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Some interesting number crunching.....

Posted by Ed Davis, DPM on 3/30/05 at 15:25 (172192)

First, go to http://www.suttondesigns.com and download the Enigma browesr. This step is not absolutely necessary but it does help with understanding as it breaks down the language barrier. The Enigma Browser, which works very similar to Internet Explorer has a feature in which entire web pages are translated to English so it does make the understanding of the process I am about to explain easier.

Once you have the Enigma Browser up and going (yes you can view this site or any other site through the Enigma browser), go to http://www.ismst.com .

Once on http://www.ismst.com then download the section that compares the various devices.

Now look at the total energy for the 5mm focus of Ossatron. It is 10.4.
Next, look at the total energy for a 5mm focus of the Sonocur. It is 10.3.

So if the Sonocur is turned up to maximum energy (remember that Ossatron does not allow one to vary energy levels), then if the Sonocur is delivered/used at its maximim energy at with local anesthesia, it has the effect of a high energy machine. Not that I feel that high energy machines are necessarily bettter but for those who are convinced that that is the case, then one can see how the Sonocur, with anesthesia, turned up to its highest level could conceivably be consdiered a high energy machine...
Ed

Re: Some interesting number crunching.....

Ralph on 3/30/05 at 15:47 (172197)

Dr. Ed,
Then the doctor providing treatment would have a choice in giving several low energy treatments or giving one high treatment or several high treatments or a mixture of both. When and how would that determination be made?

Re: Some interesting number crunching.....

elliott on 3/30/05 at 15:49 (172198)

But Ed, the Sonocur is electromagnetic and the Ossatron is electrohydraulic. Given the different methods of delivery, it could be you can't just turn the settings up to the max like in some Frankenstein movie and still get the desired results.

It might be more fitting to compare the Sonocur to the Dornier Epos, which is also electromagnetic. Or course, I think there's been some perennial confusion as to how to compare the Dornier's energy level consistently to that of the other machines.

elliott

Re: Some interesting number crunching.....

Ed Davis, DPM on 3/30/05 at 16:57 (172204)

Eliott:
Yes, in terms of comparing mechanisms, there it may be more interesting in comparing the Dornier but, the primary argument/claim that has been reiterated on this site was that high energy level machines were better than low energy level machines; an argument that I (nor the Canadians and Europeans) have ever bought into. This was brought forward to deflect the argument that it is the energy levels (high vs. low) being the determinant of machine effficacy.
Ed

Re: Some interesting number crunching.....

Ed Davis, DPM on 3/30/05 at 16:58 (172205)

Ralph:
In the US, the decision is often being made by the insurance company, not the doctor!
Ed

Re: Some interesting number crunching.....

Ralph on 3/30/05 at 17:19 (172207)

This may be a dumb question, but why would insurance companies make this decision? Apparently not many are covering the procedure at all. I don't understand how they would even know whether a doctor is planning on giving one high treatment or several low ones with the Sonocur machine if a claim isn't going to be submitted.

Re: Some interesting number crunching.....

Ed Davis, DPM on 3/30/05 at 18:33 (172211)

Ralph:
The insurance company may pre-certify and ask ahead of time which machane and protocol is to be used.They then can refuse or allow payment based on the machine and protocol. The insurances comapnies may get one bill for a hig energy session or 3 bills of lessor amounts for 3 sessions.

Only if the entire process is non-covered and on a cash basis is the insurance company out of the loop.

For example, with, Dornier, the insurnace companies may cover the ultrasound even if the ESWT is not covered.
Ed

Re: Some interesting number crunching.....

Dr. Z on 3/30/05 at 19:13 (172214)

I though that the reason the insurance companies pay for high energy only is due to the fact that that the dornier, ossatron are FDA approved for the treatment of plantar fasciosis and the Sonocur hasn't been approved for the treatment of plantar fasciitis. Why Sonocur doesn't apply for FDA approval plantar fasciosis is something that is so strange.

Re: Some interesting number crunching.....

Dr. Z on 3/30/05 at 19:17 (172216)

If you take a look at the repetitive three session treatments done by Scott from Austrialia. These are three high energy sessions as tolerated by the patient. Most of the three session treatments except with the sonocur are really high energy three session treatments. I believe the different isn't the energy level by the multiple sessions

Re: Some interesting number crunching.....

john on 3/30/05 at 19:39 (172219)

Dr Davis,

You talk about coverage decisions being made by insurance companies. Insurance companies cover high energy ESWT because the procedure has been carefully studied and received FDA approval. I am with Dr. Z. on this one, if you want Sonocur procedures covered ask them to perform an FDA study and demonstrate that it works for plnatar fasciitis. Anything less will not convince insurance companies.

Re: Some interesting number crunching.....

Ed Davis, DPM on 3/30/05 at 21:06 (172228)

Dr. Z:
This is, in part, my theory. The expectation was that Siemen's, the big boy on the block who is a multi-billion dollar player would be the one to fund FDA approval for the Sonocur. Siemens, makes only 10% of its earnings from medical so it has been slow in pouring marketing funds into its medical division. Sonocur, as the US/North American distributor was left to sink or swim by by Siemens. They have not had the funds to get Sonocur approved in the US with Siemen's not helping.
Ed

Re: Some interesting number crunching.....

Ed Davis, DPM on 3/31/05 at 19:21 (172329)

John:

Most studies (and experience) show that surgery is not a good option for plantar fasciitis. That does not keep insurance companies from covering it.

Drugs like Neurontin, Topomax are expensive drugs routinely used off label (ie no FDA studies or approval) for use in chronic nerve pain yet most insurance companies cover those drugs for chronic nerve pain.

Both Healthronics (Ossatron) and the Dornier Epos have FDA approval including studies yet most insurnace companies in my area will not cover either one.

Please explain how those examples jive with your statement.
Ed

Re: Some interesting number crunching.....

john on 3/31/05 at 20:43 (172336)

Dr Davis,

As you have noticed, even FDA approval for the Ossatron and the Epos Ultra does not guarantee insurance coverage. I don't think it is proper for compare prescriptions drugs to medical devices.

I think that insurance companies are reluctant to pay for treatments using medical devices until there is FDA approval plus demonstrated clinical studies.

I have no idea about why insurance companies pay for surgery. Given your statements about surgery, I would like to ask why your profession continues to teach surgery to podiatry students? Is it ethical to teach surgery if it does not work?

I don't think that it is as 'cut and dry' as you try to make it.

Re: Low vs. High Energy

elvis on 3/31/05 at 21:08 (172339)

I've mentioned this before. My chiropractor treats primarily sports related injuries and all 3 patients he sent to get Sonorex low energy ESWT for pf got zero relief. I know it's only a small number but so far he wasn't impressed at all.

Re: Some interesting number crunching.....

Ed Davis, DPM on 4/01/05 at 00:44 (172347)

John:
(1)90% percent of the surgery we teach to our students DOES work; we just don't teach plantar fascial realsease surgery but hundred of different procedures

2)Why is it not proper to compare prescriptions to medical devices?

3)If you have 'no idea' why insurance companies pay for surgery, especially surgery that does not work, then don't pass the buck for not knowing to me/us -- do your OWN homework and find out.

4)Why is it as not 'cut and dry' as I make it? I am not witholding any information. What information do you have that you would like to sharewith the rest of us that would make us beleieve otherwise?
Ed

Re: Low vs. High Energy

Ed Davis, DPM on 4/01/05 at 00:48 (172348)

Elvis:
3 patients is not an impressive number compared to thousands of patients that ARE being helped in Europe and Canada.
Ed

Re: Some interesting number crunching.....

john on 4/01/05 at 05:09 (172350)

Dr Davis,

(1) Maybe you can help me understand how plantar fascial release surgery is still standard of care for patients who are not helped by conservative therapy. Has the APMA come out against the surgery? Do any of your societies strongly discourage the procedure?

(2) It is not proper to compare prescription drugs to medical devices for the simple reason that they are significantly different in form and effect. Consuming a prescription drug would always have the same risks and benefits. However, applying a medical device to another part of the body could have significant risks that are unanticipated.

(3) Again, why hasn't the APMA condemned surgery in order to stop this ineffective procedure? I suspect that many in your profession believe that the procedure works. Otherwise, why don't you lobby your profession and help get this procedure stopped?

(4) There is nothing to say in response.

Re: Some interesting number crunching.....

Ed Davis, DPM on 4/01/05 at 21:35 (172399)

John:
1)The APMA is a politicial organization; it does not set standards of care. Standards of care are set by practitioners in a locale. Like the AMA, it reperesents the professsion as a whole withiut taking sides on issues of treatment.

2) 'Consuming a prescription drug would always have the same risks and benefits' That simply is not true. Variability in drug effect exists as in device and surgical situations.

3)Again, the APMA is a political body only. It has never involved itself in issues of treatment nor the standard of care.

Ed

Re: Some interesting number crunching.....

john on 4/02/05 at 06:51 (172422)

Dr Davis,

Your characterization of the APMA is false!

The APMA is responsible for acrediting the nation's podiatric medical schools and has responsibility to approve residency programs. It is through this role that they can effect the teaching of the surgery that you feel is in-effective.

You can learn more about the APMA at http://www.APMA.org . There mission statement includes the statement 'ensuring the highest quality foot and ankle care'.

If the surgery is so in-effective then I expect the APMA to take action through their acreditation standards to stop its teaching. Once it stops being taught, open surgery will eventually stop being standard of care since a podiatrist performing a procedure that is no longer being taught in podiatric medical schools risks malpractice if the procedure fails.

Re: Some interesting number crunching.....

Ed Davis, DPM on 4/02/05 at 14:13 (172432)

John:
No -- your characterization of the APMA is false. Every political organization out there has a mission statment implying that it somehow enhances the quality of services ot the public.

Second, accredidation of podiatry schools is performed via the Council on Podiatric Medical Education (CPME), affilated with but an autonomous organization. CPME is also responsible for overseeing board certification and certification of residency programs. It is not legal for a political organization to be involved in that process. I may be considered 'affilated' with this site but my 'job' in answering questions concerning heel pain and protecting the public from the type of disinformation people like you produce is as far as that relationship goes.

So again, by not having anything to do with the standards of care, the school accredidation process, the APMA has no say in matters of procedure choice. One does not have to be a member of the APMA in order to practice.
That is true for the AMA, in fact, AMA membership had reached a low of 40% of the medical profession a few years back.
Ed Davis, DPM

Re: Some interesting number crunching.....

john on 4/02/05 at 15:16 (172440)

Dr Davis,

Please look at the APMA website. The following is a quote:

=======================================================================
'The American Podiatric Medical Association is the premier professional organization representing the nation's Doctors of Podiatric Medicine (podiatrists). The APMA represents approximately 80 percent of the podiatrists in the country. Within APMA's umbrella of organizations are 53 component societies in states and other jurisdictions, as well as 22 affiliated and related societies.

APMA's Council on Podiatric Medical Education is the body designated by the US Department of Education to accredit the nation's podiatric medical schools. In addition, the Council has the responsibility to approve residency programs and continuing medical education programs. The Council recognizes certifying boards within podiatric medicine which meet its standards.

APMA's Fund For Podiatric Medical Education is a charitable organization dedicated to providing scholarships for podiatric medical students. Its Foot Health Foundation of America is a charitable/educational organization which is dedicated to providing information on foot health issues to the public and to promoting better foot health.

APMA provides foot health information to the public in a number of ways, including through its toll free number, l-800-FOOTCARE. There are more than three dozen different foot health brochures available at no charge. APMA has also initiated an Internet web site to provide information to the public, http://www.apma.org .

Doctors of Podiatric Medicine are physicians and surgeons who practice on the lower extremities, primarily on feet and ankles. The preparatory education of most DPMs includes four years of undergraduate work, followed by four years in an accredited podiatric medical school, followed by a residency.

APMA's national headquarters is located in Maryland. Its staff of 57 professionals are dedicated to promoting foot and ankle health, to member service, and to professional excellence.

MISSION STATEMENT: The American Podiatric Medical Association, Inc. is committed to advancing the profession of podiatric medicine for the benefit of its members and the public by ensuring the highest quality foot and ankle care.'

============================================================================

As you can see the 'Council of Podiatric Medical Education' is part of the APMA. My statement was not false!

Can you point me to a place on their website where they claim to be a political organization?

By the way, please stop the personal attacks!!!

Re: Some interesting number crunching.....

Ed Davis, DPM on 4/02/05 at 16:08 (172445)

John:
I really don't know why you insist on arguing about something you have no knowledge of. The CPME is autonomous. Legally it MUST be. A political organization cannot act as an accrediting body. The implication, legally, would be that one must be a member of a political organization in order to achieve acreditation or licensing and that has been shown time and time again, in the courts not to be allowable. The wording may imply to you that there is an 'ownership' relation between the APMA and CPME but there is none in actuality -- it is only an affiliaiion. It is like Scott saying 'our doctors made such a statement.' Perhaps the APMA website could do a better job explaining that as they assume that that relationship is understood by most in the manner that most readers here recognize I don't work for ScottR.

Certainly, it is the goal of a political organization to promote public and governmental recognition and, in doing so will lay claims to promoting high standards. That is true for virtually every political organization whether it represents plumbers, funeral directors or doctors.

The APMA is by its mission, performing a 'politcal' responsiblity in engaging pdoatrists in membership and creating awareness of podiatry; they may or may not have to write that down for your benefit as it is obvious to most. Any organization that organizes and promotes a trade or professsion is performing a political function and i think that most people can see that.
Ed

Re: Some interesting number crunching.....

Ed Davis, DPM on 4/02/05 at 16:29 (172446)

The Council on Podiatric Medical Education is an autonomous accrediting agency for podiatric medical education. Deriving its authority from the House of Delegates of the American Podiatric Medical Association, the Council is empowered to develop and adopt standards and policies as necessary for the implementation of all aspects of its accreditation, approval, and recognition purview. The Council has final authority for:

The accreditation of colleges of podiatric medicine, the approval of residency programs and sponsors of continuing education.

The recognition of specialty certifying boards for podiatric medical practice.

The Council is recognized by the Council on Higher Education Accreditation (CHEA) and the US Secretary of Education as the accrediting agency for first professional degree programs in podiatric medicine. Unqualified recognitions by these organizations have recently been extended for the maximum periods available. The Council also holds membership in the Association of Specialized and Professional Accreditors (ASPA), agreeing with and abiding by the ASPA Code of Good Practice which embraces the following seven values:.

1. Pursues its mission, goals, and objectives, and conducts its operations in a trustworthy manner.

2. Maximizes service, productivity, and effectiveness in the accreditation relationship.

3. Respects and protects institutional autonomy.

4. Maintains a broad perspective as the basis for wise decision making.

5. Focuses accreditation reviews on the development of knowledge and competence.

6. Exhibits integrity and professionalism in the conduct of its operations.

7. Has mechanisms to ensure that expertise and experience in the application of its standards, procedures, and values are present in members of its visiting teams, commissions, and staff.

The above is from the CPME website. Twice, they mention the fact that they are autonomous. Since the APMA has the membership of about 70% of podiatrists, the APMA will endorse and support CPME. That does not mean that another orgnization of podiatrists could not be formed should the interest exist and simultaneously endorse the work of CPME.

In general allopathic medicine there is an equivalent acrediting body and it is recognized and supported by the AMA due to the AMA being the major politcal body in medicine. It is very likely that the small Canadian Podaitric Medical Assco. endorses CPME too as they have too few members to form and support a similar acrediting body.
Ed
Ed

Re: Some interesting number crunching.....

john on 4/02/05 at 21:46 (172465)

Dr Davis,

I guess you missed the importance of the second sentence. 'Deriving its authority from the House of Delegates of the APMA...'

Kind of interesting that the CPME derives its authority from the APMA. I guess things are not that simple after all!

Re: Some interesting number crunching.....

Ed Davis. DPM on 4/03/05 at 01:09 (172474)

john:
They may not be that simple or we have poorly written legal language as the CPME would not be truly autonomous if it derived its authority from the House of Delegates of the APMA, An acrediting body, legally, must be autonomous. An example of where the AMA overstepped its legal bounds is its formation and approval of the CPT system or Curent Procedural Terminology used to describe procedures for billing. The AMA, which may or may not even represent the majority of doctors has bascially 'forced' a coding system on its own profession, not to mention osteopaths, podiatrists ,etc. that are forced to use it. The insurance industry, which demands CPT use, has basically conferred 'powers' on the AMA that it legally is not entitled to. The AMA would argue that it gives its CPT Committee a fair degree of autonomy but that argument is very weak. The CPT Committee has 'asserted' its autonomy at times by occasioanally giving unique codes to chiropractors, osteopaths and podiatrists (only on one occcasion and that was the code for, believe it or not, EPF!). The CPT Committee formally 'invites' representatives from other, related health professions to make a 'showing' (although feeble) of autonomy.

These are areas of law that often don't get dealt with until someone or some group is willing to mount a legal challenge. Nevertheless, I am a bit surprised that he Justice Department has not placed such areas on their radar screen.

If the health professsions had, say, two competing political bodies of similar stature, then the issue of autonomy would be 'forced'' or the two bodies could both endorse but not give 'authority' to such autonomous organizations.

It would not be unreasonable for such organizations to give an opinion to such autonomuous organizations as representatives of their respective meembership. Such opinions would only deal with the purpose for which those autonomous organizations were dealing with.

Lets say, an organization was formed to formulate practice guidleines. Then the APMA, for example, could poll its members to endorse (or critique) but not influence the formation of such guidelines.
Ed

Re: john.......Effectiveness of Surgery

elvis on 4/03/05 at 14:00 (172498)

A friend in Chicago just had pf release surgery 2 weeks ago. She is up walking with very little pain. She asked the doctor why this surgery is so much better than the surgery she had on her other foot a couple of years ago and what he did different this time. He said he didn't do anything different and it's just the variability of the himan body and the disease state. I think you ought to let it go man. This is a free country (or at least it used to be) and pf release surgery should be available for those who want and need it. For me personally it would be a procedure of last resort.

Re: Low vs. High Energy

elvis on 4/03/05 at 14:04 (172499)

I know 3 patients is not an impressive number and I basically said that. The orthopedic foot surgeon in LaJolla also dismissed low energy as totally ineffective. I don't know if she was referring to the Buchbinder article (i think it was Buchbinder) but she wasn't impressed with low energuy either. I wonder if the protocols vary and that's why the results seem to vary.

Re: Some interesting number crunching.....

Dr Ben Pearl on 4/04/05 at 01:39 (172538)

Quite a discussion. There have been some treatment algorhythms that acfas has put together for various conditions. I will review the latest on heel pain. What studies was John referencing on surgical outcomes?

Re: Some interesting number crunching.....

Ed Davis, DPM on 4/05/05 at 00:49 (172617)

Dr. Ben:
Yes, they can be ordered from ACFAS, http://www.acfas.org , an affiliate organization of APMA but not part of APMA. This was the point. The American College of Foot and Ankle Surgeons attempts to set standards of care in podiatric surgery because APMA cannot.
Ed

Re: Some interesting number crunching.....

john on 4/05/05 at 18:33 (172670)

Dr Davis,

We have now come full circle. The original point in my original post was if surgery is so bad then why doesn't your profession, through one of the many organizations affiliated with the APMA, stop its teaching and discourage its use? You pick the appropriate organization.

Is the ACFAS trying to discourage PF surgery through its attenpts to set standards of care in podiatric surgery?

Re: Some interesting number crunching.....

elvis on 4/05/05 at 23:59 (172694)

pf surgery is not bad. It has its advantages and disadvantages like most therapies. After I had my emergency appendectomy 4 years ago I looked up that procedure and low and behold >40% of all appendectomies are based on false positive diagnosis, ie, over 40% of appendectomies were done on patients that had a perfectly healthy appendix. That's not a reason to outlaw or ban appendectomies. Your logic is flawed and the facts you base your conclusions on are flawed. Get over it. You're wasting time on this website. Go lobby the professional societies, school governing bodies and state regualtory agencies if you want to get pg surgery outlawed.

Re: Some interesting number crunching.....

john on 4/06/05 at 14:08 (172717)

Elvis,

I don't believe that plantar fasciitis surgery is bad. I was questioning Dr. Davis who said it was bad.

Re: Some interesting number crunching.....

elvis on 4/06/05 at 16:10 (172724)

OK. I get it.

Re: Some interesting number crunching.....

Ed Davis, DPM on 4/06/05 at 19:43 (172727)

john:

I understand your point but keep in mind that the ACFAS is the American College of Foot and Ankle Surgery, the group that SUPPORTS surgery. That being said, many have maintained that it takes a good surgeon to understand when not to do surgery. The prior editor of the ACFAS journal would not even allow a great piece of ESWT research by Norris (VP of United Shockwave), et. al. to be publsihed in the journal becasue it did not involve surgery. Obviously, there is some internal dissention going on so I don't see ACFAS coming to a concensus on this area any time soon.

The other affiliate organizations don't carry the 'weight' that ACFAS does.

Just as there is an ISMST, it certainly is time to form an ASMST or American Society for Musculoskeletal Shockwave Therapy or even a North American Society for Musculoskeletal Shockwave Therapy. Smaller Europeran countries have their own societies so you would expect one here - why not? My guess is that it has been the infighting between advocates of differnt techniques and machines that has prevented formation of such a group. Read my many, many posts in which I plead to stop the infighting and get together on this. I think that we have the 'mass' to form a society with enough clout to really influence standards of care.
Ed

Re: Some interesting number crunching.....

Ed Davis, DPM on 4/06/05 at 19:47 (172728)

john:
It was my understanding that you agreed with the stats and general experience of practitioners and patients that the numbers of cures with PF release surgery and very long recovery times made it a poor option. Am I not correct in that interpretation?
Ed

Re: john.......Effectiveness of Surgery

Ed Davis, DPM on 4/06/05 at 19:49 (172729)

Elvis:
How very true on all accouts. The variability of PF release surgery results is incredible and not explainable by any scientific means I am aware of.
Ed

Re: Some interesting number crunching.....

Dr. Z on 4/06/05 at 20:33 (172731)

Ed,
A few years ago there was an ASMST formed. I have no idea the membership numbers. I do remember this. This is something I can look into in May at the ISMST meeting.

Re: Low vs. High Energy

Ed Davis, DPM on 4/12/05 at 15:26 (173060)

elvis:
I too would wonder if he is just looking at the Buchbinder study or if he is talking from experience. The http://www.ismst.com website contains one of the larger repositories of information on the subject. There is no question that protocols will eventually be refined. I feel that while there is a threshold of energy under which there may be no or effect, the key issue is the total amount of energy delivered to the tissue. That will vary by body region and also, to an extent, by the thickness of the tendon or ligament being treated.
Ed