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Guest Post: Cranial Remolding Helmets Do Not Work…Or do they? A dive into a flawed helmet study.

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Written By Andrew Allen

Google “skull deformity helmets” and nearly half of the   results on the first page are articles that criticize helmet therapy for infants, claiming that the expensive orthotics are a total waste of money. Despite numerous studies that support the effectiveness of helmet therapy in correcting plagiocephaly and brachycephaly [3-6], media sources such as The New York Times andBoston.com have released articles that discourage treatment [8,9]. The basis for nearly all of helmet therapy criticism arises from a single study published on May 1, 2014, by Renske van Wijk and a team of researchers in the Netherlands [11]. The study, Helmet therapy in infants with positional skull deformation: randomised controlled trial, compared the 24-month outcomes of infants (aged 5 to 6 months) assigned to either a helmet therapy group or a control group that received no treatment. According to the study, helmet therapy was just as effective in correcting skull deformation as no treatment. Thus, van Wijk et al. discourage the use of helmets when treating moderate cases of skull deformation. There are numerous caveats associated with these conclusions, however, that should be taken into account before deciding to leave your infant’s skull deformity untreated.Layla Mewborn

Firstly, here is some background information on the condition in the United States. In 1992, the initiation of the “Back to Sleep” campaign resulted in increased numbers of infants sleeping in a supine position to reduce the risk of Sudden Infant Death Syndrome (SIDS). While the campaign has been extremely effective in reducing instances of SIDS, static supine position is one of the leading risk factors for plagiocephaly. Thus, the increase in skull deformity cases since the 1990s is likely correlated with the 1992 campaign [1]. In 2013, plagiocephaly was estimated to affect 46.6% of infants aged 7 -12 weeks [7]. In addition to prolonged external force resulting from static supine position, other risk factors include torticollis (asymmetric tight neck muscles), prenatal uterine constraint, and perinatal birth injury [1]. The two most common treatments are cranial helmets and repositioning practices—a more conservative approach where infants are positioned in prone for short periods of time. According to the van Wijk study, however, natural course is just as effective as the more aggressive, cranial helmet treatment.   Bling Your Band

Following publication on May 1, 2014, there was a high volume of critical responses from members of the medical community regarding the study’s results and conclusions. One of the most common criticisms is that the study did not include infants with severe deformities, torticollis, or other developmental neuromuscular issues. Thus, it is still widely believed that infants with severe skull deformities or neuromuscular problems stand to benefit from cranial helmets. Jordan Steinberg, a pediatric plastic surgeon, points out the high percentages of study participants that experienced problems with the cranial helmet during its use in the study [10]. Reportedly, 96% of the infants experienced skin irritation, 76% unpleasant odor, and 33% felt some sort of pain from the helmet. Furthermore, 73% of participants reported improper fit and shifting of the orthotic [11]. Noting these issues, and the low percentages of full recovery in both subject groups, Steinberg concludes that the participants received “inadequate treatment” [10]. Kevin Kelly, a research consultant at Cranial Technologies also comments on these statistics stating, “The lack of improvement seen in their study was the direct result of their ill-fitting helmets” [2]. Had participants received properly fitting helmets and proper care, van Wijk et al. may have observed significantly different outcomes.helmet

Although many view skull deformity as solely a cosmetic issue, “untreated cranial asymmetries have been linked to visual defects, ear infections, middle ear malfunction, jaw bone changes, developmental delay, learning difficulties, and other psychomotor delays” [12]. Treating instances of plagiocephaly and brachycephaly in a timely manner is important for ensuring proper development. The results of van Wijk’s study are not completely reliable and do not annul the value of cranial helmets. The study did not include severe cases of skull deformity, and patients were not properly fitted with their orthotics. More research is certainly necessary to properly characterize the effectiveness of cranial helmets. For the time being, seeing as skull deformities can lead to numerous developmental complications, it should be of primary concern to treat the condition rather than quickly dismissing a device that has been historically successful in correcting countless cases of skull deformity.

1. Grigsby, Katrina. “Cranial Remolding Helmet Treatment of Plagiocephaly: Comparison of Results and Treatment Length in Younger Versus Older Infant Populations.” JPO Journal of Prosthetics and Orthotics 21.1 (2009): 55-63. American Academy of Orthotists and Prosthetists. Web. 1 July 2015. <http://www.oandp.org/jpo/library/2009_01_055.asp&gt;.

2. Kelly, Kevin M. “Re: Helmet Therapy in Infants with Positional Skull Deformation: Randomised Controlled Trial.” Letter to RM Van Wijk. 10 May 2014. The British Medical Journal. BMJ Publishing Group Ltd, n.d. Web. 01 July 2015. <http://www.bmj.com/content/348/bmj.g2741/rapid-responses&gt;.

3. Kim, Se Yon, Moon-Sung Park, Jeong-In Yang, and Shin-Young Yim. “Comparison of Helmet Therapy and Counter Positioning for Deformational Plagiocephaly.” Ann Rehabil Med Annals of Rehabilitation Medicine 37.6 (2013): 785-95. PubMed. Ann Rehabil Med. Web. 26 June 2015. <http://vb3lk7eb4t.search.serialssolutions.com/?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&rfr_id=info:sid/summon.serialssolutions.com&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Comparison of Helmet Therapy and Counter>.

4. Kluba, Susanne, Wiebke Kraut, Benjamin Calgeer, Siegmar Reinert, and Michael Krimmel. “Treatment of Positional Plagiocephaly – Helmet or No Helmet?” Journal of Cranio-Maxillofacial Surgery 42.5 (2013): 683-88. Science Direct. Web. 26 June 2015. <http://vb3lk7eb4t.search.serialssolutions.com/?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&rfr_id=info:sid/summon.serialssolutions.com&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Treatment of positional plagiocephaly – H>.

5. Lee, Robert P., John F. Teichgraeber, James E. Baumgartner, Amy L. Waller, Jeryl D. English, Robert E. Lasky, Charles C. Miller, Jaime Gateno, and James J. Xia. “Long-Term Treatment Effectiveness of Molding Helmet Therapy in the Correction of Posterior Deformational Plagiocephaly: A Five-Year Follow-Up.” The Cleft Palate-Craniofacial Journal 45.3 (2008): 240-45. ProQuest. Allen Press Publishing Services. Web. 26 June 2015. <http://search.proquest.com.libproxy.lib.unc.edu/docview/204925188?pq-origsite=summon&gt;.

6. Lipira, A. B., S. Gordon, T. A. Darvann, N. V. Hermann, A. E. Van Pelt, S. D. Naidoo, D. Govier, and A. A. Kane. “Helmet Versus Active Repositioning for Plagiocephaly: A Three-Dimensional Analysis.” Pediatrics 126.4 (2010): 936-45. Pediactrics. American Academy of Pediatrics. Web. 26 June 2015. <http://pediatrics.aappublications.org.libproxy.lib.unc.edu/content/126/4/e936&gt;.

7. Mawji, A., A. R. Vollman, J. Hatfield, D. A. Mcneil, and R. Sauve. “The Incidence of Positional Plagiocephaly: A Cohort Study.” Pediatrics 132.2 (2013): 298-304. Pediactrics. American Academy of Pediatrics. Web. 1 July 2015. <http://pediatrics.aappublications.org/content/132/2/298&gt;.

8. Saint Louis, Catherine. “Helmets Do Little to Help Moderate Infant Skull Flattening, Study Finds.” The New York Times. 1 May 2014. Web. 26 June 2015

9. Salahi, Lara. “Study: Corrective Baby Helmets Don’t Work.” Boston.com. Boston Globe Media Partners, 1 May 2014. Web. 26 June 2015.

10. Steinberg, Jordan P. “Re: Helmet Therapy in Infants with Positional Skull Deformation: Randomised Controlled Trial.” Letter to RM Van Wijk. 01 Nov. 2014. The British Medical Journal. BMJ Publishing Group Ltd, n.d. Web. 01 July 2015. <http://www.bmj.com/content/348/bmj.g2741/rapid-responses&gt;.

11. Van Wijk, R. M., L. A. Van Vlimmeren, C. G. M. Groothuis-Oudshoorn, C. P. B. Van Der Ploeg, M. J. Ijzerman, and M. M. Boere-Boonekamp. “Helmet Therapy in Infants with Positional Skull Deformation: Randomised Controlled Trial.” BMJ (2014): 348. Thebmj. BMJ Publishing Group Ltd. Web. 26 June 2015. <http://www.bmj.com/content/348/bmj.g2741&gt;.

12. Wang, Judy. “Babies, Misshapen Heads, and Plagiocephaly Helmets: A Physical Therapist Perspective.” Web log post. North Shore Pediatric Therapy. N.p., 20 May 2014. Web. 8 July 2015. <http://nspt4kids.com/parenting/babies-misshapen-heads-plagiocephaly-helmets-physical-therapist-perspective/&gt;.

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