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Dornier Epos study (cont.): calling Dr. Z

Posted by elliott on 8/11/02 at 15:20 (092227)

One more question on that study. Do you have the success/improvement rates for the control group (sham ESWT) for the same time periods (12 weeks and one year)? Thanks.

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Re: Dornier Epos study (cont.): calling Dr. Z

Dr. Zuckerman on 8/11/02 at 17:14 (092240)

I don't know if it exists. Pauline told us that she believes that after 12 weeks of waiting in the sham groups they were given the option to switch to treatment. So if this is true they sham data stops at 12 weeks. I don't have any follup up on the sham treatments except from the original FDA study that was on the FDA site. I am sure you can get that data under the freedom of information by writing to the FDA.

Re: Dornier Epos study (cont.): calling Dr. Z

elliott on 8/11/02 at 22:38 (092261)

And what were the results for the sham treatment group at 12 weeks from that original FDA study?

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Re: Dornier Epos study (cont.): calling Dr. Z

Dr. Zuckerman on 8/12/02 at 02:10 (092273)

I have to look it . Somewhere is the 40 percentile.

Re: OK, finally, my long-awaited comments on the Epos study

elliott on 8/12/02 at 09:31 (092281)

Due to Dr. Z's clues (thanks!), a little web sleuthing has finally yielded an abstract of the complete Dornier Epos study, well, at least through 12 weeks. The link below contains several interesting articles on ESWT, in particular the abstract I copied below it, which clearly matches everything Dr. Z said:

http://www.ismst.com/events/berlin_01_abstracts%20-%201.htm

Prospective randomized placebo controlled double blind multicenter study to evaluate safty and efficacy of extracorporeal shockwave therapy (ESWT) in chronic plantar fasciitis
Authors: M. Buch, MD,Orthopaedische Klinik, Kassel; L. Fleming, MD, Emory University, Atlanta, GA; G. Theodore, MD, Massachusetts General, Boston, MA; A. Amendola, MD, Fowler Kennedy Sports Medicine, London, Ontario; C. Bachmann, MD, Germering; C. Zingas, MD, Henry Ford, Detroit, MI
Institution: Orthopaedische Klinik Kassel, Wilhelmshöher Allee 345, 34131 Kassel

Problem:
ESWT has been used since 1995 to treat patients with plantar fasciitis who have failed available conventional therapies. Previous studies for this condition using this therapy conducted in Europe have not been carried out as a placebo controlled study.
Method:
A total of 150 patients met the inclusion/exclusion requirements and were enrolled into this study at 6 sites (76 randomized to the active group, 74 randomized to the sham group). A single treatment was performed (3800 shock waves, 0.36 mJ/mm²) with regional anaesthesia. Ultrasound controlled focussing was performed. The Sham treatment was achieved by the placement of a thin foam cushion on the therapy head preventing the shock waves from being delivered to the patient. Follow up was performed at 3-5 days, 6 weeks, 3 months, 6 months and 12 months post treatment. Sham patients meeting defined criteria were offered an active treatment at 3 months. Primary Efficacy Outcome was the difference between the Active treatment and the Sham treatment in the change from baseline in the VAS score for pain while walking for the first few minutes in the morning through three months post treatment. Primary Safety Evaluation was the number of adverse effects and severity of complications that were related to ESWT as assessed at three months by the investigator. Secondary Efficacy Outcomes included pain evaluation from the AOFAS Ankle-Hindfoot Scale Score, Roles and Maudsley score, the SF-12 score, pain measurement on palpation (point of tenderness) with an algometer, and the ROM Assessment from the AOFAS Ankle-Hindfoot. An independent statistical consultant performed the statistical analysis.
Result:
At 3 months 73 patients in the Active group and 73 patients in the Sham group were available for analysis. Four (4) patients discontinued the study prior to the 3 month follow up visit. The results of the study demonstrate that patients treated with ESWT have statistically and clinically significant improvements in the primary outcome parameter (p=0.01). The Roles and Maudsley score was statistically and clinically significant between treatment groups at 3 months post treatment (p= 0.03). Treatment related side effects are mild and of low incidence and included pain, ecchymosis, and edema.

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So far, so good. We have yet to track down the details of the completed one-year study, and it is here that I just want to issue a few words of caution. The figures that Dr. Z gave for 12 weeks (60% improvement on VAS) exactly matches the figure given in Dr. Zingas' study; see link below:

http://www.aofas.org/00summer/200007130759.asp

Well, Dr. Zingas is clearly part of the larger Dornier study; his name is one of the authors appearing at the top of the Dornier abstract. But his 60% was derived from a grand total of 7 patients (in fact it was 6 out of 7 that reached 60%). It just makes me wonder whether the 60% and 92% were from a much smaller sample (perhaps too small) derived from far fewer sites. I don't think I'm out of line for wondering this. So before we jump to definitive conclusions about the efficacy of ESWT, it is fair to want to know the sample size upon which the conclusions are based. Hopefully we can track this down in time. (Pauline, since Dr. Zingas is in fact part of this study, if you can ask him anything that will shed light on this, we will all benefit.)

That said, there are other completed studies on ESWT, e.g. using the Ossatron. Based on similar criteria (e.g. six months minimum conservative care), those studies seem to show that ESWT has an overall success/improvement rate in the neighborhood of 75% (sometimes higher depending on the definitions used I'll be a little loose with the exact definitions for brevity), but also of note is that the sham-ESWT treatment group consistently seems to get a success/improvement rate in the neighborhood of 50%. Based on this, two points are worth making: The first point is that ESWT is statistically superior to the sham treatment, in fact 50% superior to it (.75/.5 1), no doubt about it (although more conservative care for the non-ESWT group should no doubt close this gap). The second is that a random PF patient who gets ESWT treatment seems to have only a 25% chance (.75 - .25) of actually being cured as a result of the ESWT itself. That, to me, is an eye-opener, a reason to possibly consider conservative options for a longer period of time before getting ESWT.

As an example, in my first link above there is yet another abstract of a double-blind study, 'Shockwave therapy for painful heel spur: results of a prospective randomized double blind study', by Abt, et al in Germany. They gave orthotics to each group but nothing else (go to the link for more details). Here are the results after 48 weeks--almost a year! where Group I (17 patients) is the ESWT group, group II (15 patients) the sham ESWT group (for those not familiar with European journals, they use a comma instead of a decimal point):

Results:
Tolerable puncture pressure at the plantar area applied with a 1 cm2 stamp increased from 116,7/140,3 N (Group I/II) to 223,2/159,3 N after 48 weeks (p = 0,02). Morning pain decreased from 5,7/5,3 down to 0,7/2,2 (p = 0,04). Resting pain showed improvement from 4,6/3 down to 0,7/1,8 (p = 0,02). Painfree barefoot walking for 60 or more minutes was possible for 17,6/13,3 % of group I /II and increased to 64,7/46,7 %. Painfree walking with shoes and orthoses for 60 or more minutes was possible for 58,8/46,7 % of group I/II and improved to 100/86,7%. The mean plantar pressure for the affected side started initially at 13,5/14,2 N/cm2 increasing to 17,7/17 N/cm2 , results for peak pressure were 25,1/28,4 N/cm2 and increased in both groups to 35,3/34,6 N/cm2 . Pressure Time Integral started at 6,4/8,6 Ns/cm2 and showed 7,8/9 Ns/cm2 in the end. Patients reported averaged 1,5/2,9 points at the Score according to Roles and Maudsley (one = painfree, four = same condition as before treatment)

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I was wondering one other thing: who sponsored the study? If it is Dornier, I'll point out that Dr. Ed has reservations about that study which showed over-the-counter inserts to be superior to doctor-presribed orthotics, in part because the study was funded by an OTC insert company, in fact the one whose OTC product was used. This reservation is despite the fact that some very big-name, well-respected orthopedists were part of that study.

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Re: oops! a typo

elliott on 8/12/02 at 09:45 (092282)

That should read .75 - .5 = .25.

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Re: from experience I can say ESWT works!

Shane on 8/12/02 at 12:35 (092292)

I am now about 14 weeks post-ESWT. Although, I am not 100% yet - I can do things now that I haven't for the last 4 1/2 years because of plantar fasciitis. I have dramatically improved over the last month. I am now back to working out on a consistent basis. I can now stand in lines and I am now able to walk for some distance. I would say my overall progress has been 60-70%. I don't really have any bad pain days, except occasionally when I overdo it the day before. I might require an additional treatment to reach 100%, but I highly recommend ESWT. When all conservative methods fail and you've been in quite a bit of pain for awhile ESWT should definately be considered. Maybe some might not respond on the first treatment, but I would certainly give it another try. Good Luck.

Shane

Re: To Elliott OK, finally, my long-awaited comments on the Epos study

Pauline on 8/12/02 at 15:24 (092298)

Elliott,
Glad you were able to substantiate what I posted about Dr. Zingas's involvement in the FDA trials. He submitted more than one abstract for publication. You've posted the earlier one.

Re: Re:I really am confused

Dr. Zuckerman on 8/12/02 at 20:32 (092313)

Elliott,

Do you think that the greater then 60% is from the Dr. Zingas study and not the FDA study.? Is that what you are saying. This was an FDA study. It would be the first six patient FDA study in the history of science.

Now the one year. I really would like to know the number of patients. IF it is at least 75 pateints or even 50 patients then the 92% average reduction in pain is just amazing and proves ESWT is the treatment of choice for chronic insertional pf. Now go dog find me this study I too would like to see more the the summary Thanks for the work I am not sure which amazing me more the epos or elliott's research

Re: Re To Elliott :I really am confused

Pauline on 8/12/02 at 20:57 (092317)

Elliott, I'm emotional and your a dog. I think I came out on top. We're quite the pair. Your almost there though. Your getting hotter, but I got there first. No more hints.

Re: why does everyone always post unnecessary "Re:"s? :-)

elliott on 8/12/02 at 23:43 (092328)

Dr. Z, I'm not claiming the 60% is only from Zingas' study and not the FDA study. I haven't seen the FDA study, nor has just about anyone else visiting these boards; I very much would like to see it and think everyone else is entitled to see it, if for no other reason than to decide for oneself whether to shell out big bucks for the treatment. That's the point of my post. I think you're way overpushing ESWT efficacy on these boards before seeing the full study yourself; I prefer to wait before jumping on the bandwagon. I'm just asking what the sample size was, and observing that the exact same 60% figure you quote was obtained from 6 out of 7 patients in Zingas' study, a study which apparently is part of the FDA study. Whatever you have in your possession (is it from Dornier, by any chance?) seems to be extremely brief on details. I never said even Zingas' study alone had just 6 or 7 to start with; the 6 or 7 is a smaller cell of his study, namely the treatment group that happened to be available for observation.

Yes, I too would like to know the number of patients producing the 92%. I was hoping you could provide the details since you are the one espousing ESWT so strongly; apparently not. I will add, though, that if you got the gist of my last post, based on the other double-blind studies it seems clear that a lot of the observed improvement of those undergoing ESWT is coming from other than ESWT. This is not that surprising, given that conservative success rates are universally accepted to be around 90% given enough time, and just about all of the ESWT studies are setting a minimum of conservative care pre-ESWT of only 6 months, so ESWT is taking some of the credit for those who would be getting better in time anyway through rest or other means. I hope you are not too emotional about this issue to acknowledge that.

As far as 92% proving that ESWT is the treatment of choice for chronic insertional PF, I don't know--it's starting to look like Dr. Kiper's silicone orthotics are. :-)

A dog goes and fetches without thinking. I try to think first. But then again, being a dog is not so bad; every dog has its day.

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Re: why does everyone always post unnecessary "Re:"s? :-)

Dr. Zuckerman on 8/13/02 at 06:26 (092337)

What is the abstract that you are quoting from . Isn't that the FDA study.
Sure looks,smells, and tastes like the study cause it is the abstract with the total amount of patients ( 150 ) involved. That showed a result of over 60%. So keep looking cause you are going to find the 92% reduction in pain is the one year follow up from the treated group.

There are alot of factors beside the time frame involved with healing.. Every treatment has other factors involved in the sucess rate including rest,

Concerning conservative treatment yes it is accepted that if works in maybe 90% of the time if treated early . I don't think that given enough time is a proven part of the equation. Early treatment is.

I don't mind discussing any topic always have and always will. You have to admit that your and now elliott speaks gives the impression that the 60% may have come from 6-7 patients. that you are talking about and not the 150 that the FDA is talking about

Re: To Elliott

Pauline on 8/13/02 at 08:44 (092348)

Elliott.
This is a recent publication that in it's entirety may or may not contradict the abstract your seeking. J.Rompe I believe has been saying this for quite a while. I don't know if it will help with the information that you are seeking, but certainly one worth reading.

Z Orthop Ihre Grenzgeb 2002 May-Jun;140(3):267-74 Related Articles, Books, LinkOut

[Musculoskeletal shock wave therapy - current database of clinical research]

[Article in German]

Rompe JD, Buch M, Gerdesmeyer L, Haake M, Loew M, Maier M, Heine J.

Orthopadische Universitatsklinik Mainz.

During the past decade application of extracorporal shock waves became an established procedure for the treatment of various musculoskeletal diseases in Germany. Upt to now the positive results of prospective randomised controlled trials have been published for the treatment of plantar fasciitis, lateral elbow epicondylitis (tennis elbow), and of calcifying tendinitis of the rotator cuff. Most recently, contradicting results of prospective randomised placebo-controlled trials with adequate sample size calculation have been reported. The goal of this review is to present information about the current cinical database on extracorporeal shock wave tratement (ESWT).

Re: Re

elliott on 8/13/02 at 09:40 (092352)

Hate those 'Re:'s. :-)

The abstract of the 150 patients I dug up does not give any specific improvement rates at all; only the abstract of Zingas' smaller study does. I for one have never seen any details of the FDA study, so how do I know if it included the entire 150 or only some subset? It's funny that *I* have to keep looking to find out what's really going on (I don't even have PF, at least I don't think I do). I would have thought that *you* would have had the details in your hand since you keep quoting improvement rates and are a doc using the Dornier Epos machine.

I'll reiterate that studies seem to be consistently showing that around 50% of the control group (getting sham ESWT) is also getting much improved. They had PF for at least 6 months, same as the ESWT treatment group. The control group were not caught very early either, but they still got better. Either that's some placebo effect, or a large percentage is getting better without ESWT; ergo, some getting ESWT and reporting they're better a year later could be getting better just like the control group and not from ESWT, thereby inflating ESWT efficacy. Can you acknowledge that or not? A study of those who have had PF for a minimum of a few years and tried just about the full gamut of conservative treatment should make clearer the true efficacy and value of ESWT.

I am not suggesting the improvement rates are based on 6 or 7 people. I am saying I haven't seen otherwise, and you are not being clear enough on where the figures you quote are coming from. I would not put it past a company with a great financial interest at stake to distort the true figures in their favor or to slyly represent a small segment of an FDA study as the entire study. But I am not passing judgment at all. I just want to see the complete FDA study, both at 3 months and at one year. You are the logical one to have it. You don't.

Can I ask again: what source revealed to you that the final improvement rates were 92%?

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Re: Re

Dr. Zuckerman on 8/13/02 at 11:42 (092362)

I have the FDA twelve week study. It states the abstract results.(>60%) Just like the abstract that you have been quoting. The one year is a contining evaluation of decrease pain from the orginal FDA study. The 92% is an abstract graphic presentation that I have from dornier. Did you know that ossatron results were around 90% after a one year follow. This was also in a summary form if I recall.

I have used ESWT on many patients that have had pf for years. The results have been excellent. The role of placebo with any treatment and time is always a factor that we can't really evaluate completely.

There is one study just presented that listed one thousand patients with a follow I believe Dr. Odgen presented this paper in Europe just this month.

You are going to find ESWT result alot better then you think. The real problem is the cost and the lack of willingness for insurance companies to pay for ESWT. The story of lets see the facts is just a stall by the insurance companies.

Re: Re

dave r on 8/13/02 at 11:47 (092363)

Doctor Z. If an insurance company request information on eswt would giving them a copy of the study be effective?

Re: To Dr. Z

Pauline on 8/13/02 at 11:54 (092365)

Rompe is the expert. I don't think he'd use a submitted paper to promote a book he wrote, but you could ask him. His paper probably would speak to your question. You'd have to read it to find out. From this abstract I gather he is discussing the many different European Studies that were done. From the list of machines he sent me before he had access to and ran tests on machines from all the major manufacturers.

I don't believe any one paticular manufacturer funded this particular piece of research, nor any of his research as far as I can tell.

If the FDA required a particular company to run a year long test as it did with Ossatron doesn't the company foot the bill regardless of the results?
I think the same would be true with the Dornier machine if they were required to run a year long study.

Personally I feel what ever the results show in efficacy for any ESWT machine it's still far better to try ESWT before having P.F. surgery.

Although costly, I view it as a chance to avoid surgery and any conservative treatment is worth a try.

Re: did you notice...

elliott on 8/13/02 at 21:02 (092400)

that M. Buch is a co-author both of this and the 150-study?

Anyone here read German and subscribe to Z Orthop Ihre Grenzgeb? :-)

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Re: FDA study

elliott on 8/13/02 at 21:39 (092406)

Dr. Z, I take it the 12-week FDA study in your possession is more than just a few sentences long and hopefully contains some useful information. A few questions:

1. Does the 12-week FDA study you have explicitly say it is on 150 people or are you making that connection?

2. Does the 12-week study state the number of patients in the ESWT treatment group observed to have >60% improvement, and if so, how many?

3. Same question as in 2 but for the control group, i.e., how many were observed to have an improvement not exceeding whatever?

When it comes to other people having an agenda (whether it's to promote a book or orthotics or the view taken by insurance companies or whatever), you give reasons why what they say should be questioned. But when it comes to ESWT, frankly, your posts come off sounding like an ad for it; they really do. I wish you would be cautiously optimistic rather than automatically accepting everything Dornier says or sounding like its rep. No one's saying ESWT is doo-doo. But it is not a crime to be skeptical or at least cautious about accepting the 92% given by Dornier at least until the detailed study is published and analyzed. I don't suppose you could ask Dornier if it's possible to send you the detailed study so you could share it with us? Such an approach would be more cautiously optimistic. Thanks.

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Re: FDA study

Dr. Zuckerman on 8/13/02 at 22:12 (092410)

Ok here goes again.
Its the same as the abstract that you just postered but I will answer this again

1. Yes
2. It is over 60% of the treated patients ( 75 patients) rated the result as excellent or very good. No patient needed or wanted any additional treatment.
3. I believe it was 43%

I don't mind you questioning me or any other treatment on this board.
I still stand by the 92% reduction in pain after one year. It is reasonable and very similiar to the ossatron study.

Here is how I look at this. Patient is in alot of F@@##$ pain. They have tried everything under the sun. They now have the choice surgery or ESWT.
What would you do?I would have the ESWT.

I don't believe I can have the study until they publish it. When I get it I will be very happy to discuss this with you.

The only things I question is from my own personal experience. I have the experience to say that the 92% is something that is quite reasonable in my eyes.

Re: FDA study

elliott on 8/14/02 at 08:17 (092426)

4. Just to clarify: what are you saying is the same as the abstract I postered? The 150 abstract I postered doesn't state an improvement rate. The Zingas sub-study states an improvement rate but is based on a much smaller sample.

Yet more questions (here we go again):

5. Is the abstract in your possession composed by the FDA, by Dornier, or other?

6. Could you answer the first part of my no. 2 question (does the FDA 12-week study in your possession explicitly state the number of patients showing the improvement?) with a yes or no?

7. Are you sure the rest of your answer to number 2 is stated correctly? You say, 'over 60% of the treated patients ( 75 patients) rated the result as excellent or very good. No patient needed or wanted any additional treatment'. Now I'm really confused. I thought it was that just about all treated patients had 60% VAS improvement, not that over 60% of patients had a very good result. And the 'good or excellent' sounds more like a patient self-evaluation than a VAS score. And what did the other 40% want? Please clarify.

6. You believe it was 43%? So that was not in the study in your possession?

Thanks.

Re: I can't get David G's message

Rachel W. on 8/14/02 at 10:36 (092440)

I click on David G's response and all I get is a message from Dr. Z to someone called Elliot.

Re: FDA study

Dr. Zuckerman on 8/14/02 at 15:54 (092486)

The report I have is the one that was reviewed by the FDA. The FDA doesn't do the study the ESWT companies do the study and comply a report under the guildlines that the FDA outlines.
The report viewed the results in a few different way. There was VAS score which is a level of zero to 10. The 60% in the the report that I looking at rated the level of patients satisfaction. In addition there is a VAS show at each time frame. The 43% was a guess . I just didn't remember the exact percentage. I didn't have the report in front of me. When I referred to the abstract I though you were talking about the number of patients . That number is 150. The randonized study was split in half. 75 got the treatment and 75 didn't

What I do know is that every treated pateint at the 12 week mark had at least 50% improvement. At the end of one year the average VAS score was 0.6

So the way I see this is that there were patients in alot of pain with an initial VAS score of 7.7 at the end of one year it went down to 0.6 which is an average reduciton in pain of 92%

Yes there may be placebo's and cross over patients both this is a great result, even it they lost 25 pateints which I have no idea if they did still great result.

I would suggest either contacting the FDA for a transcription of the study and the discussion . This was done with the ossatron. Scan the search engine there is alot of information about the FDA and the ossatron

Re: FDA study

elliott on 8/14/02 at 16:29 (092489)

I'm still confused, and you'll be comforted to hear I'm about to give up.

Wasn't the 150 study done exclusively on the Epos? An excerpt of the 150 study says:

'A total of 150 patients met the inclusion/exclusion requirements and were enrolled into this study at 6 sites (76 randomized to the active group, 74 randomized to the sham group). A single treatment was performed (3800 shock waves, 0.36 mJ/mm²) with regional anaesthesia. Ultrasound controlled focussing was performed.'

You have repeatedly said that only the Epos has inline ultrasound. Is the ultrasound they mention some other kind? What kind of machine is associated with regional anaesthesia, Osssatron or Epos? Zingas was part of that study, and he was using the Epos. Ouch!

I thought the 12-week study you keep quoting from is an Epos study (as was Zingas'); now you're saying it's an Ossatron study?

I don't think this thread had to be as confusing as it is. I just wanted some simple answers. I tried.

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Re: FDA study

Dr. Zuckerman on 8/14/02 at 17:09 (092493)

Epos Epos Epos

What I am saying is that on THIS web site there is a transcription of the FDA study for the ossatron. This was taken directly from the FDA discussion with Healthronics when they submitted their PMA It may or may not help you with their understanding of how the FDA does the evaluation. In addition I am sure there is a transcription available for the Dornier Epos . So search this web site for the ossatron FDA study transcription and contact the FDA for the dornier EPOS.

And I am going to repeat again. The average VAS score was 0.6 after a one year follow of the patients that were treated in the Dornier FDA study.
The initial VAS score was 7.7. That is an average reduction in pain of
92%

That would include placebo's and non-treated to treated cross over patients that decided that they wanted the treatment and didn't get it during the 12 FDA study.

Re: Re To Elliott :I really am confused

john h on 8/16/02 at 19:22 (092694)

Pauline and Elliott! Bonnine & Clyde! Lum and Abner!Mo,Jo, & Curley! I like all of you--

Re: FDA study

john h on 8/16/02 at 19:27 (092695)

Dr. Z you and Elliott seem to have fallen down and can't get up. I am becoming dizzy with all the statistics and data. Both of you have fallen under the spell of Pauline. Stop before it is to late.

Re: Dornier Epos study (cont.): calling Dr. Z

Dr. Zuckerman on 8/11/02 at 17:14 (092240)

I don't know if it exists. Pauline told us that she believes that after 12 weeks of waiting in the sham groups they were given the option to switch to treatment. So if this is true they sham data stops at 12 weeks. I don't have any follup up on the sham treatments except from the original FDA study that was on the FDA site. I am sure you can get that data under the freedom of information by writing to the FDA.

Re: Dornier Epos study (cont.): calling Dr. Z

elliott on 8/11/02 at 22:38 (092261)

And what were the results for the sham treatment group at 12 weeks from that original FDA study?

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Re: Dornier Epos study (cont.): calling Dr. Z

Dr. Zuckerman on 8/12/02 at 02:10 (092273)

I have to look it . Somewhere is the 40 percentile.

Re: OK, finally, my long-awaited comments on the Epos study

elliott on 8/12/02 at 09:31 (092281)

Due to Dr. Z's clues (thanks!), a little web sleuthing has finally yielded an abstract of the complete Dornier Epos study, well, at least through 12 weeks. The link below contains several interesting articles on ESWT, in particular the abstract I copied below it, which clearly matches everything Dr. Z said:

http://www.ismst.com/events/berlin_01_abstracts%20-%201.htm

Prospective randomized placebo controlled double blind multicenter study to evaluate safty and efficacy of extracorporeal shockwave therapy (ESWT) in chronic plantar fasciitis
Authors: M. Buch, MD,Orthopaedische Klinik, Kassel; L. Fleming, MD, Emory University, Atlanta, GA; G. Theodore, MD, Massachusetts General, Boston, MA; A. Amendola, MD, Fowler Kennedy Sports Medicine, London, Ontario; C. Bachmann, MD, Germering; C. Zingas, MD, Henry Ford, Detroit, MI
Institution: Orthopaedische Klinik Kassel, Wilhelmshöher Allee 345, 34131 Kassel

Problem:
ESWT has been used since 1995 to treat patients with plantar fasciitis who have failed available conventional therapies. Previous studies for this condition using this therapy conducted in Europe have not been carried out as a placebo controlled study.
Method:
A total of 150 patients met the inclusion/exclusion requirements and were enrolled into this study at 6 sites (76 randomized to the active group, 74 randomized to the sham group). A single treatment was performed (3800 shock waves, 0.36 mJ/mm²) with regional anaesthesia. Ultrasound controlled focussing was performed. The Sham treatment was achieved by the placement of a thin foam cushion on the therapy head preventing the shock waves from being delivered to the patient. Follow up was performed at 3-5 days, 6 weeks, 3 months, 6 months and 12 months post treatment. Sham patients meeting defined criteria were offered an active treatment at 3 months. Primary Efficacy Outcome was the difference between the Active treatment and the Sham treatment in the change from baseline in the VAS score for pain while walking for the first few minutes in the morning through three months post treatment. Primary Safety Evaluation was the number of adverse effects and severity of complications that were related to ESWT as assessed at three months by the investigator. Secondary Efficacy Outcomes included pain evaluation from the AOFAS Ankle-Hindfoot Scale Score, Roles and Maudsley score, the SF-12 score, pain measurement on palpation (point of tenderness) with an algometer, and the ROM Assessment from the AOFAS Ankle-Hindfoot. An independent statistical consultant performed the statistical analysis.
Result:
At 3 months 73 patients in the Active group and 73 patients in the Sham group were available for analysis. Four (4) patients discontinued the study prior to the 3 month follow up visit. The results of the study demonstrate that patients treated with ESWT have statistically and clinically significant improvements in the primary outcome parameter (p=0.01). The Roles and Maudsley score was statistically and clinically significant between treatment groups at 3 months post treatment (p= 0.03). Treatment related side effects are mild and of low incidence and included pain, ecchymosis, and edema.

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So far, so good. We have yet to track down the details of the completed one-year study, and it is here that I just want to issue a few words of caution. The figures that Dr. Z gave for 12 weeks (60% improvement on VAS) exactly matches the figure given in Dr. Zingas' study; see link below:

http://www.aofas.org/00summer/200007130759.asp

Well, Dr. Zingas is clearly part of the larger Dornier study; his name is one of the authors appearing at the top of the Dornier abstract. But his 60% was derived from a grand total of 7 patients (in fact it was 6 out of 7 that reached 60%). It just makes me wonder whether the 60% and 92% were from a much smaller sample (perhaps too small) derived from far fewer sites. I don't think I'm out of line for wondering this. So before we jump to definitive conclusions about the efficacy of ESWT, it is fair to want to know the sample size upon which the conclusions are based. Hopefully we can track this down in time. (Pauline, since Dr. Zingas is in fact part of this study, if you can ask him anything that will shed light on this, we will all benefit.)

That said, there are other completed studies on ESWT, e.g. using the Ossatron. Based on similar criteria (e.g. six months minimum conservative care), those studies seem to show that ESWT has an overall success/improvement rate in the neighborhood of 75% (sometimes higher depending on the definitions used I'll be a little loose with the exact definitions for brevity), but also of note is that the sham-ESWT treatment group consistently seems to get a success/improvement rate in the neighborhood of 50%. Based on this, two points are worth making: The first point is that ESWT is statistically superior to the sham treatment, in fact 50% superior to it (.75/.5 1), no doubt about it (although more conservative care for the non-ESWT group should no doubt close this gap). The second is that a random PF patient who gets ESWT treatment seems to have only a 25% chance (.75 - .25) of actually being cured as a result of the ESWT itself. That, to me, is an eye-opener, a reason to possibly consider conservative options for a longer period of time before getting ESWT.

As an example, in my first link above there is yet another abstract of a double-blind study, 'Shockwave therapy for painful heel spur: results of a prospective randomized double blind study', by Abt, et al in Germany. They gave orthotics to each group but nothing else (go to the link for more details). Here are the results after 48 weeks--almost a year! where Group I (17 patients) is the ESWT group, group II (15 patients) the sham ESWT group (for those not familiar with European journals, they use a comma instead of a decimal point):

Results:
Tolerable puncture pressure at the plantar area applied with a 1 cm2 stamp increased from 116,7/140,3 N (Group I/II) to 223,2/159,3 N after 48 weeks (p = 0,02). Morning pain decreased from 5,7/5,3 down to 0,7/2,2 (p = 0,04). Resting pain showed improvement from 4,6/3 down to 0,7/1,8 (p = 0,02). Painfree barefoot walking for 60 or more minutes was possible for 17,6/13,3 % of group I /II and increased to 64,7/46,7 %. Painfree walking with shoes and orthoses for 60 or more minutes was possible for 58,8/46,7 % of group I/II and improved to 100/86,7%. The mean plantar pressure for the affected side started initially at 13,5/14,2 N/cm2 increasing to 17,7/17 N/cm2 , results for peak pressure were 25,1/28,4 N/cm2 and increased in both groups to 35,3/34,6 N/cm2 . Pressure Time Integral started at 6,4/8,6 Ns/cm2 and showed 7,8/9 Ns/cm2 in the end. Patients reported averaged 1,5/2,9 points at the Score according to Roles and Maudsley (one = painfree, four = same condition as before treatment)

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I was wondering one other thing: who sponsored the study? If it is Dornier, I'll point out that Dr. Ed has reservations about that study which showed over-the-counter inserts to be superior to doctor-presribed orthotics, in part because the study was funded by an OTC insert company, in fact the one whose OTC product was used. This reservation is despite the fact that some very big-name, well-respected orthopedists were part of that study.

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Re: oops! a typo

elliott on 8/12/02 at 09:45 (092282)

That should read .75 - .5 = .25.

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Re: from experience I can say ESWT works!

Shane on 8/12/02 at 12:35 (092292)

I am now about 14 weeks post-ESWT. Although, I am not 100% yet - I can do things now that I haven't for the last 4 1/2 years because of plantar fasciitis. I have dramatically improved over the last month. I am now back to working out on a consistent basis. I can now stand in lines and I am now able to walk for some distance. I would say my overall progress has been 60-70%. I don't really have any bad pain days, except occasionally when I overdo it the day before. I might require an additional treatment to reach 100%, but I highly recommend ESWT. When all conservative methods fail and you've been in quite a bit of pain for awhile ESWT should definately be considered. Maybe some might not respond on the first treatment, but I would certainly give it another try. Good Luck.

Shane

Re: To Elliott OK, finally, my long-awaited comments on the Epos study

Pauline on 8/12/02 at 15:24 (092298)

Elliott,
Glad you were able to substantiate what I posted about Dr. Zingas's involvement in the FDA trials. He submitted more than one abstract for publication. You've posted the earlier one.

Re: Re:I really am confused

Dr. Zuckerman on 8/12/02 at 20:32 (092313)

Elliott,

Do you think that the greater then 60% is from the Dr. Zingas study and not the FDA study.? Is that what you are saying. This was an FDA study. It would be the first six patient FDA study in the history of science.

Now the one year. I really would like to know the number of patients. IF it is at least 75 pateints or even 50 patients then the 92% average reduction in pain is just amazing and proves ESWT is the treatment of choice for chronic insertional pf. Now go dog find me this study I too would like to see more the the summary Thanks for the work I am not sure which amazing me more the epos or elliott's research

Re: Re To Elliott :I really am confused

Pauline on 8/12/02 at 20:57 (092317)

Elliott, I'm emotional and your a dog. I think I came out on top. We're quite the pair. Your almost there though. Your getting hotter, but I got there first. No more hints.

Re: why does everyone always post unnecessary "Re:"s? :-)

elliott on 8/12/02 at 23:43 (092328)

Dr. Z, I'm not claiming the 60% is only from Zingas' study and not the FDA study. I haven't seen the FDA study, nor has just about anyone else visiting these boards; I very much would like to see it and think everyone else is entitled to see it, if for no other reason than to decide for oneself whether to shell out big bucks for the treatment. That's the point of my post. I think you're way overpushing ESWT efficacy on these boards before seeing the full study yourself; I prefer to wait before jumping on the bandwagon. I'm just asking what the sample size was, and observing that the exact same 60% figure you quote was obtained from 6 out of 7 patients in Zingas' study, a study which apparently is part of the FDA study. Whatever you have in your possession (is it from Dornier, by any chance?) seems to be extremely brief on details. I never said even Zingas' study alone had just 6 or 7 to start with; the 6 or 7 is a smaller cell of his study, namely the treatment group that happened to be available for observation.

Yes, I too would like to know the number of patients producing the 92%. I was hoping you could provide the details since you are the one espousing ESWT so strongly; apparently not. I will add, though, that if you got the gist of my last post, based on the other double-blind studies it seems clear that a lot of the observed improvement of those undergoing ESWT is coming from other than ESWT. This is not that surprising, given that conservative success rates are universally accepted to be around 90% given enough time, and just about all of the ESWT studies are setting a minimum of conservative care pre-ESWT of only 6 months, so ESWT is taking some of the credit for those who would be getting better in time anyway through rest or other means. I hope you are not too emotional about this issue to acknowledge that.

As far as 92% proving that ESWT is the treatment of choice for chronic insertional PF, I don't know--it's starting to look like Dr. Kiper's silicone orthotics are. :-)

A dog goes and fetches without thinking. I try to think first. But then again, being a dog is not so bad; every dog has its day.

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Re: why does everyone always post unnecessary "Re:"s? :-)

Dr. Zuckerman on 8/13/02 at 06:26 (092337)

What is the abstract that you are quoting from . Isn't that the FDA study.
Sure looks,smells, and tastes like the study cause it is the abstract with the total amount of patients ( 150 ) involved. That showed a result of over 60%. So keep looking cause you are going to find the 92% reduction in pain is the one year follow up from the treated group.

There are alot of factors beside the time frame involved with healing.. Every treatment has other factors involved in the sucess rate including rest,

Concerning conservative treatment yes it is accepted that if works in maybe 90% of the time if treated early . I don't think that given enough time is a proven part of the equation. Early treatment is.

I don't mind discussing any topic always have and always will. You have to admit that your and now elliott speaks gives the impression that the 60% may have come from 6-7 patients. that you are talking about and not the 150 that the FDA is talking about

Re: To Elliott

Pauline on 8/13/02 at 08:44 (092348)

Elliott.
This is a recent publication that in it's entirety may or may not contradict the abstract your seeking. J.Rompe I believe has been saying this for quite a while. I don't know if it will help with the information that you are seeking, but certainly one worth reading.

Z Orthop Ihre Grenzgeb 2002 May-Jun;140(3):267-74 Related Articles, Books, LinkOut

[Musculoskeletal shock wave therapy - current database of clinical research]

[Article in German]

Rompe JD, Buch M, Gerdesmeyer L, Haake M, Loew M, Maier M, Heine J.

Orthopadische Universitatsklinik Mainz.

During the past decade application of extracorporal shock waves became an established procedure for the treatment of various musculoskeletal diseases in Germany. Upt to now the positive results of prospective randomised controlled trials have been published for the treatment of plantar fasciitis, lateral elbow epicondylitis (tennis elbow), and of calcifying tendinitis of the rotator cuff. Most recently, contradicting results of prospective randomised placebo-controlled trials with adequate sample size calculation have been reported. The goal of this review is to present information about the current cinical database on extracorporeal shock wave tratement (ESWT).

Re: Re

elliott on 8/13/02 at 09:40 (092352)

Hate those 'Re:'s. :-)

The abstract of the 150 patients I dug up does not give any specific improvement rates at all; only the abstract of Zingas' smaller study does. I for one have never seen any details of the FDA study, so how do I know if it included the entire 150 or only some subset? It's funny that *I* have to keep looking to find out what's really going on (I don't even have PF, at least I don't think I do). I would have thought that *you* would have had the details in your hand since you keep quoting improvement rates and are a doc using the Dornier Epos machine.

I'll reiterate that studies seem to be consistently showing that around 50% of the control group (getting sham ESWT) is also getting much improved. They had PF for at least 6 months, same as the ESWT treatment group. The control group were not caught very early either, but they still got better. Either that's some placebo effect, or a large percentage is getting better without ESWT; ergo, some getting ESWT and reporting they're better a year later could be getting better just like the control group and not from ESWT, thereby inflating ESWT efficacy. Can you acknowledge that or not? A study of those who have had PF for a minimum of a few years and tried just about the full gamut of conservative treatment should make clearer the true efficacy and value of ESWT.

I am not suggesting the improvement rates are based on 6 or 7 people. I am saying I haven't seen otherwise, and you are not being clear enough on where the figures you quote are coming from. I would not put it past a company with a great financial interest at stake to distort the true figures in their favor or to slyly represent a small segment of an FDA study as the entire study. But I am not passing judgment at all. I just want to see the complete FDA study, both at 3 months and at one year. You are the logical one to have it. You don't.

Can I ask again: what source revealed to you that the final improvement rates were 92%?

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Re: Re

Dr. Zuckerman on 8/13/02 at 11:42 (092362)

I have the FDA twelve week study. It states the abstract results.(>60%) Just like the abstract that you have been quoting. The one year is a contining evaluation of decrease pain from the orginal FDA study. The 92% is an abstract graphic presentation that I have from dornier. Did you know that ossatron results were around 90% after a one year follow. This was also in a summary form if I recall.

I have used ESWT on many patients that have had pf for years. The results have been excellent. The role of placebo with any treatment and time is always a factor that we can't really evaluate completely.

There is one study just presented that listed one thousand patients with a follow I believe Dr. Odgen presented this paper in Europe just this month.

You are going to find ESWT result alot better then you think. The real problem is the cost and the lack of willingness for insurance companies to pay for ESWT. The story of lets see the facts is just a stall by the insurance companies.

Re: Re

dave r on 8/13/02 at 11:47 (092363)

Doctor Z. If an insurance company request information on eswt would giving them a copy of the study be effective?

Re: To Dr. Z

Pauline on 8/13/02 at 11:54 (092365)

Rompe is the expert. I don't think he'd use a submitted paper to promote a book he wrote, but you could ask him. His paper probably would speak to your question. You'd have to read it to find out. From this abstract I gather he is discussing the many different European Studies that were done. From the list of machines he sent me before he had access to and ran tests on machines from all the major manufacturers.

I don't believe any one paticular manufacturer funded this particular piece of research, nor any of his research as far as I can tell.

If the FDA required a particular company to run a year long test as it did with Ossatron doesn't the company foot the bill regardless of the results?
I think the same would be true with the Dornier machine if they were required to run a year long study.

Personally I feel what ever the results show in efficacy for any ESWT machine it's still far better to try ESWT before having P.F. surgery.

Although costly, I view it as a chance to avoid surgery and any conservative treatment is worth a try.

Re: did you notice...

elliott on 8/13/02 at 21:02 (092400)

that M. Buch is a co-author both of this and the 150-study?

Anyone here read German and subscribe to Z Orthop Ihre Grenzgeb? :-)

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Re: FDA study

elliott on 8/13/02 at 21:39 (092406)

Dr. Z, I take it the 12-week FDA study in your possession is more than just a few sentences long and hopefully contains some useful information. A few questions:

1. Does the 12-week FDA study you have explicitly say it is on 150 people or are you making that connection?

2. Does the 12-week study state the number of patients in the ESWT treatment group observed to have >60% improvement, and if so, how many?

3. Same question as in 2 but for the control group, i.e., how many were observed to have an improvement not exceeding whatever?

When it comes to other people having an agenda (whether it's to promote a book or orthotics or the view taken by insurance companies or whatever), you give reasons why what they say should be questioned. But when it comes to ESWT, frankly, your posts come off sounding like an ad for it; they really do. I wish you would be cautiously optimistic rather than automatically accepting everything Dornier says or sounding like its rep. No one's saying ESWT is doo-doo. But it is not a crime to be skeptical or at least cautious about accepting the 92% given by Dornier at least until the detailed study is published and analyzed. I don't suppose you could ask Dornier if it's possible to send you the detailed study so you could share it with us? Such an approach would be more cautiously optimistic. Thanks.

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Re: FDA study

Dr. Zuckerman on 8/13/02 at 22:12 (092410)

Ok here goes again.
Its the same as the abstract that you just postered but I will answer this again

1. Yes
2. It is over 60% of the treated patients ( 75 patients) rated the result as excellent or very good. No patient needed or wanted any additional treatment.
3. I believe it was 43%

I don't mind you questioning me or any other treatment on this board.
I still stand by the 92% reduction in pain after one year. It is reasonable and very similiar to the ossatron study.

Here is how I look at this. Patient is in alot of F@@##$ pain. They have tried everything under the sun. They now have the choice surgery or ESWT.
What would you do?I would have the ESWT.

I don't believe I can have the study until they publish it. When I get it I will be very happy to discuss this with you.

The only things I question is from my own personal experience. I have the experience to say that the 92% is something that is quite reasonable in my eyes.

Re: FDA study

elliott on 8/14/02 at 08:17 (092426)

4. Just to clarify: what are you saying is the same as the abstract I postered? The 150 abstract I postered doesn't state an improvement rate. The Zingas sub-study states an improvement rate but is based on a much smaller sample.

Yet more questions (here we go again):

5. Is the abstract in your possession composed by the FDA, by Dornier, or other?

6. Could you answer the first part of my no. 2 question (does the FDA 12-week study in your possession explicitly state the number of patients showing the improvement?) with a yes or no?

7. Are you sure the rest of your answer to number 2 is stated correctly? You say, 'over 60% of the treated patients ( 75 patients) rated the result as excellent or very good. No patient needed or wanted any additional treatment'. Now I'm really confused. I thought it was that just about all treated patients had 60% VAS improvement, not that over 60% of patients had a very good result. And the 'good or excellent' sounds more like a patient self-evaluation than a VAS score. And what did the other 40% want? Please clarify.

6. You believe it was 43%? So that was not in the study in your possession?

Thanks.

Re: I can't get David G's message

Rachel W. on 8/14/02 at 10:36 (092440)

I click on David G's response and all I get is a message from Dr. Z to someone called Elliot.

Re: FDA study

Dr. Zuckerman on 8/14/02 at 15:54 (092486)

The report I have is the one that was reviewed by the FDA. The FDA doesn't do the study the ESWT companies do the study and comply a report under the guildlines that the FDA outlines.
The report viewed the results in a few different way. There was VAS score which is a level of zero to 10. The 60% in the the report that I looking at rated the level of patients satisfaction. In addition there is a VAS show at each time frame. The 43% was a guess . I just didn't remember the exact percentage. I didn't have the report in front of me. When I referred to the abstract I though you were talking about the number of patients . That number is 150. The randonized study was split in half. 75 got the treatment and 75 didn't

What I do know is that every treated pateint at the 12 week mark had at least 50% improvement. At the end of one year the average VAS score was 0.6

So the way I see this is that there were patients in alot of pain with an initial VAS score of 7.7 at the end of one year it went down to 0.6 which is an average reduciton in pain of 92%

Yes there may be placebo's and cross over patients both this is a great result, even it they lost 25 pateints which I have no idea if they did still great result.

I would suggest either contacting the FDA for a transcription of the study and the discussion . This was done with the ossatron. Scan the search engine there is alot of information about the FDA and the ossatron

Re: FDA study

elliott on 8/14/02 at 16:29 (092489)

I'm still confused, and you'll be comforted to hear I'm about to give up.

Wasn't the 150 study done exclusively on the Epos? An excerpt of the 150 study says:

'A total of 150 patients met the inclusion/exclusion requirements and were enrolled into this study at 6 sites (76 randomized to the active group, 74 randomized to the sham group). A single treatment was performed (3800 shock waves, 0.36 mJ/mm²) with regional anaesthesia. Ultrasound controlled focussing was performed.'

You have repeatedly said that only the Epos has inline ultrasound. Is the ultrasound they mention some other kind? What kind of machine is associated with regional anaesthesia, Osssatron or Epos? Zingas was part of that study, and he was using the Epos. Ouch!

I thought the 12-week study you keep quoting from is an Epos study (as was Zingas'); now you're saying it's an Ossatron study?

I don't think this thread had to be as confusing as it is. I just wanted some simple answers. I tried.

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Re: FDA study

Dr. Zuckerman on 8/14/02 at 17:09 (092493)

Epos Epos Epos

What I am saying is that on THIS web site there is a transcription of the FDA study for the ossatron. This was taken directly from the FDA discussion with Healthronics when they submitted their PMA It may or may not help you with their understanding of how the FDA does the evaluation. In addition I am sure there is a transcription available for the Dornier Epos . So search this web site for the ossatron FDA study transcription and contact the FDA for the dornier EPOS.

And I am going to repeat again. The average VAS score was 0.6 after a one year follow of the patients that were treated in the Dornier FDA study.
The initial VAS score was 7.7. That is an average reduction in pain of
92%

That would include placebo's and non-treated to treated cross over patients that decided that they wanted the treatment and didn't get it during the 12 FDA study.

Re: Re To Elliott :I really am confused

john h on 8/16/02 at 19:22 (092694)

Pauline and Elliott! Bonnine & Clyde! Lum and Abner!Mo,Jo, & Curley! I like all of you--

Re: FDA study

john h on 8/16/02 at 19:27 (092695)

Dr. Z you and Elliott seem to have fallen down and can't get up. I am becoming dizzy with all the statistics and data. Both of you have fallen under the spell of Pauline. Stop before it is to late.