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Effectiveness of Foot Orthoses to Treat Plantar Fasciitis

Discussion in 'Biomechanics, Sports and Foot orthoses' started by Hylton Menz, Jun 27, 2006.

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  1. Karl Landorf

    Karl Landorf Member

    Hello everyone who is interested in this thread.

    I thought now that the initial wave of comments has somewhat reduced that I would respond to some of the questions raised. From my perspective, sitting quietly in the background, it has been fascinating and sometimes amusing reading. While I don’t agree with much of what has been written on this topic, I won’t respond to any person in particular. I will instead respond more generally in two postings; the first (this) one addressing general issues and the second with specific issues around the methods of our trial.

    Firstly, as Craig Payne has pointed out, it is important to understand what randomised trial methodology is used for. Inherently, randomised trials have two components: (i) there is comparison of interventions and (ii) there is an appropriate randomisation process to allocate those interventions. Random allocation allows balancing of the groups such that all known and unknown prognostic variables (i.e. those variables that may affect the outcome) are similar across groups. Not only should allocation be randomised but it also needs to be concealed from the investigators so they cannot influence who is recruited into which group of the trial. Further to random allocation is the issue of blinding (masking). Blinding of participants and assessors, if possible, reduces bias thus ensuring the results are as valid as they can be. It has been clearly demonstrated that if the above methodological issues are not properly addressed in clinical trials then the results will over-estimate a treatment’s effectiveness[1]. In contrast, rigorously controlled randomised trials, as we should all know, are medical science’s best method to determine the effectiveness/efficacy of interventions.

    Generally, this type of trial is used to evaluate the effectiveness of one intervention compared with a placebo or sham, or indeed if that has already been established, compared with another intervention. The less these interventions differ, the more the results of the trial can explain what the ‘special ingredient’ is in the intervention that makes it effective. For example, if we designed a trial where one group received only a stock standard prefabricated orthosis and the other group received a fully customised orthosis for each individual with multiple other therapies like taping, NSAIDs, etc., we then lose the ability to know what the special ingredient is if the second group (who received the full package) improved more than the first. Researchers are constantly faced with this dilemma each time they embark on a trial. Consequently, like ours, most trials only have small differences between interventions.

    With the above in mind I want to now place our randomised trial in context. It was one component of a series of reviews and studies. [Please excuse the following self-citations, but I think it is important to build up the complete picture to show it was not an isolated piece of work.] Initially, back in 1998, we began by publishing a narrative, non-systematic review of the literature on foot orthoses[2]; this review was reprinted in two other journals[3, 4]. Later we published a more systematic (and consequently less biased) review that specifically investigated the evidence from randomised trials evaluating the effectiveness of foot orthoses to treat plantar fasciitis[5]. Soon after the first review we surveyed the profession in Australia and New Zealand to determine their orthosis prescribing habits, including what a typical customised orthosis prescription consisted of[6]. Following this we embarked on a small clinical trial that compared outcome measures to determine which one was most appropriate to use in the (at that stage) proposed randomised trial evaluating the effectiveness of foot orthoses for the treatment of plantar fasciitis[7]. Finally, we conducted the randomised trial that is the point of interest in this thread[8]. Both the orthosis prescription survey and the small trial comparing outcome measures informed the randomised trial.

    It is now seven years since we embarked on recruitment for the randomised trial and one of the burning issues then revolved around the debate between ‘customised’ versus ‘prefabricated’ orthoses (for want of more accurate terms…call them what you like - we have written before about the lack of consistent terminology when dealing with foot orthoses[2, 9]). The terminology used for these devices is really a side issue though. What is important is that we do not become caught up in nitpicking the names or types of devices. For the purpose of the trial and putting it very simply: the sham orthosis was designed to provide very little support/motion control or cushioning; the prefabricated orthosis is commonly prescribed, fairly simple to use, costs little and is relatively immediate in its effect; and the customised orthosis was as good a compromise (see ref. [6]) as we could achieve given we needed to pick ‘a’ device. Notwithstanding the terminology issue - and I recognise it is a somewhat emotive issue - the debate of cost is still a very real and appropriate one to have. In any other areas of medicine the issue of cost of interventions is important and clearly podiatry is no different. In addition to terminology, I have also often heard practitioners comment that if only you added a skive, or a notch, or some other modification, then you would have seen a different result [read: Karl mate, you’ve got no idea what you’re doing!]. Similarly, you could argue the same point for the prefabricated device; we could have added all manner of additions to them too.

    There has also been some debate on the ‘bias’ of the investigators involved in the project. I admit it; I was biased at the beginning of our trial. My bias was that I believed that the customised orthoses would be more effective than the other devices – I am after all a typical podiatrist. However, as indicated previously, by controlling the study rigorously (e.g. concealed allocation, participant blinding, self-reported outcome measures etc.) we believe there was little opportunity to bias the results. This is why it’s so important to put in place rigorous methods – to prevent bias, such as mine, from influencing the results.

    I would recommend people interested in the study, and particularly if they wish to comment on it, take the time to read the full article. It is interesting to read people’s perceptions of our study, particularly when they have not adequately informed themselves by reading the full article. We have never indicated that people in the study did not get better or that foot orthoses do not work. Quite the contrary, it is clear that our results show participants, on the whole improved both in pain and in function. Two of the figures (Figures 2 and 3) in our paper illustrate this nicely. We do need to keep in mind though, that three very real explanations for some of this improvement, which cannot be discounted (over and above that supplied but the orthoses), are that of placebo effect, Hawthorne effect and natural resolution of the condition. The figures also illustrate that on average most people in the trial improved to a level of little pain and almost perfect function (it would be interesting if the data were available to compare these levels to normative data for the population because the levels achieved in the trial are most likely similar to normal levels for this age group). However, the aim of our trial, as it is with any randomised trial, was to compare the effectiveness of the interventions we chose to evaluate. We did this for three foot orthoses (which included a sham device) and the condition we chose to investigate was plantar fasciitis. We make no claims about other conditions.

    Our paper does include one further investigation – a meta-analysis of all appropriate randomised trials that have evaluated prefabricated and customised foot orthoses. We included the meta-analysis as a way of comparing our trial results to that of others. Our estimate of the difference in effectiveness between these two types of devices is similar to the pooled estimate from all the trials. The result from this meta-analysis is overwhelming evidence - that there is little difference in the effectiveness of the two types of devices. Both work to a similar degree.

    I would like to finish this first posting with the following two points (and yes, I write this on the one hand to be provocative and on the other tongue-in-cheek). I used a quote at the beginning of my PhD thesis (suggested by friend and colleague Marc Lindy), which I think is apt, and one that continues to challenge my beliefs:

    "You are never dedicated to something you have complete confidence in. No one is fanatically shouting that the sun is going to rise tomorrow. They know it's going to rise tomorrow. When people are fanatically dedicated to political or religious faiths or any other kinds of dogmas or goals, it's always because these dogmas or goals are in doubt."
    Robert M Pirsig, Zen and the Art of Motorcycle Maintenance (p 155)


    Finally, I lied about not addressing any members of Podiatry Arena specifically. To the member who suggested "Chiropodist shoots himself in the foot...."; I will be speaking at the UK Brighton conference in November this year and would be delighted if you (a) attend the conference and (b) come and introduce yourself…I think it would be the least you can do!

    NOTE: Anyone interested in reading the full article; if you cannot easily get hold of it, please e-mail me and I will send you a copy.

    References

    1. Schulz KF, Chalmers I, Hayes RJ, Altman DG: Empirical Evidence of Bias: Dimensions of Methodological Quality Associated With Estimates of Treatment Effects in Controlled Trials. Journal of the American Medical Association 1995, 273(5):408-412.

    2. Landorf KB, Keenan A-M: Efficacy of foot orthoses: what does the literature tell us? Australasian Journal of Podiatric Medicine 1998, 32(4):105-112.
    3. Landorf KB, Keenan A-M: Efficacy of foot orthoses: what does the literature tell us? (Reprint from the Australasian Journal of Podiatric Medicine 32(4): 105-112). Podiatry Now 1999, 2(10):331-336.

    4. Landorf KB, Keenan A-M: Efficacy of foot orthoses: what does the literature tell us? (Reprint from the Australasian Journal of Podiatric Medicine 32(4): 105-112). Journal of the American Podiatric Medical Association 2000, 90(3):149-158.

    5. Landorf KB, Keenan A-M, Herbert RD: Effectiveness of Different Types of Foot Orthoses for the Treatment of Plantar Fasciitis. Journal of the American Podiatric Medical Association 2004, 94(6):542-549.

    6. Landorf K, Keenan A-M, Rushworth RL: Foot Orthosis Prescription Habits of Australian and New Zealand Podiatric Physicians. Journal of the American Podiatric Medical Association 2001, 91(4):174-183.

    7. Landorf KB, Keenan A-M: An evaluation of two foot-specific, health-related quality-of-life measuring instruments. Foot & Ankle International 2002, 23:538-546.

    8. Landorf KB, Keenan A-M, Herbert RD: Effectiveness of Foot Orthoses to Treat Plantar Fasciitis: A Randomized Trial. Archives of Internal Medicine 2006, 166(12):1305-1310.

    9. Petchell A, Keenan A-M, Landorf K: National clinical guidelines for podiatric foot orthoses. Australasian Journal of Podiatric Medicine 1998, 32(3):97-103.
     
  2. Karl Landorf

    Karl Landorf Member

    This is the second of two postings regarding our randomised trial. In it I will attempt to answer some specific questions about the trial methods (even though most of these details are contained in the full paper).

    Trail design
    · The trial was a pragmatic clinical trial where we attempted as much as possible to mimic ‘typical’ clinical practice.
    · Randomisation was generated using an appropriate computer program and allocation was concealed from the investigator recruiting participants
    · We did not use diagnostic imaging techniques because the majority of clinicians do not use these tools to diagnose plantar fasciitis.

    Ethics
    · We gained appropriate approval from our University’s Human Ethics Committee prior to beginning the trial.
    · Participants signed informed consent.
    · Participants were free to drop-out of the trial if they wished to (at the end of 12 months we only had four participants or 3% do so).
    · In addition, we believed the 12 month timeframe of the trial was also ethical because no prior studies had evaluated long-term effectiveness (a claim many make with respect to the ‘typical’ customised orthosis used in our study).

    Foot orthoses
    · The sham orthosis was called this because we did not conduct any functional (biomechanical) testing on it; therefore we thought we had no justification to call it a placebo. The term ‘sham’ is well recognised in the clinical trial literature[1]. We believe it is the appropriate term for the device we used in our trial, as it would be in many musculoskeletal intervention trials attempting to create a control/placebo group. It was essentially a piece of thin foam moulded to a ‘neutral’ unmodified cast of the foot. When the apex of the arch of the sham orthosis was pushed down on from above it flattened out with minimal force from one’s fingers. It was fabricated partly by two 4th year podiatry students that were employed as technicians. The cast had no plaster modifications, therefore all the technicians did was prepare the negative cast (I took the cast), create a positive cast, mould the foam and cut the device into an approximate shape. I then finished each sham device in a pre-determined manner (e.g. ground into a similar shape to the other devices).
    · The prefabricated orthosis was appropriately fitted and moulded to the foot as per the manufacturer’s instructions. This included heating the device and holding the foot in the neutral calcaneal stance position. No posting was used.
    · The customised orthosis was based on that which had previously been determined to be a ‘typical’ (i.e. most commonly prescribed) device that was used at the time in Australia and New Zealand. A commercial orthotic laboratory fabricated this device here in Melbourne. Students did not fabricate it.
    · Both the prefabricated and customised orthoses were decided upon based on the results of the large survey we conducted and published previously[2].
    · To assist blinding of participants, we took neutral suspension casts[3] of all participants’ feet to fabricate the sham and customised orthoses or size the prefabricated orthoses.

    I recommend those that are interested read the full journal article[4] first and then if you want further details regarding the devices to contact me and I will supply them.

    Additional treatments
    · Importantly, participants in all three groups (sham, prefabricated and customised) were treated exactly the same apart from the orthosis they received.
    · All participants received low-Dye taping between their first appointment and the second appointment when the orthoses were dispensed (there was a 2-3 week gap between appointments and participants were advised to leave the tape on for 3-5 days). Baseline outcome measures were taken at the point in time that they received the orthoses.
    · All participants were also advised about appropriate footwear and stretching the Achilles tendon (gastrocnemius/soleus complex).
    · The above was simply an initial burst of treatment that everyone received as an ethical response to participants being in pain and prior to them receiving orthoses.
    · Importantly, all participants were treated in exactly the same manner, which means that the additional treatments are a side issue and as such had no bearing on the primary results of the trial; that is, a comparison of the effectiveness of the three devices used.


    References

    1. Miller FG, Kaptchuk TJ: Sham procedures and the ethics of clinical trials. Journal of the Royal Society of Medicine 2004, 97(12):576-578.

    2. Landorf K, Keenan A-M, Rushworth RL: Foot Orthosis Prescription Habits of Australian and New Zealand Podiatric Physicians. Journal of the American Podiatric Medical Association 2001, 91(4):174-183.

    3. Root ML, Weed JH, Orien WP: Neutral position casting techniques. Los Angeles: Clinical Biomechanics Corporation; 1971.

    4. Landorf KB, Keenan A-M, Herbert RD: Effectiveness of Foot Orthoses to Treat Plantar Fasciitis: A Randomized Trial. Archives of Internal Medicine 2006, 166(12):1305-1310.


    Karl Landorf
    La Trobe University
     
  3. Regarding your justification for the use of the term sham, did you conduct biomechanical testing on the other two devices?. It's interesting that the manufacture process you describe is not too dissimilar to how many orthoses were made here in the UK in the late 1980's, certainly when I trained this was about the sum total of the plaster prep performed. I take it you have no idea of the effect these devices may or may not have had on biomechanical function because you didn't measure their effects as stated above so we really don't know what they were or were not doing. I think it was Keith Rome (feel free to correct me if I'm wrong) who suggested the aetiologic role of compression forces in plantar fasciitis; do you agree that at the very least, the devices used would have provided cushioning? Did these devices maintain their moulded form or was it lost during the course of the trial?

    Could you tell me what the beta error was please?

    From your meta-analyses, how do your results compare to studies were a "no intervention" group has been used as a control?
     
  4. admin

    admin Administrator Staff Member

    Karl - THANKS for taking the time for such a reply ... its turns this thread into a valuable resource on your study, from many different perspectives.
     
  5. Karl:

    Thanks for taking the time to reply here on Podiatry Arena. You all have done a lot of work to complete a scientific study on the orthosis treatment of plantar fasciitis. I am grateful for your and your coworker's hard work.

    However, I must say that the terms that you used for your two control orthoses "sham" and "prefabricated" were surprising to me when, in fact, both of these orthoses were in fact, in some way or another, custom-made to the patient's foot. This was first pointed out to me by a well-known American podiatric biomechanics lecturer who will be lecturing in the UK soon and he was somewhat frustrated also that the abstract says "prefabricated" where the "prefabricated orthosis" used in your study was actually a prefabricated device that was custom-molded to the patient's foot.

    If the "prefabricated orthoses" that you molded and fit to the patient's foot is indeed, as you said in your study, a "prefabricated orthosis", then what do we call the hundreds of over-the-counter orthoses that are not custom-molded to the patient's foot and are also called "prefabricated orthoses"??? Should we call these more typical over-the-counter orthoses that are widely available here in the States "non-custom molded prefabricated orthoses" or do you think they should also be called just "prefabricated orthoses"? This is misleading and certainly when I, and thousands of other podiatrists, read or hear the term "prefabricated orthosis", we are not thinking about custom-molded prefabricated orthoses that are relatively rare here in the States, but are thinking of the over-the-counter orthoses that you can buy at the running shoe store or drug store for $20-$30 (US) that are not meant to be custom-molded to the patient's foot.

    In addition, taking a 6 mm sheet of foam, custom-molding it and grinding it to fit a patient's shoe and then putting it within the patient's shoe is not exactly what I would call a "sham" orthosis. Just because minimal force was required to deform the device outside the shoe does not mean that that the same minimal force would be required to deform this "sham orthosis" inside the shoe. When a custom-molded, custom-ground piece of foam is placed within a shoe, especially depending on the interior shape of the shoe, it really becomes a "shank-dependent" custom-foot orthosis where it will resist deformation forces from the foot and provide heel cushioning properties that are much more like a typical custom-made soft foot orthosis that are also commonly made off a cast of the foot. In order to have a proper experimental control for the foot orthosis treatment of plantar fasciitis, the control device that is put into the shoe must not contact the medial longitudal arch of the foot or offer heel cushioning to the plantar heel. Your "sham orthosis" offered both medial longitudinal arch support and 6 mm of heel cushioning, both of which may mechanically make plantar fasciitis better, in my experience. I would call your "sham orthosis", rather, a cushioned-heel, custom-molded, less-controlling soft foot orthosis, not at all a "sham orthosis" or "fake orthosis".

    Even though, I do not for one second, question that you and your coworkers have done very honest and very scientific research, and I don't think that anyone that thoroughly reads your research paper will have many problems with it, I worry about the greater percentage of individuals who will only read the abstract of your paper. If individuals only read the abstract of your paper and see "prefabricated orthosis" and "sham orthosis" as the comparisons to "custom orthoses", they will then assume that custom foot orthoses are only minimally better that typical non-custom-molded prefabricated foot orthoses (what I would assume the term "prefabricated orthoses" means) that are 1/10th the cost of custom-molded foot orthoses. They may also assume, from reading the abstract only, that custom foot orthoses are only minimally better at treating plantar fasciitis than pieces of a flat insole material (what I would assume the term "sham orthosis" means) that are 1/30th the cost of custom-molded foot orthoses here in the States.

    Unfortunately, I suspect that the insurance companies and government health authorities, that are always looking for ways to deny funds for treatment of podiatric patients with legitimate painful symptoms, are going to have a field day with this one. All we can do, as clinicians that are concerned for the well-being of our patients, is to tell the insurance companies and government health authorities to read the whole paper. Hopefully they will have the time, patience and inclination to want to listen to us when we explain to them what the results of your study actually mean for our many patients with plantar fasciitis.

    I'm looking forward to more research from you and your coworkers to help us further elucidate the most effective therapeutic devices and methods to treat this very common and debilitating condition.
     
    Last edited: Jul 5, 2006
  6. Atlas

    Atlas Well-Known Member

    An interesting aside would have been to compare outcome measures pre-tape and at orthotic issuing. My gut feeling would suggest that 3-5 days of taping would improve measures over the 2-3 week gap. Irrelevant to the study I know.


    As for this whole debate, it is of no concern to the researchers, as to how the insurance companies view this; nor should it be.

    But it should be the concern of all interested, that we put the clinical conclusions in context. Felicity, some of us aren't trying to shoot the messengers; we are just trying to establish the clinical implications of the message itself (and what ingredients went into the message cake.).

    Kevin has raised some pertinent questions; whose answers can only improve and augment future research and future clinical practice.



    Ron
     
  7. Hylton Menz

    Hylton Menz Guest

    I totally agree. Researchers cannot be held responsible for what health insurance companies do with their research findings, nor should this issue have any influence on how the study is designed or how the paper is written.

    As someone who has held the sham devices and easily squished them between my thumb and forefinger, I can confidently state that these devices were essentially inert from a mechanical perspective (unless there's a new branch of "homeopathic biomechanics" I'm not familiar with ;)).

    If these devices had been considered the "custom device" in the study and found to be ineffective, I could just imagine the barrage of flak the authors would have received!

    Cheers,

    Hylton
     
  8. I agree that researchers should not be held responsible for what health insurance companies do with their research findings. However, this does not change the fact that health insurance companies are sometimes the sole determinant of whether a patient is able to, or not able to, receive vitally necessary medical care for the treatment of their pain, disability or disease. Therefore, the medical researcher does not work in a "scientific vacuum", especially if they desire to share their work with the medical community by publishing in a medical or scientific journal.

    Researchers must ultimately accept the responsibility that whether they intended it or not, their research may affect people's lives in either very positive or very negative ways. Therefore, it behooves the researcher to think about their every part of their research before it goes to print as to how it will affect the lives of the patients that their research pertains to. While they cannot control the actions of insurance companies or government health authorities, they should try their best to make sure that they are not "providing unintended ammunition" for these "medical treatment authorities" that may affect the lives of patients that live in pain, live with disease and, as a result, desperately need treatment.

    As I stated before, a 6 mm thick piece of foam under the heel provides heel cushioning which does have a mechanical effect at reducing the loading patterns on the plantar heel. In addition, a 6 mm thick piece of foam that is then heated, vacuum-formed to a non-corrected postive cast of the foot, cut to shape and then ground to fit the shoe, will certainly be providing a significant amount of medial longitudinal and lateral longitudinal arch support to a foot once that orthosis is placed within the shoe. This is irregardless of how much you squish them, squash them or massage them while they are outside the shoe.

    Let's discuss this further with a mechanical analysis of what likely causes plantar heel pain in the vast majority of the population.

    What are the two most likely mechanical causes of the abnormal tissue stresses that cause plantar heel pain? I will name them for you:

    1. Increased tensile force in central component of plantar aponeurosis caused by increased forefoot dorsiflexion moments.

    2. Increased compression force acting on medial calcaneal tubercle caused by increased magnitude and/or loading rate of ground reaction force on the plantar heel.

    What do you do to treat these conditions successfully with a foot orthosis? I will name them for you:

    1. Increase the forefoot plantarflexion moments by supporting the middle of the plantar longitudinal arch of the foot with the orthosis.

    2. Decrease the magnitude and/or loading rate of compression force acting on the medial calcaneal tubercle by decreasing the magnitude and/or loading rate of ground reaction force on the plantar heel.

    Now, what mechanical characteristics did the "sham orthosis" used in the study by Landorf et al have?

    1. Provided some medial longitidunal arch support that not only increased the forefoot plantarflexion moments but also decreased the ground reaction force on the plantar heel.

    2. Provided some cushioning to the plantar heel to decrease the magnitude and/or loading rate of ground reaction force on the plantar heel.

    As I stated earlier, the "sham orthosis" was not a true "fake orthosis", nor was it a non-functional orthosis since it was actually designed in many ways more like a custom foot orthosis than the prefabricated foot orthoses my patients buy in the drug store or running shoe store. And yes, I would have complained if these "sham orthoses" were considered typical custom foot orthoses that podiatrists make for plantar heel pain just as I am complaining now that they were considered "sham orthoses" in this study since the "sham orthoses" used in the study were neither the best that an experienced or ethical podiatrist would make for their patients or a "fake orthosis" that has no mechanical effect on the foot (as the term "sham orthosis" implies).

    As any podiatrist that has many years of treating thousands of patients with plantar heel pain could tell you, just the simple act of custom-making an insole (of nearly any moldable or formable material) that provides both medial longitidunal arch support and some heel cushioning (or heel pressure reducing effect) will help many patients with plantar fasciitis. I would have greatly preferred if a very thin material with no heel cushioning properties, no heel cup shape, and a minimal longitudinal arch height shape were used as the "sham orthosis" in the study by Landorf et al. This would have been a much more appropriate "sham orthosis" to allow a more accurate determination of the true difference in effect to the custom foot orthosis than the one used in the study.

    Great discussion, Hylton. Looking forward to your further comments.
     
  9. Karl Landorf

    Karl Landorf Member

    There has been some more discussion regarding the devices used in our trial, which I will address below (hopefully this may be my last posting on this topic):
    • We did not conduct any functional/biomechanical testing on the 'sham' device.
    • This device was fabricated from a soft (120 kg/m3) piece of EVA foam - with minimal force you can squash it, fold it in half, roll it up and twist it 360 degrees on its long axis.
    • It was not 6mm under the heel; it was ground to approximately 1-2 mm under the heel. (The 1-2 mm was chosen as it was just sufficient to stop the material tearing apart under use, even though some in the study ended up doing this).
    • It also had a significant lateral plantar grind starting at the heel and extending to the distal aspect of the orthosis; so the material thickness was only 1-2 mm under that part of the foot too.

    I have a quaint story to tell about the very first participant in the trial who, as it happened, was allocated the sham device. Her initial pain level was approximately 30 points on the Foot Health Status Questionnaire pain domain [0 is worst and 100 is best on this scale]; so she was in quite severe pain. At 3 months her pain level was approximately 95 (literally no pain). At the beginning of this appointment (and after completing her outcomes assessment) she was clearly very grateful and was singing the praises of the ‘devices’ she had received. Upon inspection, the devices were as flat as a tack, did not resemble anything like she received initially, and to top it off, the left one was in the right shoe and vice versa. I don’t tell this story to suggest the effect she experienced was purely placebo or indeed natural resolution, but it highlights that the ability for this device to withstand pressure and deformation was minimal. This example of deformation and wear of the sham device during the trial was repeated over and over again.

    As stated in one of my previous posts; because we did not perform any functional/biomechanical testing on this device we did not think it appropriate to call it a placebo (which is generally an ‘inert’ intervention). Hence, the term ‘sham’ orthosis. If it provided significant support or cushioning, then I'm the reincarnation of Mahatma Gandhi! :)

    Moving on to the prefabricated orthosis - it is exactly that, a prefabricated orthosis. The vast majority of podiatrists in Australia and New Zealand (I know no-one who doesn’t) would refer to this device as a ‘prefab’ or ‘off the shelf’ orthosis. Yes, some moulding can be achieved. But it is essentially a $36 Aust. device that a practitioner can take out of a packet and use (albeit with the requisite assessment, diagnostic and fitting skills required). The option to heat and mould this device is just that...it is an option (although the manufacturer recommends it, as we adhered to in our trial). It takes about 5 minutes total with a hair dryer to achieve such moulding. I know the company probably won't like me saying it (because they are highly respectful of health professionals' diagnostic and treatment skills...as they rightly should be), however I am reasonably certain that their device would be effective even if this moulding process wasn't performed. I know a lot of practitioners that use them this way. Essentially, it is an inexpensive, prefabricated device. Having said that I wouldn’t for the life of me suggest they work in all circumstances or for all foot pathologies. On average though, for plantar fasciitis this prefabricated orthosis was effective and just as effective as the customised orthosis we used; this is all we can conclude from our study. [Please note we have made it clear in our the 'Conclusion' of our 'Abstract' that we refer only to the "orthoses used in this trial".]

    We could discuss what ‘we should have called these devices’ until the cows come home. My co-authors and I have no control over whether practitioners choose to read the full paper or just the abstract. Likewise for the insurance companies. Of course I genuinely want people to read the full paper so they have greater understanding of what we did. As I’ve said before, if they don’t, then they shouldn’t comment on the results.

    My final point is that equitable scrutiny is fundamental to rational debate. I've spoken to Josh Burns many times about his excellent randomised trial evaluating the effect of foot orthoses for the painful cavus foot (the customised orthosis used in this trial was found to be more effective compared to a sham insole). This is a rigorous trial and Josh and colleagues have rightly been praised regarding its publication. It is interesting to note, however, that it received little attention on this forum (six replies to date). What attention it did receive was generally complimentary (as it should be). Nevertheless, there is a remarkable similarity between Josh’s trial and ours that should not be missed in this discussion regarding terminology.

    Josh used a 'sham insole’; we used a ‘sham orthosis’. (Josh also referred to the insole as a control.) The sham device in Josh’s study was designed to do very little, as was ours. The material used for Josh’s sham device has been shown (as Josh and colleagues cited) to be the least effective of a number of materials (including Spenco and PPT)[1]. However, the authors of this cited research still found it reduced mean pressure under sites of high plantar pressure by 28%[1]. Similarly, in Josh’s study pressures were reduced with their ‘sham device’. The only conclusion that can be made from this is; the device clearly had an effect. Josh rightly did not call this device a placebo; he referred to it as a ‘sham insole’ (or control). Remember his main aim was to evaluate the effectiveness of foot orthoses for the painful cavus foot, where the associated pain has been hypothesised to be, in part, due to high plantar pressures. I am unaware of anyone questioning Josh’s use of the term ‘sham’ (or even control). Why then, is our trial (and the sham device we used) receiving so much scrutiny and Josh’s trial isn’t? Is this equitable and therefore rational?

    Before I finish, two other questions have been raised that require brief answers. The beta error (or power of the study) was calculated before the study began (as it should be). We powered the study at 80%. However, because we had far fewer drop-outs than planned and we conservatively ignored the extra precision of the covariate analysis used in our hypothesis tests we had over 90% power. Finally, from our meta-analysis we can make no conclusions about comparisons with ‘no treatment’ as this data is not available from appropriate randomised trials (i.e. we could not evaluate this).

    Cheers,

    Karl Landorf
    La Trobe University


    References

    1. Leber C, Evanski PM: A comparison of shoe insole materials in plantar pressure relief. Prosthetics and Orthotics International 1986, 10:135-138.
     
    Last edited by a moderator: Jul 6, 2006
  10. davidh

    davidh Podiatry Arena Veteran

    Hi Dr Landorf,

    Just to make it quite clear - I have absolutely no problems or issues with pre-forms-vs-custom.

    I would be very happy to introduce myself when you are in the UK in the Autumn. Meantime after shooting my mouth (keyboard off) here it is only right and proper that I read the full story for myself.
    I'd be grateful for a copy.
    Regards,
    davidh
     
  11. Karl:

    Thanks for your clarification of the fabrication method of the "sham insole". It appears then that the device was thin at the heel so it provided little direct cushioning by material deformation, but probably temporarily reduced ground reaction force plantar to the heel of the patient via the custom-molding process you used that cupped the heel and supported the medial arch, which, to me, explains some of the results you note above. Again, I see patients with orthoses in the wrong shoe, but they all report that they don't know why their orthoses quit working for them!

    Again, I am looking forward to further research work from you and your coworkers on the treatment of plantar fasciitis that could tell us the exact mechanical basis behind how orthoses do and don't work at treating plantar fasciitis and how best to treat these patients, in sometimes disabling pain, with foot orthoses. This would be a great help to all of us searching for better ways to treat these many patients.
     
  12. admin

    admin Administrator Staff Member

    On that note, I think it is time to close this thread - its has runs its course and there is no point going over old ground again. I thank all those who have contributed, especially Karl for responding to the comments about the research. The thread is a valuable resource to read alongside the publication.
     
  13. admin

    admin Administrator Staff Member

  14. davidh

    davidh Podiatry Arena Veteran

    Landorf K et al Plantar Fasciitis Paper

    Hi everyone,

    Effectiveness of Foot Orthoses to Treat Plantar Fasciitis - A Randomised Trial. Landorf, Keenan and Herbert.

    This caused a bit of a stir a little while back.

    I posted this response:

    (Much cut) "Finally, I question the ethical considerations of allowing some patients/subjects to hobble around for 12 months in the interests of science. As far as I can make out, this study has only shown that foot orthoses of whatever type, as a stand-alone treatment for unquantified PF, are not particularly effective."

    At my request Karl (Landorf) kindly sent me a copy of this Paper (cheers Karl). I'm very happy to comment on it publicly, since I now consider my response to have been unfair, considering I had not then read the Paper. In my defense (is there one?) I was not acting from a purely commercial motive.

    Anyway I'm happy to report back here once I've worked through the study.

    Regards,
    davidh
     
  15. admin

    admin Administrator Staff Member

    I have reopened this thread and added David's post to the thread rather than have a new one. The reason for closing it, was that it was starting to go over old ground (ie newcomers to the thread were not reading its in its entirety and making comments that have already been gone over) - for that reason its better keeping shorter high quality threads that are useful rather than have threads that keep going over old ground, that stretch to many pages that no one bothers to read before commenting.

    Please keep that in mind for any further posts in this thread.
     
  16. davidh

    davidh Podiatry Arena Veteran

    Thanks for re-opening the thread Craig.

    This in fact was my original concern - that the findings may be taken out of context.
    Cheers,
    david
     
  17. davidh

    davidh Podiatry Arena Veteran

    In my original posts on this work I drew heavily from my own experience in treating PF, from what I know of our (podiatry) place in the wider medical marketplace, and from comments made by Douglas Altman in his book Practical Statistics for Medical Research (Chapman and Hall).
    First of all Altman makes several points concerning misuse of scientific research;
    For example he quotes one company promoting its’ product with (probably) bogus research, but (quote) “the power of research is successfully invoked”.
    Another:
    (Quote) ”few people outside the relevant field are concerned about how the research was done, only about what was found”.

    In commenting on the Paper I have to make it clear that I’m not an academic, and furthermore I’m not qualified to comment on the structure of the study, or on the statistical methods. I am however cognizant of the state of Podiatry globally today, and so my comments centre around that, and how the work may be seen by others.
    We are a small and fairly unorganized (in relation to, say, orthopaedics) profession who have neither the numbers nor the backing of big money (pharmaceutical companies) to be able to fight back effectively against adverse publicity.
    Effectiveness of Foot Orthoses to Treat Plantar Fasciitis says, in it’s Conclusions:
    (quote) “Foot orthoses produce small short-term benefits in function, and may also produce small reductions in pain for people with plantar fasciitis, but they do not have long-term beneficial effects compared with a sham device”.
    That would seem, on first reading, to be a loaded gun delivered to any and all who are unhappy about orthosis therapy.

    On to the Paper.
    The work was thorough, and the cohorts were of a size which (to my mind) would produce meaningful results at the end. Out of 136 participants at the start, only 5 (for various reasons) dropped out before the end of the study at twelve months.
    (Methods suggest that 135 participants were involved – I’ve taken my numbers from Figure 1).
    On reading the Paper thoroughly it is clear that the only objectives were to examine how effective orthoses were in the treatment of plantar fasciitis (short and log-term), and to compare the effects of three types of orthosis. To question, therefore, why orthoses were used without some form of additional therapy (as I did) was wrong. And certainly wrong before I had the chance to read the full story.
    I would like to have seen some mention of the benefits of custom over pre-fab or sham devices (eg they last longer), and of the place of adjunct therapies in the treatment of PF, but I recognize that these were not in the remit of the Paper.

    Worthwhile work or not?
    On balance I believe it’s a good thing for members of a profession to publish work which may not go along with accepted thinking. It shows that we do question ourselves and our methods, and, I think, is a sign of maturity.
    I apologise to the authors for running my mouth off, and thank Karl for sending the Paper to me. Also, I really appreciate the international cooperation which can exist within our profession..
    Regards,
    davidh
     
  18. Brian A Rothbart

    Brian A Rothbart Active Member

    Interesting study.

    Just one quick observation, maybe I missed something but, plantar fasciitis is a symptom, not an etiology. My question is, in this study, did all the patients have a common etiology for their presenting complaint (plantar fasciitis)? And if so, what was that etiology. If the patients, did indeed, have different etiologies, that would explain the less than favorable results arrived at in this study. (Different etiologies, different treatment protocols). Just recently, I saw a young boy with heel pain (inflammation of the long plantar ligament at its insertion point into the medial plantar calcaneal tubercle). The GP diagnosed it as plantar fasciitis. Eventually, the cause was identified as a bee sting in which the stinger was still inplanted in the foot, causing an inflammatory reaction in the ligament. Would this patient respond to simply prescribing orthoses, I think not. It was necessary to remove the foreign object. The pain almost immediately resided post surgery.

    Brian R
     
    Last edited: Aug 11, 2006
  19. jjvaljean

    jjvaljean Welcome New Poster

    I read this article, and the postings on this site and I shake my head.



    With regard to fabrication of "custom orthoses"-- This is an ART, based on science. These devices are not a commodity. Successful therapy greatly depends on adjustments to the devices so they fit in shoes, that they are comfortable, and that they "work". It takes an experienced, and MOTIVATED person, and they must have the materials and equipment to do it. If a practitioner relies on the lab to do this for them, the results will be disappointing. The degree and type of posting of the device is critical, and often must be modified. I have zero confidence in the Australian study with regards to the fabrication and management of the custom orthotic therapy, even if good neutral position casts were taken. Rarely have I seen anything but a "neutral shell" with modest intrinsic posting come back from even very good labs. Generally, "real" orthotics are more effective at preventing Fasciitis, than in treating it. Most commonly the condition needs to be controlled first, then an orthotic can help greatly in preventing recurrence.

    Every article I have seen, including the recent Mexican study in the Cleveland Clinic Journal of Medicine misses the main problem. It shows the lack of understanding of the real issues. Nowhere in this study does it mention the patient's SHOES; or for that matter, their activities. You can have an excellent orthotic device, but success will also largely depend on the qualities of the footwear worn. Most atheletic shoes have quite poor qualities to help with Fasciitis; even expensive ones. In order to relieve/prevent the condition, the footgear must have a RIGID SHANK, and approx. ONE INCH HEEL HEIGHT; (For example: BROOKS 257, SAUCONY REGULATE, OR STABIL, NEW BALANCE 718, 1122). Hell lift need to be added. It is not so easy to find shoes with the right qualities, and people often cannot afford them or are too frugal to purchase them; and one pair is not enough.

    One further factor is patient behavior. This is not controllable by the doctor, and a HUGE factor for failure of treatment. Their compliance drops dramatically after the pain goes away. They wear "bad shoes", slippers, scuffs, stocking feet, etc; and don't realize they are hurting themselves because it "feels good" and there is a latency period of about a day until it starts to be painful.


    So, now think again about what a "landmark study" this is supposed to be. I am amazed that such obviously learned and dedicated people can be so profoundly ignorant of the problems with this study, and the treatment for pronation related foot problems such as Plantar Fasciitis. This isn't rocket science. Its about excessive pronation, and overloading of plantar tissues.
     
  20. Craig Payne

    Craig Payne Moderator

    Articles:
    8
    I think you have a very poor understanding of randomised controlled trials.
    What evidence do you have to back up this claim? I have seen no pubiched data on this. Standard clinical practice is to use a lab to fabricate the orthotic. Are you suggesting that the study should have done something that was not standard clinical practice regarding the foot orthoses just becasue it is not the way that YOU do it?
    The opposite is the case. This is were you are showing a total misuderstanding of what a RCT is.
    The reseach question was if custom made are different to placebo and premade. If you start altering shoes and activity levels, then that is a different research question and different study. Standard clinical practice is to use one pair - the research question was not about 2 pair. Perhaps you should do the study and publish the results?
    The reseach question was if custom made are different to placebo and premade. If you start altering patient behaviour, then that is a different research question and different study.

    The points you raise (ie footwear, activity, behaviour) may or may not be valid for the clinical management of plantar fasciitis, but are totally irrelevant to the research question of the study under discussion.

    Understanding the purpose of RCT's is also not rocket science. I am amazed that such obviously learned and dedicated people can be so profoundly ignornant of RCT design.

    BTW - what evidence do you have that excessive pronation actually is the cause of plantar fasciitis - I think there is more than enough evidence starting to accumulate that this is not the case. Have you read that?
     
    Last edited by a moderator: Aug 20, 2006
  21. jjvaljean

    jjvaljean Welcome New Poster

    My intent is not to attack your study, or your methodology, but rather to illuminate truth, so that people may be helped. What your study has shown is that one type of "custom fabricated" orthoses from essentially one practitioner was no better than a "blank" device. I think that your conclusions misrepresent the benefit of a "true" biomechanical device. If it has become Standard Practice not to use the knowledge and skills we were taught in professional school to provide high quality orthotic therapy, then no wonder your results were as such. Regardless of the elegant design of your study, Fasciitis is not a problem that lends itself to randomized controlled study in this manner. It is the medical profession's lack of understanding of the problem that disturbs me. What I am saying is that Plantar Fasciitis is caused by several factors, mainly flexible flat shoes, overloading, and excessive pronation. I do not base this on myopic, flawed literature, but rather on my education and 25 years of clinical practice. If your intent is to defend your study, I will trouble you no more. If you seek truth and understanding of the nature of this condition in order to help relieve suffering, I would be pleased to help enlighten you. Your integrity as a researcher is not questioned. I am a clinician who believes he has found some truth based on experience and I am willing to share it.
     
  22. Craig Payne

    Craig Payne Moderator

    Articles:
    8
    its not my study
     
  23. Karl Landorf

    Karl Landorf Member

    Dear 'jjvaljean',

    Although Craig has already made appropriate comments about your post I would like to add some extra comments. My name is Karl Landorf and I am one of the [and I quote you, "profoundly ignorant"] authors of the research study in question. I have been called "ignorant" many times before, but "profoundly ignorant" takes this to a new level and I must thank you for such a compliment :)

    As Craig has quite rightly pointed out, you appear to have misunderstood the aims of our research. Moreover, you appear to misunderstand the very nature of what randomised trials are capable of. Accordingly, I can only suggest the following:

    (a) If you believe you have the answers then an appropriate solution would be to conduct your own rigorous clinical trial comparing treatments and have this trial published in a refereed journal that carefully scrutinises your work. If you do decide to take this path (and I strongly urge you to do so) I would firstly suggest you learn in detail about research methods (e.g. randomised trial methodology) that can be used to compare effectiveness of interventions. [Apologies if you are already an expert in this area.] Such methodology minimises bias that researchers or research methods may contribute to a study - such biases are serious and will often lead to fatal flaws in clinical trials. As clinicians criticising orthoses trials we need to keep this in mind just as much as the type of orthoses prescribed. Without the above issues taken care of, your thoughts are simply that; thoughts. I'm sorry, but this is what scientific evaluation is all about: a systematic accumulation of knowledge. It is based on methodical experimentation and deduction, not just random thoughts from individuals. Yes, I am being a bit harsh here, but surely it is reasonable that if you purport to be an expert, then you need to demonstrate a serious attempt at enquiry.

    (b) If you have read our article in full (which I'm not sure you have from your posting), then I suggest you also read the papers we published prior to this study (referenced in our article) to understand the rationale for why we did what we did in our randomised trial. If you haven't read our article in full, than as I stated previously in this thread, I am more than happy to send it to you so you can.

    (c) If you have already read our article you would have noticed that the participants in the study, on average, improved a large amount (I've stated this in one of my previous posts). We did not say, as you imply, that foot orthoses don't work. However, with plantar fasciitis there is probably a large natural resolution to the condition over time. In the short-term, and while patients wait for this natural resolution, foot orthoses are beneficial. Because we found no difference in the prefabricated and customised orthoses in our trial (i.e. both decreased pain and improved function), then we have recommended practitioners prescribe a suitable, and cheaper, prefabricated foot orthosis (i.e. similar to the commonly prescribed prefabricated device that we used in our trial). Importantly, this finding was supported by the meta-analysis we conducted, which pooled results of multiple trials.

    (d) Finally, would you please have the courtesy to make yourself known on this forum by a signature or a more transparent profile. Hiding behind anonymity makes you less credibile in a public forum such as Podiatry Arena. After all, authors of research have to place their neck on the chopping block when they publish their work. If you wish to make public comment regarding such work, you should have the decency to do the same.

    Time for me to go home, but due to my 'profound ignorance' I'll probably forget how to start my car and end up sleeping in the carpark. That is, if I remember how to get out of my office!

    Regards,

    Karl

    Dr Karl Landorf
    Department of Podiatry
    La Trobe University
    Melbourne, Australia
     
  24. "Illuminating truth"

    There is a familiar taste to the posting from Jvaljean. Here we have:-

    " a clinician who believes he has found some truth based on experience and I am willing to share it."

    Not the first time we have heard from somebody convinced they have found the way the truth and the light. The Phrase

    "I do not base this on myopic, flawed literature, but rather on my education and 25 years of clinical practice."

    Is again a familiar sentiment.

    Thing is Mr Val Jean :) your experiance and education may well be enough to convince you but it is not enough to sway the rest of us without either objective research or, at a pinch, an ironclad rational. Your sentiment that you want to help us alleviate suffering is a familiar one also. The "We make people better" slogan may even apply to you as well.

    TIPS FOR CHANGING THE WAY WE ALL WORK AND BETTERING THE WORLD BY THE GLORY AND TRUTH OF THE VALJEAN/ROTHBART/MASS/WHATEVER YOUR IDEA IS method

    1. DO NOT start your crusade by telling us that your way is better than everyone elses and the only one that works. It does'nt matter how many times you use the word paradigm no body's buying!

    2. DO Create cold hard research to demonstrate that you understand the importance of objectivity.

    3. DO NOT assume that anything which is obviously self evident to you is also obvious to the rest of us. It probably isn't.

    4. Do NOT assume that you are better at biomechanics than anyone else unless you know how good they are. Using statements like.

    "I think that your conclusions misrepresent the benefit of a "true" biomechanical device. If it has become Standard Practice not to use the knowledge and skills we were taught in professional school to provide high quality orthotic therapy, then no wonder your results were as such."
    :eek: :eek: :eek:
    This is unscientific at best and downright rude at worst!

    Regards
    Robert Isaacs

    PS
    JValJean in the musical spent most of the musical doing the right and good thing pursued by and misunderstood by Javert, the representative of the Traditional model of morality. Of course Javert was ultimatly proved to be wrong and his version of morality fatally flawed. Is this just a frightening irony or did you pick it specially? I'm just off to find a bridge! :p
     
  25. jjvaljean

    jjvaljean Welcome New Poster

    My Dear Learned Down-under Colleagues:

    I have merely applied what I learned in school. The principles are basic, and I cannot take personal credit. Apparently my "unscientific" education was different than yours. In addition to the standard medical school curriculum, we did receive a great deal of clinical training, particularly in biomechanics and orthotics. Although much knowledge has yet to be validated by controlled studies, your acceptance or rejections shall not affect its veracity as time and better designed research will.

    Your comments are received as intended, and I shall leave you in the penumbra to which you have apparently become accustomed.

    "E pur si muove!"

    Jean Valjean
    Fellow, American College of Foot and Ankle Surgeons
    Diplomate, American Board of Podiatric Surgery
     
  26. Karl Landorf

    Karl Landorf Member

    Because something above just didn't seem right, I've been doing some mooching about regarding 'Jean Valjean'.

    I have contacted the ACFAS and the ABPS in the United States and both organisations have no record of 'Dr Jean Valjean' existing on their registers. Accordingly, it can only be concluded that 'Jean Valjean' has inappropriately used such titles (i.e. Fellow and Diplomate), which is fraudulent. Both the College and Board are now interested in who this anonymous person is.

    Further to the fraudulent use of these titles, 'Jean Valjean' has still not outed him or herself. 'Jean Valjean' pretended to introduce themself in their final posting above, but they still remain anonymous. 'Jean Valjean' appears to be skating on very, very thin ice!

    Interestingly, this person, ‘Jean Valjean’, has contributed to Podiatry Arena under the pseudonym ‘jjvaljean’. I have searched the Internet for this pseudonym, but have not found much. However, when using the name ‘Jean Valjean’ it leads to a website created in about 2000:

    http://www.angelfire.com/on/podiatry/

    An explanation of who set up the website can be found on the following page:

    http://www.angelfire.com/on/podiatry/about.html

    It would appear that this person has been operating under this pseudonym (i.e. ‘Jean Valjean’) for a number of years. They appear to be a podiatrist and were disgruntled about loan repayments for their podiatry education (this may have been a reasonable issue; I make no comment on this). The true identity of this person is still unknown - one of the ‘useful’ things about the internet if anonymity is desired.

    I would just like to highlight my original concern, that if people decide they want to contribute to such a forum as Podiatry Arena (or any other forum for that matter), it would be preferable if they did so in an open and honest fashion. Anonymity in the vast majority of situations is simply not a credible way in which to operate!

    Karl Landorf
    La Trobe University

    PS. Glad I'm in the penumbra 'Jean'; it's the umbra I would be far more concerned to be in.
     
  27. Karl:

    Seems like Jean Valjean is one of the many "loser podiatrists" that spends more time complaining about podiatry and podiatry schools, trying to bring others down to the level of their dismal existence, than spending time furthering their own career. It is really pretty sad that Jean Valjean is so embarassed about their situation that he/she can't give us their real name. Instead it appears as if he/she feels that he/she must continually hide behind an alias from a play/book to "protect their identity".

    On another matter, I agree with you that if someone wants us to take them seriously on Podiatry Arena then they should give us their real names. I suppose that many people like being anonymous from reading all the pseudonyms of contributors that are used on Podiatry Arena. At least for me, if an individual on Podiatry Arena wants me to help them with one of their patients or wants me to answer an academic question, I will much more likely spend my valuable time answering their question if they actually have the common courtesy to give me their real name when they ask the question. Otherwise, they are just another Jean Valjean, as far as I'm concerned.
     
  28. Felicity Prentice

    Felicity Prentice Active Member

    Est-ce que pauvre Jean Valjean, il malheureux, ou il est est Les Miserables ?
     
  29. Jvaljean

    Vous obtenir avec l'éducation classique ! ;)
     
  30. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Here is Podiatry Today's take on this study:
    Are Orthoses Effective Against Plantar Fasciitis In The Long Run?
    - By Brian McCurdy, Senior Editor
    Link to article
     
  31. admin

    admin Administrator Staff Member

    Here is the authors response to the above story in Podiatry Today
    [/font]
     
  32. admin

    admin Administrator Staff Member

    I am keeping this thread locked for a couple of reasons:
    1. Most points have been made
    2. New contributors to old threads tend not to have read all messages, so old ground is gone over.

    If anyone has anything new to add, please send me a private message
     
  33. admin

    admin Administrator Staff Member

    Even though this thread is staying closed for reasons mentioned twice in the thread, I am adding the information below as it further adds value to the thread (if you do have something worthwhile to add to the thread, please send me a message).

    In this publication from March:
    The PEDro rating scale was used to evaluate the quality of publications of RCT's on foot orthoses. Each study was given a score by several raters.

    The publication that this thread is about received a score of 11/14 --- the highest of all the foot orthotic RCT's used in the analysis. A table of the results is attached below.

    FYI, the final conclusion of the Collins et al publication, based on the analysis of the published literature was:
     

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