Effectiveness of Foot Orthoses to Treat Plantar Fasciitis
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A Randomized Trial
Karl B. Landorf, PhD; Anne-Maree Keenan, MAppSc; Robert D. Herbert, PhD
Archives of Internal Medicine 2006;166(12), June 26:1305-1310.
Background Plantar fasciitis is one of the most common foot complaints. It is often treated with foot orthoses; however, studies of the effects of orthoses are generally of poor quality, and to our knowledge, no trials have investigated long-term effectiveness. The aim of this trial was to evaluate the short- and long-term effectiveness of foot orthoses in the treatment of plantar fasciitis.
Methods A pragmatic, participant-blinded, randomized trial was conducted from April 1999 to July 2001. The duration of follow-up for each participant was 12 months. One hundred and thirty-five participants with plantar fasciitis from the local community were recruited to a university-based clinic and were randomly allocated to receive a sham orthosis (soft, thin foam), a prefabricated orthosis (firm foam), or a customized orthosis (semirigid plastic).
Results After 3 months of treatment, estimates of effects on pain and function favored the prefabricated and customized orthoses over the sham orthoses, although only the effects on function were statistically significant. Compared with sham orthoses, the mean pain score (scale, 0-100) was 8.7 points better for the prefabricated orthoses (95% confidence interval, –0.1 to 17.6; P = .05) and 7.4 points better for the customized orthoses (95% confidence interval, –1.4 to 16.2; P = .10). Compared with sham orthoses, the mean function score (scale, 0-100) was 8.4 points better for the prefabricated orthoses (95% confidence interval, 1.0-15.8; P = .03) and 7.5 points better for the customized orthoses (95% confidence interval, 0.3-14.7; P = .04). There were no significant effects on primary outcomes at the 12-month review.
Conclusions 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. The customized and prefabricated orthoses used in this trial have similar effectiveness in the treatment of plantar fasciitis.
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Prefabricated vs custom made foot orthoses -
Hi.
I'm not sure about the reasons for carrying out this study.
Probably over 50% of the cases I treat are plantar fasciitis. I, like many others, obtain good results, but only if I back up my orthoses therapy with localised treatment for the remaining symptomology.
I question why we expect any in-shoe foot device (sham/pre-fab or custom) to be wholly effective in treating both a perceived underlying cause (faulty foot mechanics), and associated symptomology. Foot position/mechanics within the shoe during standing and ambulation, and micro-trauma, are two very different entities.
I think there are good and sound reasons why a custom device, whilst not necessarily being more effective, might be preferable to a pre-form. They are much cheaper (in cases of prolonged orthosis-wearing) than pre-forms for example. They are also thinner (stiffness to thickness ratio).
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.
Regards,
davidh -
Thanks Hylton for providing the link to this study. I have a few observations.
Clearly this will be a contentious issue for the profession and its patients and could have enormous ramifications especially in countries where insurance-led funding is central to podiatry incomes. However, it is important to remember that the trial only focused on the efficacy of foot orthoses for one condition - plantar fasciitis - and makes no claim to as to the treatment of the remaining mechanically defective foot and lower limb conditions that we treat. There is a danger that this study could be taken out of context and applied to the treatment by orthotic intervention of foot conditions generally, and that should be robustly resisted by the profession as a whole.
It would also be helpful if the authors could clarify some specific points in relation to the trial. What techniques were used to quantify and measure each of the patients? Were the custom devices laboratory made or were they manufactured as vacuum-polyprop shells (I note "custom" was referred to as semi-rigid plastic) by the podiatrist? Were other treatment protocols adopted in the treatment of the condition - such as short-term inversion strapping or mobilisation - or were the patients just supplied with devices at the outset?
There are so many variables that can influence successful outcomes even in a restricted study of this nature that I fail to see why this should become the definitive position of the custom-made -v- prefabricated argument.
Mark RussellLast edited: Jun 27, 2006 -
Therefore, even though this study is interesting, it will not change the way that most ethical podiatrists practice when treating plantar fasciitis. We will still first suggest icing, stretching, avoidance of barefoot walking and using strapping and prefab orthoses. If this does not work then cortisone injections, night splints and custom foot orthoses will be recommended.
Unfortunately, the insurance companies and national health plans will likely be using this research to deny custom foot orthoses for many patients that have failed prefab orthosis therapy since they will quote the authors: "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." This statement does little to offer pain relief to the patient that has plantar fasciitis and that suffers daily from this condition, when custom foot orthoses may be the only non-surgical option that has a good chance of releiving their chronic pain. -
Kevin,
You said:
"Anyone that has treated numbers of patients with plantar fasciitis already knows that prefabricated foot orthoses can be quite effective at treating this condition. Therefore, the results of this study are not surprising to me at all. Successful treatment of plantar fasciitis will always be dependent on multiple factors and not just on whether the orthosis is custom or prefab. Whether a custom foot orthoses is effective or not for plantar fasciitis is dependent on parameters such as the shape and flexibility of the device, the materials used, and the type of shoes the orthoses are used in. In addition, whether additional conservative treatments such as cortisone injections, strapping, stretching, and night splints are used will also determine how the patient's plantar fasciitis responds to foot orthoses."
Well said - but I thought this was fairly standard procedure?
Clearly the authors either don't think so, are unaware that this is the case, or have chosen to ignore this in the interests of making a point.
You then said:
"Unfortunately, the insurance companies and national health plans will likely be using this research to deny custom foot orthoses for many patients that have failed prefab orthosis therapy since they will quote the authors: "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."
Very valid point, and begs the question "why was the Paper written in the first place?"
Reminds me of an old newspaper headline "Chiropodist shoots himself in the foot....".
Regards,
davidh -
This study is really a landmark study in foot orthoses RCT's given how rigourous it is in its design....they do not get much better than this one. It was a mammoth undertaking.
I am somewhat familar with the work, having followed its progress, seen many confernce presentations on it, read the full publication and have been using the results from the study in my own presentations for several years....so will respond to some of the comments above the best I can.
I just think more people need to be familar with the purpose of RCT's and understand the methodologies involved before jumping to conclusions.
Hope this helps that understanding of this work. Hopefully the author will respond. -
congrats to messieurs landorf, herbert & madam keenan for the study (and having the gumption to publish it) and mr payne for the "covering" comment. This is definitely a great "educational (forum) site"........ the more 'science' we undertake, (at the very least) the more podiatry will be respected !!
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Look forward to the author's comments.
Regards,
davidh -
Mark Russell -
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.....then, as good as this study undoubtably is, it has to be taken in context. But regrettably, as far as health insurers (and other detractors) are concerned, there is a real danger it may not be qualified as such. Shades of Kilmartin et al., perhaps?
Mark Russell -
A good example of where we have to be careful is illustrated in the thread on shock wave therapy. Look at the lengths that supporters (ie owners of ESWT machines) go to in order to dismiss the one publication that shows it does not help, yet are totally unprepared to hold the papers that show it works up to the same standard of evaluation. IMHO, the ESWT paper that has the soundest and best methodology is that one that shows it does not work!!
Similarly here...there are plenty of articles on how to properly evalate RCT's and the above paper should be held up to those standards (and it stacks up well), BUT hold up those with different results to the same standard, otherwise the 3rd party funders see right thru it ----> "vested interest". -
How was plantar fasciitis determined as the diagnosis clinically?
Was this supported radiologically with MR or US?
Was an enthesopathy distinguished from pathology more distal?
Any more details regarding the prescription orthotic additions on the custom for instance arch-lowering-pf-accomodation etc.?
TIA -
I will answer them to the best of my knowledge of the study:
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I was at the university when this study was undertaken and observed the students attempts at fabrication of these devices. I would be interested to see the same study undertaken where the orthoses were fabricated by a clinician with more than five years experience. Regardless, congratulations still remain to Karl for researching an area very topical to private practitioners.
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The custom made orthotics used in the study were made by the biggest orthotic lab in the country at the time and NOT by students. My understanding is that a student(s) employed as research assistants just made the sham/placebo orthoses - which were a very soft low density EVA molded to the cast taken of the foot, so that it was made to look like it could have been a custom made device.
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I suspect not, therefore what the study really did was to compare three different kinds of fooot orthoses. -
Thanks for your comment Craig, I did only see them fabricate one type which may well have been the 'sham" device. My next question is what qualifications do technicians have?
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Good point. What I meant was is that they had no vested interest in the outcome. They had nothing to gain or loose resting on the outcome (unlike what can happen depending on funding sources; or financial interests in the outcomes).
Might have to leave Karl to respond to your other point about the "placebo" orthotic, but did notice that they called it the "sham" orthoses, so maybe they did really compare 3 orthotics rather than compare 2 to each other and a placebo. -
Guest
Hate the term "sham"- what it really was was a low density EVA, moulded orthoses. Shame they didn't include a "no treatment group" as this would have told us more than the "sham" (yuk!) group.
here i am, as usual, totally mesmerised by payne, kirby, spooner, menz.....then, who's this, this "domhogan" chappy, troublemaker methinks, i suggest admin you banish him to that other forum, you know the one.....
Craig,
Thank you so much for yet another article to add to my lecture showing that prefabs and customs are basically the same. They have basically the same mechanism of action….blocking the last tiny bit of pronation. This just underlines the need for a completely NEW paradigm.
Ed
I somehow don't think you can draw this conclusion from this study. Research Methods 101. Doh!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
And BTW, don't even go there Ed because by now everyone knows that your orthoses are sooooooo much better than everyone elses because you've dazzled us with you knowledge of foot and lower extremity biomechanics, with your engineering know how, by the research you have to back up your claims and by the studies you've published to prove that your model is better than everyone elses. Your so good at this I'm going to name my first born son Mr Ed. Cool Cool. Have a fulfilling life. Pregnant goldfish.
Indeed, bring back Brian Rothbart, at least he has references to back up his claims, I don't care if they're from the turn of the 19th/ 20th century, he's quasi-scientific rather than non-science.
Hylton and Colleagues,
I actually liked Karl, Anne-Marie and Robert Herbert's research, thought it was nicely done, and think it will further inform us of how to manage our decision-making process for treating plantar fasciitis. It would have been nice to see more positive results from custom foot orthoses when compared to prefab devices, as I have been seeing for over 20 years in my private practice. However, when I first heard that Karl was proposing to design his study the way he did, then I predicted that he would probably get the results that he did. In other words, I knew from my clinical experience that for the diagnosis he chose to study with foot orthoses (i.e. plantar fasciitis), a good prefab device works quite well at treating it. It was interesting to note that there were the fewest dropouts from the study in the subjects that had custom foot orthoses, versus the prefab and sham group, which I would also expect. Again, the research did not surprise me. However, I would have liked to see more biomechanical data, like in Josh's paper on cavus foot, using pressure data or 3D analysis data, to see if we could pin down what mechanical design parameters are necessary in orthosis design to make people with chronic plantar fasciitis get better the fastest. Craig sounds like he may have some data in this regard that may greatly help us design better orthoses for our patients.
Congratulations are in order to Karl, Anne-Marie and Robert on a well-done contribution to the orthosis research literature. Knowing Karl and having met Anne-Marie, I'm certain they had the best intentions to produce scientific, unbiased and objective information, good or bad, in their research on foot orthoses. Let's not jump down the throat of honest researchers just because their research produces results that we don't necessarily agree with or desire to see. We must be careful to not always criticize orthosis research when it seems negative to custom foot orthoses, unless there are glaring errors or biases in the research. Otherwise, we will appear to be just as biased as the researchers that we are criticizing!
Both clinicians that recommend and prescribe foot orthoses and researchers that scientifically study foot orthoses have common goals: improving pain and function of the feet and lower extremities during weightbearing activities. We must always strive toward better orthosis outcomes for our patients and I strongly feel that Karl and his coworker's research will give us a very solid base to work from to improve foot orthosis outcomes for our patients.
Landorf/Keenan Study
As the person that designed the "prefab" used in this study I would like to Point out that our product was fitted and modified appropriately by experienced Podiatrists.
It was designed to be custom moulded in the shoe to make a NSTP shell and then appropriately posted to make a "custom" device for each patient and problem.
Our product was never intended to be just taken out of the bag and put into the shoe, as some other "prefabs" are promoted.
We see ourselves as providing a "tool" that Podiatrists can use to make an accurate, effective, convenient and cost-effective device immediately in their clinic or office.
It is the knowledge, skill and experience of the clinician that determines the success of the therapy.
We have not and do not debate the efficacy of harder and more expensive Orthotic devices, prescribed by skilled Podiatrists. We do say that there are "horses for courses" and situations in which a less expensive, softer device may be the best choice, in the short or long term, either as the final therapy or as a step along the way in solving the patient's problem.
Charlie Baycroft
Charlie,
Thanks for this insight on the Landorf et al study. Sounds like the "prefab" orthoses that they used in their study are much different than the typical prefabricated orthoses handed out for plantar fasciitis by the majority of the medical community here in the States. Maybe it would have been better to call the orthoses used in the Landorf et al study a "customized foam orthosis" rather than a "sham orthosis", a "customized prefabricated orthosis" rather than a "prefabricated orthosis" and a "casted-custom molded orthosis" rather than a "customized orthosis", since the abstract is somewhat misleading as to how these orthoses were actually fabricated and shaped. This is because podiatrists, especially those who are able to produce excellent therapeutic results with foot orthoses, know that the material and shape mean nearly everything in regard to the therapeutic effectiveness of foot orthoses.
Last edited: Jul 1, 2006
Landorf et al
Dear Kevin
I may be assuming that The Formthotics were at least heated and custom fitted (to the neutral foot and shoe) and possibly posted as we recommend and not just taken out of the bag and put into the shoe. Dr. Landorf is the correct person to respond to this.
The point I wish to make is that, in my opinion, foot and leg function can only be reliably improved when a trained professional makes an assessment, uses his/her knowledge, skills and experience to construct an appropriate device and confirms that the device has the desired effects.
This is how we intend our products to be used and I do not want Podiatrists to get the idea that we consider our products to be a substitute for their professional expertise.
There are some aspects of the design, material and method of manufacture that do differentiate our products but I will not go into those here.
It should also be clearly understood that we did not have any influence or financial contribution to the selection of our product for use in this study. This was a totally independent choice by the authors, as it should always be.
What this study does tend to validate is that legitimate devices can be made by methods other than neutral subtalar casting and fabrication in a lab. The choice of what sort of device to use should, of course be related to the particular circumstances of the individual patient and problem. "Horses/courses".
I started a new thread called Formthotics System and would appreciate your comments on this.
Charlie
Kevin,
You wrote:
"We must be careful to not always criticize orthosis research when it seems negative to custom foot orthoses, unless there are glaring errors or biases in the research. Otherwise, we will appear to be just as biased as the researchers that we are criticizing!"
Whilst I and hopefully all right-thinking pods would agree with this, from the information provided thus far, it looks like the research (which I haven't read BTW) shows in-shoe devices in an unnecessarily poor light.
My biggest problem is that as professionals, rather than sellers-of-orthotics, we look to provide the best care for our patients. Best care does not mean providing orthoses and nothing else - although I concede that some pods may work like this.
Other health professionals reading this work may well decide, by inference, that podiatrists do indeed peddle orthoses, and that they (podiatrists and devices)are not particularly effective.
I don't particularly have an issue with pre-forms over custom or vice-versa.
As I've said before in this thread, I do think there is a case for custom, even if
pre-forms do just as good a job.
Regards,
davidh
While the motives appear obvious in this case (custom = dollars), good quality research should invite (primarily) and deal with (secondarily) critical questioning.
If we are to conclude "this is what the research says" and in accordance with EBP, "this is how we should act", then we owe it to ourselves and our patients to scrutinise without fear or hesitation.
Quick question. How was foot function measured?
Its wasn't really. "Function" in this study was one of the subscales of the validated measure of outcomes - the Foot Health Status Questionnaire. Its sort of a measure of how pains affects daily functioning.
The problem in using pain as an outcome measure is that pain may not improve, but "function" does. A simplistic eg is that if subjects had a VAS of 5/10 (pain) and can walk 2 blocks before that pain starts ("function") ... they then get their orthotics and "function" improves (ie they can now walk 5 blocks before pain starts).....but as they can now walk 5 blocks, the VAS is still 5/10 due to the greater amount they can walk ... thats why you should look sideways at any study that just uses pain as the only outcome measure.
I would like to hear some clinical feedback on this issue. I have been using prefabs (medially posted semi-compressible foam- Lynco brand) with very good results. Overall, most patients find these more comfortable and I get far less complaints of intolerance. Out of pocket cost is 18% that of customs in our clinic. I go with customs in patients who have had prior sucess with customs that need replacement, or those using prefabs and need longterm control- in this case, customs are cost effective due to their durability.
Let's face it, a thick wad of toilet paper stuffed in the arch will block endrange pronation as well. And from the look of some "custom" devices my that patients purchased from other practioners for over $400US, the toliet paper analogy doesn't stop there.....
Actually, there is a smart pod here in Melbourne. He makes 'non-bulky' devices that are not complicated. The smart thing is, that after a few years, he tests these devices with a "machine". The "machine" indicates that the devices have lost 20% of their support. The answer? Purchase a new pair with more technologically advanced material.
The machine, I guess was his finger. The new material was polyprop.
But his patient was happy, so that was the main thing...I guess.
Well done Karl,
It has been a long time coming; in New Zealand we appreciate strong evidence based research. Excellent Podiatric research is needed to support our clinical reasoning.
Your paper having been accepted in a prestigious journal gives strength to our emerging research profession.
Keep up the good work.
Dan Poratt DPM
Head of Podiatry School
AUT University
daniel.poratt@aut.ac.nz
What a remarkable thread. Such emoting! There is no doubt that I have had my tuppence worth of opinion on far too many issues on this forum, and the Lord knows that I love the sound of my own keyboard. But all of a sudden I have a new view.
I have known 2 of the researchers professionally since Noah was afloat, and I would have to say that it would be difficult to find more careful, considerate and thorough Podiatrists and researchers anywhere. I would offer a duel (with Blacks Files - no safety nets) to the death to anyone who would accuse them of shoddy methodology, poor ethics, or shallow insights. Dear me, I would have to describe at least one author of being so diligent and meticulous that the expletive 'anal personality' wanders in and out of the conversation (sorry mate).
But having read little abstracts here and there on the web and forrums, I can now realise how easy it is to jump to conclusions, leap to opinions, and race to comment (no matter how derogatory or high handed). This episode has taught me that we must employ the highest of standards of critical literacy to our own reading and interpretation. It is easy to judge on an abstract, but the entire story will illuminate your understanding, even if it is a tale you would rather not hear.
So I heartily invite you to read the whole article, just as Craig has, and I believe you will be in agreement with him that this is the gold-standard in RCT for our profession. Don't shoot the messengers.
cheers,
Felicity
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