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ESWT Comparison Study

Posted by Sunny Jacob - Bayshore on 4/29/02 at 20:32 (081673)

The heelspurs message board has created a lively discussion about various therapy protocols, types of equipment available on the market, treatment outcome and experience of patients. Advice to PF patients by highly experienced podiatric doctors like Dr. Zuckerman, Dr. Cozzarelli and others, is of great value. Scott has to be congratulated for the vision of creating this discussion medium through his heelspurs.com website.

Without any doubt, all present ESWT equipment manufacturers are highly reputable and internationally known. However, their sales and marketing approach may vary from country to country. In general, any new medical equipment manufacturer's clinical experience(not technical) may be limited. They have to gather clinical data from numerous reliable sources in the field. This can be expensive and takes years.
A new treatment centre usually tries to treat patients with a basic treatment protocol provided by the manufacturer which often can be basic and limited.
All ESWT equipments perform the functions they claim to do.
What a good provider or clinic tries to achieve from their experience, observations and research, is continuous improvement of the procedure in order to achieve better outcome for the patient. Therefore, clinical experience of the provider and of course how you deal with each patient on an individual basis, is extremely important for the treatment outcome. I am certain Dr. Zuckerman and other professionals who participate in these discussions may agree with me.
Another important factor is patient compliance. From time to time we do get young athletes who expect an instant cure. They want to be on the field the day after the treatment session. As a provider one can only explain the consequences.

To our knowledge, to date there are no published comparative studies available on treating tendinopathy using high/low energy with single/multiple sessions. Present evidence in this area is limited to individual providers' and manufacturers' claims.
Therefore, in February of this year Bayshore has started a random access double blind study on this subject. We have the infrastructure to do this and we do not endorse any specific manufacturer.

Re: ESWT Comparison Study

Pauline on 4/29/02 at 22:01 (081693)

Your double blind study on this subject is very interesting, because I believe postings on this board did indicate that such comparative studies existed and that multiple treatments using low energy was by far the treatment of choice.

I think all of us will be very interested in your findings. Please post them when your studies are complete.

Re: ESWT Comparison Study

Dr. Zuckerman on 4/30/02 at 11:19 (081768)

Hi

Why do you think dornier went the high energy one treatment route in the USA . I was very impressed with the VAS scores after one year. The study
showed a VAS score of 0.6% in 92% of the cases. I have received the summary of these results and I am still waiting for the complete study information. This is very impressive

I am looking forward to any and all studies I can get my hands on . Thanks for sharing your information from Bayshore ESWT Clinics

Re: ESWT Comparison Study

Pauline on 4/30/02 at 15:37 (081823)

Mr. Jacob,
I remember a post where ESWT was being used in the U.S. to treat neuromas
though there were no studies conducted anywhere or indications that it should be used for treating neuromas. Do you use ESWT to treat neruomas at Bayshore?

What limits are you held to in Canada for how and what you use ESWT to treat?

Re: Neuromas, etc.

Sunny Jacob - Bayshore on 4/30/02 at 19:23 (081859)

1. At present in the U.S. FDA has approved ESWT only for the treatment of PF, not neuromas; the ESWT equipments approved for the therapy in U.S. are Ossatron and Dornier.
2. We do not treat neuromas at Bayshore and are not aware of any studies using ESWT to treat neuromas.
3. Your question is not quite clear to me, but I hope the following may be the answer you are looking for:
In Canada, the Health Protection Branch (HPB) is the equivalent to FDA in the United States. Medical devices (such as ESWT equipment) and their use come under the Therapeutic Protection Programme (TPP) of HPB. Here, ESWT is approved for various tendinopathies as in Germany, Austria, Switzerland.

Re: Neuromas, etc.

DR Zuckerman on 4/30/02 at 19:30 (081861)

There was a paper by Dr. Weil on the treatment of neuroma's with ESWT. I have had personal communications with him on this subject. It could show pormise in the future

Re: ESWT Comparison Study

Sunny Jacob - Bayshore on 4/30/02 at 19:31 (081862)

Bayshore primarily follows the European method of multiple treatments which is based on most of the published studies.
However, we are not aware of any double blind study (as you have indicated) that compares high vs. low energy equipment as well as single and multiple treatment sessions.

Re: ESWT Comparison Study

Sunny Jacob - Bayshore on 4/30/02 at 19:40 (081864)

a) Re your question why Dornier went the 'high energy' single treatment route in USA: I suppose the only reason is pure peer pressure as far as marketing is concerned. FDA approved Ossatron for single treatment. If one introduced another equipment on the market that requires more than three times the effective treatment time (multi session), - who will capture the market?
b) We are always willing to share our experience with other clinics. This information exchange will ultimately benefit the patients.

Re: Neuromas, etc.

Pauline on 4/30/02 at 19:48 (081865)

Did he publish?

Re: Neuromas, etc.

Pauline on 4/30/02 at 20:04 (081868)

Sunny,
Basically you follow the protocols set up by your Therapeutic Protection
Programme very similar to what is done in the U.S. There have been no European studies done or U.S. studies that use ESWT to treat Neuromas.

Re: ESWT Comparison Study

lisa k on 5/01/02 at 10:05 (081944)

in st louis missouri usa -protocal r wants to use is 1500 one time only claims 80percent sucess for pf/match your info?it is fda approved machine

Re: ESWT Comparison Study

BrianG on 5/02/02 at 21:28 (082224)

Hi Lisa k,

I had the FDA approved protocol, at 3,800 pulses (Dornier). Which machine are they using in St. Louis? 1,500 sounds like a low energy treatment, but I am not a professional. I was led to believe that only the OssaTron and the Dornier are approved for PF treatment in the US. Both are using the high energy protocol.

BrianG

Re: ESWT Comparison Study

DR Zuckerman on 5/02/02 at 21:35 (082225)

The ossatron is 1500 @18kv. I have no idea what the mj/mm2 are at the F2
They don't tell you but my guess is somewhere over 0.28mg/mm2

Re: ESWT Comparison Study

Pauline on 4/29/02 at 22:01 (081693)

Your double blind study on this subject is very interesting, because I believe postings on this board did indicate that such comparative studies existed and that multiple treatments using low energy was by far the treatment of choice.

I think all of us will be very interested in your findings. Please post them when your studies are complete.

Re: ESWT Comparison Study

Dr. Zuckerman on 4/30/02 at 11:19 (081768)

Hi

Why do you think dornier went the high energy one treatment route in the USA . I was very impressed with the VAS scores after one year. The study
showed a VAS score of 0.6% in 92% of the cases. I have received the summary of these results and I am still waiting for the complete study information. This is very impressive

I am looking forward to any and all studies I can get my hands on . Thanks for sharing your information from Bayshore ESWT Clinics

Re: ESWT Comparison Study

Pauline on 4/30/02 at 15:37 (081823)

Mr. Jacob,
I remember a post where ESWT was being used in the U.S. to treat neuromas
though there were no studies conducted anywhere or indications that it should be used for treating neuromas. Do you use ESWT to treat neruomas at Bayshore?

What limits are you held to in Canada for how and what you use ESWT to treat?

Re: Neuromas, etc.

Sunny Jacob - Bayshore on 4/30/02 at 19:23 (081859)

1. At present in the U.S. FDA has approved ESWT only for the treatment of PF, not neuromas; the ESWT equipments approved for the therapy in U.S. are Ossatron and Dornier.
2. We do not treat neuromas at Bayshore and are not aware of any studies using ESWT to treat neuromas.
3. Your question is not quite clear to me, but I hope the following may be the answer you are looking for:
In Canada, the Health Protection Branch (HPB) is the equivalent to FDA in the United States. Medical devices (such as ESWT equipment) and their use come under the Therapeutic Protection Programme (TPP) of HPB. Here, ESWT is approved for various tendinopathies as in Germany, Austria, Switzerland.

Re: Neuromas, etc.

DR Zuckerman on 4/30/02 at 19:30 (081861)

There was a paper by Dr. Weil on the treatment of neuroma's with ESWT. I have had personal communications with him on this subject. It could show pormise in the future

Re: ESWT Comparison Study

Sunny Jacob - Bayshore on 4/30/02 at 19:31 (081862)

Bayshore primarily follows the European method of multiple treatments which is based on most of the published studies.
However, we are not aware of any double blind study (as you have indicated) that compares high vs. low energy equipment as well as single and multiple treatment sessions.

Re: ESWT Comparison Study

Sunny Jacob - Bayshore on 4/30/02 at 19:40 (081864)

a) Re your question why Dornier went the 'high energy' single treatment route in USA: I suppose the only reason is pure peer pressure as far as marketing is concerned. FDA approved Ossatron for single treatment. If one introduced another equipment on the market that requires more than three times the effective treatment time (multi session), - who will capture the market?
b) We are always willing to share our experience with other clinics. This information exchange will ultimately benefit the patients.

Re: Neuromas, etc.

Pauline on 4/30/02 at 19:48 (081865)

Did he publish?

Re: Neuromas, etc.

Pauline on 4/30/02 at 20:04 (081868)

Sunny,
Basically you follow the protocols set up by your Therapeutic Protection
Programme very similar to what is done in the U.S. There have been no European studies done or U.S. studies that use ESWT to treat Neuromas.

Re: ESWT Comparison Study

lisa k on 5/01/02 at 10:05 (081944)

in st louis missouri usa -protocal r wants to use is 1500 one time only claims 80percent sucess for pf/match your info?it is fda approved machine

Re: ESWT Comparison Study

BrianG on 5/02/02 at 21:28 (082224)

Hi Lisa k,

I had the FDA approved protocol, at 3,800 pulses (Dornier). Which machine are they using in St. Louis? 1,500 sounds like a low energy treatment, but I am not a professional. I was led to believe that only the OssaTron and the Dornier are approved for PF treatment in the US. Both are using the high energy protocol.

BrianG

Re: ESWT Comparison Study

DR Zuckerman on 5/02/02 at 21:35 (082225)

The ossatron is 1500 @18kv. I have no idea what the mj/mm2 are at the F2
They don't tell you but my guess is somewhere over 0.28mg/mm2