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Helmet therapy in infants with positional skull deformation: randomised controlled trial

BMJ 2014; 348 doi: (Published 01 May 2014) Cite this as: BMJ 2014;348:g2741

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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 [1] 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. [2] 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 [3], 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 [24]) 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 [1] 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

Literature cited:

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.

3. Kane AA, Mitchell LE, Craven KP, Marsh JL. Observations on a recent increase in plagiocephaly without synostosis. Pediatrics. 1996 Jun;97(6 Pt 1):877-85

4. Ripley CE, Pomatto J, Beals SP, Joganic EF, Manwaring KH, Moss SD. Treatment of positional plagiocephaly with dynamic orthotic cranioplasty. J Craniofac Surg. 1994 Jul;5(3):150-9; discussion 160.

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.

7. Kelly KM, Littlefield TR, Pomatto JK, Manwaring KH, Beals SP.Cranial growth unrestricted during treatment of deformational plagiocephaly. Pediatr Neurosurg. 1999 Apr;30(4):193-9.

8. Mulliken JB, Vander Woude DL, Hansen M, LaBrie RA, Scott RM. Analysis of posterior plagiocephaly: deformational versus synostotic. Plast Reconstr Surg. 1999 Feb;103(2):371-80.

9. Bruner TW, David LR, Gage HD, Argenta LC. Objective outcome analysis of soft shell helmet therapy in the treatment of deformational plagiocephaly. J Craniofac Surg. 2004 Jul;15(4):643-50.

10. Graham JM, Kreutzman J, Earl D, Halberg A, Samayoa C, Guo X. Deformational brachycephaly in supine-sleeping infants. J Pediatr. 2005 Feb;146(2):253-7.

11. Graham JM, Gomez M, Halberg A, Earl DL, Kreutzman JT, Cui J, Guo X. Management of deformational plagiocephaly: repositioning versus orthotic therapy. J Pediatr. 2005 Feb;146(2):258-62.

12. Elwood ET, Petronio J, Wood RJ. Parental satisfaction with the CranioCap: a new cranial orthosis for deformational plagiocephaly. Cleft Palate Craniofac J. 2005 Jul;42(4):340-3.

13. Lee WT, Richards K, Redhed J, Papay FA. A pneumatic orthotic cranial molding helmet for correcting positional plagiocephaly. J Craniofac Surg. 2006 Jan;17(1):139-44.

14. Plank LH, Giavedoni B, Lombardo JR, Geil MD, Reisner A. Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer. J Craniofac Surg. 2006 Nov;17(6):1084-91

15. Lee R, Teichgraeber J, Baumgartner J, Waller AL, English JD, Lasky RE, Miller CC, Gateno J, Xia JJ. Long-term treatment effectiveness of molding helmet therapy in the correction of posterior deformational plagiocephaly: a five-year follow-up. Cleft Palate Craniofac J. 2008;45(3):240–245

16. Thompson JT, David LR, Wood B, Argenta A, Simpson J, Argenta LC. Outcome analysis of helmet therapy for positional plagiocephaly using a three-dimensional surface scanning laser. J Craniofac Surg. 2009 Mar;20(2):362-5. doi: 10.1097/SCS.0b013e3181992382.

17. Lipira AB, Gordon S, Darvann TA, Hermann NV, Van Pelt AE, Naidoo SD, Govier D, Kane AA. Helmet versus active repositioning for plagiocephaly: a three-dimensional analysis. Pediatrics. 2010 Oct;126(4):e936-45. doi: 10.1542/peds.2009-1249.

18. Kluba S, Kraut W, Calgeer B, Reinert S, Krimmel M. Treatment of positional plagiocephaly - Helmet or no helmet? J Craniomaxillofac Surg. 2013 Oct 15. pii: S1010-5182(13)00271-0. doi: 10.1016/j.jcms.2013.09.015.

19. Seruya M, Oh AK, Sauerhammer TM, Taylor JH, Rogers GF. Correction of deformational plagiocephaly in early infancy using the plagio cradle orthotic. J Craniofac Surg. 2013 Mar;24(2):376-9. doi: 10.1097/SCS.0b013e31828010d1.

20. Moghaddam MB, Brown TM, Clausen A, DaSilva T, Ho E, Forrest CR. Outcome analysis after helmet therapy using 3D photogrammetry in patients with deformational plagiocephaly: the role of root mean square. J Plast Reconstr Aesthet Surg. 2014 Feb;67(2):159-65. doi: 10.1016/j.bjps.2013.09.036.

21. Longaker MT, Posnick JC, Rekate HL.Craniosynostosis and skull molding. J Craniofac Surg. 1998 Nov;9(6):572-600.

22. Persing J, James H, Swanson J, Kattwinkel J, American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery. Prevention and management of positional skull deformities in infants. Pediatrics. 2003 Jul;112(1 Pt 1):199-202.

23. Laughlin JL, Luerssen TG, Dias, MS, American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Neurological Surgery. Prevention and Management of Positional Skull Deformities in Infants. Pediatrics 2011;128;1236; doi: 10.1542/peds.2011-2220

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.

10 May 2014
Kevin M. Kelly
research scientist
Timothy R. Littlefield
The University of Iowa
College of Public Health, University of Iowa, Iowa City, Iowa, USA