Study questions value of plagiocephaly helmets… but recommends further research needed
7th May 2014
A study published in the British Medical Journal (BMJ) last week has questioned the value of helmets worn by infants to help correct ‘flat head syndrome’ and other head shape abnormalities.
Being the first randomised control trial (RCT), we welcome the results of this study as a step forward in the awareness of plagiocephaly treatment, and as professionals of the medical community we support the call for further research.
At Steeper Clinic, our focus is always our patients. Whilst recognising the limitations acknowledged by the researchers, we are concerned that subsequent press stories relating to the study may lead to families waiting even longer before seeking out specialist advice.
Let’s put things into context
The study tested the use of helmet therapy in a sample size of only 84 infants, aged between 5-6 months. There was only slightly better improvement in the helmet group as the control group - although this was not statistically significant. Based on this, the researchers concluded that the helmet therapy for infants, with moderate to severe skull deformation, did not help to improve skull shape by two years of age.
The researchers did acknowledge there were limitations to the study and recommended that further research be carried out to further investigate the effect of helmet therapy on severe cases of plagiocephaly.
At Steeper Clinic, we actively promote repositioning techniques as the first line of treatment for babies with positional plagiocephaly and find that orthotic treatment is not necessary for mild to moderate cases.
In our clinics, the majority of our case load falls into the severe/very severe category and significant borderline cases are assessed on an individual basis. By offering ethical professional advice and working closely with parents to support them in making informed choices, helmet treatment is recommended for less than 40% of the babies seen at Steeper Clinic.
However, if repositioning has not been successful then cranial remoulding may be considered as the next step. Evidence indicates that this course of treatment gives greater improvements in head shape than repositioning alone (4,5,9,11) and that it is particularly effective when started from an early age (3,6,7).
Main limitations of the study
Kate Chauhan BSc (Hons) MBAPO SRPros/Orth, Lead Paediatric Orthotist at Steeper Clinic, provides her analysis on the main limitations as follows:
- The study is a very small sample – only 84 babies, which is reduced to just 39 babies in the helmet group and 40 in natural change, with further exclusions. Furthermore, this is an uptake of only 21% of the possible babies within the possible clinical population.
- The study excluded babies with congenital muscular torticollis – approximately 75%+ of babies with plagiocephaly also have torticollis (1,2).
- The study excluded very severe cases.
- The study did not monitor the compliance of the families which is vital for successful treatment – if the cranial remoulding orthosis is not worn for 23 hours a day, the full possible correction will not be obtained (3).
- The trial groups were not matched for severity, so cannot truly be compared for the amount of correction achieved.
- Results were not statistically significant, this is due to varied outcomes and small sample size.
Other key points within the study to note:
Results of the study cannot be generalised
Pre-term newborns and babies with congenital muscular torticollis, dysmorphic features or other underlying conditions, were excluded from the study, despite the fact that infants in these categories have a higher incidence of developing plagiocephaly (10,11). If the infant has torticollis, very severe Brachycephaly or Plagiocephaly the results of the study do not apply.
Reported issues and side effects (eg. soreness and dryness)
100% of the families in the study reported issues with the orthosis, which poses a question regarding the initial fit of the cranial remoulding orthoses used. If the helmet did not fit correctly it will not work correctly.
All families undergoing STARband™ treatment at Steeper Clinic are made fully aware of the possible side effects, such as redness at times as the baby adjusts to the treatment. Furthermore, we conduct frequent review appointments to make any necessary adaptions during the entire treatment process.
Skull deformation still present
The study found that at 2 years of age, 75% of participants still displayed some degree of skull deformation. We accept that the condition may not improve for all babies, however 100% of babies who have completed STARband™ treatment at Steeper Clinic show demstronstable improvement. We use the state-of-the-art STARscanner™ to measure and assess throughout treatment.
Where do we go from here…
At Steeper Clinic, our philosophy is simple:
Parents who have concerns about their child’s head shape should seek medical or specialist advice to provide a diagnosis and details of treatment options, such as physiotherapy and repositioning techniques, so that they can be started at the earliest stage possible.
We adopt a holistic approach to treatment and our team are passionate about raising awareness of the condition – we focus heavily on the importance of tummy time and have a ‘tips sheet’ that we hand out to parents.
Parents should have access to sound information, and at the right stage, so that they can fully understand the condition and treatment options available, in order to make a better informed decision.
Our paediatric orthotists discuss all aspects of the condition and options so that families are provided with the information they need to make a decision based on what they feel is best for their child.
Based on feedback from our patients, the families we see and treat in clinic, we have acted on this and so this year we are launching our largest plagiocephaly campaign focusing on 'Awareness, Education and Engagement', where we will also be fundraising for the HeadStart4Babies charity. For further information about “Plagiocephaly Live 2014” and get involved CLICK HERE.
There is so much more we can do to spread the word about the condition, so that more parents are aware of the condition at the earliest stage possible in their child’s development.
We are a small team of passionate, ethically-driven and caring clinicians - your support in helping to raise awareness would be much appreciated!
CLICK HERE to read the latest article from Cranial remolding expert - Ellie Boomer (CPO) sharing her commentary on the helmet therapy article highlighted in the May 1 issue of The New York Times.
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2. Golden, K et al. Sternocleidomastoid imbalance versus Congenial Muscular Torticollis: Their relationship to Positional Plagiocephaly, Cleft Palate- Craniofacial journal, 1999, 36 (3): 256-262
3. Yoo, H et al. Outcome Analysis of Cranial remoulding Therapy in NonSynostotic Plagiocephlay, Achieves of Plastic Surgery, 2012; 39:338-344
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11. Lauglin J et al. prevention and Management of Positional Skull Deformities in Infants. American Academy of pediatrics. 128(6) 1236-1241