All,
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This study protocol for a trial to examine the efficacy of customised foot orthoses in the treatment of Achilles tendinopathy has just been published:
http://www.jfootankleres.com/content/pdf/1757-1146-2-27.pdf
Now would seem a good time to comment, rather than picking fault with the study when it is completed!
Anyone see any problems with this?
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Re: foot orthoses study protocol
Starter for ten; wot no heel lift?
Also, I'm just trying to think of the last time I had a patient with achilles tendinopathy where I used a medial heel skive...
Although the authors are suggesting using two different thickness of polyprop for shell material based on body mass, this doesn't get around variation in the load-deformation characteristics of the foot orthoses that will inevitably be present in the study group. That is due to the unique nature of the foot orthoses surface topography, the load-deformation of the foot orthoses will also be unique to that device. Since foot orthoses are basically inert devices, they can only ever exert a direct kinetic effect on the foot. If foot orthoses "work" by altering the kinetics of the foot, then these load-deformation characteristics should be uniform across all of the study devices, otherwise we are effectively giving all of the participants in this group a "different dose" of orthoses reaction forces. Kind of like doing a drug trial and giving each subject a different dose of the drug. -
A heel lift has to be part of protocol - its always part of mine!! Bizarre.
I have used a heel skive with achilles tendonopathy but the medially deviated axis "type" of foot is not often the sort of foot that presents to me with achilles tendonopathy. You?
Are you suggesting that truth be told that in a study (or real world) all devices should be individually "calibrated"?
This is though far better - to critique the design prior rather than retrospectively. -
I'm saying that if the effect of foot orthoses is via kinetic means, if we want to compare like with like with need to control the load-deformation characteristics of the orthoses within trials or use single case designs, because IMHO at the moment the trials being published are fundamentally flawed due to this problem. It gets worse as obviously one of the other major characteristics of foot orthoses that is likely to influence the kinetics is the 3-dimensional surface geometry at the foot-orthosis interface. Once again, when custom devices are employed, these are all different; so once again everyone in the study group is getting something different.
Lets say we wanted to test the effects of drug X against a placebo in the treatment of achilles tendinopathy, would you give everyone in the drug group a different, unknown dose of the drug? Some people might get toxic levels while others might receive only homeopathic levels, but we have no way of knowing who received what level of the drug, just that all got "some". No, I wouldn't design a drug trial in this way- would you? So why are we doing this in orthoses research? At best, the current way of designing trials tests only the prescription protocol, not the devices per se.
You almost need to do a couple of hundred single subject design studies and then some kind of meta-analysis on the data. Craig and I started to speak about this at the PFOLA conference a couple of years ago, I'm not sure I'm any closer to the answers, but this problem keeps on bugging me. -
In regards to heel lifts, I generally hand out a heel lift at the first visit for my patients with Achilles tendinitis and if I make an orthosis I will more commonly put in a heel lift than a medial heel skive into the orthosis. Of course, a 4 mm medial heel skive is a form of heel lift so maybe it will have a similar effect?? -
The root of the problem is the way in which we view levels of evidence and trying to apply "the gold standard" randomised placebo controlled trial to foot orthoses research. -
I totally agree. Certainly a paper that describes the inherent limitations of doing high evidence level foot orthosis research is badly needed within the peer-reviewed podiatric literature since there are many that believe that custom foot orthoses are just the same as non-custom foot orthoses. Of course, the insurance companies and governmental health bean-counters would love nothing more than to stop paying for any custom foot orthoses due to the perceived lack of high evidence level research that custom foot orthosis work better than non-custom foot orthoses.
Hopefully this research by Shannon Munteanu and company will help to support our combined clinical experience that custom foot orthoses have much greater potential to heal chronic foot and lower extremity injuries than do non-custom orthoses. -
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I agree with all of the limitations that are mentioned above, but in fairness, they have made the effort to make the devices more custom than any other study that I have seen...
If they have a pronated FPI, they get the medial heel skive, if neutral it is a basic shell, and if a supinated FPI they get a device to control supination as described in Josh Burns paper...
The devices are made at a laboratory from slipper casts, so should be close to what many Podiatrists would prescribe... well at least closer than other studies that suggest they are investigating custom foot orthosis efficacy.
For the record, I often use a medial heel skive of some description with achilles tendonosis patients.
As for a heel lift- not always. If I get a good response from from low- dye strapping, and there is no limitation in dorsiflexion, I would tend not to use a heel raise unless acutely inflamed. -
However, this thread has raised some issues that the researchers are going to have to address if the research is going to be any use to us as clinicians.
As it appears most of us tend to use heel raises in those with achilles tendonitis, are we going to believe the results of the study if they did not use them? Are those with tight calf muscles not going to respond to the foot orthotic, if a heel rasie was not used? Will this affect the overall outcomes?
In my limited understanding of random trials, is that both groups should be treated exactly the same with the only difference being in the thing that is being researched, so this issue of a heel raise may not be important as I guess we assume that the number of short calf muscles is the same in each group.
I do have an issue with the use of a medial heel skive in all those in the study with a pronated foot. Who actually does that in clinical practice? I only use them in a pronated foot if the pronatory forces are high and i don't use them in a pronated foot when those forces are low. Will that affect the results of the study? Will that affect our intrepretion of the results?
Who uses foot orthotics in everyone with achilles tendonitis? All those that meet the criteria for the study are getting foot orthotics. I am much more selective as to who gets foot orthotics. Are you going to accept the results of this study if they do not get a result?
I am pretty sure that the researchers will be somewhat dissmissive of these clinicians concerns, but how can they expect us to take the results seriously, let alone use them in our practice if they do not get addressed? -
Hi all, here's my two cents worth if anyone is interested
Much kudos needs to be given to those involved in the design and implementation of this study. Moreover, I think it is fantastic that they have published this protocol for public comment.
As for the prescription variables..... In my opinion they are doing the right thing by giving foot orthoses to everyone who meets the critieria for inclusion in the study. As yet (to my knowledge) there is no evidence to suggest that people with an ankle equinus (or any foot type for that matter) will, or will not respond to foot orthoses therapy. BUT, this study may infact give us answers in this regard. I'm sure the authors have included a subset of anthropometric measures (age, height, weight, FPI, joint ROM etc) that they will be able to use to help determine why certain people in the study improve with foot orthses and why other participants may not. Giving the potential for an algorithm to determine who will be of benefit from foot orthoses in the treatment of Achilles tendonopathy. This would be similar to that of the paper by Natalie Collins, whereby she was able to predict subsets of the population that respond best to foot orthoses in the treatment of PFPS. For example they may be able to say that a particular foot type will respond favourably, or by age, gender, ankle ROM, duration of disease etc etc... the list goes on.
You have to start somewhere if we want our profession to gain scientific evidence for our clinical reasoning. Whether this study gives us answers that we want to hear or not, it needs to be done. Otherwise we'll be thrown in the quackery basket with with chiropractors and homeopaths. The basic science and methodology of their project is excellent, I wish them good luck.
Cheers -
Could you point me in the direction of this article please?
Ian -
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cheers -
Oh you meant the work by Bill Vicenzino and colleagues - sorry I got confused when you referred to Natalie Collins paper. Thanks for clarifying.
Ian -
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http://books.google.com/books?id=oq...age&q=pharmacokinetics in drug trials&f=false
Scroll down to p.268-269 and replace the word "pharmacokinetics" with "kinetics" and "pharmacological" with "physiological" and we won't be a million miles away from what I think is required. -
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