Re: Helmet therapy in infants with positional skull deformation: randomised controlled trial
In a study of 84 infants with skull deformity randomized to either ‘no-treatment’ or ‘helmet treatment’, van Wijk and associates  found that the deformation was not corrected by either ‘helmet treatment’ or by the natural growth of the skull (i.e., no treatment). Seeing no difference, the authors conclude that “the use of a helmet as a standard treatment for healthy infants” should be discouraged.
We appreciate the investigators desire to address such a timely and difficult topic. Of significance, the authors were able to demonstrate that the ‘natural history’ of plagiocephaly is the skull deformity will not resolve on its own. This is a significant finding which may be overlooked in the hyperbole of their second conclusion, the overreaching dismissal of all helmet therapy. We assert that the author’s second conclusion is egregiously in error, and that the lack of improvement seen in their study was the direct result of their own admittedly ill-fitting helmets.
To understand our concerns, one needs to appreciate why doubters of helmet therapy have called for randomized controlled trials.
In 1979, Sterling Clarren et al.  first introduced helmet therapy for treatment of plagiocephaly. By the mid-1990’s, with what came to be recognized as an “epidemic” of skull deformity , numerous craniofacial centers began developing and using these devices, and subsequently began reporting that infants were successfully responding to treatment. Study after study [4-20] would demonstrate that helmet therapy is an effective treatment for deformational plagiocephaly, and soon invasive surgical interventions would come to be recognized as largely unwarranted [21-23].
Critics (e.g., Moss ) of helmet treatment called for randomized controlled trials, not to determine whether helmet therapy was effective, but rather to determine whether helmet therapy was necessary. The belief was that helmet therapy was not required if one simply allowed cranial growth to run its natural course. In other words, “the head will round out on its own”.
In a truly novel contribution to the medical literature, van Wijk and colleagues have documented that the natural growth did not correct the skull deformation. In other words, they have shown that untreated skull deformities persist. This finding suggests to us that the prevention and treatment of the skull deformation is justified and necessary.
However, at great variance with the medical literature [4-20], van Wijk and colleagues have reported that helmet therapy did not correct the skull deformity. Indeed, in 15 peer-reviewed studies conducted over the past 20+ years [4-20], helmet therapy has been demonstrated as an effective treatment for skull deformation. Based on a single, aberrant study, van Wijk and colleagues have concluded that all helmet therapy should be discouraged.
Helmet therapy, like any other recognized treatments, should be undertaken with a clear treatment protocol—none of which is provided in this study. On the other hand, the authors do report problems that indicate serious deviations from current standards of care. Complaints about skin irritation (96%), ill-fit (73%), pain (33%) and acceptance (24%) raise alarming concerns about treatment fidelity. In other words, was the treatment delivered in an accurate and consistent manner in accord with accepted standards? Unfortunately, the answer to that question is a resounding “no”. The van Wijk helmet therapies do not represent current standards of care and consequently, did not achieve the expected treatment outcomes.
Thus, while we applaud the investigators for documenting the ‘natural history’ of untreated plagiocephaly, we admonish them for hastily dismissing all helmet therapy. Nevertheless, van Wijk and colleagues  have added to our understanding of skull deformation by providing evidence that treatment is necessary.
Kevin M. Kelly, PhD
Associate Research Scientist, College of Public Health
Adjunct Associate Professor, Department of Anthropology,
Adjunct Associate Professor, Department of Community and Behavior Health
Adjunct Associate Professor, Department of Occupational and Environmental Health
The University of Iowa, Iowa City, Iowa, USA
Former Consultant, Cranial Technologies, Inc., Tempe, Arizona, USA
Timothy R Littlefield , MSEng
Vice President, Research and Regulatory Affairs
Cranial Technologies, Inc., Tempe, Arizona, USA
1. van Wijk RN, van Vlimmeren LA, Groothuis-Oudshoorn CGM, Van der Ploeg CPB, IJzerman MJ, Boere-Boonekamp MM. Helmet therapy in infants with positional skull. BMJ 2014; 348:g2741 doi: 10.1136/bmj.g2741
2. Clarren SK, Smith DW, Hanson JW. Helmet treatment for plagiocephaly and congenital muscular torticollis. J Pediatr. 1979 Jan;94(1):43-6.
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5. Littlefield TR, Beals SP, Manwaring KH, Pomatto JK, Joganic EF, Golden KA, Ripley CE. Treatment of craniofacial asymmetry with dynamic orthotic cranioplasty. J Craniofac Surg. 1998 Jan;9(1):11-7; discussion 18-9.
6. Kelly KM, Littlefield TR, Pomatto JK, Ripley CE, Beals SP, Joganic EF.Importance of early recognition and treatment of deformational plagiocephaly with orthotic cranioplasty. Cleft Palate Craniofac J. 1999 Mar;36(2):127-30.
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24. Moss SD. Nonsurgical, nonorthotic treatment of occipital plagiocephaly: what is the natural history of the misshapen neonatal head? J Neurosurg. 1997 Nov;87(5):667-70.
Competing interests: Kevin Kelly is former research consultant to Cranial Technologies, makers of orthotic helmets. Timothy Littlefield is Vice President, Research and Regulatory Affairs, Cranial Technologies. Together they have published three of the 15 articles cited as evidence against the authors' conclusions.