Background:
The incidence of plagiocephaly among infants in the United States has been steadily increasing. Strategies to treat plagiocephaly include orthotic helmet therapy, conservative therapy such as repositioning or stretching, or simply waiting to see if the condition resolves on its own.
Clinical Case:
The patient is a 3 month old infant, referred to Early Intervention after his pediatrician made a diagnosis of torticollis and positional plagiocephaly. Examination of the patient’s head indicates a moderate ipsilateral ear shift, and severe posterior quadrant flattening. The patient’s Cranial Vault Asymmetry Index is 10, indicating severe plagiocephaly. There is no evidence of developmental delay.
PICO:
Is orthotic helmet therapy more effective than physical therapy, repositioning therapy, or no treatment at all in treating plagiocephaly in infants?
Search Strategy:
The terms “plagiocephaly” and “helmet” were searched in the PubMed, CINAHL, and PEDRO databases. Inclusion criteria were as follows:
- The articles were published in the past 6 years.
- The subjects were infants younger than 12 months diagnosed with positional or deformational plagiocephaly with or without torticollis.
- With the exception of the above diagnosis, the infants were otherwise healthy.
- The studies evaluated the effectiveness of an orthotic helmet in treating plagiocephaly in infants.
- The articles used measurements of skull asymmetry as an outcome measure.
- The articles were in English.
Exclusion criteria were as follows:
- The subjects were given a cranial cup, shaping pillow, or other device that was not an orthotic helmet.
- The subjects were diagnosed with craniosynostosis or other type of skull deformity.
- The subjects were older than 12 months at the initiation of helmet therapy.
- Subjects received osteopathic manipulations.
Applying the above criteria, 124 articles were found. 3 duplicates were removed. 121 articles were screened, and 99 were removed as irrelevant. 22 articles were full text screened. Of these, 17 were excluded as irrelevant. Ultimately, 5 articles were included.
Results:
Is Orthotic Helmet Therapy (H) More Effective Than No Treatment (N) in Treating Skull Asymmetry?
| Author Date and Country | Level of Evidence | Key Results |
| van Wijk RM, et al.
2014 Netherlands |
Randomized control trial nested in a prospective cohort study – Level 2 | No significant between group differences for H and N |
| Kluba S, et al
2014 Germany |
Prospective non-randomized longitudinal study – Level 3 | H resulted in statistically significant reduction in asymmetry compared to N, but both H and N had a statistically significant reductions. |
| JF, et al.
2016 Germany |
Non-randomized controlled cohort – Level 3 | H resulted in statistically significant reduction in asymmetry compared to N. |
Is Orthotic Helmet Therapy (H) More Effective Than Repositioning Therapy or Physical Therapy (PT) in Treating Skull Asymmetry?
| Author Date and Country | Level of Evidence | Key Results |
| Steinberg, et al.
2014 United States |
Retrospective cohort study (Level 3) | H and PT are both effective. No between group analysis. |
| Lipira AB, et al.
2016 |
Non-randomized controlled cohort (Level 3) | H had a statistically superior reduction in overall head asymmetry compared to PT. |
Is Orthotic Helmet Therapy (H) More Effective Than No Treatment For Motor Delays (N)?
| van Wijk RM, et al.
2014 Netherlands |
Randomized control trial nested in a prospective cohort study – Level 2 | No significant between group differences for H and N. |
Clinical Bottom Line and Application to Case:
There is limited, low-level evidence which does not clearly establish whether helmets are more effective in treating plagiocephaly in infants than either no treatment or conservative treatment such as physical therapy or repositioning therapy in terms of quantitative measurements of skull shape or achievement of developmental milestones.
The ultimate decision about whether to pursue helmet therapy should be determined by the parent after education is provided regarding the current status of research.
Limitations:
Limitations include the following:
- There is limited standardization in outcome measure reporting, and in the ultimate determination of when plagiocephaly is considered to be resolved or “cured”.
- Intervention and comparison groups are similar across all studies, but are not standardized.
- Many of the studies allowed infants to switch from intervention to comparison group based on parental preference.
References:
van Wijk RM, van Vlimmeren LA, Groothuis-Oudshoorn CG, Van der Ploeg CP, Ijzerman MJ, Boere-Boonekamp MM. Helmet therapy in infants with positional skull deformation: randomised controlled trial. BMJ. 2014 May 1;348
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. Epub 2010 Sep 13.
Kluba S, Kraut W, Calgeer B, Reinert S, Krimmel M. Treatment of positional plagiocephaly–helmet or no helmet? J Craniomaxillofac Surg. 2014 Jul;42(5):683-8.
Wilbrand JF, Lautenbacher N, Pons-Kühnemann J, Streckbein P, Kähling C, Reinges MH, Howaldt HP, Wilbrand M. Treated Versus Untreated Positional Head Deformity. J Craniofac Surg. 2016 Jan;27(1):13-8.
Steinberg JP, Rawlani R, Humphriew LS, Rawlani V, Vicari FA. Effectiveness of Conservative Therapy and Helmet Therapy for Positional Cranial Deformation. Plast Reconstr Surg. 2015 Mar;135(3):833-42