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Studies supporting Sonocur for the treatment of Plantar Fasciitis

Posted by Steve on 11/09/02 at 00:01 (099654)

I have seen many posts here regarding the Sonocur which I understand has FDA approval for tennis elbow but not plantar fasciitis. Are there any reliable studies that show the Sonocur to be effective for plantar fasciitis?

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/09/02 at 09:36 (099664)

As far as I know, there are no double blind, placebo controlled studies on the effectiveness of the Sonocur for Plantar Fasciitis. In other countries, the Sonocur treatment protocol is three low energy flux density treatments over three weeks. There is significant controversy about whether three low energy flux density treatments are as effective as one high energy flux density treatment.

The Healthtronics Ossatron and the Dornier Epos are the only FDA approved devices for the treatment of PF. Both machines received approval for a single high energy treatment. Both machines deliver comparable energy to the fascia. However, the Ossatron also delivers significant energy to the surrounding bones. There have not been any studies looking at the effects of the Ossatron on the bones of the foot.

If you receive any study references, make sure that the studies have been submitted to peer reviewed journals. There are many sub-par studies that have been published, both for and against ESWT.

The recent JAMA article is an example of an article that would have not been accepted for publication had it been reviewed by experts in the field. Its conclusions are colored by the choice of treatment protocol and the patient inclusion criteria. Likewise, there are many studies showing success that would not have been accepted for publication because of other flaws.

Be diligent and be critical. There are many interested parties and non-scientific articles have either been funded by these parties or have been written by these parties. Unfortunately, it seems all too easy to get these articles published.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Steve on 11/10/02 at 19:12 (099741)

Are there any reliable studies of any kind that support the use of the Sonocur for PF?

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

john h on 11/11/02 at 07:58 (099764)

Steve: it may be self serving but I think Bayshore in Canada has a long history of providing Sonocur treatments and have enough data to be statistically significanct. Check with a search under 'Sunny' and see if he has not put out some data on there results. Dr. Z at one time had a history of results from the Big O posted for all to see. Also check the Bayshore website. From my viewpoint it is not will ESWT help you but which machine might produce the best results. Another significant question is what is the best protocol for any of the machines? Ossataron seems to have only one protocol but Sonocur and Epos have different protocols depending on who and where you are treated..

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Gunther vD on 11/11/02 at 10:04 (099787)

In fact there are:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11886900&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9063856&dopt=Abstract

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/11/02 at 13:27 (099800)

Those studies are for the use of a low energy lithotripter and are not for the use of the Sonocur. Rompe et al did not use a Sonocur so these studies do not support the use of the Sonocur any more than the Healthtronics PMA supports the use of the Dornier Epos. All low energy machines are not equal, they have different focal zones and pressure characteristics. All high energy intensity machines are also not equal for the same reason. It is important that the studies that you read support the machine that you are interested in using!

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Ed Davis, DPM on 11/11/02 at 14:19 (099809)

Bill:

The differences between machines are not sufficiently significant to warrant a separate study for every product. The issue has been low vs. high energy. You are raising the bar now that more evidence of efficacy has been provided. Technical differences in the manner which the modalities are applied are even more important than the issues you have raised.
Ed

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/11/02 at 19:27 (099836)

Ed,

I am not raising the bar. The issue has never been low vs high energy. You are over simplifying and misinforming your followers.

I have already cited the Rompe et al studies as evidence that low energy ESWT works. What I am saying is that the fact that Rompe et al get good results with their lithotripter does not mean that all low energy treatments are the same. These lithotripters have different focal zones and energy flux densities. Focal zone size and energy flux density matter. The magnitude of the positive pressure and the negative pressure matter. You have no basis to generalize them away.

I know that you would like to say that every low energy treatment is equal and that every low energy study shows that the Sonocur works but that doesn't follow logically. If it did, then every machine capable of low energy would be approved by the FDA for tennis elbow because they would be equal to an approved device. It is not that simple.

In addition, we really don't know which technical differences in the manner which the modalities are applied are important because we are still trying to understand the differences between machines. Once the differences between the machines is understood then we will be able to group machines and predict outcomes based on machine groups. Until then each machine stands or falls on its own.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Ed Davis, DPM on 11/11/02 at 20:16 (099837)

Bill:

You again are making mis-statements by claiming 'I know you would like to say that every low energy tratment is equal...' What I have said is that I would question the need to go through a comprehensive approval process, machine by machine, protocol by protocol, tendon by tendon. It will take years to to determine what type of shock wave is optimal at which energy level for each tendon in the body. Once we have ascertained that the treatment is safe and effective, optimal procedures will be refined. It is really hard to do so when the products are being kept off the market. We do not need this information in advance for approval.

You are now stating, 'The issue has never been low vs. high energy.' No kidding-- that would really have been hard to determine based on the reading of your various posts here.
Ed

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Sunny Jacob, Bayshore on 11/11/02 at 20:24 (099840)

Bill, once again, is giving misleading information on this site: 'Rompe et al did not use Sonocur'
This is news to me. Rompe has done several studies on Sonocur. Guenther vom Dorp is very knowledgeable about Sonocur and all studies related to Sonocur.

Secondly, what is the accepted definition of high/low intensity ESWT by ISMST (International Society for Musculoskeletal Shockwave Therapy), - NOT your definition, Bill, or the definition of a manufacturer, or FDA?

Also what do yo mean by 'studies are for the use of LOW ENERGY LITHOTRIPTOR?' At least express yourself clearly so that we simple folks can understand.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Dr. Zuckerman on 11/12/02 at 07:45 (099854)

Bill.

How do the various companies choose the various techanical difference? I agree that there are different focal sizes, energy flux. positive- negative pressures. Do they just guess? What goes into the research to determine what works. Please educate Dr. Z

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Gunther vD on 11/12/02 at 09:51 (099874)

The shockwave technology used for ESWT is based on lithotripsy. Very simplified benchmarking for litho: We use identical artificial stones and record with how many shock the are pulverized. Then we go into clinical trials to look at efficiacy and side effects.
We know what parameters are responsible for desintegration and what parameters are responsible for the side effects. So we can optimise the shockwave source.
Totally different issues with orthopedic application. We do not know for certain what parameter is responsible for the healing / analgesic effect of the ESWT. So it is not based on evidence if a company claims that they are more efficient because of big focus, high pressure, low flux denisity or any other of the 20 something parameters measured to quantify the physical output of a shockwave source. To record those parameters a couple of different devices are used. The devices vary in their quality and price. In addition different countries require differend measuring standarts. That's why we communicate different values in the US and in the European market.
To make a long story short: If anyone could identify a sole parameter responsible for the beneficial effect of ESWT the industry would be happy to optimise the use of the shockwave device accordingly.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/12/02 at 14:08 (099898)

Sunny,

The study that Rompe at al published in the 2002 Journal of Bone and Joint Surgery used a Seimens Osteostar. Unless you are saying that the Oseostar is a Sonocur then you are spreading misinformation. They characterize the machine as experimental.

In terms of high/low intensity, there is no agreement that all low energy machines have equal treatment results. As there is no agreement that all high energy machines have equal treatment results. Whether the machines are for ESWT or for ESWL. Each machine has pros and cons and there are not equal.

Finally, put up or shut up, give me one, just one, peer reviewed study showing that the Sonocur works. If so many exist studies exist then give me a reference for one. Otherwise, you are just an advocate. It is fine to be an advocate but don't quote studies unless they exist.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/12/02 at 14:15 (099901)

I don't really know how they choose the parameters. For renal lithotripsy, some choose large focal zones and some choose small. I'm sure that they have internal research that helps guides them and that they are choosing the parameters that best match their choice of technology.

For renal lithotripters, some companies believe that a larger focal zone is important. These companies typically use spark gap technology. Others believe that a smaller, higher power focus is important. These companies typically use electromagnetic tecnology.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/12/02 at 14:27 (099905)

Ed,

The issue is your insistance that all low energy treatments are the same. I have already referenced the Rompe study as a peer reviewed study that shows that low energy treatments work. You are twisting my words and it is getting tiresome.

The rest of your comments are your mischaracterizing of my posts to suit your own objectives.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/12/02 at 14:43 (099910)

Ed,

Gunther VD makes the point perfectly when he says that 'if anyone could identify a sole parameter responsible for the benficial effect of ESWT the industry would be happy to optimise the use of the shockwave device accordingly.'

I take this to mean that every machine is different and that you cannot lump all low energy treatments into the same bucket.

Hope that this helps you better understand the subtleties and why testing is important.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Ed Davis, DPM on 11/12/02 at 18:37 (099942)

Bill:

I have never stated that all low energy shockwave treatments are the same.
You seem determined to assert that I have said so but I think we can let readers of our posts decide -- there is no use arguing this point. I completely understand Gunther's explanations but I would have to wonder if he would agree with your concepts of how this should be regulated. Perhaps he will respond.
Ed

Re: courtesy to Sunny Jacob

Ed Davis, DPM on 11/12/02 at 18:42 (099943)

I greatly appreciate the input of Sunny Jacob. Your request that Sunny 'put up or shut up' is discourteous, especially coming from an individual who will not identify himself. It is easy for anonymous individuals to take cheap shots.
Ed

Re: High energy ESWT

Ed Davis, DPM on 11/12/02 at 19:11 (099957)

Bill:
Using your logic, you would have to agree that not all high energy shockwave treatments are the same -- hope you are ready and willing to apply the same arguments to that.
Ed

Re: High energy ESWT

Bill on 11/12/02 at 19:17 (099961)

Ed,

I agree! I have been saying that not all high energy treatments and that not all ow energy treatments are the same that is why I beleive that each machine must be tested.

Re: courtesy to Sunny Jacob

Bill on 11/12/02 at 19:42 (099963)

My statement was in response to Sunny's 'thats news to me', which was a personal attack. I wasn't misleading anyone. I read the Rompe et al article. I believe that Rompe et al used the same machine for all their PF studies. They state that their treatments were conducted from 1993-1995 using an experimental device called the Siemens Osteostar with a mobile fluoroscopy unit.

Sunny do you have inside information? Did the Osteostar become the Sonocur? What is the difference between the Osteostar and the Sonocur? What changes did Siemens make? What was the purpose of the mobile fluoroscopy unit?

Re: courtesy to Sunny Jacob

Ed Davis, DPM on 11/12/02 at 20:33 (099973)

Bill:
I am not sure that a personal attack was intended -- you may be reading into things here. Sunny is an identified individual with a reputation to protect and you are anonymous so I think many would give you less latitude for being defensive. It sounds like you have a lot of inside information in this area. If the Osteostar and Sonocur are the same or use the same waveform and protocols, the 'name' of the unit would be irrelevant. One would expect a prototype to be used to research the optimal application so it seems likely that we are dealing with a similar end product -- we will need to here from someone 'in the know' to be certain.
Ed

Re: courtesy to Sunny Jacob

Bill on 11/13/02 at 08:09 (100004)

Ed,

I agree. If Osteostar and Sonocur are the same then we have the peer reviewed study that I have been asking for.

Re: courtesy to Sunny Jacob

Gunther vD on 11/13/02 at 08:29 (100005)

Osteostar has been one of several prototypes to investigate the impact of shockwave to bone and soft tissue. After achieving positive results with that device, Sonocur was designed to provide similar output parameters in the lower half of the total output dynamic of the Osteostar. So it is a safe assumption to say that Sonocur and Osteostar are providing similar results in the low energy application.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

john h on 11/13/02 at 10:20 (100014)

I think that PF and its causes are so varied and diverse among those who have it that there will never be one best protocol or one best machine. There are just two many variables. This is like rubic's cube. To many possibilities.

Re: High energy ESWT

john h on 11/13/02 at 10:38 (100015)

Bill:From all the FDA testing on ESWT equipment I have read about the number of patients studied seemed much to small to be significant. I of course do not know statistically what numbers you need for such test but when I read about test being conducted with drugs on thousands of people comaaped to ESWT studies with a 100 or less I am not very impressed. Bayshore and Dr. Z have conducted significantly more ESWT procedures than the FDA studies.. Thousands of procedures have been done in Europe yet am I to accept a few hundred cases done by the FDA as a gold standard. With our current level of information I personally have no problem trying any of the machines. I have no idea which is best or even if there is a best machine. Like Mohez I may end up trying them all. I have little concern about the safety of this equipment as they have all been in use for some years. I think we are currently searching for answers to which there may be no answer. In any event the equipment sure is a better alternative to surgery if it works..

Re: courtesy to Sunny Jacob

Scott R on 11/13/02 at 13:50 (100044)

Rompe has been using a lot more than just one machine and he's still in the biz. Bill is not at all familiar with ESWT if he didn't know this. I still get emails from Rompe letting me know what he's up to about 1 a year.

Re: Thank you Gunther -- I hope this satisfies Bill and we can put this to rest.

Ed Davis, DPM on 11/13/02 at 14:13 (100046)

Bill -- I hope this satisfies you. If so, I will personally take you out for a beer as well as any posters who want to join.
Ed

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Ed Davis, DPM on 11/13/02 at 14:36 (100051)

John:

This is an important perspective. I do not want to be overly repetitious but it is important to emphasize the knowledge gained by the collective experiences of thousands of treatments by providers. I respect the researchers performing the studies but over-reliance on data presented by studies while discounting the multiplicity of provider/patient experiences is not a reasonable position. Bill is taking a hardcore 'academic' position by only being willing to validate information generated by certain studies.
Ed

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Steve on 11/13/02 at 19:58 (100081)

I started this post and after reading all of the followups I can conclude:

1. No one on this board is aware of any published studies that show the Sonocur to be effective for plantar fasciitis.
2. The one Rompe study cited was a 1992-1995 study. The Sonocur was not introduced in Europe until 1996 if my information is correct.
3. Sonocur has not been approved by the FDA for the treatment of plantar fasciitis.
4. The recent studies published in JAMA and the Journal of Orthopaedic Research do not support low energy ESW.
5. No one is aware of any studies that conclude that electrohydraulically generated ESW is ineffective.

It would seem that if Sonocur wants to treat P-F they should do what Healthtronics and Dornier did, go get FDA approval. Thanks to everyone for their comments. My research had turned up no Sonocur studies for P-F and this thread has confirmed that, at least based upon the collective experience of posters to this thread.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Steve on 11/13/02 at 20:17 (100084)

I started this post and after reading all of the followups I can conclude:

1. No one on this board is aware of any published studies that show the Sonocur to be effective for plantar fasciitis.
2. The one Rompe study cited was a 1992-1995 study. The Sonocur was not introduced in Europe until 1996 if my information is correct.
3. Sonocur has not been approved by the FDA for the treatment of plantar fasciitis.
4. The recent studies published in JAMA and the Journal of Orthopaedic Research do not support low energy ESW.
5. No one is aware of any studies that conclude that electrohydraulically generated ESW is ineffective.

It would seem that if Sonocur wants to treat P-F they should do what Healthtronics and Dornier did, go get FDA approval. Thanks to everyone for their comments. My research had turned up no Sonocur studies for P-F and this thread has confirmed that, at least based upon the collective experience of posters to this thread.

Re: How many times do we have to go through this

Ed Davis, DPM on 11/13/02 at 21:17 (100088)

Steve:

Are you and Bill taking turns at trying to confuse people?
1)Gunther listed studies showing the effectiveness of the Sonocur prototype in PF. We have listed numerous studies showing the effectiveness of low energy ESWT for PF.
2)Who cares when Sonocur became commercially available -- it was tested for years before. What is the point here?
3)We have discussed the FDA approval process ad nauseum on this board. Are you chosing to ignore all the information or just trying to stir the pot? I am not going to repeat the information.
4)Recent studies? There was ONE flawed study that failed to support low energy ESWT. We have pointed out what was wrong with that study in detail in prior posts.
5)Practical experience to date has shown that practitioners are having considerable success with all of the protocols discussed. Practitioners are very satisfied as are patients. Why do a few individuals insist on getting on this board to distort the information. Patients come here in pain looking for help. Help is available -- now more than ever. Those of you with hidden agendas need to crawl back in your holes and get out of the way of people who need the help.
Ed

Re: No response from Bill yet.

Ed Davis, DPM on 11/13/02 at 23:13 (100102)

Bill -- I think we are finished this conversation unless you have changed your name to Steve and we are starting all over again.....

Re: Is this Bill or Steve? Do we have to start this debate all over again?

Ed Davis, DPM on 11/13/02 at 23:18 (100103)

Steve, Bill or whoever you are. Are you really going to ignore all the information presented that refutes each of your spurious points? I am not going to repeat the whole debate -- there is more than adequate information in the last two to three pages that addresses all the issues you have raised.
Ed

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Ed Davis, DPM on 11/13/02 at 23:30 (100105)

Just curious. We finally addressed all of 'Bill's' objections only to have 'Steve' start all over again. The debate can have its amusing side, but at some point, a decision to preserve the integrity of this forum needs to be made.
Ed

Re: The board

Julie on 11/14/02 at 02:29 (100111)

Ed

My suspicions exactly. If Scott doesn't respond to your post - he doesn't always read the boards - perhaps you should email him. It's time this was brought to a halt.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

john h on 11/14/02 at 10:27 (100139)

Steve I have no idea how many treatments with the Sonocur have been perfomed by Bayshore but I would venture a guess that it exceeds a thousand easily. That would seem significant to me since FDA trials for a machine are usually less than 100. They also maintain statistical data and followup on their treatments. I would never cross them off my list as a possible source of treatment. I think Sonocur in time will be here but many people still do cross the border to receive treatment.As to it being better or worse than other treatments I have no idea..

Re: How many times do we have to go through this

Steve on 11/14/02 at 22:29 (100194)

No one is trying to confuse anyone, I was just asking to see if there was verifiable evidence of the use of the Sonocur for PF, and still have not found any. I do not know why Sonorex did not do a PF study since it is a more common condition than tennis elbow. Are they doing or planning a PF study? Regarding recent studies of the Sonocur, you may want to check out two recent articles in the Journal of Bone and Joint Surgery and the Journal of Orthopaedic research, elbow studies granted, but low energy tendinopathy treatment, and deemed ineffective in both studies.

One Rompe study was offered up supporting Sonocur and PF, which was almost 10 years old, and did not use the Sonocur as it exists today. I agree, some success is being seen with all devices, but they do need to be differentiated. Because there are so many shock wave parameters, it would seem to be prudent to evaluate each device individually.

I agree with you though, it is has been over discussed. I will wait for the Sonocur PF study results if and when they come.

Re: Is this Bill or Steve? Do we have to start this debate all over again?

Steve on 11/14/02 at 22:33 (100196)

I have read all of the information on the board. I will await Sonocur Basic PF studies. You are correct in that it has been overdiscussed. We should just wait for the evidence.

Re: How many times do we have to go through this

Ed Davis, DPM on 11/14/02 at 22:59 (100204)

Steve-- how can you say that you 'still have not found any' evidence for the efficacy of Sonocur when numerous studies showing its efficacy have been listed on this site?
Ed

Re: Is this Bill or Steve? Do we have to start this debate all over again?

Bill on 11/16/02 at 06:48 (100360)

Sorry Dr. Davis,

I agree with Steve.

Insurance companies act in their own self interest. When they pay for anything non-FDA approved it is because they believe that it will save them money. There are no FDA quality studies showing that the Sonocur works and the Rompe study is almost ten years old using a machine that localizes with x-ray. The Sonocur does not use C-ray.

How do you explain why the Sonocur is only approved for tenns elbow and not PF? Siemans is a very large company, couldn't they fund two studies at the same time? Maybe there was a Sonocur PF study but the results did not show any improvement? We really don't know.

Steve is right. We should look for a carefully designed study.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/16/02 at 07:07 (100362)

John,

Maybe Bayshore would be willing to publish a study for others to read and evaluate? With thousands of cases, they probably have the most experience in the world.

They might also be able to determine the best method for performing the procedure and this information would enhance the outcomes for patients throughout the world.

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Bill on 11/16/02 at 07:11 (100364)

Dr. Davis,

It looks like other people are not convinced either. Steve has done a good job of asking questions and I look forward to everyone's response. I don't agree with Steve on every point but he has a right to ask questions.

You mention the integrity of the board. I think that the integrity of the forum is preserved by open two-sided discussions. Don't you want opposing views expressed?

Re: No response from Bill yet.

Bill on 11/16/02 at 07:13 (100365)

Dr. Davis,

I had finished the discussion and left the board. I dropped by and starting reading Steve's posts and your responses and could not stay quiet. Please don't attribute posts to me that are written by someone else.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/16/02 at 07:22 (100366)

Steve,

I have been asking the same questions that you have for the past few weeks. I get responses from Dr. Davis that say there are many studies but when I asked him he would not provide them. I appreciate your information on the Sonocur. It seems unlikely that the machine that was used in the Rompe study was a Sonocur.

I'll take your comments one step further, I think that the reason that the Sonocur is not approved for PF is because they have not been able to a conduct study that show positive results. The FDA studies of the Ossatron and EPOS followed patients for only 3 months. As you said the Sonocur was introduced into the market in 1996, hasn't there been enough time for Siemans to conduct a proper PF study. I would guess that they have conducted studies and that the results are not acceptable so they prefer to not get FDA approval.

Re: courtesy to Sunny Jacob

Bill on 11/16/02 at 07:24 (100368)

Scott,

Do you know which of Rompe's studies used the Sonocur and where the results were published? If not, could you email Rompe and ask him that question?

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Scott R on 11/16/02 at 11:02 (100393)

Steve, Bill, and fake Bill are all on different PCs and connections.

Re: courtesy to Sunny Jacob

Scott R on 11/16/02 at 11:10 (100394)

Bill, the abstracts almost never mention the name of the machine but only 'low-energy' or 'high-energy' of by the technology electro, mechanic, piezo, etc. http://www.ncbi.nlm.nih.gov/ is a great place to look at abstracts. Rompe's newest (?) article in 2002 in the J of Bone and Joint Surgeery was on an experimental Seimens (but not sonocur). I can let you see it but I can't make it publicly avaiable because of copyright. You'll have to email me to see it. Other stuff by Rompe on low energy is at: http://www.sonorex.com/world/files/physicians/research.html

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Bill on 11/16/02 at 11:18 (100395)

Scott,

Thanks for making it clear since some are quick to accuse
posters with different viewpoint of bad intentions.

Re: courtesy to Sunny Jacob

Bill on 11/16/02 at 11:24 (100397)

Scott,

Thanks for the reply and the offer. I have the article that you are referring to butI was hoping that there was another article where the treatments occured after 1995. I can't believe that all of their PF
articles are based on their treatments from 1993-1995. It just seems
like they must have conducted further studies.

Re: courtesy to Sunny Jacob

Scott R on 11/16/02 at 11:31 (100400)

OK, so I guess I'm corrected by Bill. That does seem odd at best.

Re: courtesy to Sunny Jacob

Bill on 11/16/02 at 11:38 (100402)

Scott,

I was not trying to correct you. I am just trying to understand what studies are out there by Rompe and when the data was collected.

Re: Is this Bill or Steve? Do we have to start this debate all over again?

Ed Davis, DPM on 11/18/02 at 18:37 (100596)

Bill:

Gunther listed the early studies showing the efficacy of Sonocur for PF. Numerous smaller studies plus years of experience have proven its efficacy for PF beyond any reasonable questions of doubt except for a few critics with a hidden agenda.

ESWT will be used for tendinopathies all over the body in time. Eventually, it is time to move on and show the efficacy for other tendons amd that is what Siemens did. Some tendons and ligaments are large and thick -- plantar fascia, patellar tendon, rotator cuff and would be amenable to treatment with high or low energy machines. Other tendons which are relatively delicate and small and in proximity to structures that could potentially be injured by shock waves require a small shock head and the ability to use lower energy. This is why Siemens felt the need to move forward.

We will eventually get to the point where the Europeans are who have exercised sufficient common sense to realize that ESWT can be applied
to numerous tendinopathies throughout the body. If we are going to ask the FDA to approve this modality tendon by tendon, we will be able to treat all the tendinoapthies and enthesopathies in the human body via ESWT in about 200 years. That is simply not going to happen. Despite the flaws and politics in the approval process I believe we will have a 'body wide' indication within the next 5 years.
Ed

Re: Still waiting for your response to Gunther!

Ed Davis, DPM on 11/18/02 at 18:38 (100597)

Still waiting for your response to Gunther.
Ed

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Ed Davis, DPM on 11/18/02 at 18:49 (100599)

There is nothing wrong with presenting two sides to an argument. There is a problem when a long discussion, point and counterpoint occurs, all necessary information and evidence has been provided and an individual basically enters at the 'end' pretending that none of the information was presented. This 'process' can obviously go on indefinitely and, at some point, the informational value of the board is significantly degraded. As such, it would be up to a 'referee' to decide that all necessary information has been provided and the discussion ended.
Ed

Re: Response to Gunther is being awaited.

Ed Davis, DPM on 11/18/02 at 18:52 (100601)

Bill:
The only way you can make this statment is by ignoring Gunther. Are you going to respond to him or not?
Ed

Re: STILL WAITING!

Ed Davis, DPM on 11/19/02 at 16:17 (100664)

Still waiting.
Ed

Re: Still waiting!

Bill on 11/19/02 at 17:43 (100678)

Ed,

What message of Gunther's are you refering to?

Re: Still waiting!

Ed Davis, DPM on 11/21/02 at 21:42 (100859)

Pleeeze Bill! You wanted studies showing efficacy. Gunther presented the studies with the prototype of the Sonocur. You then questioned whether the Sonocur prototype used delivered the same type of treatment as the current Sonocur. Gunther then applied in the affirmative which should have made you very happy.
Ed

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/09/02 at 09:36 (099664)

As far as I know, there are no double blind, placebo controlled studies on the effectiveness of the Sonocur for Plantar Fasciitis. In other countries, the Sonocur treatment protocol is three low energy flux density treatments over three weeks. There is significant controversy about whether three low energy flux density treatments are as effective as one high energy flux density treatment.

The Healthtronics Ossatron and the Dornier Epos are the only FDA approved devices for the treatment of PF. Both machines received approval for a single high energy treatment. Both machines deliver comparable energy to the fascia. However, the Ossatron also delivers significant energy to the surrounding bones. There have not been any studies looking at the effects of the Ossatron on the bones of the foot.

If you receive any study references, make sure that the studies have been submitted to peer reviewed journals. There are many sub-par studies that have been published, both for and against ESWT.

The recent JAMA article is an example of an article that would have not been accepted for publication had it been reviewed by experts in the field. Its conclusions are colored by the choice of treatment protocol and the patient inclusion criteria. Likewise, there are many studies showing success that would not have been accepted for publication because of other flaws.

Be diligent and be critical. There are many interested parties and non-scientific articles have either been funded by these parties or have been written by these parties. Unfortunately, it seems all too easy to get these articles published.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Steve on 11/10/02 at 19:12 (099741)

Are there any reliable studies of any kind that support the use of the Sonocur for PF?

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

john h on 11/11/02 at 07:58 (099764)

Steve: it may be self serving but I think Bayshore in Canada has a long history of providing Sonocur treatments and have enough data to be statistically significanct. Check with a search under 'Sunny' and see if he has not put out some data on there results. Dr. Z at one time had a history of results from the Big O posted for all to see. Also check the Bayshore website. From my viewpoint it is not will ESWT help you but which machine might produce the best results. Another significant question is what is the best protocol for any of the machines? Ossataron seems to have only one protocol but Sonocur and Epos have different protocols depending on who and where you are treated..

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Gunther vD on 11/11/02 at 10:04 (099787)

In fact there are:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11886900&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9063856&dopt=Abstract

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/11/02 at 13:27 (099800)

Those studies are for the use of a low energy lithotripter and are not for the use of the Sonocur. Rompe et al did not use a Sonocur so these studies do not support the use of the Sonocur any more than the Healthtronics PMA supports the use of the Dornier Epos. All low energy machines are not equal, they have different focal zones and pressure characteristics. All high energy intensity machines are also not equal for the same reason. It is important that the studies that you read support the machine that you are interested in using!

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Ed Davis, DPM on 11/11/02 at 14:19 (099809)

Bill:

The differences between machines are not sufficiently significant to warrant a separate study for every product. The issue has been low vs. high energy. You are raising the bar now that more evidence of efficacy has been provided. Technical differences in the manner which the modalities are applied are even more important than the issues you have raised.
Ed

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/11/02 at 19:27 (099836)

Ed,

I am not raising the bar. The issue has never been low vs high energy. You are over simplifying and misinforming your followers.

I have already cited the Rompe et al studies as evidence that low energy ESWT works. What I am saying is that the fact that Rompe et al get good results with their lithotripter does not mean that all low energy treatments are the same. These lithotripters have different focal zones and energy flux densities. Focal zone size and energy flux density matter. The magnitude of the positive pressure and the negative pressure matter. You have no basis to generalize them away.

I know that you would like to say that every low energy treatment is equal and that every low energy study shows that the Sonocur works but that doesn't follow logically. If it did, then every machine capable of low energy would be approved by the FDA for tennis elbow because they would be equal to an approved device. It is not that simple.

In addition, we really don't know which technical differences in the manner which the modalities are applied are important because we are still trying to understand the differences between machines. Once the differences between the machines is understood then we will be able to group machines and predict outcomes based on machine groups. Until then each machine stands or falls on its own.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Ed Davis, DPM on 11/11/02 at 20:16 (099837)

Bill:

You again are making mis-statements by claiming 'I know you would like to say that every low energy tratment is equal...' What I have said is that I would question the need to go through a comprehensive approval process, machine by machine, protocol by protocol, tendon by tendon. It will take years to to determine what type of shock wave is optimal at which energy level for each tendon in the body. Once we have ascertained that the treatment is safe and effective, optimal procedures will be refined. It is really hard to do so when the products are being kept off the market. We do not need this information in advance for approval.

You are now stating, 'The issue has never been low vs. high energy.' No kidding-- that would really have been hard to determine based on the reading of your various posts here.
Ed

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Sunny Jacob, Bayshore on 11/11/02 at 20:24 (099840)

Bill, once again, is giving misleading information on this site: 'Rompe et al did not use Sonocur'
This is news to me. Rompe has done several studies on Sonocur. Guenther vom Dorp is very knowledgeable about Sonocur and all studies related to Sonocur.

Secondly, what is the accepted definition of high/low intensity ESWT by ISMST (International Society for Musculoskeletal Shockwave Therapy), - NOT your definition, Bill, or the definition of a manufacturer, or FDA?

Also what do yo mean by 'studies are for the use of LOW ENERGY LITHOTRIPTOR?' At least express yourself clearly so that we simple folks can understand.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Dr. Zuckerman on 11/12/02 at 07:45 (099854)

Bill.

How do the various companies choose the various techanical difference? I agree that there are different focal sizes, energy flux. positive- negative pressures. Do they just guess? What goes into the research to determine what works. Please educate Dr. Z

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Gunther vD on 11/12/02 at 09:51 (099874)

The shockwave technology used for ESWT is based on lithotripsy. Very simplified benchmarking for litho: We use identical artificial stones and record with how many shock the are pulverized. Then we go into clinical trials to look at efficiacy and side effects.
We know what parameters are responsible for desintegration and what parameters are responsible for the side effects. So we can optimise the shockwave source.
Totally different issues with orthopedic application. We do not know for certain what parameter is responsible for the healing / analgesic effect of the ESWT. So it is not based on evidence if a company claims that they are more efficient because of big focus, high pressure, low flux denisity or any other of the 20 something parameters measured to quantify the physical output of a shockwave source. To record those parameters a couple of different devices are used. The devices vary in their quality and price. In addition different countries require differend measuring standarts. That's why we communicate different values in the US and in the European market.
To make a long story short: If anyone could identify a sole parameter responsible for the beneficial effect of ESWT the industry would be happy to optimise the use of the shockwave device accordingly.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/12/02 at 14:08 (099898)

Sunny,

The study that Rompe at al published in the 2002 Journal of Bone and Joint Surgery used a Seimens Osteostar. Unless you are saying that the Oseostar is a Sonocur then you are spreading misinformation. They characterize the machine as experimental.

In terms of high/low intensity, there is no agreement that all low energy machines have equal treatment results. As there is no agreement that all high energy machines have equal treatment results. Whether the machines are for ESWT or for ESWL. Each machine has pros and cons and there are not equal.

Finally, put up or shut up, give me one, just one, peer reviewed study showing that the Sonocur works. If so many exist studies exist then give me a reference for one. Otherwise, you are just an advocate. It is fine to be an advocate but don't quote studies unless they exist.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/12/02 at 14:15 (099901)

I don't really know how they choose the parameters. For renal lithotripsy, some choose large focal zones and some choose small. I'm sure that they have internal research that helps guides them and that they are choosing the parameters that best match their choice of technology.

For renal lithotripters, some companies believe that a larger focal zone is important. These companies typically use spark gap technology. Others believe that a smaller, higher power focus is important. These companies typically use electromagnetic tecnology.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/12/02 at 14:27 (099905)

Ed,

The issue is your insistance that all low energy treatments are the same. I have already referenced the Rompe study as a peer reviewed study that shows that low energy treatments work. You are twisting my words and it is getting tiresome.

The rest of your comments are your mischaracterizing of my posts to suit your own objectives.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/12/02 at 14:43 (099910)

Ed,

Gunther VD makes the point perfectly when he says that 'if anyone could identify a sole parameter responsible for the benficial effect of ESWT the industry would be happy to optimise the use of the shockwave device accordingly.'

I take this to mean that every machine is different and that you cannot lump all low energy treatments into the same bucket.

Hope that this helps you better understand the subtleties and why testing is important.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Ed Davis, DPM on 11/12/02 at 18:37 (099942)

Bill:

I have never stated that all low energy shockwave treatments are the same.
You seem determined to assert that I have said so but I think we can let readers of our posts decide -- there is no use arguing this point. I completely understand Gunther's explanations but I would have to wonder if he would agree with your concepts of how this should be regulated. Perhaps he will respond.
Ed

Re: courtesy to Sunny Jacob

Ed Davis, DPM on 11/12/02 at 18:42 (099943)

I greatly appreciate the input of Sunny Jacob. Your request that Sunny 'put up or shut up' is discourteous, especially coming from an individual who will not identify himself. It is easy for anonymous individuals to take cheap shots.
Ed

Re: High energy ESWT

Ed Davis, DPM on 11/12/02 at 19:11 (099957)

Bill:
Using your logic, you would have to agree that not all high energy shockwave treatments are the same -- hope you are ready and willing to apply the same arguments to that.
Ed

Re: High energy ESWT

Bill on 11/12/02 at 19:17 (099961)

Ed,

I agree! I have been saying that not all high energy treatments and that not all ow energy treatments are the same that is why I beleive that each machine must be tested.

Re: courtesy to Sunny Jacob

Bill on 11/12/02 at 19:42 (099963)

My statement was in response to Sunny's 'thats news to me', which was a personal attack. I wasn't misleading anyone. I read the Rompe et al article. I believe that Rompe et al used the same machine for all their PF studies. They state that their treatments were conducted from 1993-1995 using an experimental device called the Siemens Osteostar with a mobile fluoroscopy unit.

Sunny do you have inside information? Did the Osteostar become the Sonocur? What is the difference between the Osteostar and the Sonocur? What changes did Siemens make? What was the purpose of the mobile fluoroscopy unit?

Re: courtesy to Sunny Jacob

Ed Davis, DPM on 11/12/02 at 20:33 (099973)

Bill:
I am not sure that a personal attack was intended -- you may be reading into things here. Sunny is an identified individual with a reputation to protect and you are anonymous so I think many would give you less latitude for being defensive. It sounds like you have a lot of inside information in this area. If the Osteostar and Sonocur are the same or use the same waveform and protocols, the 'name' of the unit would be irrelevant. One would expect a prototype to be used to research the optimal application so it seems likely that we are dealing with a similar end product -- we will need to here from someone 'in the know' to be certain.
Ed

Re: courtesy to Sunny Jacob

Bill on 11/13/02 at 08:09 (100004)

Ed,

I agree. If Osteostar and Sonocur are the same then we have the peer reviewed study that I have been asking for.

Re: courtesy to Sunny Jacob

Gunther vD on 11/13/02 at 08:29 (100005)

Osteostar has been one of several prototypes to investigate the impact of shockwave to bone and soft tissue. After achieving positive results with that device, Sonocur was designed to provide similar output parameters in the lower half of the total output dynamic of the Osteostar. So it is a safe assumption to say that Sonocur and Osteostar are providing similar results in the low energy application.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

john h on 11/13/02 at 10:20 (100014)

I think that PF and its causes are so varied and diverse among those who have it that there will never be one best protocol or one best machine. There are just two many variables. This is like rubic's cube. To many possibilities.

Re: High energy ESWT

john h on 11/13/02 at 10:38 (100015)

Bill:From all the FDA testing on ESWT equipment I have read about the number of patients studied seemed much to small to be significant. I of course do not know statistically what numbers you need for such test but when I read about test being conducted with drugs on thousands of people comaaped to ESWT studies with a 100 or less I am not very impressed. Bayshore and Dr. Z have conducted significantly more ESWT procedures than the FDA studies.. Thousands of procedures have been done in Europe yet am I to accept a few hundred cases done by the FDA as a gold standard. With our current level of information I personally have no problem trying any of the machines. I have no idea which is best or even if there is a best machine. Like Mohez I may end up trying them all. I have little concern about the safety of this equipment as they have all been in use for some years. I think we are currently searching for answers to which there may be no answer. In any event the equipment sure is a better alternative to surgery if it works..

Re: courtesy to Sunny Jacob

Scott R on 11/13/02 at 13:50 (100044)

Rompe has been using a lot more than just one machine and he's still in the biz. Bill is not at all familiar with ESWT if he didn't know this. I still get emails from Rompe letting me know what he's up to about 1 a year.

Re: Thank you Gunther -- I hope this satisfies Bill and we can put this to rest.

Ed Davis, DPM on 11/13/02 at 14:13 (100046)

Bill -- I hope this satisfies you. If so, I will personally take you out for a beer as well as any posters who want to join.
Ed

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Ed Davis, DPM on 11/13/02 at 14:36 (100051)

John:

This is an important perspective. I do not want to be overly repetitious but it is important to emphasize the knowledge gained by the collective experiences of thousands of treatments by providers. I respect the researchers performing the studies but over-reliance on data presented by studies while discounting the multiplicity of provider/patient experiences is not a reasonable position. Bill is taking a hardcore 'academic' position by only being willing to validate information generated by certain studies.
Ed

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Steve on 11/13/02 at 19:58 (100081)

I started this post and after reading all of the followups I can conclude:

1. No one on this board is aware of any published studies that show the Sonocur to be effective for plantar fasciitis.
2. The one Rompe study cited was a 1992-1995 study. The Sonocur was not introduced in Europe until 1996 if my information is correct.
3. Sonocur has not been approved by the FDA for the treatment of plantar fasciitis.
4. The recent studies published in JAMA and the Journal of Orthopaedic Research do not support low energy ESW.
5. No one is aware of any studies that conclude that electrohydraulically generated ESW is ineffective.

It would seem that if Sonocur wants to treat P-F they should do what Healthtronics and Dornier did, go get FDA approval. Thanks to everyone for their comments. My research had turned up no Sonocur studies for P-F and this thread has confirmed that, at least based upon the collective experience of posters to this thread.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Steve on 11/13/02 at 20:17 (100084)

I started this post and after reading all of the followups I can conclude:

1. No one on this board is aware of any published studies that show the Sonocur to be effective for plantar fasciitis.
2. The one Rompe study cited was a 1992-1995 study. The Sonocur was not introduced in Europe until 1996 if my information is correct.
3. Sonocur has not been approved by the FDA for the treatment of plantar fasciitis.
4. The recent studies published in JAMA and the Journal of Orthopaedic Research do not support low energy ESW.
5. No one is aware of any studies that conclude that electrohydraulically generated ESW is ineffective.

It would seem that if Sonocur wants to treat P-F they should do what Healthtronics and Dornier did, go get FDA approval. Thanks to everyone for their comments. My research had turned up no Sonocur studies for P-F and this thread has confirmed that, at least based upon the collective experience of posters to this thread.

Re: How many times do we have to go through this

Ed Davis, DPM on 11/13/02 at 21:17 (100088)

Steve:

Are you and Bill taking turns at trying to confuse people?
1)Gunther listed studies showing the effectiveness of the Sonocur prototype in PF. We have listed numerous studies showing the effectiveness of low energy ESWT for PF.
2)Who cares when Sonocur became commercially available -- it was tested for years before. What is the point here?
3)We have discussed the FDA approval process ad nauseum on this board. Are you chosing to ignore all the information or just trying to stir the pot? I am not going to repeat the information.
4)Recent studies? There was ONE flawed study that failed to support low energy ESWT. We have pointed out what was wrong with that study in detail in prior posts.
5)Practical experience to date has shown that practitioners are having considerable success with all of the protocols discussed. Practitioners are very satisfied as are patients. Why do a few individuals insist on getting on this board to distort the information. Patients come here in pain looking for help. Help is available -- now more than ever. Those of you with hidden agendas need to crawl back in your holes and get out of the way of people who need the help.
Ed

Re: No response from Bill yet.

Ed Davis, DPM on 11/13/02 at 23:13 (100102)

Bill -- I think we are finished this conversation unless you have changed your name to Steve and we are starting all over again.....

Re: Is this Bill or Steve? Do we have to start this debate all over again?

Ed Davis, DPM on 11/13/02 at 23:18 (100103)

Steve, Bill or whoever you are. Are you really going to ignore all the information presented that refutes each of your spurious points? I am not going to repeat the whole debate -- there is more than adequate information in the last two to three pages that addresses all the issues you have raised.
Ed

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Ed Davis, DPM on 11/13/02 at 23:30 (100105)

Just curious. We finally addressed all of 'Bill's' objections only to have 'Steve' start all over again. The debate can have its amusing side, but at some point, a decision to preserve the integrity of this forum needs to be made.
Ed

Re: The board

Julie on 11/14/02 at 02:29 (100111)

Ed

My suspicions exactly. If Scott doesn't respond to your post - he doesn't always read the boards - perhaps you should email him. It's time this was brought to a halt.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

john h on 11/14/02 at 10:27 (100139)

Steve I have no idea how many treatments with the Sonocur have been perfomed by Bayshore but I would venture a guess that it exceeds a thousand easily. That would seem significant to me since FDA trials for a machine are usually less than 100. They also maintain statistical data and followup on their treatments. I would never cross them off my list as a possible source of treatment. I think Sonocur in time will be here but many people still do cross the border to receive treatment.As to it being better or worse than other treatments I have no idea..

Re: How many times do we have to go through this

Steve on 11/14/02 at 22:29 (100194)

No one is trying to confuse anyone, I was just asking to see if there was verifiable evidence of the use of the Sonocur for PF, and still have not found any. I do not know why Sonorex did not do a PF study since it is a more common condition than tennis elbow. Are they doing or planning a PF study? Regarding recent studies of the Sonocur, you may want to check out two recent articles in the Journal of Bone and Joint Surgery and the Journal of Orthopaedic research, elbow studies granted, but low energy tendinopathy treatment, and deemed ineffective in both studies.

One Rompe study was offered up supporting Sonocur and PF, which was almost 10 years old, and did not use the Sonocur as it exists today. I agree, some success is being seen with all devices, but they do need to be differentiated. Because there are so many shock wave parameters, it would seem to be prudent to evaluate each device individually.

I agree with you though, it is has been over discussed. I will wait for the Sonocur PF study results if and when they come.

Re: Is this Bill or Steve? Do we have to start this debate all over again?

Steve on 11/14/02 at 22:33 (100196)

I have read all of the information on the board. I will await Sonocur Basic PF studies. You are correct in that it has been overdiscussed. We should just wait for the evidence.

Re: How many times do we have to go through this

Ed Davis, DPM on 11/14/02 at 22:59 (100204)

Steve-- how can you say that you 'still have not found any' evidence for the efficacy of Sonocur when numerous studies showing its efficacy have been listed on this site?
Ed

Re: Is this Bill or Steve? Do we have to start this debate all over again?

Bill on 11/16/02 at 06:48 (100360)

Sorry Dr. Davis,

I agree with Steve.

Insurance companies act in their own self interest. When they pay for anything non-FDA approved it is because they believe that it will save them money. There are no FDA quality studies showing that the Sonocur works and the Rompe study is almost ten years old using a machine that localizes with x-ray. The Sonocur does not use C-ray.

How do you explain why the Sonocur is only approved for tenns elbow and not PF? Siemans is a very large company, couldn't they fund two studies at the same time? Maybe there was a Sonocur PF study but the results did not show any improvement? We really don't know.

Steve is right. We should look for a carefully designed study.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/16/02 at 07:07 (100362)

John,

Maybe Bayshore would be willing to publish a study for others to read and evaluate? With thousands of cases, they probably have the most experience in the world.

They might also be able to determine the best method for performing the procedure and this information would enhance the outcomes for patients throughout the world.

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Bill on 11/16/02 at 07:11 (100364)

Dr. Davis,

It looks like other people are not convinced either. Steve has done a good job of asking questions and I look forward to everyone's response. I don't agree with Steve on every point but he has a right to ask questions.

You mention the integrity of the board. I think that the integrity of the forum is preserved by open two-sided discussions. Don't you want opposing views expressed?

Re: No response from Bill yet.

Bill on 11/16/02 at 07:13 (100365)

Dr. Davis,

I had finished the discussion and left the board. I dropped by and starting reading Steve's posts and your responses and could not stay quiet. Please don't attribute posts to me that are written by someone else.

Re: Studies supporting Sonocur for the treatment of Plantar Fasciitis

Bill on 11/16/02 at 07:22 (100366)

Steve,

I have been asking the same questions that you have for the past few weeks. I get responses from Dr. Davis that say there are many studies but when I asked him he would not provide them. I appreciate your information on the Sonocur. It seems unlikely that the machine that was used in the Rompe study was a Sonocur.

I'll take your comments one step further, I think that the reason that the Sonocur is not approved for PF is because they have not been able to a conduct study that show positive results. The FDA studies of the Ossatron and EPOS followed patients for only 3 months. As you said the Sonocur was introduced into the market in 1996, hasn't there been enough time for Siemans to conduct a proper PF study. I would guess that they have conducted studies and that the results are not acceptable so they prefer to not get FDA approval.

Re: courtesy to Sunny Jacob

Bill on 11/16/02 at 07:24 (100368)

Scott,

Do you know which of Rompe's studies used the Sonocur and where the results were published? If not, could you email Rompe and ask him that question?

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Scott R on 11/16/02 at 11:02 (100393)

Steve, Bill, and fake Bill are all on different PCs and connections.

Re: courtesy to Sunny Jacob

Scott R on 11/16/02 at 11:10 (100394)

Bill, the abstracts almost never mention the name of the machine but only 'low-energy' or 'high-energy' of by the technology electro, mechanic, piezo, etc. http://www.ncbi.nlm.nih.gov/ is a great place to look at abstracts. Rompe's newest (?) article in 2002 in the J of Bone and Joint Surgeery was on an experimental Seimens (but not sonocur). I can let you see it but I can't make it publicly avaiable because of copyright. You'll have to email me to see it. Other stuff by Rompe on low energy is at: http://www.sonorex.com/world/files/physicians/research.html

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Bill on 11/16/02 at 11:18 (100395)

Scott,

Thanks for making it clear since some are quick to accuse
posters with different viewpoint of bad intentions.

Re: courtesy to Sunny Jacob

Bill on 11/16/02 at 11:24 (100397)

Scott,

Thanks for the reply and the offer. I have the article that you are referring to butI was hoping that there was another article where the treatments occured after 1995. I can't believe that all of their PF
articles are based on their treatments from 1993-1995. It just seems
like they must have conducted further studies.

Re: courtesy to Sunny Jacob

Scott R on 11/16/02 at 11:31 (100400)

OK, so I guess I'm corrected by Bill. That does seem odd at best.

Re: courtesy to Sunny Jacob

Bill on 11/16/02 at 11:38 (100402)

Scott,

I was not trying to correct you. I am just trying to understand what studies are out there by Rompe and when the data was collected.

Re: Is this Bill or Steve? Do we have to start this debate all over again?

Ed Davis, DPM on 11/18/02 at 18:37 (100596)

Bill:

Gunther listed the early studies showing the efficacy of Sonocur for PF. Numerous smaller studies plus years of experience have proven its efficacy for PF beyond any reasonable questions of doubt except for a few critics with a hidden agenda.

ESWT will be used for tendinopathies all over the body in time. Eventually, it is time to move on and show the efficacy for other tendons amd that is what Siemens did. Some tendons and ligaments are large and thick -- plantar fascia, patellar tendon, rotator cuff and would be amenable to treatment with high or low energy machines. Other tendons which are relatively delicate and small and in proximity to structures that could potentially be injured by shock waves require a small shock head and the ability to use lower energy. This is why Siemens felt the need to move forward.

We will eventually get to the point where the Europeans are who have exercised sufficient common sense to realize that ESWT can be applied
to numerous tendinopathies throughout the body. If we are going to ask the FDA to approve this modality tendon by tendon, we will be able to treat all the tendinoapthies and enthesopathies in the human body via ESWT in about 200 years. That is simply not going to happen. Despite the flaws and politics in the approval process I believe we will have a 'body wide' indication within the next 5 years.
Ed

Re: Still waiting for your response to Gunther!

Ed Davis, DPM on 11/18/02 at 18:38 (100597)

Still waiting for your response to Gunther.
Ed

Re: Scott -- are "Steve" and "Bill" posts originating from different IP addressses? Preserving the integrity of this forum.

Ed Davis, DPM on 11/18/02 at 18:49 (100599)

There is nothing wrong with presenting two sides to an argument. There is a problem when a long discussion, point and counterpoint occurs, all necessary information and evidence has been provided and an individual basically enters at the 'end' pretending that none of the information was presented. This 'process' can obviously go on indefinitely and, at some point, the informational value of the board is significantly degraded. As such, it would be up to a 'referee' to decide that all necessary information has been provided and the discussion ended.
Ed

Re: Response to Gunther is being awaited.

Ed Davis, DPM on 11/18/02 at 18:52 (100601)

Bill:
The only way you can make this statment is by ignoring Gunther. Are you going to respond to him or not?
Ed

Re: STILL WAITING!

Ed Davis, DPM on 11/19/02 at 16:17 (100664)

Still waiting.
Ed

Re: Still waiting!

Bill on 11/19/02 at 17:43 (100678)

Ed,

What message of Gunther's are you refering to?

Re: Still waiting!

Ed Davis, DPM on 11/21/02 at 21:42 (100859)

Pleeeze Bill! You wanted studies showing efficacy. Gunther presented the studies with the prototype of the Sonocur. You then questioned whether the Sonocur prototype used delivered the same type of treatment as the current Sonocur. Gunther then applied in the affirmative which should have made you very happy.
Ed