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RCT comparing prefabricated to custom made foot orthoses

Discussion in 'Biomechanics, Sports and Foot orthoses' started by NewsBot, Sep 23, 2006.

  1. NewsBot

    NewsBot The Admin that posts the news.


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    Recently presented at June ACSM mtg in Denver:
    A Randomized Clinical Trial Evaluating the Effectiveness of Prefabricated and Custom Foot Orthoses Regimens Using Functional Outcome Measures
  2. admin

    admin Administrator Staff Member

    OK, new rule: Lets keep discussion in this thread to the above research and leave all the traditional prefab vs custom made stuff to the other threads. Hopefully Andy will be along soon with links to those threads.
    Last edited: Sep 23, 2006
  3. Admin2

    Admin2 Administrator Staff Member

  4. What a woefully designed study. I don'tknow how these studies get off the ground in the first place. Surely somebody pointed out the flaws in the methodology? Moreover, who then decides this is worthy of presentation? Too much of this at the moment, at best it is misleading.
  5. davidh

    davidh Podiatry Arena Veteran


    I actually agree with Simon!


  6. DaVinci

    DaVinci Well-Known Member

    Simon, I get the bit about the sample size probably being small, but they still got a statistically significant result, so do not quite understand that. Can you elaborate? Thanks
  7. Simon,

    I really think we need to not be so critical about research such as this. Let's give these authors a break since it was not a published study, instead it was presented at the ACSM meeting as a lecture. The study size was small, but the results seem consistent with what I see clinically in treating many foot and lower extremity injuries with foot orthoses of all types: customized pre-fab orthosis do quite well short term at treating many foot and lower extremity injuries.

    I use pre-fab orthoses every day in my practice and customize them for the patient, using the same mechanical principles I use for presription casted foot orthoses. However, since this study does not say anything about long term effects of customized pre-fab orthoses, we can only use it as evidence of short-term effects of orthoses. I believe where custom casted foot orthoses clearly show their superiority to customized pre-fab devices is in their long term clinical efficacy, their long term cost-effectiveness and their nearly unlimited potential for prescription variation to fit the patient's specific biomechanical and shoe style requirements.
    Last edited: Sep 24, 2006
  8. Not sure why you don't understand how they can "get a significant result" just because sample size is small? "Getting a significant result" does not mean the sample size is adequate. Without disrespect to anyone, this statement by DaVinci speaks volumes regarding the general confusion about statistics and research methods I meet among the majority of colleagues. This is why I believe that such critique by those with a greater understanding of research and statistical methods on forums such as this are important. Whether this was published or disseminated at conference is perhaps irrelevant to the moot point. How many people attended the conference and walked away with the opinion that what the researchers were saying was fact? Ultimately, how many people will be mislead on the basis of this under-powered, poorly designed study? Anyway, sample size is only one aspect of the methodological weakness here.

    Lets take the opening statement:
    "Foot orthoses are common interventions that are often intended to increase performance, reduce deformity, and improve pathology. Although prefabricated foot orthoses (PFO) are less expensive and more readily available than custom foot orthoses (CFO), the latter are more customizable. Which intervention provides superior functional outcomes is unclear."

    So if we forget the first two statements which are themselves contentious and focus on the final line which sets out the authors aim for the study: that is to determine which intervention (prefabricated or custom orthoses) provides superior functional outcomes.

    They take 19 subjects from somewhere unknown, by methods undisclosed, with a variety of unknown conditions and split them into two groups:
    "Subjects with lower extremity overuse injuries were randomized to receive either PFO’s (n = 9) or CFO’s (n = 10),"

    So from this we have no idea which conditions were being treated by which type of orthoses or their frequency within each group. So the preform group could have consisted of nine people with plantar-fasciitis, while the custom group could have been made up of ten subjects each with different pathologies. For example: trochanteric bursitis, illio-tibial band friction syndrome, osteoarthritic pain in the knee, chondromalacia patella, patella tendonitis, medial tibial stress syndrome, Achilles tendonosis, Sinus tarsi syndrome, Peroneal tendonitis or any other combination of the multitude of pathologies which may classified as "lower extremity overuse injuries"

    What if all the subjects in the PFO group were female and all in the CFO group men?

    What if all the subjects in the PFO group were aged 18-25 years and all in the CFO group were aged 65-75 years?

    So we have a potential problem with the subject groups here- we may not be comparing like with like. But here's the real kicker:

    " in combination with out patient physical therapy interventions as required."

    So they wanted "to determine which intervention (prefabricated or custom orthoses) provides superior functional outcomes", but they are also giving the patients physio as required. This clouds the issue and the ability for the researchers to determine which effects are attributable to the foot orthoses and which are due to the physio.

    Now lets assume that "out-patient physical therapy interventions are not the same for all "lower-extremity over-use injuries; that the outcomes obtained by physio's applying their techniques to this wide variety of pathologies is not the same for all pathologies; that the same physio-therapist did not administer said treatments; that some of the subjects received this treatment while others did not; that some subjects received one physio session, while other received multiple treatments etc etc. There then exists a massive potential for drawing the wrong conclusions and you start to see big problems in the methodology. It could just be that the information posted is insufficient for a reasonable critique of the methods, but when the layman reads this.....

    To be fair to the researchers they do conclude
    "Prefabricated foot orthoses, in conjunction with outpatient physical therapy interventions".

    But hey, I'd love to ask them a one word question: Sure? :rolleyes:
  9. Simon:

    Good points. I guess I just figured that they didn't list all their methodology in their abstract for brevities sake. If they don't list it, do we know they did it incorrectly or should we assume they did it correctly? I don't get too excited about research by just reading abstracts. Abstracts just gives me an idea of whether I want or need to read the full paper or not.
  10. We just don't know and that is the key. But they do make clear conclusions here. Researchers should be mindful of the fact that most will only ever see the abstract.
  11. Good point again, Dr. Spooner. Yes, we have seen other studies lately on customized pre-fab orthoses that were listed in the abstract as only being "pre-fab" orthoses. The lesson is that we should read the whole paper before we jump to too many conclusions.
  12. Agreed. Moreover, we should ensure we obtain and maintain the skills required for critical engagement with the literature.
  13. Something more for me to do in my old age, Dr. Spooner? ;)
  14. Dieter Fellner

    Dieter Fellner Well-Known Member


    On the topic of engaging research literature can you recommend reader friendly articles / texts which might be suitable specifically for the Podiatrist? I am thinking here in particular about a cohort of practitioners who wish to apply critical evaluation in their everyday work, but do not have the benefit of PhD education to drive their curiosity.
  15. Dieter and all,
    The series of articles published by Trisha Greenhalgh in the BMJ are an excellent free resource:

  16. Dieter Fellner

    Dieter Fellner Well-Known Member


    Thank you for the link. I believe I have a copy of her book - must dust it off and take another look.

    I bet someone, somewhere has constructed a 'dummy's guide' to interpreting research findings - this would be ideal for the busy clinician.

    I was reminded of this by Simon's systematic deconstruction of the above research.There are specific, key points to look at whenever a research paper appears and usually it is possible to establish in about 1 minute just how robust is the methodology, etc.

    Can someone perhaps recommend similar for statistical analysis?
  17. P OMalley

    P OMalley Member

    Some useful research papers

    I have found the following JAPMA papers quite useful in the past

    Redmond A. C., Keenan AM, (2002) Understanding Statistics Putting P-Values into Perspective, J Am Podiatr Med Assoc 92(5): 297-305

    Redmond A. C., Keenan AM, Landorf K, (2002) ‘Horses for Courses’: The Differences Between Quantitative and Qualitative Approaches to Research, J Am Podiatr Med Assoc 92(3): 159-169

    Keenan AM, Redmond A. C (2002) Integrating Research Into the Clinic. What Evidence Based Practice Means to the Practising Podiatrist, J Am Podiatr Med Assoc 92(2): 115-122

    Hope they help :cool:

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