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The Redundancy of Research on Custom Made vs Prefabricated Foot Orthotics

Discussion in 'Biomechanics, Sports and Foot orthoses' started by Craig Payne, May 23, 2011.

  1. Craig Payne

    Craig Payne Moderator


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    Following on from my previous rant and why I don’t think there is a barefoot running debate, here is my rant on why I think research on custom made vs prefabricated foot orthotics is a waste of time

    I do not really want to get back into the debate about the use of custom made vs prefabricated (premade/over-the-counter/library device/whatever) as we been there, done that; and like the barefoot running issues, I do not think there is a debate about custom vs prefabricated (or at least in the way the debate has been framed).

    There have been a number of research projects that have looked at outcomes between custom made foot orthotics and premade foot orthotics with the latest systematic review concluding that there is no difference between them in outcomes. The problem is that the only people that generally believe that conclusion are the researchers, other researchers and 3rd party funders who want to cut reimbursement (and me when it suits my purposes :drinks). Generally, clinicians do not believe the conclusion.

    The purpose of a systematic review is to follow a formal process to review the published research on the topic under investigation to draw some sort of conclusion that is allegedly not biased. To include research into a systematic review, there is a number of inclusion criteria (eg proper randomisation; blinding of the outcome assessments; adequate sample size; etc). This means only the well done studies are included in the systematic review. Those with issues in the methodology are not included in the reviews.

    This is the exact process that was done in the most recent systematic review on custom made foot orthotics vs prefabricated orthotics did to reach the conclusion that there was no difference. HOWEVER, if you look closely at the studies they included, I do not know anyone who, generally, actually uses custom foot orthoses in the way that they were used in the studies! To me, a custom made orthoses, for example, uses a thicker plastic if the person is heavier; uses a heel raise if the calf muscles are tight; uses a first ray cut out for functional hallux limitus; uses medial wedging designs if supination resistance is high; uses more vertical plastic and wider designs if there is a predominate transverse plane compensation; etc etc. In none of the studies was this sort of individualised prescription done for participants in the custom made arm of the studies. They were “custom made” in that they were made on a plaster cast, but that is all; they were all very standardised. Surely, an inclusion criteria for the systematic review should also have been something like “the foot orthotics used in the study were of the type, design and use that is actually commonly used in clinical practice”. If they did that, then none of the studies would have been included in the systematic review, hence my comment above about the results of these only being of interest to researchers and 3rd party funders and actually provide no useful information to clinicians at all.

    (I had a physiotherapy colleague complaining about the same thing for systematic reviews on different treatments for low back pain; conclusions were being reached about different interventions based on the inclusion of studies of treatments used in such a way in the studies that no one actually does it that way in clinical practice. A similar argument can be made about the inclusion of studies in systematic reviews on shock wave therapy).

    Even if such a study was done with a detailed agreed upon prescription for the custom made group vs a prefabricated foot orthoses, there is no guarantee that the custom made would do any better than it has done in the previous studies. It is just I do not think the studies can be used to make the conclusion that they are being used to make. I also think such studies are a waste of time and resources and will provide clinicians with no useful information.

    My core principle of foot orthotic prescribing is to deliver the prescription that is needed to reduce the load in the damaged tissue via design features of the foot orthotic (and keep in mind that those prescription variables can be delivered by things other than foot orthotics, such as footwear; gait retraining; etc). If we agree that plantar fasciitis is due to a higher load in the plantar fascia, then the prescription variable is to reduce that load. We have a pretty good idea what design features are needed to do that (based on some good sound biologically plausible and coherent theory and a little supportive research; and no contradictory research). So if you were to do a randomised controlled trial comparing a custom made to a prefabricated device, if both types deliver the design feature needed to reduce the load in the plantar fascia, then the patients get better in both groups and there will be no difference between the devices. How has that provided any useful information to the clinician? (the researchers will think that it has provided some useful information, but I have been listening to all the feedback from clinicians that its not).

    Another example would be custom made vs prefabricated in patellofemoral pain syndrome – if we assume that the model advanced in this thread that the role of foot orthoses is to reduce the inversion moment to a level below a threshold so that the proximal control mechanisms can do their job (again, a model that is consistent with all the evidence); then who cares if it is a custom made device or a prefabricated device? If the device delivers the prescription variable (ie reduces the inversion moment), then the patient gets better (assuming the model is correct). An RCT comparing devices will not provide clinicians any useful information.

    What would provide useful information for clinicians? ……. A study comparing the differences in outcomes between the delivering of the prescription variable assumed to be needed for that condition vs not delivering that prescription variable. In plantar fasciitis this would be design features that reduce the load in the plantar fascia vs design features that do not reduce the load. In patellofemoral pain syndrome that would be design features that lower the inversion moment vs design features that do not lower the inversion moment. Who cares if it’s a prefabricated foot orthoses or a custom made foot orthoses or a library device or a hybrid device or whatever? This would actually provide some useful information to the clinician and actually factor into the clinical decision making process. After all, is that not what it’s all about, isn’t it? Improving outcomes?

    See why I consider research comparing custom made foot orthotics to prefabricated foot orthoses is redundant? Of very little use?

    When should you use a custom made foot orthoses and when should you use a prefabricated foot orthoses? It all comes down to what is the best way to get the design features to deliver the prescription variables for that patient. Most design features can be delivered by modifying a prefabricated device. There are a few design features that can only be delivered by a custom made foot orthoses. Who cares what type of device it is? The foot dosen’t care! Let’s move on from this silly distinction. They are all foot orthotics.

    What say you?
  2. Craig, in general I agree. Which systematic review are you referring to?
  3. Craig Payne

    Craig Payne Moderator

    The collins one. I will edit my post to include a link to it.
  4. DaVinci

    DaVinci Well-Known Member

    One thing that jumped out at me during the recent australian conference was the number of researchers who commented how much the relevance of their research was to us in practice. I kept sitting there wanting to jump up and saying that it wasn't. It did not provice us with any information of clinical use. There was quite a gap between what these researchers thought they were providing us and what they actually did. The research was well done and interesting and probably worth doing, but was useless to clinicians so I kept wondering what they thought it was helping us with? :confused:
  5. Good thread Craig.

    I agree entirely. The studies, by definition, have to tightly control the type of custom of orthotic (generally canonical root) and almost by definition are limited to one or two type of pre fab. The data has value, but is almost always overstated as
    This is one of those dangerous statements which whilst pedantically true (although It would be truer to say "between root protocol FFOs and the pre fabs tested"), is always going to be overstated as "pre fabs are the same as custom".

    I'd liken it to a debate on frying verses Baking. One might find that people like fried food as much as baked food. That's not to say fried food is the SAME as baked food. There are also some dishes which are more suitable to one type of cooking than the other. But lump them all together in controlled condition you can find they both make chicken tasty and not poisonous.

    As Simon says, there are three variables in an orthotic, Geometry, load deformation and friction Co-efficient. These may be identical between pre fabs and custom. These are the variables I feel we should be looking at.

    Its not unlike the debate between POP and Foam. If you can achieve the same shape with either, who cares how it was achieved. Its the destination which counts, not the route.
  6. Apathetic sods.
  7. LuckyLisfranc

    LuckyLisfranc Well-Known Member

    Thank you Craig for being the voice of reason in this tiresome debate.

    As a clinician with a general disdain for the type of research carried out (generally) on foot orthoses, I am grateful that someone with your calibre can call it as it is.

    To expand further on why clinicians feel detached and disingaged from orthotic researchers, one need only look at the typical list of 'exclusions' in study participants. This is NOT the real world. In my world, someone may well present with a basic problem like fasciitis and require some type of orthotic management. But more often than not they have secondary co-morbidities that impact the condition and influence my decision making - eg T2 DM, PT dysfunction, obesity, 1st MTPJ OA, severe equinus, et al. They are not fit active flexible students and the like with no other significant findings...

    As a plea, can we just move on from this pointless debate. The only people that get anything out of if are 3rd party insurers who look for any opportunity to argue that orthotics are expensive. I have not heard of any other profession in health (eg optom, dental) that undermine their own clinicians ability to have freedom of choice in caring for their patients by undertaking this kind of research ad nauseum.

  8. RobinP

    RobinP Well-Known Member

    Good thread Craig. I've made my feelings clear on this before.

    It would be great if this thread could make it perfectly clear to anyone considering doing research that the delivering the prescription variable is the important element, not the method by which that variable is acheived.

    It would be great, in the example of plantar fasciitis, if we could determine the effectiveness of each of the prescription variables that are assumed to reduce plantar fascia load. i.e. doing as you suggested in comparing the effects of delivering the prescription variable and not delivering it but trying to determine which (or which combination) is the most successful/effective.

    Robert - speaking as a Glaswegian, there are no situations where baking food is better than frying it so I think your analogy is inherantly flawed;)

  9. NewsBot

    NewsBot The Admin that posts the news.

  10. I believe that Craig and I have spoken about this subject numerous times here on Podiatry Arena, in our lectures on the subject and in our private discussions.

    First of all, I have noticed over the last 15 years that there seems to be a problem with researchers who, in some cases, seem to think it is their job is to undermine custom foot orthosis therapy so that governmental authorities or insurance companies won't need to pay for a potentially valuable therapeutic treatment for individuals who daily live in pain due to foot and lower extremity mechanically-based pathologies. As Lucky Lisfranc and DaVinci stated, this tendency for researchers to, willingly or unwillingly, undermine their podiatric colleagues' practices seems to be especially common in Australia, for some reason, since podiatrists here in the US and also in the UK are generally very supportive of custom foot orthoses as a valuable method by which to treat their patients. Am I being biased or is there something here going on with the Australian podiatric research community that I simply don't understand? Craig, LL, DaVinci and other Oz podiatrists, do you want to stick your neck out to comment on this subject??

    Personally, I pretty much agree with most of what Craig says. I have a difficult time understanding orthosis research where the custom foot orthoses are generically constructed with the same prescription variables regardless of the weight, foot structure and gait examination findings and then the clinician is not allowed to adjust the orthoses if orthosis fit problems occur since this is simply not the way that ethical and knowledgeable podiatrists practice foot orthosis therapy. In addition, I don’t understand why researchers would use custom-molded foam orthoses as their “sham orthoses” or use custom-modified prefabricated foot orthoses as their comparisons to custom foot orthoses in their research. Why not just simply use a prefabricated foot orthosis from any of the many companies that supply these products as the comparison to custom molded foot orthoses? I simply don’t understand the logic of some of these researchers.

    One of the things I don’t completely agree with Craig is that I still think we need good foot orthosis research to be done, and that research should compare prefabricated orthoses to custom-molded foot orthoses. There are so many pathologies that could be studied and would easily demonstrate how custom foot orthoses are far superior in therapeutic efficacy when compared to prefabricated orthoses such as posterior tibial tendon dysfunction, 2nd metatarsophalangeal joint capsulitis (i.e. plantar plate pathology), peroneal tendinitis/tendinopathy and sinus tarsi syndrome, for example.

    Why is this research needed? This research is needed since podiatrists are continually fighting insurance companies to get valuable treatments, like custom foot orthoses, paid for in order to provide medical care that, in many cases, is the most effective treatment available to them. This research is needed since governmental authorities, in their continued effort to limit medical spending, crave research that concludes that more expensive treatments are “ineffective” in order for them to deny payment for valuable treatments for the very people that they have been delegated with the authority to protect and heal.

    Unfortunately, foot orthosis research is very difficult to do, takes a lot of time and money and there are very few funding sources which can help to support researchers who want to take on this type of project. Thank goodness for the researchers who have done their part to help preserve a valuable treatment, custom foot orthosis therapy, for the thousands upon thousands of individuals who live in pain every day. I, for one, greatly appreciate their efforts.
  11. Craig Payne

    Craig Payne Moderator

    I don't necessarily disagree, but the point I am trying to make is that if you take something like PTTD, then theoretically you get them better by delivering a really large reduction in the rearfoot inversion moment. If both the prefab and custom made devices can deliver that reduction, then the patients symptoms will theoretically improve - if you did an RCT on this, there will be no differences between the groups.

    However, in the case of PTTD it will be theoretically harder for prefab to deliver a bigger reduction in that inversion moment and harder for a prefab to limit much of the transverse plane motion. As really higher forces are needed in PTTD compared to other conditions, then it will be theoretically harder for a prefab device to be comfortable. I think/believe that comfort studies between devices when the rearfoot inversion moment is low will show no differences or preferences, but they will when the inversion moment is high.

    So rather than an RCT comparing a prefab to a custom made device for PTTD, what we need are:
    * confirmation that the rearfoot inversion moments are really really high in PTTD in a lab study (I think they will be)
    * confirmation of the design features of foot orthotics that can reduce the inversion moments in those that have really really high inversion moments in a lab study (I think we know what they are)
    * perhaps a pilot comfort like study between premade and custom in those with really really inversion moments (I suspect a custom made will be more comfortable)

    Then there can be an RCT comparing a device that lowers that inversion moment vs a device that does not (but I question the ethics of this as PTTD develops into a very disabling condition and the problems of deliberately not delivering a high inversion moment in one group is withholding an intervention has could result in adverse consequences) ... but given that so many foot orthotics are currently used for this that do not deliver a big enough reduction in the inversion moment (and then they wonder why they don't work :hammer:), this may just be replicating standard practice!

    This is the kind of research that clinicians need to base clinical decisions on.
  12. DaVinci

    DaVinci Well-Known Member

    I think what it boils down to is the increasing gulf between what clinicians need to make better decisions versus what researchers think that clinicians need or find useful. This is what hit home to me during the recent Australian conference. What is refreshing about Paynies approach is that he appears to actually be listening to what the clinicians are saying.
  13. My point is that there will likely be a big difference between the prefab and the well-made custom foot orthosis for patients with PTTD. Don't you think this needs to be researched and documented by directly comparing the kinetic, kinematic and comfort changes with a well-made custom foot orthosis?

    I agree that further kinetic, kinematic and comfort studies need to be done to understand what the optimal location and magnitude of "varus wedging" is in treating a condition such as PTTD. This is vitally important. However, I believe we also need to further hammer on the point with our orthosis research that prefab orthosis just aren't an acceptable treatment alternative for many painful conditions of the foot and lower extremity since, for many patients, if their insurance won't pay for it, they will continue to live in pain or seek treatments that may lead to further disability and unneccesary expense.
  14. Why don´t the clinicians start producing research then ?
  15. LuckyLisfranc

    LuckyLisfranc Well-Known Member

    Because we have to go to work. And sometimes fight the political fallout from 'negative' orthotics research.

  16. LL I understand and people may say Researchers research and Clinicians treat and hopefully they meet.

    But I´m a clinician and I've started to write for Journals, early days and it takes a lot longer for me than I thought it would (probably for the people I´m writing with as well) but I´m 3/4 the way through the 1st draft of a paper, learnt a lot and am enjoying the process. I also hope this paper will lead to 2 more after and I should get better and better at it.

    I just feel complaining about the wrong research being done can be fixed by getting involved as a clinician.
  17. LuckyLisfranc

    LuckyLisfranc Well-Known Member


    The unfortunate reality, once again, is that we are not like organised medicine.

    Many of the medical specialists I work with put out a paper every couple of years, usually tied to a drug trail they are involved in. They get paid handsomely either directly or indirectly for their assistance by the drug manufacturer.

    Podiatry and the custom orthotics industry would be well placed to follow this well worn path (less the dodgy falsified results that occasionally pop up).

    I know there are at least a dozen or so labs/CAD/CAM distributors in my own country who would be well placed to consider putting together a research fund that is independently administered for transparency. Imagine if they put back 5-10% of their profits into research (like a drug company!).

    THEN, watch the clinicians get involved once there is the ability to have some funding flying around.

  18. Maybe this lab might want to pay for research ... http://www.davinci-kinetics.com/

    don´t know if it is the correct DaVinci or not

    but what does the lab gain from paying for research, why would they ?
  19. PFOLA used to fund research, not sure if they still do?
  20. LuckyLisfranc

    LuckyLisfranc Well-Known Member

    It's a no-brainer.

    More clinical outcomes research into custom orthoses = less pressure from insurers to influence clinical decisions towards prefabs. Clinicians can make informed decisions, and treat with greater confidence.

    More custom orthoses prescribed = more money for labs and associated industries.

    Its no different to the drug company model.

    If they don't 'pay' for the research, clinicians/prescribers will have mistrust about the efficacy of the new product, compared to placebo or other treatments.

    Good product, with good research = strong marketing plan = more sales.

    If it works for some of the largest multi-billion $ international entitities, there must be some sense to it.

    I think its time some of these companies began to engage the profession, and provide meaningful support to this critical area.

    Just last week I was contacted by a colleague who was fighting a 3rd party insurer who was denying a claim for custom orthotic treatment for chronic plantar fasciitis. The company were quoting orthopaedic reserach form almost 10 years ago comparing prefabs, and saying this was the only way to go.

  21. Here's a paper I wrote over 11 years ago in response to the Pfeffer et al paper comparing prefabs to custom orthoses (Kirby KA: An analysis of the AOFAS paper on plantar fasciitis. Podiatry Management, 19(4):136-137, 2000). Maybe this will help your colleague.

    Attached Files:

  22. Jeff Root is now president of PFOLA. They haven't had a seminar now for the past two years and I haven't heard anything from them since their last meeting. It would be good to get the meeting up and running again but it seems that, over the past two or three years, it was becoming more of a research meeting and less of a clinical meeting.

    Maybe Jeff can comment on what the plans are since I haven't heard a thing about the meeting over the past year. During the first 11 years that I lectured at the PFOLA meeting, when Paul Scherer was running the show, he often asked my advice on how to improve the meeting and who to invite to lecture. These were the golden years of PFOLA, in my opinion. However, with good organization and planning, I am hoping these glory years can be repeated again.
  23. Stanley

    Stanley Well-Known Member

    I was asked to respond to a paper at a seminar. The paper is Efficacy of foot orthoses for the treatment of plantar heel pain: a systemic review and meta-analysis by Rasenberg et al in BJSM 3/2018.
    Regarding the comparison of custom vs. prefab orthoses, they used 5 articles. One of which (Pfeffer) had an MD watch a video from Prolab in SanFranciso for 20 minutes and then send the cast out to obtain the "custom orthotic".
    Another is Karldorf et al Effectiveness of Foot Orthoses to Treat Plantar fasciitis.
    He claims to use a standardized assessment. The orthoses were made according to principles described by Hice.

    Does anyone know what that is?

    Kevin, I enjoyed reading your analysis of the Pfeffer paper. I remember spending a little time at CCPM watching Chris Smith teach casting class. I remember how difficult it was for the students to master that class. I couldn't even imagine learning it by watching a video.


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