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in this study ESWT got "elbowed" out

Posted by elliott on 9/11/02 at 21:43 (095083)

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12188483&dopt=Abstract

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Re: note: the above is the correct post to read

elliott on 9/11/02 at 21:54 (095092)

The one below somehow has my post title with Dr. Ed's post, and if you try to reply to the post below, your post will get sucked into a black hole (the long thread on the Foot Surgery board). Scott R?

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Re: in this study ESWT got "elbowed" out

Ed Davis, DPM on 9/11/02 at 21:58 (095093)

Interesting. I was suspecting that the advantage would go to injections at the 6 week mark but the 3 month figures are surprising.

I have a feeling that the one variable that may change things is 'chronicity.' Chronicity begets scar tissue and decreased tissue quality, better addressed by ESWT while 'cortisone' via its anti-inflammatory properties has the advantage in more acute situations.
Ed

Re: and then there's ones like this that make you wonder

elliott on 9/12/02 at 15:45 (095165)

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11869669&dopt=Abstract

--------------

Re: and then there's ones like this that make you wonder

Gunther v. D. on 9/13/02 at 01:59 (095215)

Now I really have to comment to the quoted study analysis. I know both Investigators (Rompe and Haake) and have studied both protocols. To make it bold: It is inadaequate scientific work to pool data from studies with different study protocols (You wouldn't want to pool high- and low energy ESWT data either). The major difference between the Rompe and Haake protocol is that Haake applied local anesthesia prior to the treatment. New studies show that local anesthesia is counterproductive to the benefit of ESWT with LOW energy ESWT. Haake did already report (ISMST June, 2002) the results about his PF study, again 3x low e. ESWT, again anesthesia, again no diff between sham- and treat group.

Re: and then there's ones like this that make you wonder

Pauline on 9/13/02 at 08:24 (095221)

I think Dr. Zingas would agree with you. I think it would be interesting
to see the individual test site results. From my personal discussions with Dr. Zingas he did not see significant differences in the patients he treated during the FDA Dornier trials.

Re: and then there's ones like this that make you wonder

Ed Davis, DPM on 9/13/02 at 18:37 (095284)

Why would local anesthesia be counterproductive to the benefit of ESWT?
Ed

Re: and then there's ones like this that make you wonder

Dr. Z on 9/13/02 at 18:47 (095286)

The reason local anethesia would be counter produtive to low energy ESWT is due to the reliance of patients feed back with low energy eswt

Re: and then there's ones like this that make you wonder

Dr. Z on 9/13/02 at 18:51 (095289)

The individual test sites wouldn't have anything else to add. If the final results were excellent what would the individual sites show.

Pauline are you saying that Dr. Zingas told you about the FDA studies results before they were submitted to the FDA?

Re: and then there's ones like this that make you wonder

Pauline on 9/13/02 at 19:42 (095293)

Dr. Z,

'A double-blind test is a control group test where neither the evaluator nor the subject knows which items are controls'.

He conducted a double-blind study.

Re: and then there's ones like this that make you wonder

Dr. Z on 9/14/02 at 10:24 (095313)

Its actually a double blind randanized study that was used. I don't understand what this has to do with reporting individual sites and not just as a whole. I am sure if one site is so far off there were be further investigation.

Re: and then there's ones like this that make you wonder

Pauline on 9/14/02 at 10:54 (095315)

Dr.Z,
You indicated that Dr. Weil ran or is running FDA studies for the Orbie. Do you think he knows the results of 'his' study based on the facts his patients are telling him.

The goal is approval with good follow up results. If their are more high than low results does Dornier or the FDA really care? Their goal has been achieved.

Does an Olympic ice skater care that she received a low score from one judge if she still places first?

Re: and then there's ones like this that make you wonder

Dr. Z on 9/14/02 at 11:59 (095322)

Not sure what you mean. All Studies are based on what the patient tells the doctor. I have alot of information about the dornier and their FDA study . There were no poor results with the dornier study/ FDA
And yes good experienced follow up is very important with any FDA study. That is why the FDA should review the protocol. the treatment site and the information given to them from the treatment site.

The anatomy with the Olympic ice skater is not the same with the Dornier. There were no poor results recorded. I am not sure if this is true with the ossatron FDA study. I do know that the Roles/ Maundsely scoring was much higher with the dornier then the ossatron.

Re: and then there's ones like this that make you wonder

Ed Davis, DPM on 9/14/02 at 12:02 (095323)

Thanks Dr. Z -- I overlooked the fact that they were referring specifically to low energy ESWT.
Ed

Re: and then there's ones like this that make you wonder

Pauline on 9/14/02 at 12:53 (095325)

I think your hooked on numbers. If your results are telling and showing you great results you have nothing to be concerned about. Now if the results your having differ significantly then I'd call the FDA and question the study results.

How many of your patients outside those posting here on heelspurs have asked you about Dornier,Ossatron or the Big 'O's' Vas score or the Roles/Maundsely scoring before they proceeded with the treatment?

My guess is that most don't know such things exist. Their main concern is their personal result following their ESWT treatment.

This might be a good question for Jay Leno's 'Man on the Street' segment.
Wouldn't it be interesting to know America's answers to: What is a VAS score?, and Who are Roles & Maundsely? :*)

Re: and then there's ones like this that make you wonder

Sunny Jacob, Bayshore on 9/15/02 at 08:02 (095354)

'the reason local anesthesia would be counter productive to low energy ESWT is due to the reliance of patient's feedback during treatment with low energy ESWT':
I partially agree with your above comments.
1. Low energy ESWT does not require anesthesia.
2. Patient feed back during application is necessary with the initial shocks in order to be able to lock the transducer in place with the help of the in-line ultrasound. Even without anesthesia, using low energy ESWT, numbness will occur after a few minutes at the treatment area. Focus can be maintained even without the patient's directions because the ultrasound image with the cross line (on the screen) ensures that the shock waves are applied within the 5 mm pain point. It is known that the treatment area has a radius of 5 mm surrounding the focal (pain) point for effective shock wave application.

When treating with EPOS where no patient feedback is available (due to local anesthesia) and, as you say, not required, - how can the operator be sure that the shock wave is applied correctly at the pain point? Also, some patients have more than one pain point.

Re: and then there's ones like this that make you wonder

Dr. Z on 9/15/02 at 08:47 (095356)

Before you numb the foot with a local anesthetic you are determining the areas where the pain is with palpation which is patient feed back. The area is mark and then the foot is numbed. The ultrasound will provide positoin and keep position So patient feedback is before the local is given

Re: and then there's ones like this that make you wonder

Sunny Jacob, Bayshore on 9/15/02 at 09:18 (095357)

Now you have cleared my point. In either case, patient feed back is absolutely necessary.
The key differences of the equipments are:
1) Anesthesia:
Ossatron: yes
Dornier Epos in U.S.A.: no
Siemens Sonocur Plus: no
2) Sessions:
Ossatron: single
Dornier Epos in U.S.A.: single
Siemens Sonocur Plus: multiple, usually 3 sessions
3) Ultrasound imaging:
Ossatron: none
Dornier Epos in U.S.A.: out-line
Siemens Sonocur Plus: in-line
4) Energy:
Ossatron: high (definitely high energy)
Dornier Epos in U.S.A.: high energy?
Siemens Sonocur Plus: low (definitely low energy)

Re: and then there's ones like this that make you wonder

Sunny Jacob, Bayshore on 9/15/02 at 09:21 (095359)

Correction to my previous message regarding key differences in equipments.
Dornier Epos in U.S.A.: Anesthesia is yes.
sorry

Re: note: the above is the correct post to read

elliott on 9/11/02 at 21:54 (095092)

The one below somehow has my post title with Dr. Ed's post, and if you try to reply to the post below, your post will get sucked into a black hole (the long thread on the Foot Surgery board). Scott R?

-----

Re: in this study ESWT got "elbowed" out

Ed Davis, DPM on 9/11/02 at 21:58 (095093)

Interesting. I was suspecting that the advantage would go to injections at the 6 week mark but the 3 month figures are surprising.

I have a feeling that the one variable that may change things is 'chronicity.' Chronicity begets scar tissue and decreased tissue quality, better addressed by ESWT while 'cortisone' via its anti-inflammatory properties has the advantage in more acute situations.
Ed

Re: and then there's ones like this that make you wonder

elliott on 9/12/02 at 15:45 (095165)

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11869669&dopt=Abstract

--------------

Re: and then there's ones like this that make you wonder

Gunther v. D. on 9/13/02 at 01:59 (095215)

Now I really have to comment to the quoted study analysis. I know both Investigators (Rompe and Haake) and have studied both protocols. To make it bold: It is inadaequate scientific work to pool data from studies with different study protocols (You wouldn't want to pool high- and low energy ESWT data either). The major difference between the Rompe and Haake protocol is that Haake applied local anesthesia prior to the treatment. New studies show that local anesthesia is counterproductive to the benefit of ESWT with LOW energy ESWT. Haake did already report (ISMST June, 2002) the results about his PF study, again 3x low e. ESWT, again anesthesia, again no diff between sham- and treat group.

Re: and then there's ones like this that make you wonder

Pauline on 9/13/02 at 08:24 (095221)

I think Dr. Zingas would agree with you. I think it would be interesting
to see the individual test site results. From my personal discussions with Dr. Zingas he did not see significant differences in the patients he treated during the FDA Dornier trials.

Re: and then there's ones like this that make you wonder

Ed Davis, DPM on 9/13/02 at 18:37 (095284)

Why would local anesthesia be counterproductive to the benefit of ESWT?
Ed

Re: and then there's ones like this that make you wonder

Dr. Z on 9/13/02 at 18:47 (095286)

The reason local anethesia would be counter produtive to low energy ESWT is due to the reliance of patients feed back with low energy eswt

Re: and then there's ones like this that make you wonder

Dr. Z on 9/13/02 at 18:51 (095289)

The individual test sites wouldn't have anything else to add. If the final results were excellent what would the individual sites show.

Pauline are you saying that Dr. Zingas told you about the FDA studies results before they were submitted to the FDA?

Re: and then there's ones like this that make you wonder

Pauline on 9/13/02 at 19:42 (095293)

Dr. Z,

'A double-blind test is a control group test where neither the evaluator nor the subject knows which items are controls'.

He conducted a double-blind study.

Re: and then there's ones like this that make you wonder

Dr. Z on 9/14/02 at 10:24 (095313)

Its actually a double blind randanized study that was used. I don't understand what this has to do with reporting individual sites and not just as a whole. I am sure if one site is so far off there were be further investigation.

Re: and then there's ones like this that make you wonder

Pauline on 9/14/02 at 10:54 (095315)

Dr.Z,
You indicated that Dr. Weil ran or is running FDA studies for the Orbie. Do you think he knows the results of 'his' study based on the facts his patients are telling him.

The goal is approval with good follow up results. If their are more high than low results does Dornier or the FDA really care? Their goal has been achieved.

Does an Olympic ice skater care that she received a low score from one judge if she still places first?

Re: and then there's ones like this that make you wonder

Dr. Z on 9/14/02 at 11:59 (095322)

Not sure what you mean. All Studies are based on what the patient tells the doctor. I have alot of information about the dornier and their FDA study . There were no poor results with the dornier study/ FDA
And yes good experienced follow up is very important with any FDA study. That is why the FDA should review the protocol. the treatment site and the information given to them from the treatment site.

The anatomy with the Olympic ice skater is not the same with the Dornier. There were no poor results recorded. I am not sure if this is true with the ossatron FDA study. I do know that the Roles/ Maundsely scoring was much higher with the dornier then the ossatron.

Re: and then there's ones like this that make you wonder

Ed Davis, DPM on 9/14/02 at 12:02 (095323)

Thanks Dr. Z -- I overlooked the fact that they were referring specifically to low energy ESWT.
Ed

Re: and then there's ones like this that make you wonder

Pauline on 9/14/02 at 12:53 (095325)

I think your hooked on numbers. If your results are telling and showing you great results you have nothing to be concerned about. Now if the results your having differ significantly then I'd call the FDA and question the study results.

How many of your patients outside those posting here on heelspurs have asked you about Dornier,Ossatron or the Big 'O's' Vas score or the Roles/Maundsely scoring before they proceeded with the treatment?

My guess is that most don't know such things exist. Their main concern is their personal result following their ESWT treatment.

This might be a good question for Jay Leno's 'Man on the Street' segment.
Wouldn't it be interesting to know America's answers to: What is a VAS score?, and Who are Roles & Maundsely? :*)

Re: and then there's ones like this that make you wonder

Sunny Jacob, Bayshore on 9/15/02 at 08:02 (095354)

'the reason local anesthesia would be counter productive to low energy ESWT is due to the reliance of patient's feedback during treatment with low energy ESWT':
I partially agree with your above comments.
1. Low energy ESWT does not require anesthesia.
2. Patient feed back during application is necessary with the initial shocks in order to be able to lock the transducer in place with the help of the in-line ultrasound. Even without anesthesia, using low energy ESWT, numbness will occur after a few minutes at the treatment area. Focus can be maintained even without the patient's directions because the ultrasound image with the cross line (on the screen) ensures that the shock waves are applied within the 5 mm pain point. It is known that the treatment area has a radius of 5 mm surrounding the focal (pain) point for effective shock wave application.

When treating with EPOS where no patient feedback is available (due to local anesthesia) and, as you say, not required, - how can the operator be sure that the shock wave is applied correctly at the pain point? Also, some patients have more than one pain point.

Re: and then there's ones like this that make you wonder

Dr. Z on 9/15/02 at 08:47 (095356)

Before you numb the foot with a local anesthetic you are determining the areas where the pain is with palpation which is patient feed back. The area is mark and then the foot is numbed. The ultrasound will provide positoin and keep position So patient feedback is before the local is given

Re: and then there's ones like this that make you wonder

Sunny Jacob, Bayshore on 9/15/02 at 09:18 (095357)

Now you have cleared my point. In either case, patient feed back is absolutely necessary.
The key differences of the equipments are:
1) Anesthesia:
Ossatron: yes
Dornier Epos in U.S.A.: no
Siemens Sonocur Plus: no
2) Sessions:
Ossatron: single
Dornier Epos in U.S.A.: single
Siemens Sonocur Plus: multiple, usually 3 sessions
3) Ultrasound imaging:
Ossatron: none
Dornier Epos in U.S.A.: out-line
Siemens Sonocur Plus: in-line
4) Energy:
Ossatron: high (definitely high energy)
Dornier Epos in U.S.A.: high energy?
Siemens Sonocur Plus: low (definitely low energy)

Re: and then there's ones like this that make you wonder

Sunny Jacob, Bayshore on 9/15/02 at 09:21 (095359)

Correction to my previous message regarding key differences in equipments.
Dornier Epos in U.S.A.: Anesthesia is yes.
sorry