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the Dornier Epos study preliminary one-year results (at last!!)

Posted by elliott on 9/11/02 at 15:19 (095035)

Good thing too--felt we were getting old waiting for Dr. Z to come through. (Maybe he's just not enthusiastic enough about Dornier to report the official fabulous results. :-))

http://www.aofas.org/02summer/200207130852.asp

------

Re: the Dornier Epos study preliminary one-year results (at last!!)

Pauline on 9/11/02 at 15:39 (095039)

Elliott,
Sure enough that's my doc 'Zingas' in big bold letters. Interesting thing is he's not using the Dornier yet. Oh it's there, but held in red tape. An interesting story too long to put in print.

This is the study that the FDA had posted, but pulled when they found out it hadn't been formally presented. Another No No. It had to go to meetin' first.

Re: the Dornier Epos study preliminary one-year results (at last!!)

Dr. Z on 9/11/02 at 17:46 (095056)

At last. I have been reporting these results for the past few months. I
guess you need to hear from someone else. The most important thing is look how great the resuls are !!!

Re: Throw that man a bone :*)

BrianG on 9/11/02 at 18:16 (095059)

Very good Elliott, it took awhile, but you finally found it, good doggy :*)
I would like to add my two cents to these FDA trials. I did apply, back then, but was too late at the time. One thing I discovered was that they would not take anyone that had previous surgery. That could swing the odds in their favor. Also, the people that I've seen interviewed after their treatment, were all patients that had PF for approximatly 1 year.

Do you see what I'm getting at? I do believe that the trials were done under very strict guidelines, but if you only admit people who are the most apt to be healed, then what does it say for the rest of us that have had PF for years? I think someone should do some trials that consist of patients that have had PF for at least 5 years. I'd bet you anything the results would not be so rosey!!

But, don't get me wrong here, I still believe that ESWT should always be tried 1st for PF, before any surgery is considered.

BrianG

Re: Throw that man a bone :*)

Dr. Z on 9/11/02 at 20:22 (095063)

The average patient has pf for two years . That is a long time as you know already

Re: the Dornier Epos study preliminary one-year results (at last!!)

elliott on 9/11/02 at 21:10 (095074)

Actually, this is at a later point in time--one year--of the 3-month study upon which the FDA relied. Funny, but the published version of the 3-month study itself just came out:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12219661&dopt=Abstract

http://link.springer-ny.com/link/service/journals/00132/bibs/2031007/20310637.htm

If only someone had reading privileges at the second link and could copy it for us so we could see the nitty-gritty details.

-----

Re: the Dornier Epos study preliminary one-year results (at last!!)

elliott on 9/11/02 at 21:12 (095075)

There's still some fishy things going on. Earlier, you said 92% success and this says 94%. :-)

----

Re: every dog has its day :-)

elliott on 9/11/02 at 21:30 (095080)

I agree with you that some caution is warranted. We have yet to figure out why this board's ESWT experience seems nowhere close to that in the study; I think we should now be giving this much thought. (I don't blame the researchers for excluding those who had previous surgery--introduces too many new variables; also, in future people would likely be getting ESWT first anyway. Their view may also be that in future there will hardly be any patients who went 5 years without trying ESWT.) A look at the actual paper may help. In addition, as I pointed out a while back, the placebo group seems in general to do rather well too, so that one might more soberly want to view ESWT's 'value added' over that. Nevertheless, Dr. Z is claiming the *average* duration of PF was 2 years, which is not trivial.

Dr. Z, if you ever get a hold of the complete study, please post it here. Thanks.

-----

Re: the Dornier Epos study preliminary one-year results (at last!!)

Dr. Z on 9/11/02 at 21:59 (095094)

The 94% is the one year follow up using the roles/ maundsley scoring . The 92% is the average pain reduction using the VAS . The something fishy is your inability to read. Sorry I had to say this. couldn't help it . Elliott happy new year

Re: every dog has its day :-)

john h on 9/12/02 at 10:09 (095127)

Dr. Gordon in Canada suggest the Ossatron (High Power) on a foot that has had previous surgery because of scar tissue. Otherwise he says you can go with either the high power or low power protool as he uses both machines.I think he and Bayshore are still in the midst of a study comparying low power treatments vs high power treatments. My understanding is Bayshore uses both low and high power machines but uses the high power mostly on conditions other than PF..

I will end up being a good test subject since I had surgery on one foot and not on the other. I do plan on having both feet treated again hopefully before the end of the year. I can say that treatment with the Orby did improve my feet after 4 years of PF and both feet were improved equally. Treatment was with the Orby.

Re: Throw that man a bone :*)

john h on 9/12/02 at 10:10 (095129)

Dr Z: If you have had PF for 2 years are you really very different from someone who has had it for 5 years or more. Both are obviously Chronic?

Re: Throw that man a bone :*)

john h on 9/12/02 at 10:41 (095130)

Brian: I think that both you and I know the longer you have PF the more difficult it becomes to manage. As I asked Dr. Z it would seem to me that after you pass the 2 year mark or near there you are chronic and not much different than someone who has had it for 5 years. As to treatment of surgical patients there is surgery and there is surgery. Some people have had horrible and multiple surgeries while others have had MIS surgeries or other types and have been cured. Once that fascia has been cut particularly a release of 50% or more there is no going back. I am anxious to see what the results will be on my feet with one of the newer machines since I have had one foot with surgery and one without.However bascially most of my fascia is still intact. I really cannot feel much scar tissue in the foot with surgery but obviously there will be some there. In any event we all got to where we are by a different path and what will work for one may not work for the other so ultimately you must make the decision to have ESWT or not. Since ESWT is nearly a risk free procedure I would think anyone who can afford it would 'run' (pun) to try it before you become a chronic hard to manage case. I always refresh my outlook when I see a guy like Mohez cured after 10 years by the use of ESWT I also think of Yoko who is back to running marathons after over a year of barely being able to walk. There is hope out there-

Re: Throw that man a bone :*)

dave r on 9/12/02 at 11:50 (095139)

John, i thought that you were really improving? I remember awhile back that you had posted that you had gone along time without a flare up?
Are you planning on going to Canada?

Re: Throw that man a bone :*)

john h on 9/12/02 at 15:35 (095160)

Dave: i had imnproved to a pain level of 1 for about 6 months then about a month or so ago I did some stupid things and had a reversal. I am still not at the pain level many of your are but i am tired of set backs and know of people who have got themselves back to a zero pain level for over a year and are very active. why not me? i have not decided where to go or which machne to use but I can assure you I will not be paying $5000 even if I have to go to Afganastan. All considered I am much better than 4 years ago when I was really down and out. They orby brought me part of the way and intend to continue my quest for a better quality of life.

Re: yes, everyone has their own problems

elliott on 9/12/02 at 15:36 (095161)

In you're last post ewe said you've bin reporting these results four the passed few months. But actually, the 92% VAS pane reduction ewe keep reporting is know wear in the link. Knot that eye doubt ewe, as that fig your wood bee consistent with the other fig yours. Just please post the entire study when ewe get it. Thanks. Wendy ewe think that will bee? Oh, thanks, and happy knew year too ewe two.

:-)

Re: every dog has its day :-)

john h on 9/12/02 at 15:43 (095164)

I think Bayshore has some statistics on the success of their procedure and it is probably a large enough sample to be statistically significant. Seems Sunny may have posted some information on this?

Re: every dog has its day :-)

john h on 9/12/02 at 15:52 (095166)

I am always supprised at how well placebo groups do any almost any kind of study you look at. Apparently a 10%-15% improvement of the non placebo over the placebo group in any study is highly significant. In the original FDA studies on the Ossatron I was not impressed at all by the statistical results but in the world of statistics and medicine the results were considered significant.

In my real world I am not going to sweat these statistics. If I can afford it I will go out and get an ESWT treatment and if works GREAT and if does not then I tried. You can think yourself into oblivion on which is the best machine, which is the best protocol, where is the best Doctor, what ate the best statistics.. Eventually you have to step into the arena and play the game or remain a spectator in the stands. I tried the orby and it helped now I am ready to try one of the more current types of equipment.

Re: placebo effect

elliott on 9/12/02 at 16:16 (095170)

Sure you gotta play to win, and the results do seem promising, even with the placebo effect. But it still makes you wonder how strong that effect is.

For ESWTPF it seems to be in the neighborhood of 75%. We're talking long-term permanent improvement, not the transitory 'I think I feel a little better right now but I'm not completely sure' thing. I can't stop wondering whether the placebo effect for long-term sufferers on these boards would be anything close to that. If yes, give em the placebo! I think not. Which possibly brings us back to Brian G's thoughts.

----

Re: Scar tissue is not an issue

BrianG on 9/12/02 at 21:37 (095204)

Hi John,

I don't think scar tissue is really a factor in my case either. When I had my failed EPF, both incisions healed very clean, and nice. I think one reason this happened is because not enough of the fascia was cut during the EPF procedure. Here I went through a ton of pain, for basically nothing!! On the bright side, the fact that not enough of the fascia was cut. Could be one reason I didn't develope TTS after the surgery. Will a second Dornier treatment help? To be determined.....

BrianG

Re: placebo effect

RalphP on 9/12/02 at 21:57 (095207)

In this discussion of the marginal benefit of ESWT over placebo, I'm reminded that a recent Danish meta-analysis concluded that the entire concept of the placebo effect is a myth. The study began with the insight that, because human beings do often heal without any intervention, just because someone who has received a sham treatment gets better, that doesn't mean it's from the placebo -- it may just mean they happened to get better. The researchers then went out and looked for studies that tracked not only a treatment group and a placebo group, but also a group with no intervention whatsoever -- just sign people up and watch what happens to them. I think they found 100-odd such studies, involving all kinds of conditions. Looking at these 100-odd studies, they found no statistically significant difference in outcomes between the placebo and the no-treatment groups. Ergo: the 'placebo' effect is nothing but the body healing itself at a natural rate.

If this finding holds up, I would think that, in general, any treatment that is genuinely effective would tend to show a greater improvement over the 'placebo' group, the longer the average duration of the ailment -- because the longer the duration, the less likely the ailment is about to resolve itself naturally without intervention.

Re: Throw that man a bone :*)

dave r on 9/13/02 at 07:20 (095219)

good luck John.....

Re: Scar tissue is not an issue

john h on 9/13/02 at 10:43 (095234)

Brian: I have no idea what effect the scar tissue would have on the effect of ESWT. Dr.Gordon the ESWT guru from Canada called me on the phone and recommeded the Ossatron on the foot that had surgery because of the higher power. He uses both low level and high power machines and charges the same for either so he had no axe to grind. I think in most cases he uses the low power machine with multiple treatments for PF.

Re: the Dornier Epos study preliminary one-year results (at last!!)

Pauline on 9/11/02 at 15:39 (095039)

Elliott,
Sure enough that's my doc 'Zingas' in big bold letters. Interesting thing is he's not using the Dornier yet. Oh it's there, but held in red tape. An interesting story too long to put in print.

This is the study that the FDA had posted, but pulled when they found out it hadn't been formally presented. Another No No. It had to go to meetin' first.

Re: the Dornier Epos study preliminary one-year results (at last!!)

Dr. Z on 9/11/02 at 17:46 (095056)

At last. I have been reporting these results for the past few months. I
guess you need to hear from someone else. The most important thing is look how great the resuls are !!!

Re: Throw that man a bone :*)

BrianG on 9/11/02 at 18:16 (095059)

Very good Elliott, it took awhile, but you finally found it, good doggy :*)
I would like to add my two cents to these FDA trials. I did apply, back then, but was too late at the time. One thing I discovered was that they would not take anyone that had previous surgery. That could swing the odds in their favor. Also, the people that I've seen interviewed after their treatment, were all patients that had PF for approximatly 1 year.

Do you see what I'm getting at? I do believe that the trials were done under very strict guidelines, but if you only admit people who are the most apt to be healed, then what does it say for the rest of us that have had PF for years? I think someone should do some trials that consist of patients that have had PF for at least 5 years. I'd bet you anything the results would not be so rosey!!

But, don't get me wrong here, I still believe that ESWT should always be tried 1st for PF, before any surgery is considered.

BrianG

Re: Throw that man a bone :*)

Dr. Z on 9/11/02 at 20:22 (095063)

The average patient has pf for two years . That is a long time as you know already

Re: the Dornier Epos study preliminary one-year results (at last!!)

elliott on 9/11/02 at 21:10 (095074)

Actually, this is at a later point in time--one year--of the 3-month study upon which the FDA relied. Funny, but the published version of the 3-month study itself just came out:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12219661&dopt=Abstract

http://link.springer-ny.com/link/service/journals/00132/bibs/2031007/20310637.htm

If only someone had reading privileges at the second link and could copy it for us so we could see the nitty-gritty details.

-----

Re: the Dornier Epos study preliminary one-year results (at last!!)

elliott on 9/11/02 at 21:12 (095075)

There's still some fishy things going on. Earlier, you said 92% success and this says 94%. :-)

----

Re: every dog has its day :-)

elliott on 9/11/02 at 21:30 (095080)

I agree with you that some caution is warranted. We have yet to figure out why this board's ESWT experience seems nowhere close to that in the study; I think we should now be giving this much thought. (I don't blame the researchers for excluding those who had previous surgery--introduces too many new variables; also, in future people would likely be getting ESWT first anyway. Their view may also be that in future there will hardly be any patients who went 5 years without trying ESWT.) A look at the actual paper may help. In addition, as I pointed out a while back, the placebo group seems in general to do rather well too, so that one might more soberly want to view ESWT's 'value added' over that. Nevertheless, Dr. Z is claiming the *average* duration of PF was 2 years, which is not trivial.

Dr. Z, if you ever get a hold of the complete study, please post it here. Thanks.

-----

Re: the Dornier Epos study preliminary one-year results (at last!!)

Dr. Z on 9/11/02 at 21:59 (095094)

The 94% is the one year follow up using the roles/ maundsley scoring . The 92% is the average pain reduction using the VAS . The something fishy is your inability to read. Sorry I had to say this. couldn't help it . Elliott happy new year

Re: every dog has its day :-)

john h on 9/12/02 at 10:09 (095127)

Dr. Gordon in Canada suggest the Ossatron (High Power) on a foot that has had previous surgery because of scar tissue. Otherwise he says you can go with either the high power or low power protool as he uses both machines.I think he and Bayshore are still in the midst of a study comparying low power treatments vs high power treatments. My understanding is Bayshore uses both low and high power machines but uses the high power mostly on conditions other than PF..

I will end up being a good test subject since I had surgery on one foot and not on the other. I do plan on having both feet treated again hopefully before the end of the year. I can say that treatment with the Orby did improve my feet after 4 years of PF and both feet were improved equally. Treatment was with the Orby.

Re: Throw that man a bone :*)

john h on 9/12/02 at 10:10 (095129)

Dr Z: If you have had PF for 2 years are you really very different from someone who has had it for 5 years or more. Both are obviously Chronic?

Re: Throw that man a bone :*)

john h on 9/12/02 at 10:41 (095130)

Brian: I think that both you and I know the longer you have PF the more difficult it becomes to manage. As I asked Dr. Z it would seem to me that after you pass the 2 year mark or near there you are chronic and not much different than someone who has had it for 5 years. As to treatment of surgical patients there is surgery and there is surgery. Some people have had horrible and multiple surgeries while others have had MIS surgeries or other types and have been cured. Once that fascia has been cut particularly a release of 50% or more there is no going back. I am anxious to see what the results will be on my feet with one of the newer machines since I have had one foot with surgery and one without.However bascially most of my fascia is still intact. I really cannot feel much scar tissue in the foot with surgery but obviously there will be some there. In any event we all got to where we are by a different path and what will work for one may not work for the other so ultimately you must make the decision to have ESWT or not. Since ESWT is nearly a risk free procedure I would think anyone who can afford it would 'run' (pun) to try it before you become a chronic hard to manage case. I always refresh my outlook when I see a guy like Mohez cured after 10 years by the use of ESWT I also think of Yoko who is back to running marathons after over a year of barely being able to walk. There is hope out there-

Re: Throw that man a bone :*)

dave r on 9/12/02 at 11:50 (095139)

John, i thought that you were really improving? I remember awhile back that you had posted that you had gone along time without a flare up?
Are you planning on going to Canada?

Re: Throw that man a bone :*)

john h on 9/12/02 at 15:35 (095160)

Dave: i had imnproved to a pain level of 1 for about 6 months then about a month or so ago I did some stupid things and had a reversal. I am still not at the pain level many of your are but i am tired of set backs and know of people who have got themselves back to a zero pain level for over a year and are very active. why not me? i have not decided where to go or which machne to use but I can assure you I will not be paying $5000 even if I have to go to Afganastan. All considered I am much better than 4 years ago when I was really down and out. They orby brought me part of the way and intend to continue my quest for a better quality of life.

Re: yes, everyone has their own problems

elliott on 9/12/02 at 15:36 (095161)

In you're last post ewe said you've bin reporting these results four the passed few months. But actually, the 92% VAS pane reduction ewe keep reporting is know wear in the link. Knot that eye doubt ewe, as that fig your wood bee consistent with the other fig yours. Just please post the entire study when ewe get it. Thanks. Wendy ewe think that will bee? Oh, thanks, and happy knew year too ewe two.

:-)

Re: every dog has its day :-)

john h on 9/12/02 at 15:43 (095164)

I think Bayshore has some statistics on the success of their procedure and it is probably a large enough sample to be statistically significant. Seems Sunny may have posted some information on this?

Re: every dog has its day :-)

john h on 9/12/02 at 15:52 (095166)

I am always supprised at how well placebo groups do any almost any kind of study you look at. Apparently a 10%-15% improvement of the non placebo over the placebo group in any study is highly significant. In the original FDA studies on the Ossatron I was not impressed at all by the statistical results but in the world of statistics and medicine the results were considered significant.

In my real world I am not going to sweat these statistics. If I can afford it I will go out and get an ESWT treatment and if works GREAT and if does not then I tried. You can think yourself into oblivion on which is the best machine, which is the best protocol, where is the best Doctor, what ate the best statistics.. Eventually you have to step into the arena and play the game or remain a spectator in the stands. I tried the orby and it helped now I am ready to try one of the more current types of equipment.

Re: placebo effect

elliott on 9/12/02 at 16:16 (095170)

Sure you gotta play to win, and the results do seem promising, even with the placebo effect. But it still makes you wonder how strong that effect is.

For ESWTPF it seems to be in the neighborhood of 75%. We're talking long-term permanent improvement, not the transitory 'I think I feel a little better right now but I'm not completely sure' thing. I can't stop wondering whether the placebo effect for long-term sufferers on these boards would be anything close to that. If yes, give em the placebo! I think not. Which possibly brings us back to Brian G's thoughts.

----

Re: Scar tissue is not an issue

BrianG on 9/12/02 at 21:37 (095204)

Hi John,

I don't think scar tissue is really a factor in my case either. When I had my failed EPF, both incisions healed very clean, and nice. I think one reason this happened is because not enough of the fascia was cut during the EPF procedure. Here I went through a ton of pain, for basically nothing!! On the bright side, the fact that not enough of the fascia was cut. Could be one reason I didn't develope TTS after the surgery. Will a second Dornier treatment help? To be determined.....

BrianG

Re: placebo effect

RalphP on 9/12/02 at 21:57 (095207)

In this discussion of the marginal benefit of ESWT over placebo, I'm reminded that a recent Danish meta-analysis concluded that the entire concept of the placebo effect is a myth. The study began with the insight that, because human beings do often heal without any intervention, just because someone who has received a sham treatment gets better, that doesn't mean it's from the placebo -- it may just mean they happened to get better. The researchers then went out and looked for studies that tracked not only a treatment group and a placebo group, but also a group with no intervention whatsoever -- just sign people up and watch what happens to them. I think they found 100-odd such studies, involving all kinds of conditions. Looking at these 100-odd studies, they found no statistically significant difference in outcomes between the placebo and the no-treatment groups. Ergo: the 'placebo' effect is nothing but the body healing itself at a natural rate.

If this finding holds up, I would think that, in general, any treatment that is genuinely effective would tend to show a greater improvement over the 'placebo' group, the longer the average duration of the ailment -- because the longer the duration, the less likely the ailment is about to resolve itself naturally without intervention.

Re: Throw that man a bone :*)

dave r on 9/13/02 at 07:20 (095219)

good luck John.....

Re: Scar tissue is not an issue

john h on 9/13/02 at 10:43 (095234)

Brian: I have no idea what effect the scar tissue would have on the effect of ESWT. Dr.Gordon the ESWT guru from Canada called me on the phone and recommeded the Ossatron on the foot that had surgery because of the higher power. He uses both low level and high power machines and charges the same for either so he had no axe to grind. I think in most cases he uses the low power machine with multiple treatments for PF.