The London Orthotic Consultancy response to a recent published study in the British Medical Journal
For years we have been asking for a randomised blind controlled study on the effect of cranial remoulding treatment versus no therapy. And last week finally this was published, so why now all the bad press about cranial helmets?
We welcome research in this field. We are evidence based practitioners and as healthcare professional we are continually learning and developing our care pathways and treatment regimes.
Whilst evidence is good, one study is unfortunately not enough. The fundamental limitations of this study are its size and that the subjects in the comparison study had moderate-severe head shape deformities.
This is not our patient group. At The London Orthotic Consultancy we mostly treat babies with severe head shape deformities where other treatments such as repositioning and manual therapies have failed.
Brent Collett, a craniofacial specialist at the Seattle Children’s Research Institute wrote in an editorial in the BMJ that future studies, including larger samples, would be helpful in determining whether some infants respond more favourably than others. In particular, it would be of interest to learn whether children with the most severe positional plagiocephaly and brachycephaly, who were excluded from this trial, show meaningful improvement.
Ari Brown, a paediatrician from Texas said she sees an area for future research on children with more severe plagiocephaly. ‘This is where helmets make the most difference’.
The study reports that no infants with torticollis or dysmorphic features were included. However, many of the babies we see in our assessments have these clinical presentations and once again have not responded to repositioning and manual therapy techniques.
We also assess infants who have moderate-severe head shape deformities. Following assessment of each infant, correct repositioning advice is provided so that many of this group goes onto achieve natural correction without orthotic intervention.
It is reported that in neither group did the head shape normalise at the end of the trial and at 2 years old only about a quarter in both groups reached a normal head shape. We disagree, all infants we treat achieve statistically significant improvements to their head shapes and many progress to a head shape within the normal range at the end of their treatment.
Much was reported on the side effects on helmet treatment. Side effects of helmets are minimal and temporary. Skin irritation reported as the major side effect in the study is usually nothing more than a mild sweat rash where sudocrem is all that is required to treat it. We discuss all possible side effects with parents at the beginning of the treatment so they are fully aware of what can happen before making a decision. Unfortunately this has been hugely exaggerated in the press surrounding the research last week.
We cannot ignore the influx of parents contacting us for help, who have children of primary and even secondary school age where their children’s head shapes have not improved, despite the advice they received from their GP and health visitors that it would self correct. Unfortunately we cannot help these families when the child is older than 18 months.
But when a child is less than 18 months we can offer help with correct repositioning advice and cranial remoulding therapy where clinically appropriate. Treatment is most effective when it is started between 4 and 7 months and we are concerned that bad press about this research may lead to parents delaying treatment.
Mrs. Sally Hews
BSc(Hons) SROtho MBAPO