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This could be interesting.

Posted by Dr. Z on 3/14/04 at 01:34 (146918)

Elliott/Pauline, everyone
I have tried to obtain the PMA studies for ESWL. At that time ESWL would be a class three device. I would like to see exactly what the double blind studies were like and if they were similiar to the ESWT FDA studies that were done today. I have searched the FDA site, no luck. Any idea on how to obtain them.? Maybe too long ago.
Here we would have a NEW shockwave technology pma submission and we would be able to see exactly how it became the gold standard over time.
I would think that the study had to be a double blind,randonized multicenter just like the ESWT studies were? Not sure.

Re: This could be interesting.

Scott D. on 3/14/04 at 13:26 (146946)

Dr. Z:

The original PMA for the HM3 was #P840008 and was approved on 2/5/86. Hope this helps.

Scott

Re: This could be interesting.

Dr. Z on 3/14/04 at 13:49 (146950)

Thanks,

Would you please repeat to me the protocol that was used for your tennis elbow. If you would rather use my e-mail it is (email removed)

Re: This could be interesting.

Scott D. on 3/14/04 at 15:08 (146958)

Dr. Z:

As you know, that was a treatment we performed on myself. It was not at all a scientific arrival at a dosage nor a protocol. It simply worked in one isolated instance. It was also discussed in a private forum and I would prefer to keep it that way.

Scott

Re: This could be interesting.

Ed Davis, DPM on 3/14/04 at 17:19 (146969)

Scott:
There is quite a bit of tennis elbow experience with the Sonocur. Dornier has variable power output so it may be helpful to try to duplicate some of those protocols. Call David Lowy of Sonorex Treatment Center in Vancouver, BC (he posts here occasionally). As you probably realize, the high success rates for tennis elbow (lateral epicondylitis) do not translate to golf elbow (medial epicondylitis)-- sorry golfers...
Ed

Re: This could be interesting.

Ed Davis, DPM on 3/14/04 at 18:26 (146994)

David:
Give David Lowy a call on this.
Ed

Re: This could be interesting.

Dr. Z on 3/14/04 at 18:33 (146998)

Thanks. I am looking for a high energy protocol that is either one or at the most two sessions. Any help???

Re: This could be interesting.

Ed Davis, DPM on 3/14/04 at 18:44 (147000)

Hmm. The Dornier with its variable output would denfinitely need to be used at a smaller focus and lower energy when one considers the size of the lateral epicondyle. I have a bit of difficulty envisioning use of the Ossatron but it is being used for lateral epicondylitis. If someone does not have an existing protocol, this may take some 'pioneering' and be looking at something basically 'in between' that which would be accomplished by Ossatron and Sonocur in order to formulate a 'high energy' protocol. Eventually, I could see a formula that takes into account tendon volume, width, thickness, etc (hint for our researchers) --until we get there, one must use good clinical judgement. Yes, there is subjectivity, but, be patient, objectivity will come in time as more infromation exists. I have full confidence in your clinical judgement and feel THAT is why we need people with a good level of clinical experience and judgement doing this procedure.
Ed

Re: This could be interesting.

Dr. Z on 3/14/04 at 18:55 (147001)

Ed,
I think the dornier is the perfect machine to do this so far. I have reviewed a few one treatment protools with high energy that at this time don't make sense to me. The Sonocur or Sonocur plus appears to be a very good machine and protool. The problem is that you are going to have to change the entire model for treatment location.
If there wasn't an FDA and the machines were at a reasonable price we could just use the Canadian model end of story.
E-mail me sometime I will tell you my experience and what I have about the development of ESWT protocols.
There is a Dornier FDA elbow and shoulder study going on but when it will be completed I have no idea or can I find out

Re: This could be interesting.

Ed Davis, DPM on 3/14/04 at 19:05 (147002)

Dr. Z:
Thanks ahead of time. Can you envision using the Ossatron for lateral epicondylitis? I have some trouble with that. I can only see adding a LOT of water to try to decrease the focal spot, act as a 'damper' and reducing the number of shocks. What do you think?
Ed

Re: This could be interesting.

Dr. Z on 3/14/04 at 19:22 (147007)

Ed,

It is my understanding that the tennis elbow
protocol for the ossatron is the same used for chronic pf.
The adding water would be a very logical approach. I am not sure if that is what they are doing for the ossatron treatment. This is one of the reasons why I keep asking about mj/mm2 for the ossatron. It might help with understanding their treatment protocols.