09 May 2014
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 professionals, 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 of 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.
Right from the beginning, we got the answers that we were looking for and left the clinic knowing what we were going to do. Everything just felt really simple every time we went for an appointment. I would definitely recommend LOC to other parents, and if anyone is in doubt about whether they should go for treatment, I’d say take advantage of the free consultation, because it was so worth it to go and get confirmation. I’m so happy I did it.
When we visited LOC there was no sales pitch or pressure – just honest, helpful advice and support. We’re very happy with the service we received from LOC and, most of all, we are delighted with the results!
At the start of the treatment, Saeed told us that we could expect the cephalic ratio to reduce by nine or ten points at most. In fact, it has reduced by 109 to 94. That’s a reduction of 15 points which is more than any of us hoped for. And his asymmetry has reduced from 10mm to just 1mm. We were so happy with the results that we felt it was a natural breakpoint for him and we were advised that the treatment is less effective the older a child is.
To say we are delighted with the service and results of the treatment would be an understatement! We felt cared for every step of the way, with regular check-ups meaning we were always aware of our twins’ development. Thank you so much to Sally at LOC, you are a star and have made a real difference to the future well-being of our boys!
Thank you again for taking care of Amrit's flat head. We are very pleased with the results. Attached are some pics of our visits to the clinic which we thought you may want to keep and use to show others the painless process for the baby.
We would be very happy for Francis to be included on the case histories page of your website. We are so pleased with the outcome of his treatment - I can only hope the images will give other parents confidence in the treatment where needed.
Ewan was four months old and I could breastfeed while he was wearing the helmet. At the clinic, they took their time with him. It made a huge difference knowing that we could trust them.
Ewen is now a confident and happy child, and the helmet therapy was definitely the right decision for us. I would (and have) recommended LOC to anyone, the clinic was friendly and reassuring.
From the very start, everyone at LOC was professional and friendly. Every step of the way was well-explained and measuring and fitting was quick. It only took Magnus one day to get used to the band and after that, he wasn’t bothered by it at all. And, most importantly, it worked! His head now looks completely normal. I would 100% get a LOCband again if we were to face the same situation again.
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
This is very much dependent on how fast your baby is growing. The faster the growth, the more frequently your baby will be seen so that the helmet can be adjusted. In general, reviews will happen at two to four-week intervals.
The price of treatment covers:
Yes - All babies that have completed their course of treatment with us have achieved a measurable improvement in head shape. However, you don’t have to take our word for it.
Recent independent research conducted by a University Hospital in Germany has endorsed the treatment for babies with moderate or severe plagiocephaly.
A larger, retrospective study has just been published that found complete correction was achieved in 94.4% of babies treated with helmet therapy.
The results were conclusive: repositioning achieved acceptable correction in 77.1% of cases, but 15.8% were moved onto helmet therapy because re-positioning was not working. Meanwhile, 94.4% of the infants who started in the helmet-treated group achieved full correction, as did 96.1% of those who were transferred from the repositioning group into the helmet-treated group.
Further information can be found on our Plagiocephaly Research page.
If your baby has a temperature or a fever due to illness you must remove the band. The band can be put back on once the temperature has returned to normal.
The optimum age for treatment is between four and seven months.
This is because the skull is most malleable at this age and improvements to head shape tend to take less time and are more dramatic. That is not to say that helmet therapy should be ruled out if the baby is older than seven months. Routinely, babies up to the age of 16 months can be treated very successfully.
The cut off age is around 18 months when the fontanelles (soft spots on the head) are no longer malleable. As babies grow and develop at different rates, it is always worth checking if you are not sure. There have been cases where a baby’s fontanelles have not fused yet by the age of 18 months, who have achieved successful, but less-marked results with cranial remoulding therapy.
Torticollis is a condition in which a tight or shortened muscle in one side of the neck causes the head to tilt or turn to one side, resulting in the infant resting its head in the same position. In 2013, we analysed the data from all first appointments in our Kingston clinic and found that 20% of the babies examined had some kind of neck condition that was causing head immobility.
The clinics and clinicians that provide this treatment in the UK will have received similar training and experience. However, we are the only clinic that manufactures its own helmet and our clinicians are closely involved with the process for each individual helmet that we produce.
In addition, we do not restrict review appointments to a set number, we are extremely flexible and respond to individual parents' needs so that the best outcome can be achieved for each baby.
The LOCband is non-invasive and works by applying gentle, constant pressure over the areas of the baby’s skull that are most prominent while allowing unrestricted growth over the flattened areas. The band consists of a soft foam layer inside a thermoplastic shell. As the baby grows, the band will be adjusted frequently to gently guide the skull into a more symmetrical shape.