Home The Book Dr Articles Products Message Boards Journal Articles Search Our Surveys Surgery ESWT Dr Messages Find Good Drs video

I think this is a report on the Dornier FDA study at the 1-year mark!

Posted by elliott on 12/05/02 at 10:24 (101848)

I dug this off a German site giving abstracts of its organization's latest ESWT conference:

----------

Shockwave Therapy for Plantar Fasciitis of the Eposcorporus Dornier

Authors: Christopher Zingas, David Collon, Kyle Anderson

Institution: Henry Ford Health System William Clay Ford Center for Athletic Medicine

The study is designed to assess the safety and efficacy of musculoskeletal shock wave therapy in the treatment of chronic plantar fasciitis. The authors hypothesize that shock wave therapy will be useful in the treatment of chronic plantar fasciitis which has failed conventional conservative methods.

Preliminary twelve month results indicate that shock wave therapy may provide an effective alternative treatment for chronic plantar fasciitis with minor transient adverse effects.

One hundred and fifty patients with chronic plantar fasciitis were enrolled in a randomized, 1:1 allocated, placebo-controlled, prospective, double blind clinical study with two groups: one receiving Extracorporeal Shock Wave Therapy (ESWT) with Dornier Epos Ultra and the other receiving sham treatment. All 150 patients had failed at least six months of physician supervised conventional conservative methods and would have been considered surgical candidates by guidelines set forth by the AOFAS. All patients were greater than 18 years of age with unilateral single site plantar medial heel pain, and had a visual analog score of >5 (scale 1-10) for the first few minutes of morning walking. There were 119 women and 31 men enrolled. The mean age was 50 years (26-69) for the active group and 53 years (31-72) for the sham group. Each active treatment patient was subjected to a single 20 minute ESWT session which delivered approximately 1300mJ/mm2 to the treatment area. The control group patients went through the identical treatment procedure without shock wave penetration. All patients were evaluated 3-5 days, 6 weeks, 3 months, 6 months, and 1 year post-treatment. Patients were assessed using the Visual Analog Score (VAS) during the first few minutes of walking and the Roles and Maudley score. The participants were unblinded at 3 months post-treatment. Patients in the sham treatment group who did not improve at 3 months were offered active ESWT and were considered the 'Crossover Group'.

The VAS for the first few minutes of walking at 3 months post-treatment showed a 45% success rate in the sham treatment group and 56% success in the active group. The Roles and Maudsley scoring showed a 40% success rate in the sham group and 62% success rate in the active group at 3 months. The VAS for the first few minutes of walking at 12 months post-treatment showed a 94% success rate in the active group. The Roles and Maudsley scoring showed also 94% success rate in the active group at 12 months. The crossover group at 12 months had a VAS score 63% success and Roles and Maudsley scoring of 93% success.

There were 17 active, 19 sham, 11 crossover mild transient complications seen. These included ecchymosis, edema, hypesthesia, paresthesia, petechiae, rash, neuralgia, injections site hemorrhage, nonpalpable pulse (sham treatment), and infection. These all resolved within a few days post-treatment. There was 1 permanent minor complication of paresthesia. No major transient or permanent complications were noted.

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

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

Pauline on 12/05/02 at 10:59 (101849)

Elliott,
Too much digging. This is also available at:
http://www.aofas.org/02summer/200207130852.asp I've also seen another one on the same site.

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

elliott on 12/05/02 at 11:10 (101850)

And you kept this all to yourself all this time, Pauline?!?

[]

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

Pauline on 12/05/02 at 11:37 (101852)

Elliott,
It's not keeping things to myself, but rather people are unwilling to believe. Had you not posted this information first they would have thought I was lying. The accusations have always been there way back to the days of the 'Big O' , but you were actually the first person put the 'word' in print and ask if I was being accused of lying. As I remember, you got no response and as it turned out every word I posted even about 'Big O' came to pass.

I more than likely could have helped provide you with the information you were seeking via backboarding in a more timely fashion. You just have to believe and I think you have all along.

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

Dr. Z on 12/05/02 at 11:45 (101853)

Do you think the one year follow is a very positive report for ESWT with the dornier Epos. ??

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

elliott on 12/05/02 at 14:13 (101862)

Dr. Z, is your question addressed to me or Pauline?

[]

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

elliott on 12/05/02 at 14:25 (101863)

Pauline, too cryptic for me. I wish you'd just come right out and say what's on your mind.

[]

Re: the Dornier FDA study at the 1-year mark

elliott on 12/06/02 at 09:36 (101958)

You know, it's interesting, Dr. Z, as important as the implications of this study might be, no one at all on these boards bothered to give an opinion on these long-awaited final results. You'd think what with 93% success or whatever, they'd find the time to take a break from discussing snow on Social to dance up and down with joy (if their PF allows them to) at what would essentially signify the end of PF in our times as we know it. Conservative means failed? No problem! You still got over 90% odds with Dr. Z's ESWT!

Well, if no one else is going to give it a shot, here's my thoughts on the one-year preliminary results:

The first thing I will say is that it shows good promise for the merits of ESWT, as the treatment group beat the control group by quite a bit more than random. It is certainly a reason to consider ESWT, if the cost is not prohibitive, before a more risky surgery, especially what with some of the post-surgery horror stories we see here. That said, I'll observe that at three months, the control group also had substantial VAS success, even as compared to the treatment group (45% vs. 56%). That should at least be an eye-opening reminder to tread with caution before jumping to far-reaching conclusions, i.e., it is apparent that we are observing a good chunk who would have got better without ESWT (as to be expected with PF) due either to normal progression or else falling for one hell of a placebo effect. Furthermore, the crossover group--those who failed to improve with the sham treatment and were then offered the real thing at 3 months--offers a very interesting insight on things, since they didn't fall for sham ESWT and didn't improve in those first three months, and so this group is perhaps more likely than the rest not to fall for the real ESWT if it happens not to work for them. And indeed, at the 12-month mark (which if I'm reading the abstract right, is 9 months post-ESWT for this crossover group) had a high R & M score, they showed only 63% VAS success as compared to 94% for the other treatment group. Why? It seems to me highly unlikely that this is due to being 'only' 9 months post-op instead of 12, not least because the original treatment group already achieved just about this exact same figure at the 3-month mark. Also, one does wonder if the selection criteria (not that I have a problem with them) somehow played a role, as we are witnessing far too many failed ESWT results on patients on these boards to equate their chances to a 90%+ success rate.

One further point: it looks like Dr. Zingas wasn't some two-bit player in this study; with his name appearing first, it looks more like he ran the whole kit & kaboodle. If Pauline says Dr. Zingas is somewhat hesitant about the results, I for one believe she is not lying. I am still wondering if he might have changed his mind more favorably since she last spoke with him, so maybe we should all pitch in and cover her co-pay for another visit, whether she needs it or not. :-)

[]

Re: the Dornier FDA study at the 1-year mark

Carole C in NOLA on 12/06/02 at 10:27 (101964)

Elliott, both traditional conservative treatments for PF and ESWT show a high percentage of success. I know that if I still had PF symptoms (which I don't, due to my success in applying traditional conservative treatments), I would do everything possible to heal it. It only makes sense to progress from the most conservative and inexpensive treatments to more expensive and surgical treatments rather than in the reverse order.

So yes, had traditional conservative treatments failed me, I would have paid for ESWT. I would have done that whether the success rate was fabulously improved or only slightly improved with ESWT, because ESWT would have been the next logical step to take. I do not believe that ESWT makes PF worse, so why not? As expensive as ESWT is, I hated having PF so much that I would have paid for it even if my chances of improvement were only very slightly better than without it.

As long as the percentage improved is not worse with ESWT than without, it really makes no difference in the course of action that I would have taken. You may find the study interesting but that doesn't mean that we all do. So please, discuss away but don't expect everyone to hang on your every word. The study is an interesting bit of trivia but not necessarily relevant to what treatment I would have sought and in what order, assuming that ESWT is not harmful. I believe that assumption to be correct.

If traditional conservative means had failed me, and ESWT had failed me, I would have then looked into surgery.

I HATE PF!!! I hated having it and I am SO GLAD to be feeling better now and I never, never, never ever want to have to go through that again.

PF symptoms and depression are so closely tied, each seeming to feed off the other. During the holiday season, when so many people with or without PF are depressed, there is nothing wrong and everything right with sharing our snow stories and cameraderie, and discussing the snow on the social board. It makes this time more bearable for those with PF. The social board is for discussions that aren't related to specific foot topics like ESWT, so what is wrong with good cheer there?

Carole C

Re: the Dornier FDA study at the 1-year mark

elliott on 12/06/02 at 10:45 (101970)

Carole C, thanks for your comments. I agree with just about everything you said, even discussing snow as a distraction (we got nailed here too). It's just that one would think there'd sometimes be a bit more sophisticated discussion by at least some of its sufferers on items very relevant to beating PF rather than sometimes nothing at all. I don't expect everyone to hang on my every word either, and I certainly don't expect the applause you no doubt would have gotten from members of the G8 if you had posted the exact same thing. Just deadly silence for me. I could just cry. Sob. :-)

[]

Re: the Dornier FDA study at the 1-year mark

Carole C in NOLA on 12/06/02 at 11:25 (101977)

But Elliott, my posts are mostly just stuff that I've observed from my own personal experience. Mine are not especially intellectually interesting, in my opinion, but are simply meant to give people hope and maybe some ideas of things that might help them.

I base my posts on the premise that foot professionals will help us with about 30% of what we need, and that to be healed by traditional conservative means we have to get the other 70% from listening to what our feet are telling us, using common sense, and trying different conservative techniques to find the right combination for us as individuals.

I think everyone appreciates posts that are 'more sophisticated' and more intellectually interesting if they don't seem combative or anything. But when it comes right down to my own feet, often sophisticated posts didn't seem as relevant as 'use a bag of peas to ice your foot, instead of a ziplock full of ice cubes'. Still, they do address that 30% and that's nice. It also gives the doctors a chance for some podiatric repartee, so to speak.

So, YAY, ELLIOTT! for the intellectual aspects of your posts. (Good enough?) :) Yahoo, whoopee? :)

As long as the doctors here realize that we really, really appreciate their posts here and their help, and what they are doing for their patients, if they enjoy the repartee then so much the better. Maybe it keeps them coming back, and if so then you deserve a double 'YAY!!!'

Carole C

Re: the Dornier FDA study at the 1-year mark

elliott on 12/06/02 at 11:38 (101981)

Carole, thanks, I feel so much better now. :-)

Re: the Dornier FDA study at the 1-year mark

elliott on 12/06/02 at 12:02 (101983)

PS, Carole, whether someone who has lost their job due to PF and has mounting debts should borrow $3,000 for ESWT if able is of more than just passing 'intellectual' curiosity.

Re: the Dornier FDA study at the 1-year mark

Carole C in NOLA on 12/06/02 at 12:46 (101990)

I think whether or not that hypothetical person should borrow $3000 for ESWT should NOT depend on the percentage of people who are improved via ESWT, as long as it isn't detrimental. When it comes to my feet (or the hypothetical person's feet) what counts is whether or not the feet in question are improved, more than the percentages.

I'd tell him that if he'd borrow the money for 90% chance of improvement, then he should borrow the money for 51% chance of improvement, contingent on his being ABSOLUTELY SURE that ESWT is not likely to harm his feet.

I feel certain that that is the case.

I don't think a price can be put on one's foot health; either you can afford it, or you can't, but I don't think you can say your foot health is worth X dollars but not (X+1) dollars. This is especially true if the PF sufferer is responsible for supporting dependants, whose welfare may very well depend on him being able to get up on his feet.

So, my feeling is that the hypothetical person who has lost his job due to PF and has mounting debts, should prioritize, not place a price on his foot health. Let's pretend I'm that hypothetical person so that I can write in first person:

Survival has to come first (feeding and sheltering self and family in MINIMAL style). After that, my priorities are such that I'd borrow $3000, or $3005, or $3010 or whatever it takes for ESWT, given that it would improve chances of my getting better. Now if all I could borrow was $3005, and was told 'no' to $3010, that would pretty well put a limit on it. But a desire for a more than minimal standard of living would not. If I could get ESWT for $3005 and it had a 51% chance of helping me, I'd tell my family they'd be eating sloppy joes and not steaks for the foreseeable future, and I'd go ahead and have it done.

Then when/if my feet were better, I'd work overtime and make it up to them. I'm not saying that everyone has my priorities; but I'm saying that this is why the percentages are not as relevant to me as they could be.

Carole C

Re: the Dornier FDA study at the 1-year mark

Carole C in NOLA on 12/06/02 at 12:50 (101991)

Good! :)

So now, you are accepted, lauded, yea, even CHEERED! At last, you are part of the 'G9' to replace the 'G8'? Just imagine the flack you'll get for that. (grin)

Carole C

Re: what I mean is...

Carole C in NOLA on 12/06/02 at 16:47 (102011)

I mean, basically spending the money for ESWT is not like buying a car. It's not like you can get model '51%' for $2500 or model '93%' for $3500. Otherwise, the unemployed hypothetical person might be more interested in the percentages. But as I understand it, most people who get ESWT just go to the best ESWT doctor they know of, pay their money and live with the percentages.

Carole C

Re: Statistics and decisions

Julie on 12/07/02 at 02:38 (102043)

Carole, you make an important point (and Elliott, this does not mean that I don't think you make important points too, and with considerable intellectual rigour :).

Statistics are relevant in the global sense, useful for making global decisions, e.g. in establishing the directions future research might take. For individuals faced with individual decisions, they're relevant only up to a point, and are not necessarily a useful basis for decision-taking. Any individual for whom conservative treatments for PF have failed has before him/her a choice to make about the next logical step, ESWT. If I were faced with that choice, I wouldn't make it on the basis of percentages. Even if were clear from the statistics that only 10%, or 4%, of people showed considerable improvement, I would go for it it with hope that I would be among the lucky ones, and would take comfort from knowing that the treatment would at least do me no harm. (And no, I am not forgetting the expense.)

People suffering from serious cancers go for second and even third rounds of chemotherapy all the time, with similarly based hopes, and with much less reason, for it seems to be quite clear that repeated courses rarely are successful (in terms of increased life expectancy) but almost always do harm (in terms of quality of remaining life).

Perhaps we get a skewed view of things on this heel pain site, but it would seem that the doctors here, particularly Dr Zuckerman and Sunny Jacob, have been pioneering a treatment that has already saved a lot of people from the much more drastic and potentially harmful surgery. So whatever the statistics show, and however they are interpreted, I think thanks are due.

Re: Elliott

Carole C in NOLA on 12/07/02 at 08:02 (102054)

See, Elliott? Now that you are part of the 'G9' you are getting lots of praise and compliments from people. So, no more complaints, ok? (grin)

Carole C

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 10:11 (102067)

Carole I tend to agree with you most people on the board are looking for something practical they can apply right now. We are operating where the rubber meets the road and not in a lab. It is great to uncerstand the dynamics of flight but when you are landing a jet at 160 knots in fog with a 200 foot ceiling and low on fuel then aerodynamics are not really important at that stage of the game.

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 10:14 (102068)

I think it was last year that I seriously offered either $5000 or $10,000 to Sunny/Bayshore if they could cure my bilaterial PF or if they did not there would be no charge. Quiet correctly, Sunny stated that they did not operate in that fashion and probably stretches ethics somewhat. Anyway it was a very serious offer.

Re: what I mean is...

john h on 12/07/02 at 10:28 (102070)

When you have a long term case of bad PF you could care less about stats,cost, your dog, or your cat. You just want help anyway you can find it and will try anythhing from emui oil to a voodoo doll. If you are at a pain level of 9 then a 10% chance of cure from ESWT sounds real good. I can say without qualification that my kidney stone was a pain level 10 and I would have accepted any risk they could thow at me to stop the pain. If some Doc had started quoting studies or stats to me I would have kicked him in the groin and said lets get this sled on the road.

Re: Statistics and decisions

john h on 12/07/02 at 10:35 (102071)

Julie: Looking at stats they may show 20% of women will get breast cancer but if you get it then the only stat that is meaningful to you is you have a 100% chance of getting it. Stats are certainly important in the lab and for the big picutre but once you become a stat with a serious life altering disease then the rules change for you. I sat in a large room in the Phillipines going through jungle survival school. About 50 of us were in the room. The instructor said that stats indicated probably 4 of us would be shot down. That did not impress me very much because that sounded like pretty good odds. Those odds did not look very good when my aircraft went down Laos. Stats are great to have intelectual discussions about but become less meaningful when you have a disease or become one of the stats.

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/07/02 at 12:05 (102081)

John,
What a silly thing to do. Canadian prices are so reasonable just pay the going rate and be done with it. I don't see why you hesitate. All your postings already indicate your belief in it, you've got all the numbers, and vas scores committed to memory, and Sunny is saying that most of their patients are greatly improved if not cured.

Why the hold up? Just go and get treated then come back and tell us as Amy did how great your doing. Time to go see Sunny, John. Put what your quoting on paper into your cure.

I hope you find the courage to go.

Re: Statistics and decisions

Julie on 12/07/02 at 12:06 (102082)

John, yes, that's exactly what I meant.

Re: the Dornier FDA study at the 1-year mark

Dr. Z on 12/07/02 at 12:16 (102084)

John,

the only other treatment before another round of eswt would be radio frequency lesioning procedure. YOu can find it on Dr. Cozzz web site. Why this procedure.? There may be a small nerve in your foot . The ESWT injuries the areas and the small nerve is hurt but not killed. ( this is a guest) but it comes back . Radio lesioning could just kill this nerve. Your trigger point pain area is very easy to find and this is an excellent indication . Talk to Dr. Cozz he knows alot about this treatment

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 13:21 (102105)

Pauline. Right you are. Sometimes we need a little push. If my pain level was where it was 4 or 5 years ago I would be on the next plane north. It is only about a 3 hour flight.

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 13:24 (102106)

Dr. Z: I had radio frequency lesioning in the low back a couple of years ago. Interesting procedure. I got to watch the needle enter the spinal column on the monitor. I did not know this was used on the foot.

Re: the Dornier FDA study at the 1-year mark

Dr. Z on 12/07/02 at 15:28 (102116)

Yes it is used. You can read about it on Dr. Cozz web site. It can work.

Re: the Dornier FDA study at the 1-year mark

elliott on 12/07/02 at 18:48 (102140)

John h, while it's popular for you and others to say the odds don't matter that much, it's interesting to see your 'double or nothing' post (which actually makes a lot of sense in many ways) contradicting all your other posts by placing a more clearcut value on the expense of the treatment (you either get cured albeit at a great expense or it doesn't cost you anything).

The reason many here don't bother trying certain 'fringe' treatments is that they consider the chances of success not worth the money or time. According to the dominant view in this thread, you all should be trying just about everything (note also that eventually there might be a cumulative expense threshold too). It may be easier for someone like Carole (a single professional) to jump in and say she'd just take the ESWT regardless of cost, but others may not have the same utility function for its value. The idea behind these ESWT studies is to get a handle on at least a ballpark figure of what the true chances of success are. I think the jury's still out a bit on that. If it turns out to be more like 25%, well, maybe it's worth trying a second pair of orthotics or a different night splint or whatever first, as they may offer a greater chance of success at lower cost.

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 19:15 (102146)

Elliott: I was trying to convey that if one is suffering from PF with some low pain level he/she will have an entirely different viewpoint about stats/odds than someone suffering from a pain level of 9-10. When you become a stat your view of stats and even good information changes drastically. There are numerous so called cures for cancer and other deadly diseases that are not taken seriously by the medical community or most of the rest of us who are unafflected but once you get the disease people stop analyzing so much and resort to most anything that might help regardless of what other reasonable people might think. Ten years ago if you would have suggest I use emui oil,accupuncture, or wear birk samdals for a disease I would have laughed in your face. Things sure changed when I got PF and my world changed as I had known it. In 1968 I had a lot of philosophical discussion about war and Vietnam but once I got there I no longer cared about the philosophy of war and whether it was right or wrong but more about how to survive and do my job each day. The view on almost any subject is drastically altered depending on where you view it from.I would think Julie's views and my wifes on many things changed with the serious disease they encountered. I have always considered myself mainstream, pragmatic, and researched things concerning my health and other important matters. When I got PF I suddenly was not so mainstream anymore and found out what most on this board have discovered and that is few of your relatives or friends know or will ever know what you are going through.

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 19:22 (102149)

Elliott: My perception is that most people on this board will try almost anything fringe or otherwise. It is just my perception. I certainly have including PF surgery,TTS surgery, cortizone shots, birks,ice, ibuprofen creame. almost ever anti-inflamatory, accupuncture, 4 eswt treatments flying from Little Rock to New Jersey, 3 sets of custom orthotics, night splints, jade, various vitimins, ointments, and creames, night splints, stretching, dozens of over the counter orthotics. I am not sure what I have not tried that has been suggested here. If I do not think it will kill me I am likely to try it regardless of odds or stats because like you I would like to run a couple of miles once again.

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/07/02 at 20:22 (102159)

John,
I think few know what P.F. sufferers go through because it's not one of the more important health conditions on the medical charts. To many doctors, it's a sore foot that according to medical text books goes away with conservative treatment and time. What's all the fuss about?

When a person with this condition can't show his boss, his wife, relatives or friends any outward signs of a body ravaged by disease or a bone poking through skin we can't expect them to understand the daily pain that is associated with P.F. nor the probability that it's long term effects will often result in depression and additional complications.

I personally think that statistics for treatments are important in any disease be it P.F. or cancer. The problem I see here are that the reportings are so many and so often they appear more like an advertisement for treatment rather than simply meaningful information.

Just as we often see posting that say the people who post here are the hard core chronic cases we must also say the doctors who post here and quote the statistics and virtues of ESWT are also the ones who directly benefit from a patient having the theatment.

I'm not saying there is anything wrong with this, but as Elliott has pointed out in the past statistics, with potential personal gains attached, tossed out in the midst a captured audience are certainly up for debate and scrutiny.

I for one am glad we have people like Elliott on this site, and in the world who are willing to challenge the printed word and statistics put in print by others until they reach their own unequivocal answers.

Re: the Dornier FDA study at the 1-year mark

Dr. Z on 12/07/02 at 20:48 (102164)

Pauline is there anything wrong with quoting the FDA studies for the Dornier Epos. Yes i benefit but patients are the ones that really benefit>

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 21:07 (102171)

I am certainly glad Elliott is here also as I respect his opinions and read his post and threads to studies he post on a regular basis. Knowledge can do nothing but educate and inform. Pain and suffering cannot be reduced to statistics. Medicine is more of an art than science (my opinion). The older I get the more I depend less on statistics than I do my instincts based on years of experience amd living. I think they call this wisdom. In my lifetime I have seen so manny things turn around 180 degrees and so many studies prove to be defective that I am somewhat of a skeptic. Concerning PF it seems clear no one really can prove they know what causes it or how to cure it. What works for some people make other people worse. The debate on ESWT (high power,low power,number of treatments) continues. For every study or stat there seems to be one to counter it. I read so many studies I got tired of reading them. I can say for me that ESWT did provide some help but not a cure and in the final analysis that is all I really know about ESWT that is worth while.

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/07/02 at 22:19 (102177)

John,
I'm a walk(well mostly sitting) example of statistics that went astray. It all looked good on paper, the numbers were there and certainly the doctor had the expertise performing 400 cases per year. He teaches his technique around the world, but I can tell you what should have been, what could have been, and ought to have been didn't happen.

Instead 6 weeks later this surgery patient is still recovering inspite of all the statistics, numbers and patients that had the same surgery because of my bodies reaction, not the physicians technique.

Re: the Dornier FDA study at the 1-year mark

elliott on 12/08/02 at 08:10 (102199)

john h, the fact that for every ESWT study or stat there seems to be one to counter it is a reason, at least for some, not to rush and plunk down $3000 until the picture becomes more clear. You can keep repeating that once you have cancer you take a different view, but that does not change the reasoning in my previous sentence. Suppose the ESWT odds were 5% and the cost $100,000. According to you, everyone should still rush to get it. I say the cost and odds would push it out of favor.

Re: the Dornier FDA study at the 1-year mark

elliott on 12/08/02 at 08:16 (102200)

Pauline, judging from my surgeries and those of friends and neighbors, I believe that surgery stats in general are inflated to present a rosier picture than reality, and your reaction to your own surgery is probably more common than a doc would want to admit. What I'm saying is, it's not always that relying on stats is a problem, but rather that the stats are not always portrayed as accurately as they should be. Best wishes for a full recovery.

[]

Re: Pauline, thanks for the kind words (nm)

elliott on 12/08/02 at 08:19 (102202)

.

Re: the Dornier FDA study at the 1-year mark

elliott on 12/08/02 at 08:25 (102204)

Pauline, are you by any chance suggesting that the chances of Amy having successful ESWT were more like 100%, if you know what I mean? :-)

[]

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/08/02 at 09:56 (102216)

Elliott,
In a perfect world, I'd like to believe that everyone's chance for a cure from ESWT begins at 100%. The problem is this is not a perfect world and we're dealing with medical science, machines and more importantly individual human body response so what one may actually achieve in terms of a cure, as I see it, can never be based on a definite 100%.

I don't think any center is providing this quarantee although they are striving to achieve it. My questions lie in how much do you try before
a patient successfully achieves tissue or nerve damage.

Although a much different animal, studies do indicate soft tissue damage
possibilites from blasting Kidney Stones.

I'm realize that I'm comparing apples to oranges, but since the possibility for over use exists so does my quandary.

Re: the Dornier FDA study at the 1-year mark

john h on 12/08/02 at 10:18 (102221)

No Elliott if the odds were 5% and it cost $100,000 I would not rush out to get ESWT. My pain is not that severe. $5000 is witin my reach and when the pain level is high enough I will accept whateve odds are out there be they 5% or 70%. Regarless of the disease there comes a point you would not spend all your money and leave your family with nothing. Unfortunately nearly all of us are limited on what we can spend even if it means life or death. I have never said anyone should 'rush' to get anything. I am not medical specialist of any sort. I can only recount what has worked and or not worked for me. I have suggested that people look at ESWT before surgery but in the final analysis each of us must make our own choice based on what we read including many of your studies you have reported and what your Doctor suggest As I write this I am not sure what we are disagreeing about. Sometimes disagreements occur and get a life of their own and some minor disagreement is lost in the wind. One thing about this board nearly all are facing the same problem and looking for help. Get well Elliott and have a good day.

Re: the Dornier FDA study at the 1-year mark

john h on 12/08/02 at 11:19 (102229)

There have been enough docuumented cases of tissue damage during lithotripsy to know that it exist. Faced with the pain of a kidney stone most patients will quickly opt for the lithotripsy without a second thought. ESWT for various parts of the body has been around a long time and you do not read very much about damage to the foot although there are some cases reported. Sort of like smallpox vaccinations in my mind. I think I read that 2 in one million will die. During the 60's and 70's I think I had about 5 smallpox vaccinations due to world wide travel. My daughter who works in a hospital has been asked to take a smallpox vaccination as she frequently works in the emergeny room. She is going to take it although some of her fellow workers refuse. One of the Canadian doctors who has worked with PF and ESWT on several machines told me that of the chronic patients there are about 15% that just are not going to respond to anything. He did not base this on a study but on many years of experience and treating thousands of patients. If someone with chronic PF arrives on this board and reads all post and Scotts book and many of the various medical and FDA studies I am not sure what conclusion you could arrive at. Some that I conclude is that surgery is risky and can make you worse for life but it also cures many more people than it harms so an individual is left with making the choice if all else fails, to take the risk or not. Considering the nuumber of surgeries performed it appears the risk are not really high but I do not know if we have enough data to assess that risk. I think we have a lot of data right before our eyes with Dr. ED and Dr Z who have perfomed many more ESWT procedures than we see in FDA studies. I trust them both and if it appears they are pushing a product I have no problem with that because I think they not only perform the procedure but believe in it. I have run into a couple of Doctors who were ready to operate withing 10 minutes of talking to me and never even watch me walk so there are people out there that put $$$ first. There is more data on this site with the post, URL's to studies, and patient reports than exist in Wheelless.Book of Ortopedics. One just has to read it and digest it and proceed along with your trusted Doctor to find help.

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/08/02 at 12:07 (102242)

John,
Aren't we having a problem here with reading? If insurance companies are having difficulty in reconciling the JAMA and the FDA reports how do you expect the average patient that pops into this site to digest all the reports, studies and numbers that flash before their eyes?

Re: the Dornier FDA study at the 1-year mark

Dr. Z on 12/08/02 at 12:20 (102244)

The insurance companies aren't having difficulty with the JAMA/ FDA reports. This is an intentional use by the insurance companies to use the JAMA article to support their statements that ESWT is an experimental procedure and that it isn't effective.

I really blame the equipment manufactors for not getting a CPT real code before or shortly after the FDA approval process. Once there is a real CPT code then things should move in the approval process. ESWL had a code right at the start and for Medicare within six months so I am told by the ESWL industry

Re: the Dornier FDA study at the 1-year mark

john h on 12/09/02 at 12:47 (102361)

From a laymans point of view how do I have a lot of confidence in studies that sometimes have only 100 people or so? It seems to me I should absorb these studies and compare it to real world Doctors experience like Dr Ed, Bayshore,Dr. Z,etc who have performed thousands of ESWT procedures.

Most advice on selecting a hospital for a given surgery have you first look at how many of these procedures have been performed in the hospital and what was the outcome. More frequently the hospitals who do it the most are the best and have the better outcomes.

It is not uncommon to see various studies performed by the FDA or other large testing organizations on 20-40,000 people. A test on 100 people does not instill a lot of confidence in me..

Re: the Dornier FDA study at the 1-year mark

john h on 12/09/02 at 12:53 (102362)

I suggest a large number of people decide to have ESWT largely on how much pain they are in and how it has effected their lives. If the pain is bad enough they will somehow figure how to come up with the money. I do not think there are to many PF sufferers reading studies and stats outside the participants on this board. Most are going with what their Doctor suggest.

Re: Statistics and decisions

john h on 12/09/02 at 12:55 (102363)

Julie: What a well writen post.

Re: the Dornier FDA study at the 1-year mark

dave r on 12/09/02 at 12:59 (102365)

John, you hit that nail on the head. i know many people that have pf. men and women alike. I know four personally that have had surgery for it. None of them have ever heard of eswt. I just recently saw one friend at a wake and he said that he had pf and that his doctor said that there was a new procedure out there that cures pf. Its called ewst.
I also started going back to my pod. I saw him last week. I hadnt seen him in over a year, he said that he was training to perform eswt on the Dornier Epos with inline ultrasound. He was very suprised to hear that i had the procedure done twice. He was surprised how much i knew about it and that most patients dont have any idea whats out there. they just want relief in any way or shape. Some are desperate and will try anything.

Re: the Dornier FDA study at the 1-year mark

john h on 12/09/02 at 13:12 (102366)

Pauline: You are right. in my opinion most average people who pop in here might go into a trance reading all these various studies. Probably 98% of all PF patients never read any study or have any idea about outcomes of ESWT and surgery. Most by far will depend on the advice of their Physician.

Re: Carole C... cost is what?

Sheila S on 12/10/02 at 07:30 (102504)

Carole, I couldn't come up with a good search to find this and feel sure it's been discussed; what is the cost of an ESWT machine? at $3,000 for treatment I'm wondering how many treatments before the machine is paid for....and why so expensive. Or is the cost primarily for the knowledge required to use it?

My pod's fee was about $800 for his part in my neuroma surgery...with hospital fees, anesthesia & -ologists, etc., it all totalled $5,200 when said and done. BUT he charged $225 PER SHOT for 7 Sclerosing injections in his office. No wonder he isn't doing surgeries anymore.....do the math.

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

Pauline on 12/05/02 at 10:59 (101849)

Elliott,
Too much digging. This is also available at:
http://www.aofas.org/02summer/200207130852.asp I've also seen another one on the same site.

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

elliott on 12/05/02 at 11:10 (101850)

And you kept this all to yourself all this time, Pauline?!?

[]

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

Pauline on 12/05/02 at 11:37 (101852)

Elliott,
It's not keeping things to myself, but rather people are unwilling to believe. Had you not posted this information first they would have thought I was lying. The accusations have always been there way back to the days of the 'Big O' , but you were actually the first person put the 'word' in print and ask if I was being accused of lying. As I remember, you got no response and as it turned out every word I posted even about 'Big O' came to pass.

I more than likely could have helped provide you with the information you were seeking via backboarding in a more timely fashion. You just have to believe and I think you have all along.

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

Dr. Z on 12/05/02 at 11:45 (101853)

Do you think the one year follow is a very positive report for ESWT with the dornier Epos. ??

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

elliott on 12/05/02 at 14:13 (101862)

Dr. Z, is your question addressed to me or Pauline?

[]

Re: I think this is a report on the Dornier FDA study at the 1-year mark!

elliott on 12/05/02 at 14:25 (101863)

Pauline, too cryptic for me. I wish you'd just come right out and say what's on your mind.

[]

Re: the Dornier FDA study at the 1-year mark

elliott on 12/06/02 at 09:36 (101958)

You know, it's interesting, Dr. Z, as important as the implications of this study might be, no one at all on these boards bothered to give an opinion on these long-awaited final results. You'd think what with 93% success or whatever, they'd find the time to take a break from discussing snow on Social to dance up and down with joy (if their PF allows them to) at what would essentially signify the end of PF in our times as we know it. Conservative means failed? No problem! You still got over 90% odds with Dr. Z's ESWT!

Well, if no one else is going to give it a shot, here's my thoughts on the one-year preliminary results:

The first thing I will say is that it shows good promise for the merits of ESWT, as the treatment group beat the control group by quite a bit more than random. It is certainly a reason to consider ESWT, if the cost is not prohibitive, before a more risky surgery, especially what with some of the post-surgery horror stories we see here. That said, I'll observe that at three months, the control group also had substantial VAS success, even as compared to the treatment group (45% vs. 56%). That should at least be an eye-opening reminder to tread with caution before jumping to far-reaching conclusions, i.e., it is apparent that we are observing a good chunk who would have got better without ESWT (as to be expected with PF) due either to normal progression or else falling for one hell of a placebo effect. Furthermore, the crossover group--those who failed to improve with the sham treatment and were then offered the real thing at 3 months--offers a very interesting insight on things, since they didn't fall for sham ESWT and didn't improve in those first three months, and so this group is perhaps more likely than the rest not to fall for the real ESWT if it happens not to work for them. And indeed, at the 12-month mark (which if I'm reading the abstract right, is 9 months post-ESWT for this crossover group) had a high R & M score, they showed only 63% VAS success as compared to 94% for the other treatment group. Why? It seems to me highly unlikely that this is due to being 'only' 9 months post-op instead of 12, not least because the original treatment group already achieved just about this exact same figure at the 3-month mark. Also, one does wonder if the selection criteria (not that I have a problem with them) somehow played a role, as we are witnessing far too many failed ESWT results on patients on these boards to equate their chances to a 90%+ success rate.

One further point: it looks like Dr. Zingas wasn't some two-bit player in this study; with his name appearing first, it looks more like he ran the whole kit & kaboodle. If Pauline says Dr. Zingas is somewhat hesitant about the results, I for one believe she is not lying. I am still wondering if he might have changed his mind more favorably since she last spoke with him, so maybe we should all pitch in and cover her co-pay for another visit, whether she needs it or not. :-)

[]

Re: the Dornier FDA study at the 1-year mark

Carole C in NOLA on 12/06/02 at 10:27 (101964)

Elliott, both traditional conservative treatments for PF and ESWT show a high percentage of success. I know that if I still had PF symptoms (which I don't, due to my success in applying traditional conservative treatments), I would do everything possible to heal it. It only makes sense to progress from the most conservative and inexpensive treatments to more expensive and surgical treatments rather than in the reverse order.

So yes, had traditional conservative treatments failed me, I would have paid for ESWT. I would have done that whether the success rate was fabulously improved or only slightly improved with ESWT, because ESWT would have been the next logical step to take. I do not believe that ESWT makes PF worse, so why not? As expensive as ESWT is, I hated having PF so much that I would have paid for it even if my chances of improvement were only very slightly better than without it.

As long as the percentage improved is not worse with ESWT than without, it really makes no difference in the course of action that I would have taken. You may find the study interesting but that doesn't mean that we all do. So please, discuss away but don't expect everyone to hang on your every word. The study is an interesting bit of trivia but not necessarily relevant to what treatment I would have sought and in what order, assuming that ESWT is not harmful. I believe that assumption to be correct.

If traditional conservative means had failed me, and ESWT had failed me, I would have then looked into surgery.

I HATE PF!!! I hated having it and I am SO GLAD to be feeling better now and I never, never, never ever want to have to go through that again.

PF symptoms and depression are so closely tied, each seeming to feed off the other. During the holiday season, when so many people with or without PF are depressed, there is nothing wrong and everything right with sharing our snow stories and cameraderie, and discussing the snow on the social board. It makes this time more bearable for those with PF. The social board is for discussions that aren't related to specific foot topics like ESWT, so what is wrong with good cheer there?

Carole C

Re: the Dornier FDA study at the 1-year mark

elliott on 12/06/02 at 10:45 (101970)

Carole C, thanks for your comments. I agree with just about everything you said, even discussing snow as a distraction (we got nailed here too). It's just that one would think there'd sometimes be a bit more sophisticated discussion by at least some of its sufferers on items very relevant to beating PF rather than sometimes nothing at all. I don't expect everyone to hang on my every word either, and I certainly don't expect the applause you no doubt would have gotten from members of the G8 if you had posted the exact same thing. Just deadly silence for me. I could just cry. Sob. :-)

[]

Re: the Dornier FDA study at the 1-year mark

Carole C in NOLA on 12/06/02 at 11:25 (101977)

But Elliott, my posts are mostly just stuff that I've observed from my own personal experience. Mine are not especially intellectually interesting, in my opinion, but are simply meant to give people hope and maybe some ideas of things that might help them.

I base my posts on the premise that foot professionals will help us with about 30% of what we need, and that to be healed by traditional conservative means we have to get the other 70% from listening to what our feet are telling us, using common sense, and trying different conservative techniques to find the right combination for us as individuals.

I think everyone appreciates posts that are 'more sophisticated' and more intellectually interesting if they don't seem combative or anything. But when it comes right down to my own feet, often sophisticated posts didn't seem as relevant as 'use a bag of peas to ice your foot, instead of a ziplock full of ice cubes'. Still, they do address that 30% and that's nice. It also gives the doctors a chance for some podiatric repartee, so to speak.

So, YAY, ELLIOTT! for the intellectual aspects of your posts. (Good enough?) :) Yahoo, whoopee? :)

As long as the doctors here realize that we really, really appreciate their posts here and their help, and what they are doing for their patients, if they enjoy the repartee then so much the better. Maybe it keeps them coming back, and if so then you deserve a double 'YAY!!!'

Carole C

Re: the Dornier FDA study at the 1-year mark

elliott on 12/06/02 at 11:38 (101981)

Carole, thanks, I feel so much better now. :-)

Re: the Dornier FDA study at the 1-year mark

elliott on 12/06/02 at 12:02 (101983)

PS, Carole, whether someone who has lost their job due to PF and has mounting debts should borrow $3,000 for ESWT if able is of more than just passing 'intellectual' curiosity.

Re: the Dornier FDA study at the 1-year mark

Carole C in NOLA on 12/06/02 at 12:46 (101990)

I think whether or not that hypothetical person should borrow $3000 for ESWT should NOT depend on the percentage of people who are improved via ESWT, as long as it isn't detrimental. When it comes to my feet (or the hypothetical person's feet) what counts is whether or not the feet in question are improved, more than the percentages.

I'd tell him that if he'd borrow the money for 90% chance of improvement, then he should borrow the money for 51% chance of improvement, contingent on his being ABSOLUTELY SURE that ESWT is not likely to harm his feet.

I feel certain that that is the case.

I don't think a price can be put on one's foot health; either you can afford it, or you can't, but I don't think you can say your foot health is worth X dollars but not (X+1) dollars. This is especially true if the PF sufferer is responsible for supporting dependants, whose welfare may very well depend on him being able to get up on his feet.

So, my feeling is that the hypothetical person who has lost his job due to PF and has mounting debts, should prioritize, not place a price on his foot health. Let's pretend I'm that hypothetical person so that I can write in first person:

Survival has to come first (feeding and sheltering self and family in MINIMAL style). After that, my priorities are such that I'd borrow $3000, or $3005, or $3010 or whatever it takes for ESWT, given that it would improve chances of my getting better. Now if all I could borrow was $3005, and was told 'no' to $3010, that would pretty well put a limit on it. But a desire for a more than minimal standard of living would not. If I could get ESWT for $3005 and it had a 51% chance of helping me, I'd tell my family they'd be eating sloppy joes and not steaks for the foreseeable future, and I'd go ahead and have it done.

Then when/if my feet were better, I'd work overtime and make it up to them. I'm not saying that everyone has my priorities; but I'm saying that this is why the percentages are not as relevant to me as they could be.

Carole C

Re: the Dornier FDA study at the 1-year mark

Carole C in NOLA on 12/06/02 at 12:50 (101991)

Good! :)

So now, you are accepted, lauded, yea, even CHEERED! At last, you are part of the 'G9' to replace the 'G8'? Just imagine the flack you'll get for that. (grin)

Carole C

Re: what I mean is...

Carole C in NOLA on 12/06/02 at 16:47 (102011)

I mean, basically spending the money for ESWT is not like buying a car. It's not like you can get model '51%' for $2500 or model '93%' for $3500. Otherwise, the unemployed hypothetical person might be more interested in the percentages. But as I understand it, most people who get ESWT just go to the best ESWT doctor they know of, pay their money and live with the percentages.

Carole C

Re: Statistics and decisions

Julie on 12/07/02 at 02:38 (102043)

Carole, you make an important point (and Elliott, this does not mean that I don't think you make important points too, and with considerable intellectual rigour :).

Statistics are relevant in the global sense, useful for making global decisions, e.g. in establishing the directions future research might take. For individuals faced with individual decisions, they're relevant only up to a point, and are not necessarily a useful basis for decision-taking. Any individual for whom conservative treatments for PF have failed has before him/her a choice to make about the next logical step, ESWT. If I were faced with that choice, I wouldn't make it on the basis of percentages. Even if were clear from the statistics that only 10%, or 4%, of people showed considerable improvement, I would go for it it with hope that I would be among the lucky ones, and would take comfort from knowing that the treatment would at least do me no harm. (And no, I am not forgetting the expense.)

People suffering from serious cancers go for second and even third rounds of chemotherapy all the time, with similarly based hopes, and with much less reason, for it seems to be quite clear that repeated courses rarely are successful (in terms of increased life expectancy) but almost always do harm (in terms of quality of remaining life).

Perhaps we get a skewed view of things on this heel pain site, but it would seem that the doctors here, particularly Dr Zuckerman and Sunny Jacob, have been pioneering a treatment that has already saved a lot of people from the much more drastic and potentially harmful surgery. So whatever the statistics show, and however they are interpreted, I think thanks are due.

Re: Elliott

Carole C in NOLA on 12/07/02 at 08:02 (102054)

See, Elliott? Now that you are part of the 'G9' you are getting lots of praise and compliments from people. So, no more complaints, ok? (grin)

Carole C

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 10:11 (102067)

Carole I tend to agree with you most people on the board are looking for something practical they can apply right now. We are operating where the rubber meets the road and not in a lab. It is great to uncerstand the dynamics of flight but when you are landing a jet at 160 knots in fog with a 200 foot ceiling and low on fuel then aerodynamics are not really important at that stage of the game.

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 10:14 (102068)

I think it was last year that I seriously offered either $5000 or $10,000 to Sunny/Bayshore if they could cure my bilaterial PF or if they did not there would be no charge. Quiet correctly, Sunny stated that they did not operate in that fashion and probably stretches ethics somewhat. Anyway it was a very serious offer.

Re: what I mean is...

john h on 12/07/02 at 10:28 (102070)

When you have a long term case of bad PF you could care less about stats,cost, your dog, or your cat. You just want help anyway you can find it and will try anythhing from emui oil to a voodoo doll. If you are at a pain level of 9 then a 10% chance of cure from ESWT sounds real good. I can say without qualification that my kidney stone was a pain level 10 and I would have accepted any risk they could thow at me to stop the pain. If some Doc had started quoting studies or stats to me I would have kicked him in the groin and said lets get this sled on the road.

Re: Statistics and decisions

john h on 12/07/02 at 10:35 (102071)

Julie: Looking at stats they may show 20% of women will get breast cancer but if you get it then the only stat that is meaningful to you is you have a 100% chance of getting it. Stats are certainly important in the lab and for the big picutre but once you become a stat with a serious life altering disease then the rules change for you. I sat in a large room in the Phillipines going through jungle survival school. About 50 of us were in the room. The instructor said that stats indicated probably 4 of us would be shot down. That did not impress me very much because that sounded like pretty good odds. Those odds did not look very good when my aircraft went down Laos. Stats are great to have intelectual discussions about but become less meaningful when you have a disease or become one of the stats.

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/07/02 at 12:05 (102081)

John,
What a silly thing to do. Canadian prices are so reasonable just pay the going rate and be done with it. I don't see why you hesitate. All your postings already indicate your belief in it, you've got all the numbers, and vas scores committed to memory, and Sunny is saying that most of their patients are greatly improved if not cured.

Why the hold up? Just go and get treated then come back and tell us as Amy did how great your doing. Time to go see Sunny, John. Put what your quoting on paper into your cure.

I hope you find the courage to go.

Re: Statistics and decisions

Julie on 12/07/02 at 12:06 (102082)

John, yes, that's exactly what I meant.

Re: the Dornier FDA study at the 1-year mark

Dr. Z on 12/07/02 at 12:16 (102084)

John,

the only other treatment before another round of eswt would be radio frequency lesioning procedure. YOu can find it on Dr. Cozzz web site. Why this procedure.? There may be a small nerve in your foot . The ESWT injuries the areas and the small nerve is hurt but not killed. ( this is a guest) but it comes back . Radio lesioning could just kill this nerve. Your trigger point pain area is very easy to find and this is an excellent indication . Talk to Dr. Cozz he knows alot about this treatment

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 13:21 (102105)

Pauline. Right you are. Sometimes we need a little push. If my pain level was where it was 4 or 5 years ago I would be on the next plane north. It is only about a 3 hour flight.

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 13:24 (102106)

Dr. Z: I had radio frequency lesioning in the low back a couple of years ago. Interesting procedure. I got to watch the needle enter the spinal column on the monitor. I did not know this was used on the foot.

Re: the Dornier FDA study at the 1-year mark

Dr. Z on 12/07/02 at 15:28 (102116)

Yes it is used. You can read about it on Dr. Cozz web site. It can work.

Re: the Dornier FDA study at the 1-year mark

elliott on 12/07/02 at 18:48 (102140)

John h, while it's popular for you and others to say the odds don't matter that much, it's interesting to see your 'double or nothing' post (which actually makes a lot of sense in many ways) contradicting all your other posts by placing a more clearcut value on the expense of the treatment (you either get cured albeit at a great expense or it doesn't cost you anything).

The reason many here don't bother trying certain 'fringe' treatments is that they consider the chances of success not worth the money or time. According to the dominant view in this thread, you all should be trying just about everything (note also that eventually there might be a cumulative expense threshold too). It may be easier for someone like Carole (a single professional) to jump in and say she'd just take the ESWT regardless of cost, but others may not have the same utility function for its value. The idea behind these ESWT studies is to get a handle on at least a ballpark figure of what the true chances of success are. I think the jury's still out a bit on that. If it turns out to be more like 25%, well, maybe it's worth trying a second pair of orthotics or a different night splint or whatever first, as they may offer a greater chance of success at lower cost.

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 19:15 (102146)

Elliott: I was trying to convey that if one is suffering from PF with some low pain level he/she will have an entirely different viewpoint about stats/odds than someone suffering from a pain level of 9-10. When you become a stat your view of stats and even good information changes drastically. There are numerous so called cures for cancer and other deadly diseases that are not taken seriously by the medical community or most of the rest of us who are unafflected but once you get the disease people stop analyzing so much and resort to most anything that might help regardless of what other reasonable people might think. Ten years ago if you would have suggest I use emui oil,accupuncture, or wear birk samdals for a disease I would have laughed in your face. Things sure changed when I got PF and my world changed as I had known it. In 1968 I had a lot of philosophical discussion about war and Vietnam but once I got there I no longer cared about the philosophy of war and whether it was right or wrong but more about how to survive and do my job each day. The view on almost any subject is drastically altered depending on where you view it from.I would think Julie's views and my wifes on many things changed with the serious disease they encountered. I have always considered myself mainstream, pragmatic, and researched things concerning my health and other important matters. When I got PF I suddenly was not so mainstream anymore and found out what most on this board have discovered and that is few of your relatives or friends know or will ever know what you are going through.

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 19:22 (102149)

Elliott: My perception is that most people on this board will try almost anything fringe or otherwise. It is just my perception. I certainly have including PF surgery,TTS surgery, cortizone shots, birks,ice, ibuprofen creame. almost ever anti-inflamatory, accupuncture, 4 eswt treatments flying from Little Rock to New Jersey, 3 sets of custom orthotics, night splints, jade, various vitimins, ointments, and creames, night splints, stretching, dozens of over the counter orthotics. I am not sure what I have not tried that has been suggested here. If I do not think it will kill me I am likely to try it regardless of odds or stats because like you I would like to run a couple of miles once again.

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/07/02 at 20:22 (102159)

John,
I think few know what P.F. sufferers go through because it's not one of the more important health conditions on the medical charts. To many doctors, it's a sore foot that according to medical text books goes away with conservative treatment and time. What's all the fuss about?

When a person with this condition can't show his boss, his wife, relatives or friends any outward signs of a body ravaged by disease or a bone poking through skin we can't expect them to understand the daily pain that is associated with P.F. nor the probability that it's long term effects will often result in depression and additional complications.

I personally think that statistics for treatments are important in any disease be it P.F. or cancer. The problem I see here are that the reportings are so many and so often they appear more like an advertisement for treatment rather than simply meaningful information.

Just as we often see posting that say the people who post here are the hard core chronic cases we must also say the doctors who post here and quote the statistics and virtues of ESWT are also the ones who directly benefit from a patient having the theatment.

I'm not saying there is anything wrong with this, but as Elliott has pointed out in the past statistics, with potential personal gains attached, tossed out in the midst a captured audience are certainly up for debate and scrutiny.

I for one am glad we have people like Elliott on this site, and in the world who are willing to challenge the printed word and statistics put in print by others until they reach their own unequivocal answers.

Re: the Dornier FDA study at the 1-year mark

Dr. Z on 12/07/02 at 20:48 (102164)

Pauline is there anything wrong with quoting the FDA studies for the Dornier Epos. Yes i benefit but patients are the ones that really benefit>

Re: the Dornier FDA study at the 1-year mark

john h on 12/07/02 at 21:07 (102171)

I am certainly glad Elliott is here also as I respect his opinions and read his post and threads to studies he post on a regular basis. Knowledge can do nothing but educate and inform. Pain and suffering cannot be reduced to statistics. Medicine is more of an art than science (my opinion). The older I get the more I depend less on statistics than I do my instincts based on years of experience amd living. I think they call this wisdom. In my lifetime I have seen so manny things turn around 180 degrees and so many studies prove to be defective that I am somewhat of a skeptic. Concerning PF it seems clear no one really can prove they know what causes it or how to cure it. What works for some people make other people worse. The debate on ESWT (high power,low power,number of treatments) continues. For every study or stat there seems to be one to counter it. I read so many studies I got tired of reading them. I can say for me that ESWT did provide some help but not a cure and in the final analysis that is all I really know about ESWT that is worth while.

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/07/02 at 22:19 (102177)

John,
I'm a walk(well mostly sitting) example of statistics that went astray. It all looked good on paper, the numbers were there and certainly the doctor had the expertise performing 400 cases per year. He teaches his technique around the world, but I can tell you what should have been, what could have been, and ought to have been didn't happen.

Instead 6 weeks later this surgery patient is still recovering inspite of all the statistics, numbers and patients that had the same surgery because of my bodies reaction, not the physicians technique.

Re: the Dornier FDA study at the 1-year mark

elliott on 12/08/02 at 08:10 (102199)

john h, the fact that for every ESWT study or stat there seems to be one to counter it is a reason, at least for some, not to rush and plunk down $3000 until the picture becomes more clear. You can keep repeating that once you have cancer you take a different view, but that does not change the reasoning in my previous sentence. Suppose the ESWT odds were 5% and the cost $100,000. According to you, everyone should still rush to get it. I say the cost and odds would push it out of favor.

Re: the Dornier FDA study at the 1-year mark

elliott on 12/08/02 at 08:16 (102200)

Pauline, judging from my surgeries and those of friends and neighbors, I believe that surgery stats in general are inflated to present a rosier picture than reality, and your reaction to your own surgery is probably more common than a doc would want to admit. What I'm saying is, it's not always that relying on stats is a problem, but rather that the stats are not always portrayed as accurately as they should be. Best wishes for a full recovery.

[]

Re: Pauline, thanks for the kind words (nm)

elliott on 12/08/02 at 08:19 (102202)

.

Re: the Dornier FDA study at the 1-year mark

elliott on 12/08/02 at 08:25 (102204)

Pauline, are you by any chance suggesting that the chances of Amy having successful ESWT were more like 100%, if you know what I mean? :-)

[]

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/08/02 at 09:56 (102216)

Elliott,
In a perfect world, I'd like to believe that everyone's chance for a cure from ESWT begins at 100%. The problem is this is not a perfect world and we're dealing with medical science, machines and more importantly individual human body response so what one may actually achieve in terms of a cure, as I see it, can never be based on a definite 100%.

I don't think any center is providing this quarantee although they are striving to achieve it. My questions lie in how much do you try before
a patient successfully achieves tissue or nerve damage.

Although a much different animal, studies do indicate soft tissue damage
possibilites from blasting Kidney Stones.

I'm realize that I'm comparing apples to oranges, but since the possibility for over use exists so does my quandary.

Re: the Dornier FDA study at the 1-year mark

john h on 12/08/02 at 10:18 (102221)

No Elliott if the odds were 5% and it cost $100,000 I would not rush out to get ESWT. My pain is not that severe. $5000 is witin my reach and when the pain level is high enough I will accept whateve odds are out there be they 5% or 70%. Regarless of the disease there comes a point you would not spend all your money and leave your family with nothing. Unfortunately nearly all of us are limited on what we can spend even if it means life or death. I have never said anyone should 'rush' to get anything. I am not medical specialist of any sort. I can only recount what has worked and or not worked for me. I have suggested that people look at ESWT before surgery but in the final analysis each of us must make our own choice based on what we read including many of your studies you have reported and what your Doctor suggest As I write this I am not sure what we are disagreeing about. Sometimes disagreements occur and get a life of their own and some minor disagreement is lost in the wind. One thing about this board nearly all are facing the same problem and looking for help. Get well Elliott and have a good day.

Re: the Dornier FDA study at the 1-year mark

john h on 12/08/02 at 11:19 (102229)

There have been enough docuumented cases of tissue damage during lithotripsy to know that it exist. Faced with the pain of a kidney stone most patients will quickly opt for the lithotripsy without a second thought. ESWT for various parts of the body has been around a long time and you do not read very much about damage to the foot although there are some cases reported. Sort of like smallpox vaccinations in my mind. I think I read that 2 in one million will die. During the 60's and 70's I think I had about 5 smallpox vaccinations due to world wide travel. My daughter who works in a hospital has been asked to take a smallpox vaccination as she frequently works in the emergeny room. She is going to take it although some of her fellow workers refuse. One of the Canadian doctors who has worked with PF and ESWT on several machines told me that of the chronic patients there are about 15% that just are not going to respond to anything. He did not base this on a study but on many years of experience and treating thousands of patients. If someone with chronic PF arrives on this board and reads all post and Scotts book and many of the various medical and FDA studies I am not sure what conclusion you could arrive at. Some that I conclude is that surgery is risky and can make you worse for life but it also cures many more people than it harms so an individual is left with making the choice if all else fails, to take the risk or not. Considering the nuumber of surgeries performed it appears the risk are not really high but I do not know if we have enough data to assess that risk. I think we have a lot of data right before our eyes with Dr. ED and Dr Z who have perfomed many more ESWT procedures than we see in FDA studies. I trust them both and if it appears they are pushing a product I have no problem with that because I think they not only perform the procedure but believe in it. I have run into a couple of Doctors who were ready to operate withing 10 minutes of talking to me and never even watch me walk so there are people out there that put $$$ first. There is more data on this site with the post, URL's to studies, and patient reports than exist in Wheelless.Book of Ortopedics. One just has to read it and digest it and proceed along with your trusted Doctor to find help.

Re: the Dornier FDA study at the 1-year mark

Pauline on 12/08/02 at 12:07 (102242)

John,
Aren't we having a problem here with reading? If insurance companies are having difficulty in reconciling the JAMA and the FDA reports how do you expect the average patient that pops into this site to digest all the reports, studies and numbers that flash before their eyes?

Re: the Dornier FDA study at the 1-year mark

Dr. Z on 12/08/02 at 12:20 (102244)

The insurance companies aren't having difficulty with the JAMA/ FDA reports. This is an intentional use by the insurance companies to use the JAMA article to support their statements that ESWT is an experimental procedure and that it isn't effective.

I really blame the equipment manufactors for not getting a CPT real code before or shortly after the FDA approval process. Once there is a real CPT code then things should move in the approval process. ESWL had a code right at the start and for Medicare within six months so I am told by the ESWL industry

Re: the Dornier FDA study at the 1-year mark

john h on 12/09/02 at 12:47 (102361)

From a laymans point of view how do I have a lot of confidence in studies that sometimes have only 100 people or so? It seems to me I should absorb these studies and compare it to real world Doctors experience like Dr Ed, Bayshore,Dr. Z,etc who have performed thousands of ESWT procedures.

Most advice on selecting a hospital for a given surgery have you first look at how many of these procedures have been performed in the hospital and what was the outcome. More frequently the hospitals who do it the most are the best and have the better outcomes.

It is not uncommon to see various studies performed by the FDA or other large testing organizations on 20-40,000 people. A test on 100 people does not instill a lot of confidence in me..

Re: the Dornier FDA study at the 1-year mark

john h on 12/09/02 at 12:53 (102362)

I suggest a large number of people decide to have ESWT largely on how much pain they are in and how it has effected their lives. If the pain is bad enough they will somehow figure how to come up with the money. I do not think there are to many PF sufferers reading studies and stats outside the participants on this board. Most are going with what their Doctor suggest.

Re: Statistics and decisions

john h on 12/09/02 at 12:55 (102363)

Julie: What a well writen post.

Re: the Dornier FDA study at the 1-year mark

dave r on 12/09/02 at 12:59 (102365)

John, you hit that nail on the head. i know many people that have pf. men and women alike. I know four personally that have had surgery for it. None of them have ever heard of eswt. I just recently saw one friend at a wake and he said that he had pf and that his doctor said that there was a new procedure out there that cures pf. Its called ewst.
I also started going back to my pod. I saw him last week. I hadnt seen him in over a year, he said that he was training to perform eswt on the Dornier Epos with inline ultrasound. He was very suprised to hear that i had the procedure done twice. He was surprised how much i knew about it and that most patients dont have any idea whats out there. they just want relief in any way or shape. Some are desperate and will try anything.

Re: the Dornier FDA study at the 1-year mark

john h on 12/09/02 at 13:12 (102366)

Pauline: You are right. in my opinion most average people who pop in here might go into a trance reading all these various studies. Probably 98% of all PF patients never read any study or have any idea about outcomes of ESWT and surgery. Most by far will depend on the advice of their Physician.

Re: Carole C... cost is what?

Sheila S on 12/10/02 at 07:30 (102504)

Carole, I couldn't come up with a good search to find this and feel sure it's been discussed; what is the cost of an ESWT machine? at $3,000 for treatment I'm wondering how many treatments before the machine is paid for....and why so expensive. Or is the cost primarily for the knowledge required to use it?

My pod's fee was about $800 for his part in my neuroma surgery...with hospital fees, anesthesia & -ologists, etc., it all totalled $5,200 when said and done. BUT he charged $225 PER SHOT for 7 Sclerosing injections in his office. No wonder he isn't doing surgeries anymore.....do the math.