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No evidence for foot orthoses in children

Discussion in 'Pediatrics' started by NewsBot, Jun 27, 2007.

  1. NewsBot

    NewsBot The Admin that posts the news.


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    A randomized controlled trial of two types of in-shoe orthoses in children with flexible excess pronation of the feet.
    Whitford D, Esterman A.
    Foot Ankle Int. 2007 Jun;28(6):715-23
     
  2. Admin2

    Admin2 Administrator Staff Member

  3. Fellow skeptics,

    Are Whitford & Esterman qualified to evaluate children for this "flexible excess pronation"?
    Whitford apparantly is a family medicine practitoner with Esterman being a statistician.
    I , maybe with a little paranoia, think that the journal is looking for evidence , although it is may contain invalid and research , that orthoses are useless.

    Do I have a point here?

    Tony Jagger
     
  4. davidh

    davidh Podiatry Arena Veteran

    I agree Tony,
    In fairness to the authors I haven't read the Paper, but I do tend to query this type of research, which can be very loaded against whatever therapy is being tested.
     
  5. Robertisaacs

    Robertisaacs Well-Known Member

    Found some other evidence. Below are some bits i cut and pasted from a literature review in a Paper called Orthotic Treatment of Flat Feet in Children with Low Muscle Tone By Carolyn Kates, MS, PT. Its mainly neurology publications but interesting nonetheless. So far as i know the literature review was never published other than online. You can see the whole article http://www.boyercc.org/docs/print/EBP_Orthotic_Treatment.doc here.

    Hope it is of interest

    Regards
    Robert
     
  6. Shane Toohey

    Shane Toohey Well-Known Member

    Comrades,

    Maybe some of you can access the whole article and outline the methodology used for creating the custom made devices? Who was the prescriber and what is his/their experience?
    What ready made devices were used?
    How did they measure function and assess if there were any changes.
    What pain measuring system was used?

    My personal comment is that if I had a child with painful feet aged between 7 and 11 these guys wouldn't be on the top of my list to see. If the average pod cannot make a difference to these painful conditions within 3 months I would hope they would refer elsewhere. I question the ethics of continuing the study for 12 months without getting any result.

    I'll need convincing that this study was not conducted by a very crappy
    academic.

    Cheers
    Shane
     
  7. Kevin Kirby

    Kevin Kirby Well-Known Member

    It wasn't too long ago, that many "experts" said that there was no evidence that foot orthoses changed the movements of the foot and lower extremity and therefore speculated whether foot orthoses actually did anything at all, other than offering a placebo effect. Then along came better measurement techniques (3D kinematic analysis combined with kinetic analysis and inverse dynamics techniques) and better custom orthosis studies that have now produced a whole series of papers that show foot orthoses not only change motion patterns but also change gait kinetics. I wonder what happened to all those "experts" that said orthoses didn't work??

    In much the same fashion, there are many pediatricians and orthopedic surgeons who think foot orthoses for children are worthless, think that podiatrists who make orthoses for children with flatfeet are unethical and are only acting to line their wallets and have, as a result, designed research studies that will have little ability to show how foot orthoses mechanically affect the feet and lower extremities of children. It seems that if these physicians had become more familiar with the orthosis literature that shows their therapeutic and biomechanical effectiveness, they would design their studies more appropriately to more realistically show what they do and don't do.

    That is not to say that the above researchers designed their research poorly, since I have not had the opportunity to personally read their paper. However, if anyone can access a copy of the paper and send it my way, I would be happy to read it over and give my objective opinion on the paper and it's design.

    On the other side of the coin, there are plenty of podiatrists around the world that are making custom foot orthoses for children that I , and many other podiatrists, wouldn't think of treating at all with foot orthoses. It only takes a few of these unethical individuals in a community to spoil things for the other podiatrists who are appropriately treating only those children that actually need treatment. So we can't just blame the rest of the medical profession for research projects such as this, we must assume some of the blame ourselves if we are to be fair about it.
     
  8. esterman

    esterman New Member

    I think that it is a bit rich to criticize a paper without having read it. Dr Whitford trained as a pediatric physiotherapist - she is not a family physician. Foot and Ankle International has a strong peer review process, the paper would not have been accepted if the study was of poor quality. Finally, Australian podiatrists were involved in the study and undertook the foot examinations.

    Adrian Esterman PhD
     
  9. Kevin Kirby

    Kevin Kirby Well-Known Member

    Adrian:

    Thanks for coming on to Podiatry Arena defend your paper. Just a few questions, please. What exact types of foot orthoses were made for your subjects? How much experience in treating children with foot orthoses did the clinicians have who evaluated, casted and prescribed foot orthoses for your study? How were the subjects casted(i.e. plaster, foam box, contact pins, or optical)? Was STJ neutral used or any casting modifications used such as plantarflexing the first ray during casting?

    Did you have a foot orthosis prescription protocol to establish prescribing guidelines? In other words, how did you decide on the following orthosis prescription parameters in your young subjects:

    1. Degree of heel inversion of positive cast.
    2. Amount of medial heel skive/Blake inverted technique.
    3. Amount of medial longitudinal arch fill.
    4. Height of heel cup.
    5. Thickness of plastic.
    6. Type of rearfoot post and degrees of rearfoot post motion.
    7. Presence or absence of medial/lateral flanges.

    In addition, were there any controls for shoes being worn? In other words, were the children allowed to wear any shoes with their orthoses and was heel counter eversion or midsole durometer inspected by the researchers to see if shoe biomechanics could have affected orthosis function?

    The reason I ask you these questions is because I have been treating children with flatfeet with foot orthoses for over 20 years and have found them to be quite remarkable in the successful conservative treatment of painful feet and lower extremities due to excessive pronation moments acting across the subtalar joint during weightbearing activities. Therefore, when I hear of a study that goes against what myself, and many of my teachers and my podiatric colleagues around the world have been experiencing for the last few decades in our own patients, I have to wonder what the researchers are doing with their foot orthoses that does not allow them to see the therapeutic benefits of foot orthoses that I have seen during my practice career.

    Congratulations on having your paper published in Foot and Ankle International, the official journal of the American Orthopaedic Foot and Ankle Society.
     
    Last edited: Jul 4, 2007
  10. Shane Toohey

    Shane Toohey Well-Known Member

    Dear Adrian,

    You wrote:
    The result of the research was very poor and this goes completely against my experience. I reserve the right to question and criticize. Because you were published does not mean that the results have to be accepted without examination. When I was studying clinical research methods quite a few years ago I certainly came across published work that proved to have inaccurate conclusions, including even double blind multi centred studies. So congratulations on being published, but do you expect someone who has been using this therapy for over 20 years to just stop because of the headlines of your study. You do have to defend it properly.

    The study could easily be accepted and still have non sequiters (?) included.
    I asked for more detail on the methodology and you have not responded to that.
    You can also do harm by getting the headlines of your paper published resulting in children who could be treated not getting treatment. You may appreciate that there are many ways of doing something that comes under an umbrella of "custom-made orthoses". Despite this your results mean that your methodology did not work rather than other ways of doing therapy would not work. Hopefully this makes sense, I'm trying to be succinct.

    I'm very happy to continue this discussion but need more detail on what you guys have done.

    Cheers
    Shane
     
  11. Kevin Kirby

    Kevin Kirby Well-Known Member

    Questions regarding research

    I have now been able download the full paper done by Deirdre Whitford and Adrian Esterman on treating children's flatfeet with foot orthoses (I'm assuming Adrian may be too busy to respond). Here is what they did in their research:

    1. Children between the ages of 7 and 11 with bilateral "flexible excess pronation" were studied.

    2. Three study groups were included: custom orthoses, Vasyli ready-made orthoses and no orthoses.

    3. Custom orthoses casted with plaster by "method described by Michaud" and then were sent to an orthosis lab (there was no detail on what orthosis prescribing parameters were used, I assume all orthoses were balanced with heel vertical). Orthoses were "rigid" and with vinyl topcovers to end of orthosis. No mention was made within the paper as to rearfoot posts, medial heel skives, heel cup depth, what "rigid" meant, thickness of medial expansion plaster or whether the casts were balanced inverted.

    4. "Exercise efficiency" was measured as maximal oxygen uptake (VO2 max) using a multi-stage 20-m shuttle run test. Unfortunately, whether known by the researchers or reviewers of this paper or not, VO2 max is not a measure of "exercise efficiency" but is rather a measure rather of maximal oxygen uptake ability of the subject. If "exercise efficiency" was to be measured, then the oxygen uptake at steady state exercise with and without the foot orthoses would need to be measured with a children wearing oxygen uptake apparatus doing a standard exercise task, such as running on a treadmill or riding a bicycle ergometer. The researchers did not do any of this in their study. So I consider this part of the experiment to be not meaningful and their testing or results from their study should not in any way be concluded to have anything to do with "exercise efficiency".

    5. Pain was measured as a parameter also. However, it was not clear whether the pain measured by their Varni Thompson Pediatric Pain Questionnaire related to symptoms in their feet and lower extremities only or if whole body pain was included.

    6. The authors listed only two or three papers that showed the many positive kinetic and kinematic and therapeutic effects of orthoses. I am very surprised that these Australian researchers did not mention the fine work from their fellow Aussie, Angela Evans, PhD, regarding her successful treatment of children with foot orthoses with "growing pains" (Evans A: Relationship between "growing pains" and foot posture in children. Single-case experimental designs in clinical practice. JAPMA, 93(2): 111-117, 2003.) I saw much more negative foot orthosis research being reviewed by the authors than positive foot orthosis research. If the authors are following along, I would be happy to provide them with my current list of references regarding the numbers of positive therapeutic, kinetic and kinematic research papers that show why ethical podiatrists prescribe foot orthoses for children and why there is ample justification for the use of foot orthoses in children with symptomatic flatfoot deformity.

    All in all, it seems to have been a study that was carried out in a careful manner and, other than the complaints listed above, I have no problems with the study. The last paragraph of the study does bother me in that it starts out rightly pointing out that the results from the study are inconclusive and that foot pronation may cause injury at a later age and the treatment with orthoses may need to be carried out longer than their study. Then, after making this reasonable statement, their last sentence of the paper was "There appears to be little justification for the use of in-shoe orthoses in children of this age with this condition." Where did that statement come from when the authors appeared to understand the limitations of their study in the earlier sections of their paper?! This last statement worries me about the objectivity of the authors.

    I feel that the last sentence of the paper should have read instead: "This study did not show any significant effects of custom or non-custom foot orthoses on children so that further study will be necessary to determine why many clinicians report significant reductions in pain in flatfooted children with foot orthosis treatment."
     
  12. Shane Toohey

    Shane Toohey Well-Known Member

    Thanks for passing on that information, Kevin.

    I can now be a little more specific and make this statement:

    A child with a painful foot condition (not described) is unlikely to be helped within 12 months by the following treatment method.
    They would also not be helped by the use of Vasyli orthoses.

    The point I want to make to the authors of the paper is that custom made orthoses and the therapeutic result can/will vary significantly when:
    different casting methods are used and even by who takes the casts:
    what prescription is used for the lab to work on the casts: what lab is used: and how the intervention is followed up ( in that orthoses are often fine-tuned/tweaked to maximize the result. In fact to get the desired result it is not unusual for a podiatrist to add wedges and pads of one sort or another to preformed devices as well. Seriously, how much did your methodology involve exploring how to get a positive result (as would occur in an optimal treatment environment)? I don't think it did, otherwise you wouldn't have children in pain for 12 months. That would only be done by someone who was not experienced in producing clinical results with this therapy.

    So if you headline:
    and conclude that:
    and say that you tested custom made and preformed orthoses to arrive at that conclusion.

    That conclusion is unfounded! You can only say that if you do things the way you describe then you don't get results.

    There are probably a few lessons from this study. I do still see unnecessary poor results in orthotic therapy that have been salvaged by a bit of tweaking.

    Cheers
    Shane
     
  13. Kevin Kirby

    Kevin Kirby Well-Known Member

    Sorry Shane, there is probably too much heat in the "research kitchen" to answer our questions or reply to our comments.
     
  14. Dean Hartley

    Dean Hartley Well-Known Member

    Interesting thread. Kevin would you be able to point me in the right direction of these more recent research papers which show the affects of foot orthoses changing motion patterns and gait kinetics?

    Regards,

    Dean
     
  15. Kevin Kirby

    Kevin Kirby Well-Known Member

    Dean and Colleagues:

    Here is an excerpt from my most recently published paper on foot orthoses (Kirby, KA: Foot orthoses: therapeutic efficacy, theory and research evidence for their biomechanical effect. Foot Ankle Quarterly, 18(2):49-57, 2006):

    Hope this helps.

    I have also just completed a chapter titled: "Evolution of Foot Orthoses in Sports: Biomechanical Effects" for a book to be published by Springer next year "Athletic Footwear and Foot Orthoses in Sports Medicine" which will review the subject in more depth.
     
    Last edited: Jul 8, 2007
  16. Hylton Menz

    Hylton Menz Guest

    Here we go again. A study is published with unfavourable results, and there's a reflex response to condemn it, even before the full paper has been read. By all means critique the paper, but please, don't make it so obvious that you have no intention of accepting the findings simply because they're negative.
     
  17. Whitford

    Whitford New Member

    Kevin

    In answer to your queries:

    The children in the custom-made orthoses intervention group received orthoses produced in an orthotics laboratory to the prescription of respected and experienced podiatrists who were employed on the research team and who, like you, were conviced of the value of these devices. The podiatrists used current methods for examination, casting, prescription, fitting and follow-up.

    A foot orthosis prescription protocol was used and each of the issues you list was decided on a case by case basis based on the information gathered during examination of each child by the podiatrist.

    Shoes were inspected during initial examination, and again when fitting the orthoses. Parents were advised of the suitability of the child's shoes for use with their orthoses and parents were provided with an information sheet about choosing suitable shoes if they needed to replace the child's shoes during the period of the trial. Most parents were compliant with this advice.

    Children were not included or excluded from the trial on the basis of pain as in practice pain does not always determine whether a child will be prescribed orthoses. A subgroup analysis was carried out using the data of children who presented with lower limb pain at baseline. The findings of the subgroup analysis (which had sufficient power) were very similar to the findings of the trial overall.

    We found a small improvement in pain at three months, which did not reach statistical significance, was not supported by improvement in the other parameters measured, and did not persist to twelve months. This small improvement may be responsible for the reinforcement of podiatrist and patient belief in these devices.

    While this trial, a randomised control trial, provides the highest level of scientific evidence possible from a single trial, no single trial can definitively answer such a clinical question. I look forward to further scientific contributions to the body of knowledge about foot pain and its management.

    Dee
     
  18. Paul B

    Paul B Well-Known Member

    Dear Dee, Adrian and Colleagues,

    Thank you for taking the time to respond to the publication of your paper. I am extremely familiar with the research conducted and would make the following comments:

    I am disappointed that the paper "A randomized controlled trial of two types of in-shoe orthoses in children with flexible excess pronation of the feet. Whitford D, Esterman A. Foot Ankle Int. 2007 Jun;28(6):715-23" was published in the format that it was due to its potentially misleading conclusions.

    Most importantly, the study design did not set out with an a-priori hypothesis to specifically test the effects of functional foot orthoses on the treatment of painful flat feet. Consequently, post hoc testing on samples of, at baseline, Controls n = 6, ready made orthoses n = 10 and custom made orthoses n = 11 was both methodologically flawed and scientifically unsound. Claims statistical power was achieved are not supported in the published article. With experience in understanding the precision of VAS’s, this is highly unlikely to have been achieved. More importantly, it is impossible for the reader of this article to independently and meaningfully make this judgement because the actual “cut off values” for what constituted a “painful foot” are not reported. The reader can only assume this was an arbitrary determination, thus further reducing merit of this conclusion, and raising uncertainty in the readers mind.

    Further illustrating this point, no set diagnostic criteria was applied specifically to the “painful” flatfoot classification. Morphological classification is a separate issue, which has the potential to confuse and misrepresented the results.

    Prudent podiatry practitioners have long since moved on from treating “asymptomatic” hypermobile flat feet, but unfortunately the published article confuses this issue, to the potential detriment of good clinical care. Most clinicians’ (as pointed out on this post) note the long established merit in treating correctly diagnosed symptomatic feet in children, accompanied by either the presence or absence of “flat feet”. The current research confirms the former statement, but miss-represents the later.

    Another important point, pain is associated with inflammation and the typical timeframe for judging treatment (intervention) effectiveness is a matter of weeks, not three months as is the case with the post hoc testing performed here. This is a fundamental flaw in the papers logic, further reducing its credibility.

    The reason why I’m expressing disappointment with this published article is that the above points were drawn to the author attention in good faith well before this paper was published. Should a contrary view be held, then it must be supported by the science, a point possibly missed by the journal reviewers.
     
  19. Robertisaacs

    Robertisaacs Well-Known Member

    This seems a rather large assumption to me. Perhaps i am in the "imprudent group" but i will often treat asymptomatic flat feet.

    A rather liked Kevin Kirby's criteria, posted on another thread

    If i am imprudent i am in good company :rolleyes: ;) .

    Respectfully
    Robert
     
  20. DaVinci

    DaVinci Well-Known Member

    Certainly makes a mockery of the claim earlier in the thread that
    That journal has become legendary for what slips through their peer review process.
     
  21. Whitford

    Whitford New Member

    Paul

    Disappoinment all round I'm afraid. Your response fails to recognise the basic scientific principles on which this trial was conducted and the detail you quote is incorrect.

    The participants in this trial were not chosen on the basis of pain because prescription of orthoses, at the time of the trial, was not limited to children with pain. There was a view, at that time, that in-shoe orthoses prevented progression of asymptomatic excess flexible pronation to a painful condition.

    The a priori null hypothesis relating to pain was that pre and post measures of pain would not be significantly different between the treatment groups and over the trial period and they were not. Approximately 50% of all participants reported lower limb pain at baseline. The trial had sufficient power to demonstrate a reduction in pain in the treated groups compared with the control group had a reduction in pain occurred.

    There IS a very stringent review process not only for publication of articles of this nature in FAI but also for the NHMRC funding received for this trial. This RCT underwent extensive high level review, was designed, conducted, and analysed on the basis of a priori hypotheses, and reported according to the principles of the CONSORT statement. No higher level of peer reviewed evidence is currently available from a single trial.

    It is time to move on to producing further high level evidence to either refute or support the findings of this trial; and to build the current body of scientific knowledge about foot health in children and effective treatments to improve foot health and function.

    Dee
     
    Last edited: Jul 30, 2007
  22. hurst07

    hurst07 New Member

    Hi Shane and the rest of you boys. The testosterone is intoxicating! Shane, i was just wondering why a child that was in pain wouldn't be on the top of your list to see? Doesn't that seem a little un ethical? It's just that symptomatic children are pushed to the top of the list in my practice, just wanted to share your thought's.

    Another school of thought is: why do we treat if there are no symptoms?

    Is anyone ever going to be able to answer this question? Will we believe them if they do?

    The only way you would answer this one would be to do a massive retrospective study. Anyone got any spare time on their hands? Should be a doddle!
     
  23. CraigT

    CraigT Well-Known Member

    You have to re read the statement...
    Shane was saying that he would not see these practitioners if his child had symptomatic feet.

    Methodology etc aside I do not find it surprising the result of this study... I find it staggering!
    I am sure that I am not alone on this forum to say that children often have the most profoundly positive results with orthotic therapy (simple wedges, OTC or custom)...and that includes supposedly asymptomatic children (that is if you define pain as the only symptom...) is lack of co-ordination a symptom? non-specific growing pains?
    Would I treat my asymptomatic child if they had hyperpronated feet? Without a moments hesitation.
     
  24. Craig Payne

    Craig Payne Moderator

  25. Kevin Kirby

    Kevin Kirby Well-Known Member

    Craig:

    I enjoy your enthusiasm. I was talking with one of the delegates at Biomechanics Summer School 2007 in the UK a few days ago about a case that your comments reminded me of. He approached me during one of the lecture breaks and told me this story:

    "A few years ago when you lectured on the medial heel skive and treating children's flatfoot deformities at this seminar, I went back to my practice to apply this technique to a 13 year old girl who had excessively pronated feet, had poor self-esteem because she couldn't run or walk much without pain, and even walked with her head down, almost in shame. She had already had three pairs of foot orthoses that didn't work well to relieve her pain. Once I made the orthoses the way you described in your lecture with a medial heel skive, the girl came back to me happy, standing and walking tall and with extreme confidence in herself. It was simply amazing. I have told this story to many of the students and podiatrists I lecture to about not only the positive transformation in her gait but also in the amazing positive change in her personality with being able to walk and run without pain for the first time in a very long time. This case is about as good as it gets for a podiatrist!"

    The type of treatment results that this experienced podiatrist achieved is not all that unusual for the podiatrist that understands the biomechanics regarding how to properly treat children with flatfoot deformity. No matter how many research studies tell me that "foot orthoses are not indicated in the treatment of pediatric flatfoot deformity", I will continue offering this valuable service to these patients and their parents simply due to the hundreds of positive life-altering experiences that I have seen over the past 22+ years in using properly constructed prescription foot orthoses to treat pediatric flatfoot deformity.
     
  26. 2whiskers1

    2whiskers1 Member

    I recently attended a workshop run by Dr Angela Evans on paediatrics. It was very insightful and we were brought up to date with current research for flatfeet, intoeing, growing pains etc. In particular we learnt the importance of the pFFP (paediatric flat foot proforma) assessment tool and when to intervene with treatment for symptomatic flexible flat feet.

    I am still unsure however, as to what specific design features a paediatric orthoses should have when prescribing for a pronated foot. Whether soft Vs rigid, material, length of the device etc. Is it just a case of seeing what works and making adjustments ?

    I would be most grateful for some feedback.
    Regards.
     
  27. RobinP

    RobinP Well-Known Member

    Define the prescription variable that is required e.g. reduce residual pronation moments at the tib post, reduce rate at which end range pronation takes plance and design a device accordingly. Shape of device and friction at the interphase will play a major role in determining the design variables such as material choice etc. Of course patient compliance with the devices will also influence design.

    Not sure how much help this is. Personally, I don't think along the lines of best device or prescription for kids feet any more. As with most things in this business, it all depends......

    Robin
     
  28. Robertisaacs

    Robertisaacs Well-Known Member

    What he said. :rolleyes:;)

    Dr. Evans work is insightful and interesting. However like all pathways of care it has to reduce rather complex human situations into tick boxes and criteria. People don't work that way.

    I do paediatrics almost exclusively. Sometimes I see patients who are structurally or functionally unremarkable, but still have pathology. Sometimes I see people who are conventionally "flat footed" but appear to have good function. Lifestyle, footwear, compliance, other clinical elements (like proximal muscle function/tension or dyspraxia) are significant also.

    People simply don't fit into neat boxes. The prescription you use must depend on the person in front of you, in all their complexity.

    It should not just be a case of "see what works and adjust" (although there may be elements of that). You should be using your knowledge and experience to guide you before hand, to influence your prescription. That is the TRUE nature of custom orthoses. Not to mould every foot the same way and to make every insole the same way with the same material.

    For EG, if you have two clinically identical patients, one a teenage girl who in spite your best efforts persists in wearing ballet pumps and the other who wears sturdy shoes. Given that the prescription is a composite of the footwear and the orthotic, the footwear alters the load deformation characteristics in many devices, would you use the same? I'd not.

    Your question, therefore,
    Is impossible to answer, not least because "a pronated foot" is a meaningless definition,:bang: but also because the nature of the foot is only one very small part of the matrix of variables which constitutes a prescription.
     
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