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Effectiveness of Foot Orthoses to Treat Plantar Fasciitis

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

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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 Russell

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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.

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.

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Sincerely,

Kevin

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Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College

e-mail: kevinakirby@comcast.net

Private Practice:
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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. The research question was essentially is there a difference in clinical outcomes between custom made and prefabrication foot orthoses and are they better than placebo/sham foot orthoses for plantar fasciitis. The methodology was designed to answer that question. Thas not really an issue as the subjects all gave informed consent prior to the study and were well aware that they could be in the placebo/sham group. However, they were not really left to hobble for 12 months as the results showed that by 12 months those in the placebo/sham group caught up to the orthoses groups in pain reduction ... this shows that the natural history of plantar fasciitis is to get better. One of the really impressive aspects of the methodology of this study was the lengths the investigators went to, to ensure the methodology was sound. All participants had a cast taken, so as far they were concerned they could be getting custom made orthoses. One of the issues the investigators faced was which prefab to use and which custom made prescription to use? They did the right thing and surveyed the profession to decide which was the most common prefab used and which was the most common prescription protocol used for the custom made (they have previously published this survey: link). Based on that they used Formthotics as the prefab and the modified Root type custom made, casted using the technique that loads the 4th and 5th met head with STJ in neutral and the orthoses manufatucred to hold the foot in NCSP (as this is what the survey said is the most common prefab and the most comon prescription protocol for custom made). The casts were taken by an experienced podiatrist and one of the biggest orthotic labs in Australia (TOL) made them out of 4mm polypro. Thats not an issue --- it was a pragmatic RCT. No other treatments were offered by the researchers, BUT in reality some participants might take some drugs for it, some may stretch etc etc, BUT, that does not matters as participants were randomised to each group and the assumption is that equal numbers of participants randomised to each group would, for eg, start stretching (much research elsewhere supports this assumption as being correct). I would disagree, the study has determined exactly that and when combined with previous meta-analyses, the evidence is getting stronger (eg this one). I could not agree more. I have emailed Chris Mac (PFOLA President) about this as there is a big role here for them. BUT, we can not dismiss the accumulating evidence and 3rd party funders do have a role to get best "bang for the buck".

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.

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Craig Payne
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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 !!

Thanks for the clarification Craig.

Look forward to the author's comments.

Regards,
davidh

I was making the point that this study related only to one condition - plantar fasciitis - and not to any other condition that can be succesfully treated by foot orthoses. Is it your contention that outcomes for all foot problems treated by foot orthoses fall withn the findings of this study?

Mark Russell

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no....

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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

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This is why I mentioned PFOLA above --- professional bodies have a responsibility to ensure the appropriate intrepretation in the appropriate context, while at the same time avoiding being tagged by the 3rd party funders as having vested financial interests. Two of the three authors of the above paper are podiatrists and while I can not speak for them, I assume they would have been just as happy with the results if custom made came out better - they had no vested interest -- they simply started with a research question and no biases. ..... which is how research should be done.

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".

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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: It was done clinically. We have done several plantar fasciitis studies now and rely on a clinical inclusion criteria, with a long list of things to check for to exclude it. It was based on the results of the survey as what was most commonly used. You and I may disagree with the prescription protocol used in the study, but in fairness to the authors, they picked the most commonly used one at the time. There were no plantar fascial accommodations and I do not know what the protocol was for arch fill, except to say that the orthotic lab that makes them, by default, adds way too much plaster, so the assumption could be that the arch profile of the orthoses could have been lower than what most of us would now use.

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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.

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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Congratulations to the authors. However, sounds like their placebo devices, weren't really placebo's at all. Did they perform any studies to assess the kinematic / kinetic effects of these placebo's to ensure they were "inert'?
I suspect not, therefore what the study really did was to compare three different kinds of fooot orthoses.

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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?

Nice idea, but rarely true. We all have inherant bias. To say that the researchers have no biases is to say that they have no ideas and no point of view, pretty much an impossibility.

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"My mission drive is to open up my eyes, 'cause the wicked lies and all the sh!te you say..." http://www.youtube.com/watch?v=V4NW5S1UTPQ

"Science is the antidote to the poison of enthusiasm and superstition."

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.

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A Tale of Two Orthotic Studies

It was the best of times....

...it was the worst of times:

Apologies to Dickens, and equal congratulations to Josh and Karl.

Cheers,

Hylton

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.

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Who? What? When? Why? Yeah? And? So? What?

"My mission drive is to open up my eyes, 'cause the wicked lies and all the sh!te you say..." http://www.youtube.com/watch?v=V4NW5S1UTPQ

"Science is the antidote to the poison of enthusiasm and superstition."

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!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! !!!!!

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Who? What? When? Why? Yeah? And? So? What?

"My mission drive is to open up my eyes, 'cause the wicked lies and all the sh!te you say..." http://www.youtube.com/watch?v=V4NW5S1UTPQ

"Science is the antidote to the poison of enthusiasm and superstition."

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.

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Who? What? When? Why? Yeah? And? So? What?

"My mission drive is to open up my eyes, 'cause the wicked lies and all the sh!te you say..." http://www.youtube.com/watch?v=V4NW5S1UTPQ

"Science is the antidote to the poison of enthusiasm and superstition."

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.

__________________
Who? What? When? Why? Yeah? And? So? What?

"My mission drive is to open up my eyes, 'cause the wicked lies and all the sh!te you say..." http://www.youtube.com/watch?v=V4NW5S1UTPQ

"Science is the antidote to the poison of enthusiasm and superstition."

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.

__________________
Sincerely,

Kevin

**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College

e-mail: kevinakirby@comcast.net

Private Practice:
107 Scripps Drive, Suite 200
Sacramento, CA 95825 USA
My location

Voice: (916) 925-8111 Fax: (916) 925-8136
**************************************************

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