Although there is limited published data from uncontrolled case series, the literature describes the effectiveness of the CRO device as a nonsurgical alternative or as an adjunctive to infant cranial surgery. In order to validate the treatment, a controlled group case series is considered particularly important to compare outcomes since mild positional molding may self-correct over time or become inapparent due to hair growth. One needs only to examine the heads in the adult population to realize that the number of appreciable asymmetry is far less in this age range than in the neonatal population. The deduction is that the natural remodeling process of the human head must correct many of the deformities seen in childhood. Repositioning has been shown to be as effective in restoring symmetry to the cranium.
There are case studies of infants with mild to moderate abnormalities exhibiting successful correction of asymmetries when using a CRO device. Moderate to severe abnormalities may require a combination use of surgery and a CRO device to prevent regression of the repair post-operatively. Positional plagiocephaly does not pose a threat to the child's physical health. There are no published data on the effects of positional plagiocephaly on neuropsychological deficits, developmental delay, temporomandibular joint disorders, or psychosocial concerns related to a perceived abnormal appearance. The major reason for intervention is to optimize the cranial contour to achieve an acceptable appearance, not to prevent or correct adverse developmental consequences.
The incidence of positional plagiocephaly has increased rapidly in recent years as a result of the “Back to Sleep” campaign recommended by the American Academy of Pediatrics (AAP), in which a supine sleeping position is recommended to reduction of the risk of sudden infant death syndrome (SIDS). It is estimated that one of every 60 newborns may have some degree of plagiocephaly.
There are three basic options for treating plagiocephaly:
- No therapy,
- Repositioning (increased “tummy time”) therapy, or
- Helmet or Cranial band orthosis therapy.
Helmet or cranial band orthosis is generally considered after a failure of an initial trial of repositioning. However, some providers recommend early helmet or cranial banding earlier on older infants as the orthosis therapy may be increasingly less effective in the older infant when their cranial sutures begin to close. Therefore, requiring a two month trial of repositioning therapy in children older than six to nine months may limit the effectiveness of the helmet or cranial band therapy. Furthermore, reposition therapy may be less effective in older infants who are increasingly more mobile and do not maintain a single sleeping position.
In 2003, the AAP issued a policy indicating that improvement in skull shape is usually seen in two to three months with exercise and repositioning of the infant. The AAP indicated that the use of skull-molding helmets seems to be beneficial primarily when there has been a lack of response to mechanical adjustments and exercises. However, the AAP noted further studies are needed to identify outcome with and without skull-molding helmets. Furthermore, the AAP did not report any functional impairment associated with plagiocephaly.
July 2007 Update:
A MEDLINE search for the period 2005 through July 2007 identified the absence of controlled studies and the relationship between deformational plagiocephaly and functional defects. This relationship remains controversial in the scientific literature.
A number of publications discuss an increase in the prevalence of positional plagiocephaly coincident with national recommendations for infants to sleep in the supine position (to reduce the potential for SIDS). One of these reports suggests that referrals for plagiocephaly-associated torticollis may be rising at the same rate. Retrospective chart review found that 95% of referrals to a tertiary care center with a primary diagnosis of torticollis (110 of 139 referred infants had adequate records for review) also presented with plagiocephaly or facial asymmetry. Based on clinical evidence of differing etiologies, the authors concluded that 88% of the torticollis cases were secondary to plagiocephaly. Since head tilt and occipital flattening may both exacerbate maintenance of an abnormal head position, the authors suggest that an early active program for treatment for both the plagiocephaly and torticollis be instituted. Additional studies are needed to confirm this association.
As technology advances, clinical questions persist about the most accurate documentation of three-dimensional head shape measurements. Plank and colleagues studied a method of quantifying head shape and used that method to evaluate the success of orthotic treatment. Two hundred twenty-four infants diagnosed with deformational plagiocephaly received either a CRO or a repositioning program with no CRO intervention. Data from 25 head shape variables were collected using a noninvasive laser shape digitalizer. The study identified four variables as particularly important in assessing the head shape of infants with plagiocephaly: the cranial vault asymmetry index, radial symmetry index, posterior symmetry ratio, and overall symmetry ratio. Ninety-six percent or more of the subjects in the treatment group (CRO intervention) showed improvement in each of the variables.
A search of peer reviewed literature through June 2013 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.
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