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Background: We sought to evaluate the safety and effectiveness of extracorporeal shockwave therapy as a therapeutic treatment for destroying Morton’s neuroma.
Methods: Twenty-five patients (25 feet) were included in the study. Indications for participation were more than 8 months of conservative care with a visual analog scale pain score of 4 or greater. The mean overall pain score on a modified visual analog scale was 6.9 preoperatively.
Results: Thirteen patients were randomized to the active group and 12 to the sham group. Two patients in the sham group were lost to follow-up. Post-treatment evaluations were performed at 1, 6, and 12 weeks by a blinded investigator (L.W.). The end point evaluation parameter was the reduction in visual analog scale score. The treatment group showed a significant difference before and after extracorporeal shockwave therapy (P < .0001). The sham group did not have a significant difference after 12 weeks (P = .1218).
Conclusions: Extracorporeal shockwave therapy is a possible alternative to surgical excision for Morton’s neuroma
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:
Quote:
Vickers AJ, Altman DG: Statistics Notes: Analysing controlled trials with baseline and follow up measurements. BMJ 2001, 323(7321):1123-1124.
Twisk J, Proper K: Evaluation of the results of a randomized controlled trial: how to define changes between baseline and follow-up. J Clin Epidemiol 2004, 57(3):223-228.
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?
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
The Following 2 Users Say Thank You to Craig Payne For This Useful Post:
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.
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.
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?
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.
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
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.
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.
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
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.
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.
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
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!
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
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
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.
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
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.
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?
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?
claire
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.
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
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.
Shockwave therapy for Morton's neuroma
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