Colorado Spine Treatment CenterPosted by Ed Davis, DPM on 11/13/04 at 00:11 (163789)
Orthopedic centers, in treating the whole body have found broader uses for ESWT:
Re: Colorado Spine Treatment CenterEd Davis, DPM on 11/13/04 at 00:20 (163790)
Another of the many orhtopedic centers turning to Sonocur for treamtent of tendinopathies:
Re: Orthopods in Louisiana offer patients the opportunity...Ed Davis, DPM on 11/13/04 at 00:23 (163791)
Orhtopedic surgeons in Louisiana offer their patients the opportunity to join the 90 percent of patients cured economically with a minumum of pain...
Re: An orthopod from Georgia offers an explaination for ESWT....Ed Davis, DPM on 11/13/04 at 00:27 (163792)
Re: Versatility of low energy ESWT....Ed Davis, DPM on 11/13/04 at 00:33 (163793)
Re: Avoiding surgery and NO downside....Ed Davis, DPM on 11/13/04 at 00:39 (163794)
How many medical treatments do you knw with near zero downside??
Re: A view from a holistic podiatrist....Ed Davis, DPM on 11/13/04 at 00:56 (163795)
Re: A view from a holistic podiatrist....john on 11/13/04 at 07:52 (163804)
Please post data and not advertisements. Most of the websites that you posted got their information from marketing material supplied by Sonorex. They are not objective. They are in a business relationship with Sonorex through their equipment lease agreements.
As you know, determining whether a device successfully treats pain is hard because patients tend to respond due to the treatment effect. For this reason, pain studies must always be double blind, placebo controlled. The treatment effect and proper blinding was a major concern of Dr. Buchbinder in her 2002 JAMA article on ESWT.
Re: An orthopod from Georgia offers an explaination for ESWT....Dr. Z on 11/13/04 at 09:02 (163811)
That must one site that Elliott missed
Re: A view from a holistic podiatrist....Ed Davis, DPM on 11/13/04 at 10:04 (163815)
Please don't tell me what to post and not to post. These may be considered adds but are informational websites from licensed credible practitioners. You have based your entire set of arguments here on the actions of a government agency, the FDA. You have continually avoided answering the questions which I posed to you below. So, until we have an edict from the moderator, I will post what I wish to post and you will post what you wish and let the readers make the decisions, not you nor I.
Re: A view from a holistic podiatrist....Dr. Z on 11/13/04 at 17:31 (163859)
This specific site is posting incorrect data. It states that you can locate pathology by pain feed back. Dr. Ed why are you bothering with these posts. We all knows that there are low energy web sites as well as ossatron and dornier web site. what is the point.
Re: A view from a holistic podiatrist....Dr. Z on 11/13/04 at 17:33 (163860)
Actually if the mocerator considers these advertizment then you still a few left. I think it is seven. So I guess you can keep going
Re: A view from a holistic podiatrist....Ed Davis. DPM on 11/14/04 at 19:28 (163919)
The point is that I have been placed in a position here by reps from the high energy companies including the anonymous John who insist on questioning my credibility and the credibility of low enrgy ESWT. I am simply showing readers that there are plenty of end users of low energy out there who are reputable practitioners.
I will continue to provide examples of such until the attacks from John and
Vince cease so until those two are ready to stop, expect me to continue my defense.
Re: A view from a holistic podiatrist....Dr. Z on 11/14/04 at 19:33 (163922)
I have to admit you are really good. Much better then I was in my defensive days ! The only problem that I have with low energy is that Siemans is supporting companies that are promoting off label use of the sonocur in the USA. This has nothing to do with the treatment.
Re: A view from a holistic podiatrist....Ed Davis. DPM on 11/14/04 at 20:07 (163933)
Thank you for the compliment. I would rather be doing something better with my time at this point than defending myself from Vince and anonymous John.
Unfortunately, I am not anonymous and value my reputation and my high cure rate on PF via traditional means and ESWT. As long as the attack is kept up, I am going to be on the defense.
Re: A view from a holistic podiatrist....Ed Davis. DPM on 11/14/04 at 20:10 (163935)
Geez, it is Sunday and you think these guys would take a rest.
Re: Colorado Spine Treatment CenterScott D. on 11/15/04 at 09:09 (163956)
Over a year ago, I asked the FDA for clarification on this type of promotion by a local facility. Specifically, I asked them if it was within guidelines to promote an approved device for an off-label use.
The response I received was...
'Not guidelines, but laws prohibit the off-label promotion of an approved device. It's called misbranding under the law, which the Food, Drug & Cosmetic Act prohibits. I will forward your email to our Office of Compliance (OC) for their review/investigation. Thank you for making us aware of this.'
In posting these links for review here are you suggesting to promote the off-label uses that they are advertising?
Re: Colorado Spine Treatment CenterEd Davis, DPM on 11/15/04 at 09:25 (163960)
Every time a discussion occurs concerning services offered, that can be construed as a form of advertising. The FDA has specifically forbidden manufacturers from advertsing off label use of drugs/devices but has allowed the physician to make the choice of whether to use drugs/devices in an off label fashion. It occurs far more often with drugs as you are aware. Interestingly, drug companies that continue to develop new membrane stabilizing drugs presumably for seizure control, do so in full realization that, out in 'the field' those drugs will be used more 'off label.'
Re: Colorado Spine Treatment CenterEd Davis, DPM on 11/15/04 at 09:29 (163961)
ps There are times that using drugs in an off label fashion actually contributes to public safety. An example of this includes the drugs marketed for nail fungus. eg. Lamisil is marketed to be taken every day for 90 days, nevertheless many of us have found that it is potentially safer and more effective to have patients skip a week every three weeks, using less drug and having equal efficacy. Physicians often use their experiences to try to protect their patients.
Re: Colorado Spine Treatment CenterScott D. on 11/15/04 at 09:37 (163963)
I am not suggesting that there is no place for off-label uses, in fact I agree that they are extremely important in some cases! The fact though, is that they are NOT allowed to be promoted/advertised. Not by manufacturers OR physicians! If someone calls my office and asks if we do an off-label procedure, I will answer them. I am prohibited though from doing anything more!
Re: Colorado Spine Treatment CenterEd Davis, DPM on 11/15/04 at 09:52 (163965)
Are you a provider? I think you need to take another look at the rules as while I can see your caution in not advertising an off label use of a product, it would be making an untrue statement if one stated that one 'does not use drugs/devices' in an off label fashion since that is something virtually every physician/provider in America does. There may be a few specialties where that does not occur but they are few and far in between. I am sure the FDA has a threshold for promotion and it is unlikely that as a provider, you would get near that. We let people know that we do ESWT but do both high and low energy. Patients who want services pertaining to what is on and off label are informed of such in the office.
Re: Colorado Spine Treatment CenterScott D. on 11/15/04 at 10:13 (163968)
You didn't read closely enough. I didn't say that we refuse off-label procedures. I said that I (and all other providers for that matter) am prohibited from advertising or promoting (a company owned website is both advertising and promoting)anything which is not specifically FDA approved. Because others were doing it, I asked for clarification of the law from the FDA directly before undertaking such a risk for our Center. From their respone, plain and simple, it is illegal to advertise or promote that you will provide an off-label use or treatment. The websites that you posted links to are advertising an off-label use and doing so illegally. If you want to decide where the FDA threshold lies (ie: how much you can get away with) then go right ahead. I know that they are not very gentle though when discovering people who have knowingly violating the law.
Re: Hmmm....Just An Observer on 11/15/04 at 10:24 (163969)
Somehow.. I don't beleive that. You seem to spend a great deal of time and energy on these boards doing just that.
As the saying goes.. Withdraw your investment of energy from the perpetrators in your life and they will wither and disappear from your radar screen!
Re: Colorado Spine Treatment CenterEd Davis, DPM on 11/15/04 at 11:08 (163973)
If you click on the Sonorex link for US citizens, you will see a direct link to all provider addresses. I'm sorry but its been a while since you posted here so don't remember exactly what services you provide.
It seemed, if I remember correctly, that you focus on ESWT and litohtripsy as a center. I am a podiatrist and, quite frankly, ESWT probably accounts for less than 2% of my income. I see a variety of foot problems, do a decent amount of foot surgery. I treat a lot of heel pain with about 90% of it resolving conventionally. As such I really don't have a specific need to advertise ESWT but my ESWT patients often come from my 'patient pool' with a small handful being referred specifically for ESWT by other practitioners. The depth of my interest is quite altruistic in that I am convinced that 90% of the plantar fascial release surgeries being done in the US today do not need to be performed. I make a lot more dollars on PF release surgery although by performing few, I sleep a lot better at night, and, hopefully have happier patients who refer others. Before ESWT was available locally, patients had to be sent to Sonorex in Vancouver for a 2.5 hour drive -- I have yet to find anyone who regretted the drive.
Re: Colorado Spine Treatment CenterScott D. on 11/15/04 at 11:13 (163975)
Again, you haven't read, or perhaps uunderstood my post. I am not questioning you at all, simply wondering why you are choosing to promote (you posted the links) an off-label use.
Re: Colorado Spine Treatment CenterEd Davis, DPM on 11/15/04 at 13:32 (163988)
The reason I did so was because I was placed in a defensive position by John and others who advocated high energy only and implied that providers using low energy were providing a disservice. I was showing that a number of reputable clinics use low energy in the US, beyond those we are familiar with in Canada. My philosophy is that, based on years now of seeing ESWT results, that both high and low energy work for intractable PF. I do feel that, in time, we will find optimal energy levels and protocols/techniques for all, if not most of the commonly treated tendinopathies and enthesopathies in the body. We are way too early in the development of that knowledge base to be arguing those issues. I have taken a stand against the infighting going on in this young field as being counterproductive to all but especially the patients who stand to benefit from ESWT.
Re: Colorado Spine Treatment CenterDr. Z on 11/15/04 at 15:51 (163995)
This though just came into my mind. With the new, recent ,introduction of the study by Dr. Rompe in the AMA journal showing better results with High energy for Shoulder supraspinatus tendinosis,would there be any changes in protocol in your ESWT clinic ? What is your experience with low energy and Shoulder supraspinatus tendinosis. with or without calcification ?
Re: Colorado Spine Treatment CenterJ. P. (Sunny) Jacob on 11/15/04 at 20:25 (164007)
Regarding ESWT energy levels, what I know is as follows:
Siemens Sonocur Plus has an energy range of 0.04 mJ/mm2 to 0.5 mJ/mm2 and the energy level can be adjusted through 8 energy level settings.
- Pain therapy energy range is from 0.2 to 0.6 mJ/mm2
- Lithotripsy range is from 0.08 to 0.60 mJ/mm2
- Osteotherapy ranges from 0.33 to 1.2 mJ/mm2
The ‘low energy' and ‘high energy' level terminology was created by various manufacturers. As you know, there is no consistency in the use of this terminology. To date I also have not come across a clear definition in the literature. Perhaps Prof. Rompe or someone in his peer group can comment on that.
My opinion is that ‘low energy' is between 0.12 to 0.46/0.47 mJ/mm2 (between the start of cell membrane permeability and the beginning of disintegration of the cell nucleus).
To my understanding, ‘high energy' ranges from 0.47 to 1.2 mJ/mm2.
When you see the closeness in the energy level ranges for pain therapy and lithotripsy, 0.2 to 0.4 mJ/mm2, and that they are overlapping most of the time, it shows that pain therapy could actually be performed on most lithotriptors. In other words, if an operator has a lithotriptor, theoretically they would not require a separate equipment for pain therapy, except that there would be certain ergonomic inconveniences. As you probably know, early studies and treatments for PF and tendonitis were done on lithotriptors. One could ask the question if Dornier Epos is a lithotriptor or an ESWT dedicated equipment.
On the other hand, lithotriptors cost $ 750K and up. So the manufacturers created a new series of equipments for the orthopedic market with basically the same components but at approx. 25% of the cost.
I do not blame the manufacturers for selling more equipment, but the approval authorities like FDA created hurdles with the different classification for ESWT and the approval process, thereby making a non-invasive ESWT procedure less competitive and expensive, punishing the patients in USA. It is therefore no surprise that certain providers use 'off label' treatments without anesthetics. It may be the right thing to do for the benefit of the patient.
Re.: Supra spinatus tendinosis:
Although the majority of patients treated at our clinic suffer from PF, we have successfully treated shoulder tendonitis, Achilles tendonitis and lateral epicondylitis, plus the occasional patellar tendonitis. I cannot recall that we treated any patient with supraspinatus tendinosis with calcification. With in-line ultrasound and the small focal area I cannot envisage a problem to treat this condition. I would not consider changing our 3-session treatment, but the protocol differs slightly for different locations.
As Dr. Rompe has access to ‘low' and ‘high' energy equipment in the university hospital, I am not questioning his observation of a better result using high energy for the shoulder treatment.
Re: Colorado Spine Treatment CenterJ. P. (Sunny) Jacob on 11/15/04 at 20:41 (164010)
Correction to my previous post regarding the energy levels:
Pain therapy - 0.08 to 0.4 mJ/mm2
Lithotripsy - 0.08 to 0.6 mJ/mm2
Osteotherapy - 0.33 to 1.2 mJ/mm2
Re: Colorado Spine Treatment CenterDr. Z on 11/15/04 at 21:40 (164014)
Thanks for your detailed reply/information. While reading Rompe's recent article in the AMA journal regarding ESWT treatment for shoulder tendinosis/calcification he defines high energy as .32mj/mm2.
Re: Colorado Spine Treatment CenterEd Davis, DPM on 11/15/04 at 22:36 (164015)
The key point is what is the most cost effective way to treat intractable PF. I return to my old analogy that one can drive from Seattle to Portland in a Chevy or in a Mercedes. Imagine Mercedes trying to get a government agency to mandate that all trips from Seattle to Portland be in a Mercedes only. I see this as the equivalent argument. After years of seeing Sonocur work and do so at reasonable cost, the argument for use of high energy boils down to healthcare politics. Obviously, when big dollars are involved, it is easier to pay for the studies. Often a study is needed but after years of experience we see that the Chevy will make it to Portland just fine. It would be nice to have more studies showing the Chevy will make it but then we would have to charge a lot more for the Chevy.
Re: Hmmm....Just An Observer on 11/16/04 at 09:34 (164034)
Observer 2 - I think you missed the point, Ed.
Re: Colorado Spine Treatment CenterEd Davis,DPM on 11/16/04 at 12:16 (164062)
Sunny makes a good point. When the 'dust settles' on the various issues, try using your Dornier times 3 in your office via low energy. After using the different methods, I have to admit that the patients seem to like the idea of coming in for an office visit, getting no 'shots' and a quick ESWT treatment times 3. Again, I would probably wait a while before doing this because, as you can see just from this board, the 'issue' is a bit too hot to deal with now. I think we have virtually 'squeezed' patient posters off this board with the debates. Hopefully, we are 'argued out' and can give things a rest and let patients get back here.
Re: Colorado Spine Treatment CenterDr. Z on 11/16/04 at 14:20 (164064)
I find in my hands patients love the single treatment. The local regional block should be almost painless. The treatment is over in about 18 minutes and there is no more treatments scheduled. I would like to compare to compare three treatment protocol but it is tough with my patient population. We have patients that travel and wouldn't want to come back three more times over a three week period. I hope that posters got something out of the debates and learned from them.