treatment for skull deformation in both groups.

Seventy-nine infants were followed up at 24 months. Primary outcome measures included change in skull shape from baseline to 24 months of age assessed using plagiocephalometry, as well as change in scores for plagiocephaly and brachycephaly. Secondary outcomes included ear deviation, facial asymmetry, occipital lift and motor development in the infant, quality of life and parental satisfaction and anxiety.

Overall, study results showed the change score for both plagiocephaly and brachycephaly had a mean difference of –0.2 in the helmet therapy group and a mean difference of 0.2 in the no treatment group. Researchers found 26% of participants in the helmet therapy group achieved full recovery vs. 23% of participants in the natural course group. All parents in both groups reported at least one side effect.

“This pragmatic randomised controlled trial found no evidence of a significant or clinically meaningful difference in improvement of skull shape at 2 years of age between infants who were treated with helmet therapy and those in whom the natural course of skull deformation was awaited,” the researchers wrote.

The letter from the American Orthotic & Prosthetic Association raised concerns about the low participation rate (21%) and a 73% incidence of basic fitting problems, which may have affected appropriate clinical applications of the helmets used in the study.

“Nothing in the BMJ article either questioned or studies the appropriateness of treatment with cranial helmets for these patients with more significant symptoms,” Liberman-Lampear wrote. “As to this BMJ study, science demands replicability, and any new finding must be demonstrated as being capable of validation through similar results reached by other investigators using parallel methods — in short, with rare exception, no single article changes existing science.”

For more information:

Van Wijk RM. BMJ. 2014;doi:10.1136/bmj.g2741.

AOPA letter to The New York Times. Published at: Accessed May 5, 2014.

Disclosure: The researchers have no relevant financial disclosures.

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