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JAMA Article

Posted by walt w. on 9/18/02 at 07:47 (095607)

I just wanted to see what Dr. Z's comments are on the recent JAMA article about ESWT. They claim that the results of a double-blind, randomized, placebo controlled trial conducted between April 1999 and June 2001, using the Dornier Epos Ultra found no evidence to support a beneficial effect on pain, function and quality of life of ultrasound-proven plantar fasciitis 6 and 12 weeks following treatment.

I also read where the manufacturers of the Dornier say that the test was flawed because the dose administered was too low to be meaningful. I guess my question would be, what effect will this study have on the insurance industry regarding ESWT. Will they use this as ammunition to turn down claims?

Re: JAMA Article

walt w. on 9/18/02 at 07:48 (095608)

I forgot to mention that this test was conducted in Australia and involved 166 patients afflicted with Plantar Fasciitis.

Re: JAMA Article, made the Boston news tonight !!

BrianG on 9/18/02 at 15:33 (095632)

Hi Walt,

This should heat up the ESWT wars quite a bit. You just know that the insurance companies will now be referring to this study, rather than the FDA trials. I hate to see this type of article, but as someone who had the Dornier treatment without any success, I have to wonder how much credence it (the Austrailian study) has? I have copied and pasted the abbreviated article.

BrianG

Vol. 288 No. 11,
September 18, 2002
Original Contribution
 
 
See Related:
Authors' Articles
 
 
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Table of Contents
 
  
Author/Article Information
  
Ultrasound-Guided Extracorporeal Shock Wave Therapy for Plantar Fasciitis  
 
A Randomized Controlled Trial 
 
  Rachelle Buchbinder, MBBS, MSc; Ronnie Ptasznik, MBBS, FRANZCR; Jeanine Gordon, BAppSci; Joylene Buchanan, DipAppSci; Vasuki Prabaharan, BSc, MAppSci; Andrew Forbes, PhD
Context  Extracorporeal shock wave therapy (ESWT) is increasingly used for plantar fasciitis, but limited evidence supports its use.
Objective  To determine whether ultrasound-guided ESWT reduces pain and improves function in patients with plantar fasciitis.
Design  Double-blind, randomized, placebo-controlled trial conducted between April 1999 and June 2001.
Setting  Participants were recruited from the community-based referring physicians (primary care physicians, rheumatologists, orthopedic surgeons, and sports physicians) of a radiology group in Melbourne, Australia.
Participants  We screened 178 patients and enrolled 166; 160 completed the 15-week protocol. Entry criteria included age at least 18 years with plantar fasciitis, defined as heel pain maximal over the plantar aspect of the foot of at least 6 weeks' duration, and an ultrasound-confirmed lesion, defined as thickening of the origin of the plantar fascia of at least 4 mm, hypoechogenicity, and alterations in the normal fibrillary pattern.
Interventions  Patients were randomly assigned to receive either ultrasound-guided ESWT given weekly for 3 weeks to a total dose of at least 1000 mJ/mm2 (n = 81), or identical placebo to a total dose of 6.0 mJ/mm2 (n = 85).
Main Outcome Measures  Overall, morning, and activity pain, measured on a visual analog scale; Maryland Foot Score; walking ability; Short-Form–36 Health Survey (SF-36) score; and Problem Elicitation Technique score, measured at 6 and 12 weeks after treatment completion.
Results  At 6 and 12 weeks, there were significant improvements in overall pain in both the active group and placebo group (mean [SD] improvement, 18.1 [30.6] and 19.8 [33.7] at 6 weeks [P = .74 for between-group difference], and 26.3 [34.8] and 25.7 [34.9] at 12 weeks [P = .99], respectively). Similar improvements in both groups were also observed for morning and activity pain, walking ability, Maryland Foot Score, Problem Elicitation Technique, and SF-36. There were no statistically significant differences in the degree of improvement between treatment groups for any measured outcomes.
Conclusion  We found no evidence to support a beneficial effect on pain, function, and quality of life of ultrasound-guided ESWT over placebo in patients with ultrasound-proven plantar fasciitis 6 and 12 weeks following treatment.
JAMA. 2002;288:1364-1372
View Full Text    
 
 
Author/Article Information
 
 
Author Affiliations: Department of Clinical Epidemiology, Cabrini Hospital, and Cabrini Medical Centre, Malvern, Victoria, Australia (Dr Buchbinder); Department of Epidemiology and Preventive Medicine, Monash University (Drs Buchbinder and Forbes and Ms Prabaharan); Radiology Department, Latrobe University Medical Centre (Dr Ptasznik); and Mayne Health Diagnostic Imaging, Epworth Hospital (Mss Gordon and Buchanan), Melbourne, Australia.
 
Corresponding Author and Reprints: Rachelle Buchbinder, MBBS, MSc, FRACP, Department of Clinical Epidemiology, Suite 41, Cabrini Medical Centre, 183 Wattletree Rd, Malvern, Victoria, Australia 3144 (e-mail: (email removed)).
Author Contributions: Study concept and design: Buchbinder, Ptasznik, Gordon, Forbes.
Acquisition of data: Buchbinder, Ptasznik, Gordon, Buchanan.
Analysis and interpretation of data: Buchbinder, Prabaharan, Forbes.
Drafting of the manuscript: Buchbinder, Forbes.
Critical revision of the manuscript for important intellectual content: Buchbinder, Ptasznik, Gordon, Buchanan, Prabaharan, Forbes.
Statistical expertise: Prabaharan, Forbes.
Administrative, technical, or material support: Buchbinder, Ptasznik, Gordon, Buchanan.
Study supervision: Buchbinder, Ptasznik.
Funding/Support: Melbourne Diagnostic Imaging Group and Mayne Health Diagnostic Imaging funded this study.
Acknowledgment: We gratefully acknowledge the support of the partnership of the Melbourne Diagnostic Imaging Group and research assistants Suzanne Gregory, BAppSci, Jenny Gmehling, DipAppSci, and Naomi Zalcman, and the cooperation and assistance of Dornier MedTech Inc and Mayne Health Diagnostic Imaging.

 
 
 
 
 
© 2002 American Medical Association. All rights reserved.
 

Re: JAMA Article, made the Boston news tonight !!

Pauline on 9/18/02 at 18:10 (095642)

Brian,
Wouldn't this be just about the time that Dornier was going through the FDA trials here in the states? How do the experts reconcile the two different reports, this one and the one Elliot recently posted?

I'd have to say when I talked to Dr. Zingas on one of my visits during this time period, he was more closely aligned with this JAMA article than the last one. I think Dr. Rompe's papers are also more aligned with this one.

I would think those of us who have followed ESWT on heelsuprs from its birth here would like to see everyone on common ground especially if your thinking about ESWT and going to have to pay out of pocket for it. It only stands to reason you want some good assurance that the results might be as good as the articles are reporting. Just when you think it's finally in black and white this JAMA report surfaces. I assume this was just published. Am I correct?

It might be interesting if the doctors here or Scott could get one of the authors from each of the articles to post on the board to give their take on why the difference in each paper.

Perhaps the doctor that was posting from Australia that used the Dornier would comment on this report. I can't remember his name, but I think John
communicated with him a lot. If he doesn't respond, maybe John could contact him. I wonder if he saw this article.

Re: JAMA Article, made the Boston news tonight !!

David L on 9/18/02 at 19:21 (095653)

The recent article in JAMA from Dr. Buchbinder and colleagues (epidemiologists and radiologists) uses the Dornier Epos ESWT device. The study was performed using ultrasound to locate the area for treatment. The authors treated the area of the plantar fascia nearest the calcaneous that showed thickening. The energy levels varied from low to high (.02-.33mj/mm2). By treating only an anatomic structure instead of using patient feedback, there is an increased risk of not treating the correct area. You cannot see pain. Also, the inclusion criteria for the study were 18 years of age or older and at least 6-weeks of heel pain. With less than 6 months of heel pain, the likelihood of resolution without any treatment is high. This is the most likely reason for the high positive response in the placebo group. The authors actually state in the article that over 80% of symptoms resolve within 12 months if nothing is done.

Conclusion: Use patient feedback and treat chronic (greater than 6 months duration) plantar fasciitis.

Re: Both the control and treated patients received ESWT

Dr. Z on 9/18/02 at 20:16 (095658)

Hi
Here are a few of my comments just off the top my head

1. The Australian physicians treated the control group with low energy, but they still treated the so called control group.

2. Six weeks of heel pain. Most of six weeks of heel pain will get better with or without treatment. In the USA we use six months of pain not six weeks

3. In the USA high energy one session is used not low energy three sessions

4. Where was the orthopedic/podiatric peer review Why was this not sent to any of the orthopedic or podiatric journals.

5 This is only of many studies. There are many studies showing the benefits of ESWT.

6. The results were positive in this study. The conclusion can only be that both groups that were treated with ESWT, one with low energy and one with lower energy got better .

What does this show. Watch the insurance companies stop approving ESWT.

Re: JAMA Article, made the Boston news tonight !!

Dr. Z on 9/18/02 at 20:29 (095660)

Strange All of the papers Dr. Rompe's papers show excellent results with ESWT. It is very important that people do get facts and information. DR. Zingas was part of the dornier FDA study. He reported results were also excellent. I don't understand where you are getting your informaton about both doctors. Please help me out Pauline.

Read my post about the differents between the two papers. They are like comparing apples to onions. There is no comparison !!

Re: JAMA Article, made the Boston news tonight !!

Pauline on 9/18/02 at 20:55 (095665)

David,
Do I understand that your saying only ultrasound was used to pick the pain location? It says 'ultrasound guided' which is what the doctors are doing today.

When I read this article I see nothing that says the doctors didn't palpitate or were restricted from palpitating the foot to identify the location for treatment. It does say that the lesion was confirmed by ultrasound, but it does not appear at least in print to rule out the doctors hand in selecting the 'sweet' spot.

What leads you to believe that the doctors did no palpitation what so ever, but meerly used ultrasound to pick the spot? I interpreted 'ultrasound confirmed' to mean it was used to confirm the thickest part of the lesion, but it didn't rule out the doctors hand in finding it. At least I didn't see that restriction made definate in this abstract.

I also read it to say patients must have had pain for at least 6 weeks. I take that as a minimum amount of time, but I see nothing in print that specifically restricted persons in pain for more than 6 months from participating in the study. Again it doesn't specifically state that only persons having P.F. for 6 weeks were used.

Reading only the words available on the website in this article I don't really know if the doctors were forbidden to palpitate, if the patients were not allowed to say 'that's where it hurts' or if someone having P.F. longer than 6 weeks was band from the study. All these facts are missing.

Maybe the full article actually includes this specific information as facts, but I don't see this in the abstract Brian posted.

Re: JAMA Article, made the Boston news tonight !!

BrianG on 9/18/02 at 21:25 (095671)

Unfortunatly JAMA only prints abstracts of the study. To get the complete study, you have to be a registered professional (with JAMA), and then pay something like $9 to get the full study. It may be available at some other site on the Net, for free. I don't know.

BrianG

Re: JAMA Article, made the Boston news tonight !!

Dr. Z on 9/18/02 at 22:11 (095677)

This study is not valid period. There was no control . They treated all the patients. Don't you agree that you must have a control in any study

Re: Dr. Z, a few questions and a few comments

elliott on 9/18/02 at 22:19 (095678)

Questions:

1. Can you explain exactly what those energy numbers including the symbols appearing in the reports mean, e.g. 1000 mJ/mm2 in this latest study and 1300 mJ/mm2 in the US study, and also whether these figures are cumulative with repeated treatments, or are they instead single energy highs? Also, what about the number of pulses? Anything you can say to shed light on all this would be welcomed.

2. What's the cutoff or ranges for something to be considered high, low, or medium energy?

Comments:

1. I agree JAMA is not as prestigious or rigorous as many other journals.

2. I take your last point ('The conclusion can only be that both groups that were treated with ESWT, one with low energy and one with lower energy got better') to imply that the conclusion can only be that they got better due to ESWT (for otherwise it would be just be restatement of the results). (Here is a perfect example of why clarity in writing can be crucial; if I am misreading, sorry.) Well, it's not the only possible conclusion. Some other possibilities would be that the control group as a whole also got better due to the placebo effect, or that both groups were getting better anyway.

Yes, there are conflicting results on ESWT, and yes, many of them are encouragingly positive. I find interesting that most studies to date, even those with a 6-month minimum, find large improvement even among the control groups. Here's yet another study showing great overall performance for the treatment group at LOW energy, coupled with POOR overall performance for the control group:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12226782&dopt=Abstract

The possibilities for both success and failure seem numerous. If some want to be a bit more cautious before jumping on the ESWT bandwagon, that should be OK. After all, it's their money.

On a related topic, Dr. Manoli's post on the Treatments board had an interesting quote by a doctor, namely that 80% of PF cases get better in a year or so with just rest (what does that mean, one can ask) and nothing else. If true, that might put not only some of the ESWT studies in a different light, but also the efficacy of some of the other traditional conservative treatments.

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Re: JAMA Article, made the Boston news tonight !!

Pauline on 9/18/02 at 22:36 (095679)

Dr. Z,
After the trials were finished I was his patient. We discussed the trials
and at that time I was begging for treatment and hoping for Dornier to have a speedy trip through the FDA because I was in pain. He had the machine in his office, but couldn't use it because it had not received FDA approval yet. I watched that machine for over a year sit collecting dust every time I went to his office. Obviously you were not in the room with us, but I was told at that time he did not see significant differences in any of the patients in the trial. He wasn't impressed by the results. Because it was a double blind random study he didn't know which patients received what, but they still kept their return appointments and talked to him about their pain and progress. Surely he would have been jumping up and down if he saw great results happening. It just wasn't there. I don't know which stage the final report was in at the time.

I haven't been back to see him in well over 8 months. His office consists of many Orthopedic specialist who all specialize in specific parts of the body. I returned to see a different physician for a hip problem. I saw him in the hallway and we chatted briefly. You have to remember I'd been his patient for over 2 years by this time and about the same some years before he Dornier's existance so I'd say he knows me pretty well.

He indicated he at that time he was still not using the Dornier or any ESWT machine.

I make no excuses for what I report knowing what ever I say could never satisify you. Best you check out what I'm saying for yourself. Only then will you feel comfortable.

If we want to really begin to examine and discuss getting facts correct we might also want to examine some doctors web sites. The web is full of false and misleading claims about snip and go operations, painless ESWT treatments, speedy recoveries, Medical groups adopting and issuing a formal position on ESWT when it didn't exist, and many more and I don't limit this issue to only foot and ankle doctors. It exists on other sites as well.

Like you, I probably won't feel good until someone helps me understand where they are getting their facts too, so I think I know how you might feel.

Re: JAMA Article, made the Boston news tonight !!

Dr. Z on 9/19/02 at 08:29 (095699)

I am just going to repeat Three things and then I am not going to contiune to repeat myself

Dr. Rhompe has written many excellent articles of ESWT all positive
DR. Zingas was part of the FDA study and the study speaks for itself.
There were control studies in the AMA study . They all received ESWT and they were all chronic patients.

Re: Dr. Z, a few questions and a few comments

Dr. Z on 9/19/02 at 08:35 (095701)

Hi

Just so you understand what I was saying about the treatment groups both receiving some level of ESWT energy. This isn't a controlled study at all.
There was no control. We do know that both groups did get better. The AMA study has no relationship or should there be any comparsion to the FDA dornier study. That is my point. To do this is just not scientific.

Re: can you please explain the energy numbers? thanks (nm)

elliott on 9/19/02 at 09:20 (095711)

.

Re: Dr. Z, a few questions and a few comments

john a on 9/19/02 at 11:06 (095720)

Dr. Z, from the extract 'Patients were randomly assigned to receive either ultrasound-guided ESWT given weekly for 3 weeks to a total dose of at least 1000 mJ/mm2 (n = 81), or identical placebo to a total dose of 6.0 mJ/mm2 (n = 85).' So, yes, the placebo group received ESWT also, but at such a low dose, that it is assumed to be the same as doing nothing. Are you suggesting that even at this very low dose, ESWT can be effective? Admittedly, it is difficult to give placebo ESWT, because the patients will tend to know they are not being given the real treatment, primarily because it doesn't hurt! But you have to try to make the patients think they are getting effectively treated, or else there will be no placebo effect. I think the most accurate conclusion that you can draw from this study is that below a certain dose level, there is no demonstrative benefit of ESWT.

Re: JAMA Article - AMA bias

Scott R on 9/19/02 at 11:51 (095721)

Since ESWT is mainly in the hands of podiatrists, I wonder if the AMA chose to publish this one negative study because it hurts one of its competitors for patients ( MDs verses DPMs ). I believe the AMA has lost in court at least twice for libel against podiatric entities. Choosing what articles to publish is the primary way journals are not scientific, peer-reveiwed or not. This may all be cleared up in the next issues 'letters to the editor', if they choose to publish contrary opinions, but the damage has been done as can be seen in HealthTronics stock drop of 22% or so ysterday making it one of the biggest losers for the day. Of course, they could probably not have come up with 166 patients if they chose 6 month criteria, so they chose the 6 week criteria Since something like 80% of patients improve by the 6 month mark, you can bet 80% of their 166 patients would not have qualified to be in the FDA studies. Since they were going to get better anyway, the controls just dilute any significance that would have been present in the treated group. So, either the AMA is ignorant in choosing this study to publish, or just plain wicked. But it's interesting that a doctor told me just last week that he thinks the trauma from just the anesthesia could be what's helping, although there are probably plenty of studies where anesthesia is not used, and i don't know if it was used in this study.

Re: can you please explain the energy numbers? thanks (nm)

Dr. Zuckerman on 9/19/02 at 13:06 (095727)

The energy levels I believe you stated 1000mj/mm2 for the AMA study and 1300mj2/mm for the FDA study This is the total amount of energy received at the focal point or the area of treatment. With the AMA study they used three sessions and with the FDA dornier study it was one high energy treatment. The AMA study was much lower then the FDA study.

Re: can you please explain the energy numbers? thanks (nm)

Pauline on 9/19/02 at 13:41 (095731)

Isn't this similar to the study currently being run at the Canadian sites that are using the Dornier. They were using 3 low dose treatments. Now I understand they are testing the U.S. FDA protocol, one high dose treatment, vs their 3 lower dose one. I know they were doing this at Fowler Kennedy Medical Center.

Have they published on this yet?

I'm thinking the AMA report could have an effect on G.P's handing out referrals to Pods. and Orthos. for patients wanting to try ESWT. Many couldn't get insurance covered treatment if they can't get a referral from their primary care doctor. He is more likely to believe the AMA report.

No doubt someone will come up with a report that combines the efforts of both organizations.

Re: BC / BS of Massachusetts version of the study

BrianG on 9/19/02 at 14:52 (095734)

I could be wrong, but I don't think this study was sponsored by JAMA. It was one of many orginizations that reported on the study. Since yesterday, I have read different versions of the Austrailian study at 3 different web sites, JAMA, WEBMD and BC / BS of Massachusetts. Plus someone sent me the same study fom the AskJeeves website today, but I could not open it.

I think people should give JAMA a break, they are only one of the messengers of this study. If I'm wrong here, and JAMA was in fact behind the study, I apologise.

BrianG

PS here is the BC / BS article:

Study Jolts Shock-Wave Therapy for Heel Pain

New research saying that shocking plantar fasciitis won't heal it comes under fire.
By Ed Edelson
TUESDAY, Sept. 17 (HealthScoutNews) -- A newly approved shock-wave therapy for the painful heel condition called plantar fasciitis doesn't work, says an Australian study that is drawing cries of dissent and caustic criticism from companies that make the machines.
The study, done by Dr. Rachelle Buchbinder and colleagues at the Cabrini Medical Center in Malvern, used the Dornier MedTech EPOS Ultra system, which was approved by the U.S. Food and Drug Administration (FDA) at the beginning of this year, for adults whose plantar fasciitis hasn't been helped by other treatment after six months.
Plantar fasciitis is a sometimes excruciatingly painful condition that occurs when the tissue supporting the foot arch becomes inflamed and breaks, creating scar tissue. It is likeliest to afflict runners, but experts say it strikes one in 10 people even if they aren't athletes.
It is treated by anti-inflammatory medications, stretching, massage and the use of splints at night, which are effective in about 95 percent of patients. Until the new devices came along, the alternative for the other 5 percent was surgery.
The Dornier device and other machines are designed to relieve the pain by sending shock waves through the foot, a technology similar to that used to break up kidney stones. The shock waves work by increasing blood flow and easing inflammation.
A report in tomorrow's issue of the Journal of the American Medical Association says Buchbinder and her colleagues tested the shock-wave therapy in 160 patients over a 15-week period. Half got the shock waves, the other half got a placebo. After six weeks, the results were essentially identical in both groups, the researchers say, with 30.6 percent of the shock-wave patients and 33.7 percent of the fake treatment patients reporting improvement. Ditto after 12 weeks, they say: 34.8 percent improvement for shock-wave treatment, 34.9 percent for fake treatment.
Buchbinder explains the difference between her results and the studies that won FDA approval by saying her study was more rigorous. 'Participants in our trial not only had to have a clinical history compatible with plantar fasciitis, but they also had to have confirmation of the condition by having changes confirmed by ultrasound,' she says. 'All previous trials relied solely on clinical criteria alone or required the presence of a heel spur or bone pain.'
Whatever the results of the Australian study, they don't apply to us, says Dr. Argil J. Wheelock, chief executive officer of HealthTronics Surgical Services Inc., the American manufacturer of the OssaTron, the first shock wave machine to get FDA approval. The OssaTron uses a spark plug to generate the shock waves, while the Dornier system passes an electric current through a coil, and the difference is vital, Wheelock says.
'This verifies what we have said all along, that there is a significant technological difference between low-energy devices and high-energy devices,' he says, noting the OssaTron is a high-energy device and the Dornier machine is not. The Dornier machine 'has a very narrow focal point, and therefore tends not to give the type of tissue damage needed to benefit from the treatment.'
More than 5,000 patients have been successfully treated with the 60 OssaTron machines now in practice, Wheelock says, 'and there will be papers forthcoming that will verify the value of the technology.'
At Dornier, marketing director Kirk Wilks describes the Australian study as 'poorly constructed and poorly executed, a substandard study that the FDA here in the United States would not look at.'
Among other flaws, he maintains, the study did not include the kind of chronic pain sufferers who were in the trial that won FDA approval. 'They didn't even have their pain level measured,' he says. 'In our studies, we had a pain scale of 1 to 10 and treated only people with a score of 5 or more. They took everybody.'
The biggest difference, Wilks says, is that patients in the FDA approval studies got only shock-wave therapy. The Australian study let patients use drugs or other treatment, which muddied the results, he says.
Buchbinder is skeptical. 'I am not convinced from the data of the previous trials that there was a clinically important benefit of shock wave over placebo,' she says. 'Both trials that resulted in FDA approval demonstrated small differences between groups.'
What To Do
Surgery is another option if your plantar fasciitis refuses to heal, but there are risks, whereas shock-wave therapy is a low-risk option. You can learn more about plantar fasciitis and other pains in the foot from the American Academy of Family Physicians or the University of Michigan.
SOURCES: Rachelle Buchbinder, M.B.B.S., director, department of clinical epidemiology, Cabrini Hospital, Malvern, Australia; Argil J. Wheelock, M.D., chief executive officer, HealthTronics Surgical Services Inc., Marietta, Ga.; Kirk Wilks, marketing director, Dornier MedTech, Atlanta; Sept. 18, 2002, Journal of the American Medical Association
Copyright © 2002 ScoutNews, LLC. All rights reserved.
 
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Re: BC / BS of Massachusetts version of the study

Dr. Chris Reynolds on 9/19/02 at 18:24 (095767)

Brian, the study was funded by The Melbourne Diagnostic Imaging Group and Mayne Health Diagnostic Imaging.

You may be interested to read the acknowledgements -

'We gratefully acknowledge the support of the partnership of the Melbourne Diagnostic Imaging Group and research assistants Suzanne Gregory, Jenny Gmehling and Naomi Zalcman and the cooperation and assistance of Dornier MedTech and Mayne Health Diagnostic Imaging.'

I'm sure Dornier were not happy about the findings. But isn't this what heelspurs.com is all about - the truth?

Re: BC / BS of Massachusetts version of the study

Pauline on 9/19/02 at 18:49 (095769)

Holy Cow, Dornier assisted with their own demise. It's like the O.J. trial you shouldn't assist the prosecutors.

Re: JAMA Article, made the Boston news tonight !!

Dr. Chris Reynolds on 9/19/02 at 19:58 (095776)

The study IS valid.
Please refer to the following Study Design.

METHODS
Study Design
A double-blind randomized, placebo-controlled trial was conducted between April 1999 and June 2001. Patients who fulfilled inclusion criteria and consented to take part in the study were randomized, stratified by treatment centre (3 treatment sites) in blocks of 4 (to ensure close to equal numbers in experimental and placebo arms at each treatment site) to receive either experimental or placebo regimens according to a computer-generated random numbers list created by the study biostatistician. Both the patients and a single outcome assessor were blinded to the therapy received.

Re: JAMA Article, made the Boston news tonight !!

Dr. Z on 9/19/02 at 21:03 (095780)

Where is the placebo Dr. Reynolds. There was treatment of low energy to all patients. I know of no double-blind randomized placebo-controlled trial where there were the controlled group received treatment. I have many many patients that have had high ESWT treatment with a cure yes a cure post three years. If you talk to them i am sure they will tell you that they are cured by ESWT and not by chance.

Re: BC / BS of Massachusetts version of the study

BGCPed on 9/19/02 at 22:17 (095786)

Well I would like a study done to explain why there is such a discrepency between mail rooms at BC/BS. I have mailed bills 3 and 4 times only to be told 'sorry we didnt get it, mail it again' some of my bills are over 4 months old form this nonsense.
On the other hand the same company will send you a cancel notice like an atomic clock or cash your premium check the day they get it. You get a late notice if you dont get payment to them in time but you dont get a notice when they are going to pay you a few months after you billed them.

My question is does the technology exist to coordinate the billing AND receivable people that are served by the same mail room to get on the same program?

Re: JAMA Article - AMA bias

Scott R on 9/20/02 at 06:41 (095799)

I didn't say that JAMA funded or ws behind the study, I said that it's possible that they picked this study to publish rather than any other studies because it was negative.

The primary author of the study responded to my complaint about the short duration of symptoms:

thanks for your email
average duration of heel pain was 6-7 months so about half had it longer. we looked at duration of symptoms and there was no benefit of ESWT in those who had it for long periods. that is duration of symptoms made no difference to the results - they were the same irrespective of duration of symptoms. i agree that 80% are better by 12 months irrespective of treatment.
Rachelle Buchbinder

So they had a patient population of about 85 patients who had had heel pain longer than 6 month verses the FDA studies of about 300. When she says 'no difference in results' for those who had it longer, she probably and should mean it in terms of statistical significance. Since the patient population is smaller, it is much more difficult to make 'statistical significance'.

Re: JAMA Article - AMA bias

elliott on 9/20/02 at 07:52 (095808)

Well, actually, the JAMA study had a patient population around double your figure, only that half were the control group (which does offer useful information). And the U.S. FDA part of the greater Dornier study we've talked about here that has publshed preliminary results had half your figure, of which half again were the control group, so the JAMA and US FDA studies are very comparable in numbers, and otherwise of acceptable size. I think the real problem is that if 80% really do get better on their own, then you're dealing with only 20% of those numbers who might actually be benefiting from ESWT (and you don't even know who they are), or around 15 patients. Now that's a rather small sample, even if statistically significant, as other variables might now be more likely to distort things. For example, maybe some patients rested smarter. For a statistical example, the 80%, even if true, no doubt has some variance associated with it, with the result being that the number actually having improved from ESWT could be far less.

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Re: JAMA Article

Scott R on 9/20/02 at 11:21 (095835)

She sent me a copy of the journal article. My complaints are:
1) It's low energy, although not lower than maybe most other ESWT studies
2) Almost half the patients would not have qualified to be in the FDA studies because they had it less than 6 months.
3) The control patients may have had better care than they would have received in the U.S.

I think it's the best study I've seen on ESWT, but that it only demonstrates that low energy used early in the course of the condition does not provide more benefit than the treatments that were allowed in the study. It does not rule out that higher energy and/or late-treatment ESWT might also be of no more benefit than conservative care. Since the results are muddled by apparently mild cases, i can't say that it shows low energy is of no benefit in chrnoic cases.

Re: JAMA Article - AMA bias

BlindBlind on 9/20/02 at 14:37 (095854)

I'm not sure I understand the data reported by the authors
in regards to the blinding of their study. The article states that
for the active treatment group

'Treatment began on level 1 and was gradually increased through to
the highest tolerable level of pain for each participant.'

The article goes on to say that only

'Nineteen participants (24.4%) in the active group correctly identified
their treatment group'

My question is simple. If EPOS operator increased the level until
pain tolerance then why didn't more patients in the treatment group
correctly guess that they were being treated? Didn't they reach a
level of pain in the treatment?

Just thought that it would be interesting to see what others
thought about this point.

Re: JAMA Article - AMA bias

Scott R on 9/20/02 at 16:52 (095864)

Controls may not have known that they were supposed to feel any pain, but that would have to have been carefully controlled for by what the operator says. For example asking 'do you feel any pain YET' would have obviously undone the blindness for both control and active groups. Of course there's no way the operator could have not known which was treated and which was not since it was 100 pulses for the controls and 2500 pulses for the active group. So i assume the operator was not the diagnosis or followup physician in order for them to say that end was blind. Then if the operator knows, then I have to wonder how they made sure his interaction with the patients didn't convey the information. I've always questioned and wondered about the legitimacy of the blind-blind aspects of the ESWT studies.

Re: JAMA Article - AMA bias

BlindBlind on 9/20/02 at 17:05 (095866)

Independent of the operator's actions, don't you think that
patients that felt pain would guess that they received treatment?
Wouldn't they associate treatment pain with active treatment?

I think that more members of the active group should have associated
treatment pain with active treatment. Otherwise, I have to assume
that the active treatment group did not receive treatment at a
level of pain tolerance, which was the study protocol.

Re: JAMA Article, made the Boston news tonight !!

BrianG on 9/20/02 at 20:41 (095874)

Hi Dr. Reynolds,

Glad to see you stop in now and again. Are you getting ready for summer, down under?

Regards
BrianG

Re: JAMA Article

rob a on 9/22/02 at 09:46 (095943)

It seems that if we want to compare apples to apples, then we may have to wait until the canadian studies are complete. They originally used the EPOS with low power multiple treatments but are now trying the high powered FDA treatment protocol. When those results are published then we will be able to, for the first time, actually compare the differences between two different protocols on the same device. As far as I am aware, there are no studies on the Sonocur or Ossatron being done that will allow us to examine differences in protocol on the same device. I think this will be an interesting finding. If the studies show that higher energy treatments give better results then that will justify sedation and the higher cost of ESWT that currently exist in the U.S. If not, then there is the possibility that insurance copmpanies will be reluctent to pay higher reimbursments to cover anesthesia and outpatient cost. This would move ESWT to an office base treatment and reduce the overall cost of the procedure.

Re: JAMA Article

Dr. Z on 9/22/02 at 10:25 (095945)

Good Points. We are already using the Dornier Epos in an office setting using the FDA protocol. The use of an ASC and sedation has never been justified . All the FDA Dornier studies and ossatron studies used a local anesthetic anyway with the use of an ASC. Ths only reason ASC are being used is due to the insurance companies and their outdated policies for ESWL ( kidney stone ESWT)

Re: JAMA Article

Bill E on 9/22/02 at 13:02 (095962)

Any idea when the results of this study will be completed and published? Which machinces are being compared?

Re: JAMA Article, made the Boston news tonight !!

Ed Davis, DPM on 9/23/02 at 23:20 (096061)

One study with non-favorable results has little impact when compared to the numerous studies that show excellent results with ESWT. It certainly can make the news due to its controversial nature.

Beyond the studies, one must look at the collective experiences of the practitioners using this modality. It may be relatively new to the USA but it has been around for a while in Europe with an impressive track record.

The significance of ESWT is its ability to affect tissue quality and that is an issue with chronic PF, not PF that has been around 6 weeks. Yes, the study stated 'at least 6 weeks' so some of those in the study could have had PF longer, but do we know how many? Failure to list how many of those individuals had chronic PF is a major flaw in the design of that experiment. ESWT is for 'recalcitrant' PF so the 6 week minimum criteria was a faulty inclusion criterion to begin with.

The study mentioned how the targeting was done. One cannot assume that the docs or technicians had the leeway to target in any different fashion than by the method listed. Yes, in theory the thickest part of the plantar fascia should be the most painful but it that is often not the case. Chronic plantar fasciitis exists in individuals with chronic excess plantar fascial tension. The plantar fascia is expected to thicken in response to such tension -- that is a normal response of the human body.
We have not established precisely when such thickening is pathologic.

Finally, ESWT used alone will have limited efficacy since it addresses one third of the treatment triad. Many individuals experiencing relief from ESWT have recalcitrant PF and have already had the other two legs of the triad adequately addressed.
Ed

Re: One flawed study does not reveal the truth

Ed Davis, DPM on 9/23/02 at 23:22 (096062)

One flawed study does not reveal the truth.
Ed

Re: What is the factual basis for the statement that "80% will get better on their own"?

Ed Davis, DPM on 9/23/02 at 23:27 (096063)

I don't think it is the AMA bias here but, unfortunately for all those who have suffered so long waiting for third parties to extend coverage, this will be used as an excuse by insurers to deny payment.
Ed

Re: JAMA Article - AMA bias

Ed Davis, DPM on 9/23/02 at 23:29 (096064)

Good point BlindBlind -- I really cannot come up with an answer.
Ed

Re: anesthesia?

Ed Davis, DPM on 9/23/02 at 23:31 (096066)

What type of anesthesia was used in the study?
Ed

Re: Half of the patients had PF less than 6 months

Ed Davis, DPM on 9/23/02 at 23:56 (096070)

Sort of reminds me of the flawed PF study where recent onset cases were provided both oTC inserts and custom orthotics with the study showing the two modalities being equal.

Lets go back to the treatment triad because it is fundamental to understanding the process. Acute PF is basically a sprain of the fascia, it is an inflammatory condition. It thus can be treated successfully with anti-inflammatories -- oral or injections or cortisone plus the use of soft heel pads or inserts (acute PF can sometimes progress to chronic PF but lets leave that out for simplicity's sake for now).

Plantar fasciitis that persists or becomes chronic does so for one of two reasons....
...abnormal or excessive strain persists on the fascia. This may be due to work conditions, poor shoegear, poor body mechanics: subtalar joint overpronation, midtarsal joint oversupination, tight achille-gastrosoleus.
...tissue quality deteriorates. This can occur due to chronic inflammation which leads to tissue damage, genetic factors leading to poor connective tissue quality or a combination of both.

The 3 'legs' of the triad thus have different 'height' at different times.
Initially the first leg, 'inflammation' is by far the predominant process. As such expect modalities such as cortisone shots to work reasonably well in the first few weeks or few months, then gradually decrease in effectiveness with time. As time goes on and PF persists, the second leg must be focused on. The body can and does repair itself and if that is not happening then one must remove impediments, ie. find and remove the biomechanical problems preventing that from occurring. Look carefully at the second leg from 6 weeks to 6 months. Inflammation and tissue damage occurring for extended periods of time (say greater than 6 months) will compromise the body's ability to repair tissue. The tissue becomes badly scarred and devascularized. This is the point where the third leg predominates -- tissue quality. So ESWT is really the great breakthrough as a modality for affecting tissue quality. One is accomplishing very little in aiming an ESWT machine at PF which is of adequate tissue quality.
Why did half of the patients in the study have a modality applied which have no reason to be applied? It makes as much sense as giving penicillin to someone with a headache, the headache persists, so penicillin is criticized.

Now, one caveat, PF often waxes and wanes in the early stages for a number of patients so the 'stages' I discussed cannot be affixed to firm time periods. For example, a patient can low grade chronic PF for years, change jobs to one that requires more standing and develops a bout of acute PF superimposed on the chronic process.
Ed

Re: JAMA Article

walt w. on 9/18/02 at 07:48 (095608)

I forgot to mention that this test was conducted in Australia and involved 166 patients afflicted with Plantar Fasciitis.

Re: JAMA Article, made the Boston news tonight !!

BrianG on 9/18/02 at 15:33 (095632)

Hi Walt,

This should heat up the ESWT wars quite a bit. You just know that the insurance companies will now be referring to this study, rather than the FDA trials. I hate to see this type of article, but as someone who had the Dornier treatment without any success, I have to wonder how much credence it (the Austrailian study) has? I have copied and pasted the abbreviated article.

BrianG

Vol. 288 No. 11,
September 18, 2002
Original Contribution
 
 
See Related:
Authors' Articles
 
 
Return to
Table of Contents
 
  
Author/Article Information
  
Ultrasound-Guided Extracorporeal Shock Wave Therapy for Plantar Fasciitis  
 
A Randomized Controlled Trial 
 
  Rachelle Buchbinder, MBBS, MSc; Ronnie Ptasznik, MBBS, FRANZCR; Jeanine Gordon, BAppSci; Joylene Buchanan, DipAppSci; Vasuki Prabaharan, BSc, MAppSci; Andrew Forbes, PhD
Context  Extracorporeal shock wave therapy (ESWT) is increasingly used for plantar fasciitis, but limited evidence supports its use.
Objective  To determine whether ultrasound-guided ESWT reduces pain and improves function in patients with plantar fasciitis.
Design  Double-blind, randomized, placebo-controlled trial conducted between April 1999 and June 2001.
Setting  Participants were recruited from the community-based referring physicians (primary care physicians, rheumatologists, orthopedic surgeons, and sports physicians) of a radiology group in Melbourne, Australia.
Participants  We screened 178 patients and enrolled 166; 160 completed the 15-week protocol. Entry criteria included age at least 18 years with plantar fasciitis, defined as heel pain maximal over the plantar aspect of the foot of at least 6 weeks' duration, and an ultrasound-confirmed lesion, defined as thickening of the origin of the plantar fascia of at least 4 mm, hypoechogenicity, and alterations in the normal fibrillary pattern.
Interventions  Patients were randomly assigned to receive either ultrasound-guided ESWT given weekly for 3 weeks to a total dose of at least 1000 mJ/mm2 (n = 81), or identical placebo to a total dose of 6.0 mJ/mm2 (n = 85).
Main Outcome Measures  Overall, morning, and activity pain, measured on a visual analog scale; Maryland Foot Score; walking ability; Short-Form–36 Health Survey (SF-36) score; and Problem Elicitation Technique score, measured at 6 and 12 weeks after treatment completion.
Results  At 6 and 12 weeks, there were significant improvements in overall pain in both the active group and placebo group (mean [SD] improvement, 18.1 [30.6] and 19.8 [33.7] at 6 weeks [P = .74 for between-group difference], and 26.3 [34.8] and 25.7 [34.9] at 12 weeks [P = .99], respectively). Similar improvements in both groups were also observed for morning and activity pain, walking ability, Maryland Foot Score, Problem Elicitation Technique, and SF-36. There were no statistically significant differences in the degree of improvement between treatment groups for any measured outcomes.
Conclusion  We found no evidence to support a beneficial effect on pain, function, and quality of life of ultrasound-guided ESWT over placebo in patients with ultrasound-proven plantar fasciitis 6 and 12 weeks following treatment.
JAMA. 2002;288:1364-1372
View Full Text    
 
 
Author/Article Information
 
 
Author Affiliations: Department of Clinical Epidemiology, Cabrini Hospital, and Cabrini Medical Centre, Malvern, Victoria, Australia (Dr Buchbinder); Department of Epidemiology and Preventive Medicine, Monash University (Drs Buchbinder and Forbes and Ms Prabaharan); Radiology Department, Latrobe University Medical Centre (Dr Ptasznik); and Mayne Health Diagnostic Imaging, Epworth Hospital (Mss Gordon and Buchanan), Melbourne, Australia.
 
Corresponding Author and Reprints: Rachelle Buchbinder, MBBS, MSc, FRACP, Department of Clinical Epidemiology, Suite 41, Cabrini Medical Centre, 183 Wattletree Rd, Malvern, Victoria, Australia 3144 (e-mail: (email removed)).
Author Contributions: Study concept and design: Buchbinder, Ptasznik, Gordon, Forbes.
Acquisition of data: Buchbinder, Ptasznik, Gordon, Buchanan.
Analysis and interpretation of data: Buchbinder, Prabaharan, Forbes.
Drafting of the manuscript: Buchbinder, Forbes.
Critical revision of the manuscript for important intellectual content: Buchbinder, Ptasznik, Gordon, Buchanan, Prabaharan, Forbes.
Statistical expertise: Prabaharan, Forbes.
Administrative, technical, or material support: Buchbinder, Ptasznik, Gordon, Buchanan.
Study supervision: Buchbinder, Ptasznik.
Funding/Support: Melbourne Diagnostic Imaging Group and Mayne Health Diagnostic Imaging funded this study.
Acknowledgment: We gratefully acknowledge the support of the partnership of the Melbourne Diagnostic Imaging Group and research assistants Suzanne Gregory, BAppSci, Jenny Gmehling, DipAppSci, and Naomi Zalcman, and the cooperation and assistance of Dornier MedTech Inc and Mayne Health Diagnostic Imaging.

 
 
 
 
 
© 2002 American Medical Association. All rights reserved.
 

Re: JAMA Article, made the Boston news tonight !!

Pauline on 9/18/02 at 18:10 (095642)

Brian,
Wouldn't this be just about the time that Dornier was going through the FDA trials here in the states? How do the experts reconcile the two different reports, this one and the one Elliot recently posted?

I'd have to say when I talked to Dr. Zingas on one of my visits during this time period, he was more closely aligned with this JAMA article than the last one. I think Dr. Rompe's papers are also more aligned with this one.

I would think those of us who have followed ESWT on heelsuprs from its birth here would like to see everyone on common ground especially if your thinking about ESWT and going to have to pay out of pocket for it. It only stands to reason you want some good assurance that the results might be as good as the articles are reporting. Just when you think it's finally in black and white this JAMA report surfaces. I assume this was just published. Am I correct?

It might be interesting if the doctors here or Scott could get one of the authors from each of the articles to post on the board to give their take on why the difference in each paper.

Perhaps the doctor that was posting from Australia that used the Dornier would comment on this report. I can't remember his name, but I think John
communicated with him a lot. If he doesn't respond, maybe John could contact him. I wonder if he saw this article.

Re: JAMA Article, made the Boston news tonight !!

David L on 9/18/02 at 19:21 (095653)

The recent article in JAMA from Dr. Buchbinder and colleagues (epidemiologists and radiologists) uses the Dornier Epos ESWT device. The study was performed using ultrasound to locate the area for treatment. The authors treated the area of the plantar fascia nearest the calcaneous that showed thickening. The energy levels varied from low to high (.02-.33mj/mm2). By treating only an anatomic structure instead of using patient feedback, there is an increased risk of not treating the correct area. You cannot see pain. Also, the inclusion criteria for the study were 18 years of age or older and at least 6-weeks of heel pain. With less than 6 months of heel pain, the likelihood of resolution without any treatment is high. This is the most likely reason for the high positive response in the placebo group. The authors actually state in the article that over 80% of symptoms resolve within 12 months if nothing is done.

Conclusion: Use patient feedback and treat chronic (greater than 6 months duration) plantar fasciitis.

Re: Both the control and treated patients received ESWT

Dr. Z on 9/18/02 at 20:16 (095658)

Hi
Here are a few of my comments just off the top my head

1. The Australian physicians treated the control group with low energy, but they still treated the so called control group.

2. Six weeks of heel pain. Most of six weeks of heel pain will get better with or without treatment. In the USA we use six months of pain not six weeks

3. In the USA high energy one session is used not low energy three sessions

4. Where was the orthopedic/podiatric peer review Why was this not sent to any of the orthopedic or podiatric journals.

5 This is only of many studies. There are many studies showing the benefits of ESWT.

6. The results were positive in this study. The conclusion can only be that both groups that were treated with ESWT, one with low energy and one with lower energy got better .

What does this show. Watch the insurance companies stop approving ESWT.

Re: JAMA Article, made the Boston news tonight !!

Dr. Z on 9/18/02 at 20:29 (095660)

Strange All of the papers Dr. Rompe's papers show excellent results with ESWT. It is very important that people do get facts and information. DR. Zingas was part of the dornier FDA study. He reported results were also excellent. I don't understand where you are getting your informaton about both doctors. Please help me out Pauline.

Read my post about the differents between the two papers. They are like comparing apples to onions. There is no comparison !!

Re: JAMA Article, made the Boston news tonight !!

Pauline on 9/18/02 at 20:55 (095665)

David,
Do I understand that your saying only ultrasound was used to pick the pain location? It says 'ultrasound guided' which is what the doctors are doing today.

When I read this article I see nothing that says the doctors didn't palpitate or were restricted from palpitating the foot to identify the location for treatment. It does say that the lesion was confirmed by ultrasound, but it does not appear at least in print to rule out the doctors hand in selecting the 'sweet' spot.

What leads you to believe that the doctors did no palpitation what so ever, but meerly used ultrasound to pick the spot? I interpreted 'ultrasound confirmed' to mean it was used to confirm the thickest part of the lesion, but it didn't rule out the doctors hand in finding it. At least I didn't see that restriction made definate in this abstract.

I also read it to say patients must have had pain for at least 6 weeks. I take that as a minimum amount of time, but I see nothing in print that specifically restricted persons in pain for more than 6 months from participating in the study. Again it doesn't specifically state that only persons having P.F. for 6 weeks were used.

Reading only the words available on the website in this article I don't really know if the doctors were forbidden to palpitate, if the patients were not allowed to say 'that's where it hurts' or if someone having P.F. longer than 6 weeks was band from the study. All these facts are missing.

Maybe the full article actually includes this specific information as facts, but I don't see this in the abstract Brian posted.

Re: JAMA Article, made the Boston news tonight !!

BrianG on 9/18/02 at 21:25 (095671)

Unfortunatly JAMA only prints abstracts of the study. To get the complete study, you have to be a registered professional (with JAMA), and then pay something like $9 to get the full study. It may be available at some other site on the Net, for free. I don't know.

BrianG

Re: JAMA Article, made the Boston news tonight !!

Dr. Z on 9/18/02 at 22:11 (095677)

This study is not valid period. There was no control . They treated all the patients. Don't you agree that you must have a control in any study

Re: Dr. Z, a few questions and a few comments

elliott on 9/18/02 at 22:19 (095678)

Questions:

1. Can you explain exactly what those energy numbers including the symbols appearing in the reports mean, e.g. 1000 mJ/mm2 in this latest study and 1300 mJ/mm2 in the US study, and also whether these figures are cumulative with repeated treatments, or are they instead single energy highs? Also, what about the number of pulses? Anything you can say to shed light on all this would be welcomed.

2. What's the cutoff or ranges for something to be considered high, low, or medium energy?

Comments:

1. I agree JAMA is not as prestigious or rigorous as many other journals.

2. I take your last point ('The conclusion can only be that both groups that were treated with ESWT, one with low energy and one with lower energy got better') to imply that the conclusion can only be that they got better due to ESWT (for otherwise it would be just be restatement of the results). (Here is a perfect example of why clarity in writing can be crucial; if I am misreading, sorry.) Well, it's not the only possible conclusion. Some other possibilities would be that the control group as a whole also got better due to the placebo effect, or that both groups were getting better anyway.

Yes, there are conflicting results on ESWT, and yes, many of them are encouragingly positive. I find interesting that most studies to date, even those with a 6-month minimum, find large improvement even among the control groups. Here's yet another study showing great overall performance for the treatment group at LOW energy, coupled with POOR overall performance for the control group:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12226782&dopt=Abstract

The possibilities for both success and failure seem numerous. If some want to be a bit more cautious before jumping on the ESWT bandwagon, that should be OK. After all, it's their money.

On a related topic, Dr. Manoli's post on the Treatments board had an interesting quote by a doctor, namely that 80% of PF cases get better in a year or so with just rest (what does that mean, one can ask) and nothing else. If true, that might put not only some of the ESWT studies in a different light, but also the efficacy of some of the other traditional conservative treatments.

[[[[[[[[[

Re: JAMA Article, made the Boston news tonight !!

Pauline on 9/18/02 at 22:36 (095679)

Dr. Z,
After the trials were finished I was his patient. We discussed the trials
and at that time I was begging for treatment and hoping for Dornier to have a speedy trip through the FDA because I was in pain. He had the machine in his office, but couldn't use it because it had not received FDA approval yet. I watched that machine for over a year sit collecting dust every time I went to his office. Obviously you were not in the room with us, but I was told at that time he did not see significant differences in any of the patients in the trial. He wasn't impressed by the results. Because it was a double blind random study he didn't know which patients received what, but they still kept their return appointments and talked to him about their pain and progress. Surely he would have been jumping up and down if he saw great results happening. It just wasn't there. I don't know which stage the final report was in at the time.

I haven't been back to see him in well over 8 months. His office consists of many Orthopedic specialist who all specialize in specific parts of the body. I returned to see a different physician for a hip problem. I saw him in the hallway and we chatted briefly. You have to remember I'd been his patient for over 2 years by this time and about the same some years before he Dornier's existance so I'd say he knows me pretty well.

He indicated he at that time he was still not using the Dornier or any ESWT machine.

I make no excuses for what I report knowing what ever I say could never satisify you. Best you check out what I'm saying for yourself. Only then will you feel comfortable.

If we want to really begin to examine and discuss getting facts correct we might also want to examine some doctors web sites. The web is full of false and misleading claims about snip and go operations, painless ESWT treatments, speedy recoveries, Medical groups adopting and issuing a formal position on ESWT when it didn't exist, and many more and I don't limit this issue to only foot and ankle doctors. It exists on other sites as well.

Like you, I probably won't feel good until someone helps me understand where they are getting their facts too, so I think I know how you might feel.

Re: JAMA Article, made the Boston news tonight !!

Dr. Z on 9/19/02 at 08:29 (095699)

I am just going to repeat Three things and then I am not going to contiune to repeat myself

Dr. Rhompe has written many excellent articles of ESWT all positive
DR. Zingas was part of the FDA study and the study speaks for itself.
There were control studies in the AMA study . They all received ESWT and they were all chronic patients.

Re: Dr. Z, a few questions and a few comments

Dr. Z on 9/19/02 at 08:35 (095701)

Hi

Just so you understand what I was saying about the treatment groups both receiving some level of ESWT energy. This isn't a controlled study at all.
There was no control. We do know that both groups did get better. The AMA study has no relationship or should there be any comparsion to the FDA dornier study. That is my point. To do this is just not scientific.

Re: can you please explain the energy numbers? thanks (nm)

elliott on 9/19/02 at 09:20 (095711)

.

Re: Dr. Z, a few questions and a few comments

john a on 9/19/02 at 11:06 (095720)

Dr. Z, from the extract 'Patients were randomly assigned to receive either ultrasound-guided ESWT given weekly for 3 weeks to a total dose of at least 1000 mJ/mm2 (n = 81), or identical placebo to a total dose of 6.0 mJ/mm2 (n = 85).' So, yes, the placebo group received ESWT also, but at such a low dose, that it is assumed to be the same as doing nothing. Are you suggesting that even at this very low dose, ESWT can be effective? Admittedly, it is difficult to give placebo ESWT, because the patients will tend to know they are not being given the real treatment, primarily because it doesn't hurt! But you have to try to make the patients think they are getting effectively treated, or else there will be no placebo effect. I think the most accurate conclusion that you can draw from this study is that below a certain dose level, there is no demonstrative benefit of ESWT.

Re: JAMA Article - AMA bias

Scott R on 9/19/02 at 11:51 (095721)

Since ESWT is mainly in the hands of podiatrists, I wonder if the AMA chose to publish this one negative study because it hurts one of its competitors for patients ( MDs verses DPMs ). I believe the AMA has lost in court at least twice for libel against podiatric entities. Choosing what articles to publish is the primary way journals are not scientific, peer-reveiwed or not. This may all be cleared up in the next issues 'letters to the editor', if they choose to publish contrary opinions, but the damage has been done as can be seen in HealthTronics stock drop of 22% or so ysterday making it one of the biggest losers for the day. Of course, they could probably not have come up with 166 patients if they chose 6 month criteria, so they chose the 6 week criteria Since something like 80% of patients improve by the 6 month mark, you can bet 80% of their 166 patients would not have qualified to be in the FDA studies. Since they were going to get better anyway, the controls just dilute any significance that would have been present in the treated group. So, either the AMA is ignorant in choosing this study to publish, or just plain wicked. But it's interesting that a doctor told me just last week that he thinks the trauma from just the anesthesia could be what's helping, although there are probably plenty of studies where anesthesia is not used, and i don't know if it was used in this study.

Re: can you please explain the energy numbers? thanks (nm)

Dr. Zuckerman on 9/19/02 at 13:06 (095727)

The energy levels I believe you stated 1000mj/mm2 for the AMA study and 1300mj2/mm for the FDA study This is the total amount of energy received at the focal point or the area of treatment. With the AMA study they used three sessions and with the FDA dornier study it was one high energy treatment. The AMA study was much lower then the FDA study.

Re: can you please explain the energy numbers? thanks (nm)

Pauline on 9/19/02 at 13:41 (095731)

Isn't this similar to the study currently being run at the Canadian sites that are using the Dornier. They were using 3 low dose treatments. Now I understand they are testing the U.S. FDA protocol, one high dose treatment, vs their 3 lower dose one. I know they were doing this at Fowler Kennedy Medical Center.

Have they published on this yet?

I'm thinking the AMA report could have an effect on G.P's handing out referrals to Pods. and Orthos. for patients wanting to try ESWT. Many couldn't get insurance covered treatment if they can't get a referral from their primary care doctor. He is more likely to believe the AMA report.

No doubt someone will come up with a report that combines the efforts of both organizations.

Re: BC / BS of Massachusetts version of the study

BrianG on 9/19/02 at 14:52 (095734)

I could be wrong, but I don't think this study was sponsored by JAMA. It was one of many orginizations that reported on the study. Since yesterday, I have read different versions of the Austrailian study at 3 different web sites, JAMA, WEBMD and BC / BS of Massachusetts. Plus someone sent me the same study fom the AskJeeves website today, but I could not open it.

I think people should give JAMA a break, they are only one of the messengers of this study. If I'm wrong here, and JAMA was in fact behind the study, I apologise.

BrianG

PS here is the BC / BS article:

Study Jolts Shock-Wave Therapy for Heel Pain

New research saying that shocking plantar fasciitis won't heal it comes under fire.
By Ed Edelson
TUESDAY, Sept. 17 (HealthScoutNews) -- A newly approved shock-wave therapy for the painful heel condition called plantar fasciitis doesn't work, says an Australian study that is drawing cries of dissent and caustic criticism from companies that make the machines.
The study, done by Dr. Rachelle Buchbinder and colleagues at the Cabrini Medical Center in Malvern, used the Dornier MedTech EPOS Ultra system, which was approved by the U.S. Food and Drug Administration (FDA) at the beginning of this year, for adults whose plantar fasciitis hasn't been helped by other treatment after six months.
Plantar fasciitis is a sometimes excruciatingly painful condition that occurs when the tissue supporting the foot arch becomes inflamed and breaks, creating scar tissue. It is likeliest to afflict runners, but experts say it strikes one in 10 people even if they aren't athletes.
It is treated by anti-inflammatory medications, stretching, massage and the use of splints at night, which are effective in about 95 percent of patients. Until the new devices came along, the alternative for the other 5 percent was surgery.
The Dornier device and other machines are designed to relieve the pain by sending shock waves through the foot, a technology similar to that used to break up kidney stones. The shock waves work by increasing blood flow and easing inflammation.
A report in tomorrow's issue of the Journal of the American Medical Association says Buchbinder and her colleagues tested the shock-wave therapy in 160 patients over a 15-week period. Half got the shock waves, the other half got a placebo. After six weeks, the results were essentially identical in both groups, the researchers say, with 30.6 percent of the shock-wave patients and 33.7 percent of the fake treatment patients reporting improvement. Ditto after 12 weeks, they say: 34.8 percent improvement for shock-wave treatment, 34.9 percent for fake treatment.
Buchbinder explains the difference between her results and the studies that won FDA approval by saying her study was more rigorous. 'Participants in our trial not only had to have a clinical history compatible with plantar fasciitis, but they also had to have confirmation of the condition by having changes confirmed by ultrasound,' she says. 'All previous trials relied solely on clinical criteria alone or required the presence of a heel spur or bone pain.'
Whatever the results of the Australian study, they don't apply to us, says Dr. Argil J. Wheelock, chief executive officer of HealthTronics Surgical Services Inc., the American manufacturer of the OssaTron, the first shock wave machine to get FDA approval. The OssaTron uses a spark plug to generate the shock waves, while the Dornier system passes an electric current through a coil, and the difference is vital, Wheelock says.
'This verifies what we have said all along, that there is a significant technological difference between low-energy devices and high-energy devices,' he says, noting the OssaTron is a high-energy device and the Dornier machine is not. The Dornier machine 'has a very narrow focal point, and therefore tends not to give the type of tissue damage needed to benefit from the treatment.'
More than 5,000 patients have been successfully treated with the 60 OssaTron machines now in practice, Wheelock says, 'and there will be papers forthcoming that will verify the value of the technology.'
At Dornier, marketing director Kirk Wilks describes the Australian study as 'poorly constructed and poorly executed, a substandard study that the FDA here in the United States would not look at.'
Among other flaws, he maintains, the study did not include the kind of chronic pain sufferers who were in the trial that won FDA approval. 'They didn't even have their pain level measured,' he says. 'In our studies, we had a pain scale of 1 to 10 and treated only people with a score of 5 or more. They took everybody.'
The biggest difference, Wilks says, is that patients in the FDA approval studies got only shock-wave therapy. The Australian study let patients use drugs or other treatment, which muddied the results, he says.
Buchbinder is skeptical. 'I am not convinced from the data of the previous trials that there was a clinically important benefit of shock wave over placebo,' she says. 'Both trials that resulted in FDA approval demonstrated small differences between groups.'
What To Do
Surgery is another option if your plantar fasciitis refuses to heal, but there are risks, whereas shock-wave therapy is a low-risk option. You can learn more about plantar fasciitis and other pains in the foot from the American Academy of Family Physicians or the University of Michigan.
SOURCES: Rachelle Buchbinder, M.B.B.S., director, department of clinical epidemiology, Cabrini Hospital, Malvern, Australia; Argil J. Wheelock, M.D., chief executive officer, HealthTronics Surgical Services Inc., Marietta, Ga.; Kirk Wilks, marketing director, Dornier MedTech, Atlanta; Sept. 18, 2002, Journal of the American Medical Association
Copyright © 2002 ScoutNews, LLC. All rights reserved.
 
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Re: BC / BS of Massachusetts version of the study

Dr. Chris Reynolds on 9/19/02 at 18:24 (095767)

Brian, the study was funded by The Melbourne Diagnostic Imaging Group and Mayne Health Diagnostic Imaging.

You may be interested to read the acknowledgements -

'We gratefully acknowledge the support of the partnership of the Melbourne Diagnostic Imaging Group and research assistants Suzanne Gregory, Jenny Gmehling and Naomi Zalcman and the cooperation and assistance of Dornier MedTech and Mayne Health Diagnostic Imaging.'

I'm sure Dornier were not happy about the findings. But isn't this what heelspurs.com is all about - the truth?

Re: BC / BS of Massachusetts version of the study

Pauline on 9/19/02 at 18:49 (095769)

Holy Cow, Dornier assisted with their own demise. It's like the O.J. trial you shouldn't assist the prosecutors.

Re: JAMA Article, made the Boston news tonight !!

Dr. Chris Reynolds on 9/19/02 at 19:58 (095776)

The study IS valid.
Please refer to the following Study Design.

METHODS
Study Design
A double-blind randomized, placebo-controlled trial was conducted between April 1999 and June 2001. Patients who fulfilled inclusion criteria and consented to take part in the study were randomized, stratified by treatment centre (3 treatment sites) in blocks of 4 (to ensure close to equal numbers in experimental and placebo arms at each treatment site) to receive either experimental or placebo regimens according to a computer-generated random numbers list created by the study biostatistician. Both the patients and a single outcome assessor were blinded to the therapy received.

Re: JAMA Article, made the Boston news tonight !!

Dr. Z on 9/19/02 at 21:03 (095780)

Where is the placebo Dr. Reynolds. There was treatment of low energy to all patients. I know of no double-blind randomized placebo-controlled trial where there were the controlled group received treatment. I have many many patients that have had high ESWT treatment with a cure yes a cure post three years. If you talk to them i am sure they will tell you that they are cured by ESWT and not by chance.

Re: BC / BS of Massachusetts version of the study

BGCPed on 9/19/02 at 22:17 (095786)

Well I would like a study done to explain why there is such a discrepency between mail rooms at BC/BS. I have mailed bills 3 and 4 times only to be told 'sorry we didnt get it, mail it again' some of my bills are over 4 months old form this nonsense.
On the other hand the same company will send you a cancel notice like an atomic clock or cash your premium check the day they get it. You get a late notice if you dont get payment to them in time but you dont get a notice when they are going to pay you a few months after you billed them.

My question is does the technology exist to coordinate the billing AND receivable people that are served by the same mail room to get on the same program?

Re: JAMA Article - AMA bias

Scott R on 9/20/02 at 06:41 (095799)

I didn't say that JAMA funded or ws behind the study, I said that it's possible that they picked this study to publish rather than any other studies because it was negative.

The primary author of the study responded to my complaint about the short duration of symptoms:

thanks for your email
average duration of heel pain was 6-7 months so about half had it longer. we looked at duration of symptoms and there was no benefit of ESWT in those who had it for long periods. that is duration of symptoms made no difference to the results - they were the same irrespective of duration of symptoms. i agree that 80% are better by 12 months irrespective of treatment.
Rachelle Buchbinder

So they had a patient population of about 85 patients who had had heel pain longer than 6 month verses the FDA studies of about 300. When she says 'no difference in results' for those who had it longer, she probably and should mean it in terms of statistical significance. Since the patient population is smaller, it is much more difficult to make 'statistical significance'.

Re: JAMA Article - AMA bias

elliott on 9/20/02 at 07:52 (095808)

Well, actually, the JAMA study had a patient population around double your figure, only that half were the control group (which does offer useful information). And the U.S. FDA part of the greater Dornier study we've talked about here that has publshed preliminary results had half your figure, of which half again were the control group, so the JAMA and US FDA studies are very comparable in numbers, and otherwise of acceptable size. I think the real problem is that if 80% really do get better on their own, then you're dealing with only 20% of those numbers who might actually be benefiting from ESWT (and you don't even know who they are), or around 15 patients. Now that's a rather small sample, even if statistically significant, as other variables might now be more likely to distort things. For example, maybe some patients rested smarter. For a statistical example, the 80%, even if true, no doubt has some variance associated with it, with the result being that the number actually having improved from ESWT could be far less.

[[[[[[[[

Re: JAMA Article

Scott R on 9/20/02 at 11:21 (095835)

She sent me a copy of the journal article. My complaints are:
1) It's low energy, although not lower than maybe most other ESWT studies
2) Almost half the patients would not have qualified to be in the FDA studies because they had it less than 6 months.
3) The control patients may have had better care than they would have received in the U.S.

I think it's the best study I've seen on ESWT, but that it only demonstrates that low energy used early in the course of the condition does not provide more benefit than the treatments that were allowed in the study. It does not rule out that higher energy and/or late-treatment ESWT might also be of no more benefit than conservative care. Since the results are muddled by apparently mild cases, i can't say that it shows low energy is of no benefit in chrnoic cases.

Re: JAMA Article - AMA bias

BlindBlind on 9/20/02 at 14:37 (095854)

I'm not sure I understand the data reported by the authors
in regards to the blinding of their study. The article states that
for the active treatment group

'Treatment began on level 1 and was gradually increased through to
the highest tolerable level of pain for each participant.'

The article goes on to say that only

'Nineteen participants (24.4%) in the active group correctly identified
their treatment group'

My question is simple. If EPOS operator increased the level until
pain tolerance then why didn't more patients in the treatment group
correctly guess that they were being treated? Didn't they reach a
level of pain in the treatment?

Just thought that it would be interesting to see what others
thought about this point.

Re: JAMA Article - AMA bias

Scott R on 9/20/02 at 16:52 (095864)

Controls may not have known that they were supposed to feel any pain, but that would have to have been carefully controlled for by what the operator says. For example asking 'do you feel any pain YET' would have obviously undone the blindness for both control and active groups. Of course there's no way the operator could have not known which was treated and which was not since it was 100 pulses for the controls and 2500 pulses for the active group. So i assume the operator was not the diagnosis or followup physician in order for them to say that end was blind. Then if the operator knows, then I have to wonder how they made sure his interaction with the patients didn't convey the information. I've always questioned and wondered about the legitimacy of the blind-blind aspects of the ESWT studies.

Re: JAMA Article - AMA bias

BlindBlind on 9/20/02 at 17:05 (095866)

Independent of the operator's actions, don't you think that
patients that felt pain would guess that they received treatment?
Wouldn't they associate treatment pain with active treatment?

I think that more members of the active group should have associated
treatment pain with active treatment. Otherwise, I have to assume
that the active treatment group did not receive treatment at a
level of pain tolerance, which was the study protocol.

Re: JAMA Article, made the Boston news tonight !!

BrianG on 9/20/02 at 20:41 (095874)

Hi Dr. Reynolds,

Glad to see you stop in now and again. Are you getting ready for summer, down under?

Regards
BrianG

Re: JAMA Article

rob a on 9/22/02 at 09:46 (095943)

It seems that if we want to compare apples to apples, then we may have to wait until the canadian studies are complete. They originally used the EPOS with low power multiple treatments but are now trying the high powered FDA treatment protocol. When those results are published then we will be able to, for the first time, actually compare the differences between two different protocols on the same device. As far as I am aware, there are no studies on the Sonocur or Ossatron being done that will allow us to examine differences in protocol on the same device. I think this will be an interesting finding. If the studies show that higher energy treatments give better results then that will justify sedation and the higher cost of ESWT that currently exist in the U.S. If not, then there is the possibility that insurance copmpanies will be reluctent to pay higher reimbursments to cover anesthesia and outpatient cost. This would move ESWT to an office base treatment and reduce the overall cost of the procedure.

Re: JAMA Article

Dr. Z on 9/22/02 at 10:25 (095945)

Good Points. We are already using the Dornier Epos in an office setting using the FDA protocol. The use of an ASC and sedation has never been justified . All the FDA Dornier studies and ossatron studies used a local anesthetic anyway with the use of an ASC. Ths only reason ASC are being used is due to the insurance companies and their outdated policies for ESWL ( kidney stone ESWT)

Re: JAMA Article

Bill E on 9/22/02 at 13:02 (095962)

Any idea when the results of this study will be completed and published? Which machinces are being compared?

Re: JAMA Article, made the Boston news tonight !!

Ed Davis, DPM on 9/23/02 at 23:20 (096061)

One study with non-favorable results has little impact when compared to the numerous studies that show excellent results with ESWT. It certainly can make the news due to its controversial nature.

Beyond the studies, one must look at the collective experiences of the practitioners using this modality. It may be relatively new to the USA but it has been around for a while in Europe with an impressive track record.

The significance of ESWT is its ability to affect tissue quality and that is an issue with chronic PF, not PF that has been around 6 weeks. Yes, the study stated 'at least 6 weeks' so some of those in the study could have had PF longer, but do we know how many? Failure to list how many of those individuals had chronic PF is a major flaw in the design of that experiment. ESWT is for 'recalcitrant' PF so the 6 week minimum criteria was a faulty inclusion criterion to begin with.

The study mentioned how the targeting was done. One cannot assume that the docs or technicians had the leeway to target in any different fashion than by the method listed. Yes, in theory the thickest part of the plantar fascia should be the most painful but it that is often not the case. Chronic plantar fasciitis exists in individuals with chronic excess plantar fascial tension. The plantar fascia is expected to thicken in response to such tension -- that is a normal response of the human body.
We have not established precisely when such thickening is pathologic.

Finally, ESWT used alone will have limited efficacy since it addresses one third of the treatment triad. Many individuals experiencing relief from ESWT have recalcitrant PF and have already had the other two legs of the triad adequately addressed.
Ed

Re: One flawed study does not reveal the truth

Ed Davis, DPM on 9/23/02 at 23:22 (096062)

One flawed study does not reveal the truth.
Ed

Re: What is the factual basis for the statement that "80% will get better on their own"?

Ed Davis, DPM on 9/23/02 at 23:27 (096063)

I don't think it is the AMA bias here but, unfortunately for all those who have suffered so long waiting for third parties to extend coverage, this will be used as an excuse by insurers to deny payment.
Ed

Re: JAMA Article - AMA bias

Ed Davis, DPM on 9/23/02 at 23:29 (096064)

Good point BlindBlind -- I really cannot come up with an answer.
Ed

Re: anesthesia?

Ed Davis, DPM on 9/23/02 at 23:31 (096066)

What type of anesthesia was used in the study?
Ed

Re: Half of the patients had PF less than 6 months

Ed Davis, DPM on 9/23/02 at 23:56 (096070)

Sort of reminds me of the flawed PF study where recent onset cases were provided both oTC inserts and custom orthotics with the study showing the two modalities being equal.

Lets go back to the treatment triad because it is fundamental to understanding the process. Acute PF is basically a sprain of the fascia, it is an inflammatory condition. It thus can be treated successfully with anti-inflammatories -- oral or injections or cortisone plus the use of soft heel pads or inserts (acute PF can sometimes progress to chronic PF but lets leave that out for simplicity's sake for now).

Plantar fasciitis that persists or becomes chronic does so for one of two reasons....
...abnormal or excessive strain persists on the fascia. This may be due to work conditions, poor shoegear, poor body mechanics: subtalar joint overpronation, midtarsal joint oversupination, tight achille-gastrosoleus.
...tissue quality deteriorates. This can occur due to chronic inflammation which leads to tissue damage, genetic factors leading to poor connective tissue quality or a combination of both.

The 3 'legs' of the triad thus have different 'height' at different times.
Initially the first leg, 'inflammation' is by far the predominant process. As such expect modalities such as cortisone shots to work reasonably well in the first few weeks or few months, then gradually decrease in effectiveness with time. As time goes on and PF persists, the second leg must be focused on. The body can and does repair itself and if that is not happening then one must remove impediments, ie. find and remove the biomechanical problems preventing that from occurring. Look carefully at the second leg from 6 weeks to 6 months. Inflammation and tissue damage occurring for extended periods of time (say greater than 6 months) will compromise the body's ability to repair tissue. The tissue becomes badly scarred and devascularized. This is the point where the third leg predominates -- tissue quality. So ESWT is really the great breakthrough as a modality for affecting tissue quality. One is accomplishing very little in aiming an ESWT machine at PF which is of adequate tissue quality.
Why did half of the patients in the study have a modality applied which have no reason to be applied? It makes as much sense as giving penicillin to someone with a headache, the headache persists, so penicillin is criticized.

Now, one caveat, PF often waxes and wanes in the early stages for a number of patients so the 'stages' I discussed cannot be affixed to firm time periods. For example, a patient can low grade chronic PF for years, change jobs to one that requires more standing and develops a bout of acute PF superimposed on the chronic process.
Ed

Re: Treatment Triad

Max K on 8/17/05 at 14:42 (180631)

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