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Shockwave therapy for Morton's neuroma

Discussion in 'General Issues and Discussion Forum' started by NewsBot, May 19, 2009.

  1. NewsBot

    NewsBot The Admin that posts the news.


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    Extracorporeal Shockwave Therapy for Interdigital Neuroma: A Randomized, Placebo-Controlled, Double-Blind Trial
    Robert Fridman, Jarrett D. Cain, and Lowell Weil, Jr.
    Journal of the American Podiatric Medical Association; Volume 99 Number 3 191-193 2009
  2. Admin2

    Admin2 Administrator Staff Member

  3. Craig Payne

    Craig Payne Moderator

    Let again, JAPMA's review process has let us down.

    I seriously question the role of the ethics committee/institutional review board in permitting this hopelessly underpowered study from proceeding. Its unethical to do a RCT (ie give a placebo intervention) if it is so underpowered, there is no possibility of a result.

    The authors conclusion is not supported by the data.

    The authors analysed the data by looking at the baseline and outcome values in within each group and concluded that there was an improvement in shockwave group and not in the sham group.

    The authors, reviewer and editor need to go back and do RCT's 101 again as that is NOT how you analyse a RCT. For eg see these:
    You have to compare the outcomes BETWEEN the two groups!

    The two groups were different at baseline, so the appropriate statistical technique is ANCOVA. The authors put each subects data in a table in the paper, so I ran that stats test on their data and got a p value of 0.27!! Not even close to showing a difference!

    (not to mention that the gold standard analysis for a RCT is intention to treat anaylsis and they left out the drop outs!)

    Put simply, I serious question how this research was permitted to proceed; why the authors did such a wrong analysis, when the correct analysis does not come close to supporting their conclusion; how it got through the JAPMA review process; and how it got published?
  4. DaVinci

    DaVinci Well-Known Member

    Paynie, thanks for your usual 'on the ball' anaylsis. This kind of poor quaility trial making it through the JAPMA review process is becoming a bit of a problem.
  5. William Fowler

    William Fowler Active Member

    I read this abstract when newsbot first posted it and was impressed with the potential to use shockwave for neuromas. I ordered the full article via our library. I just came back here to look at responses and was quite shocked to read what Craig wrote. I am very grateful for his comments as I am a total newbie when it comes to these issues and would have been totally unaware of them if they were not posted here.
  6. Craig:

    The only way for us to correct this type of problem is to have you write a letter to the editor of JAPMA regarding your concerns. I encourage you to do so.
  7. Craig Payne

    Craig Payne Moderator

    Its in hand and its going to be coming from a lot more people than just me. Its also not the only paper in the same JAPMA issue that is similarly problematic.
  8. Good job Craig. I think that there are simply not very many reviewers for JAPMA that understand these subjects very well. I'm sure your letter will positively affect the future course for our journal.
  9. DaVinci

    DaVinci Well-Known Member

    Isn't it a worry that some will read this paper (or just the abstract) and start using shockwave therapy for neuromas on the basis of the claim by the authors that it works. In reality they showed it was no better than placebo!
  10. stevewells

    stevewells Active Member

    This worries me as a subscriber and associate member of JAPMA - I chose the journal as it has the best broad coverage of subjects for the profession (IMO) - I'm in the UK so cheap it ain't!! - Will reconsider my subscription next year if things don't improve
  11. No scientific journal is perfect, Steve. This is the very nature of published scientific journals.....they area only as good as their contributors and reviewers. I know Lowell Weil, Jr and he is a very bright guy. However, many clinicians, myself included, have had to learn about the intricacies of statistical analysis and research design after we left podiatry school and our residencies. You won't see me arguing with Craig or Simon over statistical analysis.....I just sit on the sidelines on those discussions and try to learn.

    Warren Joseph, the editor of JAPMA, is a good friend of mine and truly has the best interest of the quality of our podiatry journal in mind. I'm sure that Craig's letter to the editor is the best way to stimulate more interest within our colleagues regarding the quality of papers published in JAPMA so that the Journal continues to improve.
  12. stevewells

    stevewells Active Member

    Thanks Kevin - point taken
  13. facfsfapwca

    facfsfapwca Active Member

    We all know tight shoes cause "Morton's Neuroma". We all know cessation (completely for 6 weeks) cures "Morton's Neuroma". If they cheat the pain comes back. Just like relieving stress on Plantar fascia after 6 weeks cures plantar fascitis. We are Doctors we know the cause why do we not treat the cause. Or is banging a person with a kidney machine more profitable less risk and maybe even more fun. Yeah they hurt for a while don't run or wear tight shoes so the symptoms go away for awhile did you really treat the cause when you smacked them with an ultrasound?
  14. moggy

    moggy Active Member

    Hi all
    sorry if this has already been discussed in previous threads but what is the criteria for surgical removal of a neuroma -ie is it based on size or symptoms or level of deformity caused - we were discussing this the other day and I wasn't sure I had always assumed it was related to size and unresponsiveness to injection - can anyone help?
  15. Craig Payne

    Craig Payne Moderator

    The letters to the editor on this paper have appeared in the current JAPMA:Payne, Landorf and Turlik. The authors have responded, acknowledging that they got it wrong.

    There is no explanation of how this got through the JAPMA review process and no explanation of why the editor has not withdrawn the paper from publication. This is a serious matter as the conclusions in the paper were the opposite of what the data said.
  16. Paul Bowles

    Paul Bowles Well-Known Member

    Nice work Craig and Karl.
  17. segregorich

    segregorich Welcome New Poster


    I am a public health statistician and new to this list.

    I read the Fridman article and agree that their analysis was flawed.

    I also read the 3 replies. The authors of the replies considered two
    tests of group differences: a simple test of post-treatment group
    pain score difference and an ANCOVA that tested the post-treatment
    group difference, conditional on the pre-treatment pain scores.

    Both of those tests are legitimate. However, there is a third legitimate
    possibility--a test of the groups-by-time interaction effect. In this case
    that test can be performed by calculating an outcome difference score
    for each patient (post-treatment pain score minus pre-treatment pain
    score) and conducting a t-test on the difference scores. I did that: the
    resulting p-value equaled 0.0763. That is not significant by conventional
    criteria. However, it does suggest that ESWT may deserve additional

    Yes, the authors, reviewers, and editors should have been more
    methodologically savvy. However, when considered as a pilot study,
    I am not ready to discount the Fridman results--more investigation
    is warranted.

    Steve Gregorich
    University of California, San Francisco
  18. NewsBot

    NewsBot The Admin that posts the news.

    Extracorporeal Shockwave Therapy in Patients with Morton's Neuroma
    A Randomized, Placebo-Controlled Trial

    Journal of the American Podiatric Medical Association: March 2016, Vol. 106, No. 2, pp. 93-99.
    Hyun Seok , MD, PhD, Sang-Hyun Kim , MD, PhD, Seung Yeol Lee , MD, Sung Won Park , MD
  19. Craig Payne

    Craig Payne Moderator

    WTF! JAPMA have screwed up yet again. Read all the comments above and then look at this study just published:
    They claimed their study showed shock wave worked.
    They used the same wrong analysis as the first study in this thread (How can JAPMA's review process screw up twice on the same thing?)

    Those with access to the full paper, look at Fig 3(A) - compare the one week and the 4 week outcomes for the shock wave and placebo. Notice they are the same - ie the outcomes between the two groups are no different!!!!!. If they did the proper between groups analysis they would have showed (like the first study in this thread) that shockwave for mortons neuroma does not work.

    They only got a result using the wrong analysis because the baseline score in the neuroma group was higher ... HINT: look at table 3 .... how could the reviewers and editor get this wrong yet again.
  20. Craig Payne

    Craig Payne Moderator


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