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Plantar fasciitis symptoms and two different running shoes

Discussion in 'Biomechanics, Sports and Foot orthoses' started by NewsBot, Jan 6, 2010.

  1. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Examining the degree of pain reduction using a multielement exercise model with a conventional training shoe versus an ultraflexible training shoe for treating plantar fasciitis.
    Ryan M, Fraser S, McDonald K, Taunton J.
    Phys Sportsmed. 2009 Dec;37(4):68-74.
     
  2. Admin2

    Admin2 Administrator Staff Member

  3. Craig Payne

    Craig Payne Moderator

    Articles:
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    I finally had a chance to read the full paper. I see BIG problems with the authors conclusions.

    The way the study is reported does not meet the CONSORT statement for the transparent reporting of clinical trials.

    There was a statistical difference in the duration of symptoms at baseline between the two groups - they should have used an ANCOVA for the analysis and not the 2-way ANOVA that they did use to account for this.

    Two subjects in the Nike free group got worse and were eliminated from the data analysis. The standard way of analysing RCT's is to use 'intention to treat' analysis (as per the CONSORT statement). These subjects data should have been included in the analysis.

    They should have used a validated measure for foot pain (eg FHSQ) and not the oversimplified VAS score.

    I would be surprised if the authors could have made the same conclusion if this study was analysed as per the recommended guidelines (ie CONSORT):
    Can you see how the elimination of the two subjects who got worse from the Nike Free group would have massively biased the results?
     
  4. What is a conventional training shoe?
     
  5. Craig Payne

    Craig Payne Moderator

    Articles:
    6
    In this study it was just the running shoes that the athlete was currently wearing.
     
  6. The shoes they got the injury in.
     
  7. Craig Payne

    Craig Payne Moderator

    Articles:
    6
    Yes.....
     
  8. Craig Payne

    Craig Payne Moderator

    Articles:
    6
    I have been thinking more about this study as it has recently come up in a couple of other threads ….

    Let’s consider a fictitious study:

    Let’s say there was a drug company (eg Nike) that sponsored a trial between their new drug (eg the Nike Free) compared to the standard drug (eg conventional running shoe) in treating a certain disease (eg plantar fasciitis). Let’s say the study found no statistical difference between the two drugs, but decided in the published study to say that there was a trend toward the sponsors (eg Nike) product (eg Nike free) doing better, when in reality a non-statistical difference is a non-statistical difference! However, the reason they got the no-difference results was because two people actually had to withdraw from the study as they got so sick using the sponsors drug (eg the Nike Free), so their data was not included in the published results to make the sponsors product look better. This is contrary to the standard way of reporting clinical trials (see what I posted above). If they had included the outcome data from those two (which is what the guidelines say to do), then the results certainly would have not been a trend towards to sponsors product, but probably a trend against the sponsor product, if not a statistical difference going against the sponsor product.

    As a result of the 'trend', the FDA decided to approve the drug for widespread use of the condition! ... when in reality the new drug (ie Nike Free) was probably worse than the current drug (ie conventional running shoes) in treating the condition (ie plantar fasciitis) (fortunately the FDA are not stupid and this study would not even get past the front door due to the lack of the intention to treat analysis to include the two that dropped out).

    If this was a real drug study and the results were published as above, then this would be a scandal and there would be outrage in the community that they can get away with doing this.

    Could someone who is promoting minimalism explain why there is no outrage about this? Why the blind acceptance of the results?

    The results of this study tell me that runners with plantar fasciitis are better off staying in their conventional running shoe (ie the shoe they actually got the injury in!) than use a minimalist running shoe! - this is the opposite of what the authors claimed! How else should we interpret the results?
     
  9. David Wedemeyer

    David Wedemeyer Well-Known Member

    Excellent analysis Craig. BTW notice what systematic review this study is cited by:

    http://www.ncbi.nlm.nih.gov/pubmed/22389869

    Can anyone think of someone or a couple of people who constantly reference this study by Rasmussen et al which included this study in their review? :rolleyes:
     
  10. toomoon

    toomoon Well-Known Member

    It is interesting is it not Craig.. I just wish there was not so much nonsense from each end of the debate, and from both sides people just looked at the science, and analysed it on its merits or other wise.
    There is no doubt that if that happened, we would move forward faster to develop product that might be better than any of the current footwear..oh well..
     
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