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Dornier vs OssaTron

Posted by elvis on 3/10/05 at 14:17 (170886)

1. Could someone please explain the conclusions of Haake et al:

http://bmj.bmjjournals.com/cgi/content/abstract/327/7406/75?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=shock+wave&andorexactfulltext=and&searchid=1110482019598_20667&stored_search=&FIRSTINDEX=0&sortspec=relevance&resourcetype=1

2. Could someone please explain if the protocol used by Haake et al is the same protocol currently being used by practioners using the Dornier Epos Ultra in the US today. From reading the banter back and forth between the various authors (see link below in #6) it appears tha tthe Haake et al protocol used a 'low energy' (whatever that means) dose while Theodore et al use a much higher dose and presumably the dornier machine got FDA approval using the 'high energy' dose described in Theodore et al.

3. Are the Haake et al team funded by the OssaTron company?

4. Could someone explain the results of the OssaTron reported on their website and does it show superiority of Ossatron over Dornier?

http://www.hmt-ag.ch/ww/en/pub/news/statement_of_hmt_to_article_.htm

5. Ogden et al, who were funded by HealthTronics, the maker of the Ossatron machine, seem to indicate that electrohydraulic high energy shock wave therapy is effective for chronic ESWT.

http://www.ejbjs.org/cgi/content/abstract/86/10/2216

I see some differnces in success of Phase I vs Phase 2 especially at the 3 month reporting preiod for Phase 2.

6. Now here's the clinicians arguing with each other over the various papers, protocols, conclusions, etc balh, blah, blah. Ogden vs Rompe vs Buchbinder. It seems to me that all of these arguments are apples vs oranges comparisons that are difficult to come to a reasoanble conclusions on. I must say it is very suspect for initial data and conclusions to be changed upon further review of the data especially when the initial data says points to no activity of the treatment. Any comment on this?

http://www.ejbjs.org/cgi/eletters/86/10/2216#777

7. Am I correst in concluding that the 2 major differences between OssaTron and Dornier are:

(1) the method of producing the sound waves (OssaTron - electrohydraulic vs Dornier - electromagnetic) and

(2) deliver of shock wave (OssaTron - bottom of foot vs Dornier - from side of foot)

Anybody here think these 2 differerences matter?

8. I guess this is the justification that the insurnace companies use in declining coverage for this 'controversial' treatment. Can't say that I blame them.

What a mess, huh?

Re: Dornier vs OssaTron

Rob M on 3/10/05 at 15:06 (170891)

Dear Elvis

I can't answer your questions, but there is excellent discussion of the study further down the first page you quote.

As for the differences between the major equipment manufacturers, I suspect that they are minor compared to therapist skill, knowledge and experience.

Re: Dornier vs OssaTron

Fed Up Also on 3/10/05 at 15:30 (170897)

Basically, I think this is where the doctors are getting their stats for their web sites.

Of the 272 individuals that participated in the study, 94% (256 patients) had some results... HOWEVER, of these 256 patient (94%), 137 patients were given a placebo and also had positive results.

Of the group using the actual therapy, 34% saw a positive result or success rate and the group given the placebo saw a 30% success rate.

So, of the total that participated, 94% completed the study and had some results, 34% of those using the machine and 30% on placebo.

The Conclusion, Extracorporeal shock wave therapy is ineffective in the treatment of chronic plantar fasciitis.

Re: Post card recieved today

Fed Up Also on 3/10/05 at 15:54 (170898)

I received a post card today from Excellent Shock Wave Therapy' with a picute of a beautiful women on the front and the caption 'Remember life Before Pain?'

On the back it states 94% success rate, well, I called the 800 number and inquired about the 94% success rate. No one there was able to state where the figures came from, how there were achieved and what the success rate was (i.e. completed cure, somewhat cured, a little cured, etc.), go figure........94% from the study, 94% on the card.......

Anyway, if you have question that they may (or may not) be able to answer here is the number, 1-800-382-9029

Re: Post card recieved today

elvis on 3/10/05 at 16:17 (170900)

thanx Elliott! LOL

Re: Post card recieved today

Dr. Zuckerman on 3/10/05 at 16:49 (170903)

Call Dr. Z at '-856-848-3338 . I will answer any questions that you may have.

Re: Post card recieved today

Fed Up Also on 3/10/05 at 17:33 (170905)

Dr. Z., aren't you and Denise Ashcraft owner of ESWT business partners?

Dr. David Zuckerman says his business partnership with Denise Ashcraft originated 'through a fluke.'

Hired by the Woodbury podiatrist to get his computers on target, Ashcraft came up with the idea for an equipment provider for physicians who practice ESWT, or Extra-Corporeal Shock Wave Therapy, an 18-minute non-surgical procedure that enables them to cure chronic heel pain without the risk of surgery and long recovery periods.


Wouldn't this fall under somewhat of a 'kick-back', he sents the cards and directs them to you for treatment.

I'll ask again, where does the 94% success rate come from? says Zuckerman. 'Ultrasound has increased the success rate to 94 percent from 80.'

Re: Post card recieved today ScottR

Dr. Zuckerman on 3/10/05 at 18:36 (170906)

The 94% comes from the one year follow up Dornier FDA PMA study that has been published in Foot and Ankle International. The author is Dr. Christopher Zingas
In answer to your kickback question. The answer is no.

Re: Dornier vs OssaTron

elvis on 3/10/05 at 18:48 (170907)

I just read the full text of the Haake et al article. It is a low energy ESWT protocol. My orthopedic doctor and chiropractor have told me that the low energy ESWT doesn't work. Here's the dose given in Haake et al:

'Extracorporeal shock wave therapy comprised 4000 impulses of a positive energy flux density (0.08 mJ/mm2) under local anaesthesia with 2 ml mepi-vacaine 1%. Therapy was applied every two weeks plus or minus two days (3 x 4000 impulses).... The total positive dose was 0.96 J/mm2, the energy flux density was 0.22 mJ/mm2, and the positive pressure was 13.7 MPa.'

I didn't know that the full text paper was available on-line. Sorry for causing even more confusion.

Re: Post card recieved today ScottR

Fed Up Also on 3/10/05 at 20:07 (170910)

Isn't Dr. Zingas also part of your group, Excellent Shock Wave Therapy and United?

Re: Post card recieved today ScottR

Dr. Z on 3/10/05 at 20:14 (170912)

Yes he is a part of Excellence Shockwave Therapy Group. He joined our group years later. He is one of the top foot and ankle orthopedic surgeons in the USA.

Re: Dornier vs OssaTron

Scott R on 3/10/05 at 22:26 (170921)

Hey Fed Up, your numbers don't make any sense. How does a 34% and a 30% combine to give a 94%?

Re: Dornier vs OssaTron

elvis on 3/10/05 at 22:29 (170922)

Dude.....Did you take a stupid pill today? The article you quote from which I posted a link to earlier related to low energy ESWT. That author at that time didn't see a positive effect from low energy ESWT. Other studies have been published showing a positive effect from low energy ESWT. Most of the discussions on this website have dealt with high energy ESWT. It's really too bad that ESWT didn't work for you. If you didn't know it there are no guarantees in medicine. Did you get a second treatment knucklehead? Did you follow post treatment recommendations? The reason you didn't get a postivie effect is because you spend most of your time with your foot in your mouth!

Re: Haake

elliott on 3/11/05 at 12:28 (170951)

Elvis:

What I found most interesting about the Haake study is that it is the only one at least that I know of where the placebos were kept blinded for a full year. The placebos had a very respectable 76% success rate at one year based exclusively on the same 4-point Roles & Maudsley test being quoted so often. This highlights the dangers of making too much out of a single 12-month success measure for an ESWT treatment group in isolation.

Haake did come up with an interesting and ethical way to keep his subjects blinded for so long. He allowed all patients, both placebo and control, to seek any other conservative treatment within the year. Perhaps the 76% figure would have been lower in a more controlled setting, but one could argue that this setup of allowing other treatments after ESWT is actually more like what goes on in real life. The power of (real-life) ESWT treatment at one year would then be more like the difference between the real-life success rates of the two groups, maybe something on the order of 20%, or 1 in 5 (I think the technical jargon would be that the Number Needed to Treat, or NNT, is 5).

Re: Dornier vs OssaTron

elliott on 3/11/05 at 13:17 (170954)

Elvis:

You asked for comment on one of your links,

http://www.ejbjs.org/cgi/content/abstract/86/10/2216

I'll bet Ossatron has been kicking itself for ever publishing the 81% overall success rate, what with Dornier researchers and providers often highlighting just the 94% figure using 4-point R & M. It seems to me that this latest article by Ossatron's researchers is an attempt to address that.

If you find the abstract difficult to read, I am guessing the article was no better, because as evidenced from their letters, Buchbinder and Rompe had trouble fathoming what it was talking about, in particular whether this was the same group as from the initial FDA study and why the success rates were now suddenly higher than before. Their letters are accessible to all in the links at the bottom. The Ossatron researchers' response, also linked, was, to me at least, rambling and almost unfathomable, but one thing came through from it: apparently, their new success rates are based on just 4-point R & M (surprise). I'm not sure if and how they could have obtained the 4-point R & M at 3 months on the original group since they apparently didn't even use that test at all back then, but if I'm reading it correctly--and given the poor language, don't hold me to it--it appears to me that the one-year success rate for the treatment group using just 4-point R & M comes out to 65/67 = 97%. So, if you're willing to ignore study differences (everyone seems to), 97% may be the correct number to compare to Dornier's 94%. OTOH, I'm guessing that the 97% figure may well include those who had repeat treatments, and that would not be fair to Dornier. (There sure were a lot of groups in Ossatron's study.) They should make things crystal clear, not leave them ambiguous; they could use some writing lessons.

If someone really wants to accurately highlight the one-year 4-point R & M comparison between machines, perhaps contacting the Ossatron authors would reveal the correct figure, if there is one, to compare to Dornier's. That said, I agree with you; I don't like it at all that they seem to be generating new success figures after the fact.

Re: Dornier vs OssaTron

Dr. Zuckerman on 3/11/05 at 13:23 (170956)

Anyone care to comment on the poor results that are included in the Ossatron study.

Re: Dornier vs OssaTron

vince on 3/12/05 at 06:43 (171002)

It is important for you to consider that the problem your having with your right foot may not significantly be traction degeneration of the plantar fascia at the medial tubericle but possibly be complicated by another problem like a Baxter's nerve entrapment? If this exists then you would probably have diminished results no matter what ESWT method was used. A important fact to consider is whether or not you have post kinetic dyskinesia or whether you have pain only following activity.