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different ESWT technologies, my experiences

Posted by Patrick M. on 10/03/03 at 20:08 (132118)

I have had to deal with plantar fasciitis for almost 3 years. When you have it in both feet and when your job involves a lot of standing and walking, life can be very difficult.

I basically did the typical routine of physical therapy, stretching orthotics which got me about 50% better and wondered what I could do to bring this to resolution and if that was possible.

I opted for ESWT on my left foot in December, 2002 and had it done via a Healthtronics Ossatron. It was a decent experience and my left foot was much better by the end of March but not totally cured. My left was a bit worse than the right and since my insurance did not cover the treatment, I elected to do one foot at a time.

I did some research and decided to try the Siemen's Sonocur in early March for my right foot. It really just involved walking into the clinic, getting it done and walking out akin to going for an office visit. No anesthesia was used and I was less sore the next day.

My right foot was completley healed by the end of July. I have some persisting pain on the left but not enough to slow me down. I would like to get rid of that nagging soreness so I will probably do the second round with the Sonocur.

The technology is, in my opinion, a major leap forward. Based on my personal experiences and my reading, all of the available ESWT technologies seem to work. Personally, I have to place my bets on the Sonocur. It is much less expensive, much more convenient and involves no trip to the surgicenter nor anesthesia. It is simply the most cost effective way to get the job done.

I did a lot of reading on the ismst.com site that several have recommended here and used the locator on http://www.sonorex.com to find a provider in my area.

Patrick

Re: different ESWT technologies, my experiences

Dr Z on 10/03/03 at 21:36 (132125)

Patrick,
I am really glad that you have gotten relief from a technology that is in my opinion a the major leap.
Here is the problem I see with the Soncur compared to the product that we use the Dornier Epos Ultra. Lets place aside that the dornier is fda approved and the soncur isn't for Chronic pf.
The Soncur isn't pain free for everyone and can lead to more then just three treatments.
At the level of energy that the low energy soncur treats plantar fasciitis you are treating pain receptors and arene't treating or healing the plantar fascia. Yes you will have increase metabolism but there is no direct interaction with low energy eswt.and plantar fascia tissue. The Soncur works by using hyperstimulation
The dornier using high energy had direct biological interaction with the fascia and does promote direct healing. So you say so what.
Ok lets assume that patients are better serviced with low energy and not high energy. The soncur CAN'T go to high energy treatments
The dornier can use low, medium and high energy ranges. The treating doctor can determine that best level of treatment.
I just performed an 18 minute dornier treatment today. The patient walked out. The heel was numb . The patient experienced no pain.
What happens with the patient that can't tolerate the low energy soncur
treatment. Add local anesthesia. No that will interfere with treatment results.

Presently the dornier is my bet, but I am willing to get that in the next five years we will have a dornier type machine built by some company for 1/3 the price now that is the company to look out for. As for Healthronic well read the Wall Street Journal .

Re: different ESWT technologies, my experiences

Ed Davis, DPM on 10/03/03 at 21:57 (132130)

Dr. Z:

You are making a couple of assumptions here. I agree that the Dornier is more flexible in that it can deliver all ranges of power. But I cannot agree that low energy 'cannot heal' the fascia as I have seen it happen numerous times both locally and via patients seen in Canada. The 'hyperstimulation' you speak of would only result in a transient phenomenon of relief but we are seeing long term cures on patients who have had PF for years. For example, one patient that I had seen in July 2002 had PF of 9 year duration and had had surgery recommended by 4 podiatrists. She was in considerable pain with a VAS level of 8 to 9. I sent her to the Sonorex Center in Vancouver, BC. This was before the machines were available in the US. She recieved more treatments than most, 4 rounds of 3 treatments. She was completely pain free, VAS level 0, by November 2002. I saw her recently and she remains pain free. I have used this example beforebecause she represented one of the worst cases around. I had spent time visiting the Sonorex Center in BC before I had made my decision and had time to talk to staff and patients. They had autographed pictures of numerous professional athletes from the US with letters of appreciation on their walls. Canada and Europe have largely concluded that low energy ESWT works for PF. They are achieving cures in significant numbers and, beyond all of the studies, the success of those machines out in the field is impressive.

I have, in a number of patients (but not a large number) have taken measurements of plantar fascial thickness by diagnostic ultrasound and there is a measurable and significant decrease in thickness of the fascia after ESWT performed with both high and low energy machines. It is apparent to me that both technologies are effective in promoting healing of the fascia.

Most patients tolerate Sonocur without anesthesia but I have encountered 2 or 3 patients that had difficulty. The solution to the problem was quite simple. We started the treatment without anesthesia, identifying the area in need of treatment. All patients can tolerate lower levels of energy. Treatment is interupted for a block, then resumed at the same location that was previously identified.
Ed

Re: different ESWT technologies, my experiences

Dan D. on 10/04/03 at 06:44 (132152)

Patrick,
Where did you get your Sonocur treatment done?

Dan

Re: different ESWT technologies, my experiences

Dr Z on 10/04/03 at 09:56 (132160)

Ed,
I agree that there are long term low energy excellent results or cures
I can tell you many many stories of patients that are pain free with the
dornier with just one treatment that were just as bad off as your example but that wasn't my point.
I was talking about machines, the market which machine type will probaby be in the future.
I have used the method that sonocur used back in the days of the orbasone. I found that 'All patients can't tolerate lower levels of energy
I am pretty sure the lower level range of the soncour and the dornier are almost the same. I have use those levels also. Some pateints just can't tolerate ESWT and will need either shortened treatments with plus five or more sessions or some type of local.
So I have used low energy, I have done multiple sessions low energy
They do work. I presently use the dornier epos and I just love the typical one session with a regional ankle block
The very rare patients I will do the three session low energy on the dornier. I always use the three session low energy for non-insertional
achilles tendon.
Now if we talk about the Canada model for delivery of ESWT. Well all I can say is the USA and the manufactor's better open their eyes and hear
and at least learn about the sonocur business model.
Take a look at the Blue Book on energy levels and tissue effects. This is where I make the statement about low energy and hyperstimulation. Low energy can only create this effect. As to what sequential events take place after the hyperstimulation I am not sure what happens. But low energy doesn't have a direct biological effect on plantar fascia. There is no micro-trauma interaction.
It is my opinion that in the fasciosis condition of plantar fascia disease you need the micro-trauma to achieve fibroblastic activity.
I don't think that ultrasound changes indicate fibroblastic activity.
One more point. I enjoy discussions and in no way am I stating that your use of ESWT is inferior to my use of the dornier I learn along time ago that the machine is not the important thing it is the doctor and you are a very good doctor. So if anyone from this board learns one thing from any of Dr. Ed and Dr. Z discussions it is isn't the machine it is the doctor who makes the correct diagnosis, and then providers treatment with 100%
Medicine is an art as well as a science. You can have two doctors both using either dornier and or the sonocur on the same patients both can receive treatment. One will get better and one will won't . Why it is the art of medicine. I have seen this so many time.
I once went to visit a doctor who have a great simple wart treatment. He applied a medication and in one visit the wart was gone. Mother had their children lined up for hours in the waiting. I tried his method. I tried.
It was really a simple treatment. Well when I did the treatment the kids had pain, the complained. It just didn't seen so care feel and simple to the kids when this other doctor did the treatment.
I worked on this treatment for months and watch. Maybe it was the look on his face when he removed the bandage. Maybe it was the jokes he told.
Maybe this Maybe that. Who knowns. Medicine is an art as well as a science
By the way I still can't get rid of warts like this doctor
So pick your doctor and treatment but the doctor should be your first choice.

Re: different ESWT technologies, my experiences

Dr Z on 10/04/03 at 10:01 (132161)

My reading glasses were in the other room and my little yorkie is sleeping my lap so sorry about some of the spelling etc but I hope everyone gets the point. I now have my glasses

Re: So how does ESWT work ????

Dr Z on 10/04/03 at 10:35 (132165)

For discussion purposes only

Dr. Ed,

Do you know of any source where low energy studies on animals showed the promotion of neo-vascularization in tissue. This is something I have been rsearching and and asked many international eswt physicians. No one has been able to show me that it does or does.
Why do I ask? It is my opinion from research etc that high energy works by micro-trauma to the plantar fascia. This is thru cavitation?
Low energy works thru hyperstimulation of the local pain receptors. Now what happens next: We don't have micro-trama of the pf with low energy. Do we have any sympathetic local response that increases blood flow?
Does stopping the pain cycle promote natural healing? The Sonnex web site and most low energy theories talk about neo-vascularization. I haven't been able to find research done in this area. I do know that it happens with medium to high energy but I can't find it with low energy
Are the sucess stories with low energy from faciitis and not fasciosis?
There is a abstract on this board I will go get it that talks about a five year low energy study and re-occurence. I will start a new thread and
maybe we can discuss it.

Re: Low term results with ESWT

Dr Z on 10/04/03 at 11:16 (132172)

Here is an five year abstact for low energy eswt. The re-occurrence rate after five years is fairly high . Dr. Ed do you know of any other long term
low energy eswt follow up. I have personal data from my own practice and the FDA study for the high energy dornier. It appears that the low energy treatment could have a much higher incidence of re-occurrence.

TITLE: 5-years lithotripsy of plantar of plantar heel spur: experiences and results--a follow-up study after 36.9 months
TITLE: 5 Jahre Lithotripsie des plantaren Fersenspornes: Erfahrungen und Ergebnisse--eine Nachuntersuchung nach 36,9 Monaten.
Z Orthop Ihre Grenzgeb 1998 Sep-Oct;136(5):402-6 31
AUTHORS: Sistermann R; Katthagen BD AUTHOR AFFILIATION: Orthopadische Klinik, Stadtische Kliniken Dortmund, Klinikzentrum Mitte. PUBLICATION TYPES: JOURNAL ARTICLE LANGUAGES: Ger
ABSTRACT: INTRODUCTION: Effectivity and application as well as possible complications and side effects of extracorporeal shock wave lithotripsy of plantar heel spurs should be evaluated. METHOD: We applied extracorporeal shock wave lithotripsy (ECSL) to treat plantar fasciitis in 54 patients (period from: 3/1/1993 to 3/1/1996). 20 persons were treated with Lithostar plus (group 1) and ultrasound focussing and 34 patients (group 2) were treated by a Lithostar and X-ray focussing. RESULTS: After 6 weeks 14 (70%) of group 1 and 27 (79.4%) of group 2 were free of pain. After 36.9 months 8 (40%) of group 1 and 23 (67.6%) of group 2 were still painfree. We could not recognize any severe complications after 36.9 months. CONCLUSION: ECSL is an effective and noninvasive method of treatment. It is not the method of choice for the first treatment of plantar fasciitis but is an alternative option for operation. NLM

Re: Low term results with ESWT

Ed Davis, DPM on 10/04/03 at 12:43 (132174)

Dr. Z:
Thank you for your responses. The concept of cavitation has been discussed before in terms of comparing radial shock wave therapy (RSWT) which applies shock waves without the cavitation phenomenon. Its advocates claim efficacy. The creation of cavitation in terms of a necessaity fo tissue healing is uncertain.

As far as long term studies, there is a paucity of long term studies both in high and low energy ESWT. It may be somewhat easier to find such a study which you have due to the greater use and experience with low energy ESWT in Europe.

The number of variables that affect long term outcomes may be difficult to control. Once patients are effectively 'cured' they often go back to the vocation/avocation that nay have been an instigating factor in the disease process, stop stretching, may not use their orthotics and stop payig attention to shoegear. These variables are difficult to control over the long term but any long term study would have to take these into account if a correlation is to be attempted.

It would be advantageous to have an objective parameter beyond the VAS scale to measure tissue level effects as that would enable us to get a better comparison. The only parameter we have is the measurement of plantar fascial thickness via MRI or ultrasound. It is true that the correlation between fascial thickness measured and the existence of fasciitis/fasciosis is problematic when applied to populations, different conclusions can be reached when that measurement is applied to individuals. When an individual (or group of individuals) has a specific thickness measurement and the application of one of the ESWT technologies leads to a measurable and significant change over time, a tissue level effect has been shown to have occurred. Keeping in mind that such patients entered ESWT with all of the other treatments in place, the only two parameters available to effect fascial thinning would be rest and/or ESWT. Most patients who I see already have moderated their activity level for an extended period of time so rest is apparently not the factor, ESWT is, with the thinning occurring irrespective of high or low energy use. This discussion has provided me an incentive to use diagnostic ultrasound imaging of the fascia more frequently in order to increase the numbers of patients I have made this observation on.
Ed

Re: Low term results with ESWT

Dr Z on 10/04/03 at 13:06 (132177)

Ok

Here is how I look at this in very simple terms. When I did mininial incision foot surgery for chronic pf, my long term results were EXCELLENT in the patient that received an initial cure. The cure lasted. I have cures post 20 years.
The long term re-occurence was very very small whether the patient had orthosis, stretched, jumped ran or whatever post surgery. This was a reparative process at the inserion where I cut the fascia This is what my standard is for ESWT to be considered an option for long term cure for chronic insertinal plantar fasciitis in the chronic patients Not changing life style. because we did ESWT for two reason to get rid of pain and to improve quality of life and life activity.

I expect and I am seeing very similiar outcomes with the high energy eswt
patients. Now is this true for low energy eswt. From what I read from the European experience so far isn't true. In that one abstract the re-occurence rate is 30%.
Low energy may turn into physical therapy that may or may not be needed to be repeated and repeated down the road. Not judging that this is right or wrong just what it may be .
Do you know of any long term studies showing excellent cure and small
re-occurrence. I can't help it sorry. ( Its one of your quotes a love) . Its time for the Europena winnies to show us their stuff. Ok I am sorry. I will be serious
We may find out that low energy has a high re-occurence rate but still may be better for the patient. After all how many patients will go to physical therapy three times per week for six weeks. Isn't three plus ESWT session alot better.
Cost-effectiveness if it is going to be used as a reason to have low energy to the insurance companies and to the public should have the rate of re-occurence because that adds to the cost.
Ok out for the afternoon. I do know I can never win in a debate with you cause I have read you social posts. Dam you are good. but I do bring some very important and interesting points because the market place always tells the truth about how things work and will the patient pay. The Healthronics situation was something that even Dr. Z knew was coming The low energy model and the high energy model will boil down to ease of treatment, effectivenes on a long term scale and cost effectivenes.
I do see some day the Canadian model for ESWT delivery being the USA model of ESWT delivery in the future. Ther doctors office won't be used
for ESWT treatment. There will be only centers just like physical therapy is delivered.

Re: Low term results with ESWT

Ed Davis, DPM on 10/04/03 at 13:19 (132179)

Dr. Z:
I think that we will have more answers in the upcoming years. Canada is only 3 hours north of me, so I am going to have to look up there for more long term info. It is easier to drive across the border into Canada, than cross back into the US. Have a great weekend!
Ed

Re: different ESWT technologies, my experiences

Dorothy on 10/04/03 at 15:14 (132190)

Yorkies are so cute.

Re: different ESWT technologies, my experiences

Dr Z on 10/04/03 at 16:51 (132203)

thanks Dorothy,

Mine is named Josi Ann. It is my wedding aniversary and my parents just brought us an oil painting of her. It is so cute. Josi is three and one half pounds. She love's everyone who comes to the house. It is her birthday also she is one. If you can tell I am crazy about her you are so right. She is on my lap at this very moment again. Every where I go she just follows Dr. Z

Re: different ESWT technologies, my experiences

Dorothy on 10/04/03 at 19:13 (132220)

Happy Anniversary to you and Mrs. Dr. Z!! And happy birthday to your little bitty Josi Ann. Now this would be a good subject for your new digital camera, eh? I hope you are all having a wonderful day!

Re: different ESWT technologies, my experiences

Dr Z on 10/04/03 at 19:44 (132221)

Thanks.

Re: different ESWT technologies, my experiences

Jan R. on 10/05/03 at 03:27 (132278)

Sir:

When reading the responses to your letter I became aware once more that there is more belief than scientifically based knowledge on shock wave technology.

There is no reason to think that low-energy technology is superior to high-energy or vice versa.

These are the facts:

A) Basic Research

The therapeutic mechanism involved remains speculative.

High-energy:
Ogden et al. (2001)postulated high-energy shock waves to be directed at controlled internal fascial tissue microdisruption that initiates a more appropriate healing response within the fascia and a better long-term capacity to adapt to biologic and biomechanical demands. No evidence was presented!!!

Low-energy:
Ohtori investigated the pathomechanism of pain relief induced by ESWT. In 2001 he reported about low-energy shock wave application to rat skin. To investigate the analgesic properties of low-energy shock wave application, he analyzed whether it produced morphologic changes in cutaneous nerve fibres. In normal rat skin, the epidermis is heavily innervated by nerve fibres immunoreactive for protein gene product (PGP) 9.5 and by some fibres immunoreactive for calcitonin gene-related peptide (CGRP). There was nearly complete degeneration of epidermal nerve fibres in the shock wave-treated skin, as indicated by the loss of immunoreactivity for PGP 9.5 or CGRP. Reinnervation of the epidermis occurred 2 weeks after treatment. These data showed that relief of pain after shock wave application might result from rapid degeneration of the nerve fibres.
Takahashi (2003), co-worker of Dr. Ohtori, most recently reported that application of low-energy shock waves to rat skin decreased calcitonin gene-related peptide immunoreactivity in dorsal root ganglion neurons. To investigate the analgesic properties of low-energy shock wave application, he analyzed changes in calcitonin gene-related peptide (CGRP)-immunoreactive (ir) dorsal root ganglion (DRG) neurons. In the nontreated group, fluorogold-labeled dorsal root ganglion neurons innervating the most middle foot pad of hind paw were distributed in the L4 and L5 dorsal root ganglia. Of these neurons, 61% were CGRP-ir. However, in the shock wave-treated group, the percentage of FG-labeled CGRP-ir DRG neurons decreased to 18%. These data clearly showed that relief of clinical pain after low-energy shock wave application might result from reduced CGRP expression in DRG neurons.

B) Clinical Trials
There is no consensus so far concerning the (repeated) use of low-energy shock waves requiring no local anaesthesia and the (single) use of high-energy shock waves requiring local or regional anaesthesia.

Indeed, there is no consensus so far how to differentiate low-energy from high-energy shock waves, as multiple physical parameters are involved.

While the clinical effect of both protocols appears to be comparable there is clear evidence of increasing side effects with increasing energy levels applied.

The low-energy treatment regimen makes deletary side effects extremely unlikely compared with an application of higher energy flux densities. No local anaesthesia is required, so related side effects are lacking. The only 'disadvantage' is that according to the experience of the presenting author a repeated application is recommended.

For both technologies strict adherence is obligatory to treatment protocols which have demonstrated clinical effectiveness over control / sham treatment(high-energy: Ogden 2001;Abt 2002; Buch 2002. low-energy: Rompe 2002, 2003).

It must be clear that ESWT is not effective under all circumstances, as several diverging protocols did not result in a significant effectiveness over placebo (Haake 2003, Speed 2003, Buchbinder 2002).

Re: different ESWT technologies, my experiences

Dr Z on 10/05/03 at 07:48 (132289)

Good morning,

I appreciate your comments. These research statements from your post, concur that low energy works by hyperstimulation. I am not saying that this is good or bad just that is how it works. Do we have any research showing that this is a direct biological effects on the plantar fascia with low energy.. Do we have reseach showing neo-vascularization. More importantly do you have long term re-occurence rates for low energy treatments from the European experience. Due to lack of not being able to translate alot of the studies the only studies I have are from the medline abstracts in English
Re-occurrence rate is an important parameter when evaluating treatments. The European experimence should be able to contribute to this answer. I will even love to have long term high energy studies greater then three years results..
Any information or contact you can place Dr. Z with I would appreciate. . I would hope that they can be answered so that I can contribute to helping the economic ESWT problems we have in the USA.
Why do you think that most all of the ESWT manufactors have gone the high energy route when applying for PMA for plantar fasciitis?

Re: different ESWT technologies, my experiences

Donald Iain Scott on 10/05/03 at 08:31 (132290)

Jan,
The Buchbinder study was flawed. If you are Jan Rompe who has written many papers on ESWT, then contact Buchbinder and check out her prerequisite for her trial study, age,m/f,length/thickness of tendon, duration of pain,X-Ray, Ultrasounds etc.
No Podiatrist was involved in biomechanical assessment. No footwear specalist to check out their footwear. No dietician was present to determine obesity factor and the list goes on.
Everything was going fine until the Buchbinder results were published in JAMA.
Stats. can be manipulated to suit whatever outcome you want.
ie Some say the glass is half full or some say the glass is half empty and the engineer says the glass is too big and some will argue black is white.
So whatever we say or do you can please some of the people some of the time and some of the people none of the time.
Practitioners must treat each patient individually and provide the best outcome for that person.

160 people tested by Buchbinder is equal to about 0.000002666%population on the planet.
1.42% population in the US has Plantar Fasciitis, but if you have PF all you want is relief

We are only here to help. As long as the patient has a total of 1,000-1,500mJ/mm2 and can wait for the healing process to take place, as well as abide with the post treatment protocols set out by the practitioner then a positive outcome should arise.

If ANY INJURY occurs post ESWT then the patient must start from scratch and should not blame the ESWT for failing to live up to their expectations.

Donald Iain Scott
Podiatrist
ESWT Therapist
Australia

Re: different ESWT technologies, my experiences

Dr Z on 10/05/03 at 09:06 (132291)

Good morning, Don or is it morning,

In my post to Dr. Rompf . I am looking for research answers to help patients understand the benefits of low and high energy and how we can offer cost-effectivess ESWT to third party payors in the USA. What I don't want happening is a hugh amount of low energy treatments whether low or high energy treatment turning into a hugh amounts of re-occurrence. From my experience since 1999 I haven't seen alot of high energy re-occurence. We have a hugh numbers of patient treated with low energy treated in Europe that can help us KNOW ahead of time just what the re-occurence is.
On another note what does Dr. Rompf have to do with making sure Dr. Buchbinder is an ok person or qualified to do research. Has this reseach paper effected your practice or your patient's acceptance of ESWT.
If you need well written responses to this paper I can help you just let me know.

Re: different ESWT technologies, my experiences

Ed Davis, DPM on 10/05/03 at 13:00 (132315)

Dr. Rompe:

This discussion underscores the need to have a more objective parameter that can be measured to determine tissue effect. Perhaps biopsy may be the ideal but somewhat difficult to apply. See my comments on plantar fascial thickness as a parameter when applied to individuals as opposed to populations.

There have been suggestions as to what constitute ranges of normal for plantar fascial thicknesses in the population as a whole. I feel that that need adjustment for body weight, vocation/avocation and gender.

Moving away from the issue of what is normal plantar fascial thickness among populations, looking at individuals is more rewarding. The question then becomes, when an ESWT technology is applied and the fascial thickness is measured by ultrasound at intervals: prior to ESWT, at 12 weeks and at, say, 20 weeks do we see a consistent and significant decrease in thickness in those individuals.

I would appreciate yopur comments on this suggestion.
Ed

Re: different ESWT technologies, my experiences

Ed Davis, DPM on 10/05/03 at 13:03 (132317)

PS
We should be only doing htese measurements on individuals who have PF of at least 6 months duration and, prefereably have a plantar fascial thickness above the range of normal adjusted to body weight, gender, vocation/avocation. This criterion does add subjective element but, I feel, has the effect of tightening the criterion used.
Ed

Re: different ESWT technologies, my experiences

Dr Z on 10/05/03 at 13:46 (132319)

Ed,

I find that the thickness does change after six months for most post eswt treated patient. I have also seen great results with patients that have no change in the thickness of the pf months down the road. Maybe it was the hyperstimulation that was the result of the pain free result or maybe more time is needed. I am trying very hard to follow up one year two years with ultrasound evaluation to try to determine a pattern. It tough as you know.
I always perform a pre-eswt evaluation with ultrasound. One thing I like to do is measure the non painful pf and compare it to the painful pf.

Re: different ESWT technologies, my experiences

Dr Z on 10/05/03 at 13:53 (132320)

Ed,

Here is an area that maybe very helpful for relief of pain with patients. Using low energy eswt on patients that are below six months and aren't getting better.
If we put cost aside here is what I would want on my foot.
Lets say I have severe pain, duration two months and I have a history of GI bleeding or allergy to ASA. I am wearing orthosis to control my function, I am stretching, I am icing soaking. I am STILL in alot of dam pain. Ok the doctor wants to do physical therapy three times per week
for six weeks. Please give me some low energy eswt for three days.
That is what I would want for myself and my patients. By the way I hate needles and I don't want that local steriod injection.
Low energy eswt for acute inflamation should really help the patient alot. I believe there are some papers out there talking about this only with professional soccer plays from Italy during the world cup a few years ago.

Re: different ESWT technologies, my experiences

Donald Iain Scott on 10/05/03 at 18:13 (132335)

To All,
Rachelle Buchbinder is and A/Professor of Epidemiology and is the Director of Epidemiology at Monash University Melbourne Australia. She is highly qualified both in Australia and Canada, but I am still critical of her study that was published in JAMA.
If you want more information on her you go to Google, ESWT, Australia,Monash,Buchbinder

Good Luck
Donald Iain Scott

Re: different ESWT technologies, my experiences

Dr. Z on 10/05/03 at 19:07 (132342)

I have yet to find anyone that isn't criteria of the methods used in this study ,except for Aetna US Healthcare and Cigna Healthcare.

Re: different ESWT technologies, my experiences

Jan R. on 10/06/03 at 04:26 (132397)

Sir:

(1)Do we have any research showing that this is a direct biological effects on the plantar fascia with low energy?

No, we haven´t. But: Until now we only speculate about the biological counterpart of heel pain. For example, the majority of patients with a spur obviously does not suffer from pain. So, what biological effect are you thinking of? And what would it mean for dealing with this pain disorder at the heel?

There is clear evidence now, that there is no such thing as plantar 'fasciitis'. Lemont (JAPMA 2003) made it very clear: There is no evidence of inflammation histologically. On the other hand, there is substantial evidence that this disorder is associated changes of the plantar fascia, which may be best classified as 'fasciosis' rather than a 'fasciitis'.

Under these degenerative aspects: I don´t think it to be very likely that any therapy can produce a complete remission of these changes. I am not aware of any experimental trial showing a 'neo-vascularisation' in a physiologically almost avascular structure as the plantar fascia or the fibrocartilage interface between bone and fascia.

(2)Do you have long term re-occurence rates for low energy treatments from the European experience?

Within 5 years after active treatment (3x 1000 shocks, low-energy, no local anesthesia) only 13% of patients required an operative release of the fascia. All patients had been recommended surgery before they were included in this trial (Rompe 2002, JBJS [Am]).

So I think recurrence rate is negligible in the long run.

(3)I would hope that they can be answered so that I can contribute to helping the economic ESWT problems we have in the USA.

In my view it is a primary task of scientific organizations to answer open questions. Mostly, more questions arise than are answered when you begin to dig deeper. But: There is no primary interest in helping to solve economic problems that you encounter in the US.

Re: different ESWT technologies, my experiences

Jan R. on 10/06/03 at 04:41 (132398)

Dr. Davis:

The main problem of such a trial is: How do you make certain, that your measurements are reproducible? At which distance to the calcaneal insertion do you measure the thickness of the fascia? Medial or central or lateral band (see below)?

Vohra et al. (JAPMA 2002) measured the thickness of the medial, central, and lateral bands of the plantar fascia using ultrasonographic techniques in 109 symptomatic patients with 211 painful heels. Plantar fasciitis was diagnosed by the presence of plantar heel pain and tenderness of the plantar fascia on palpation and was correlated with plantar fascia thickness.

All of the symptomatic feet had medial band tenderness, with an average thickness of 5.9 mm, 68% had central band tenderness, with an average thickness of 5.3 mm, and 26% had lateral band tenderness, with an average thickness of 4.4 mm. The average thickness of all symptomatic bands was 5.35 mm, which was significantly greater than that for all asymptomatic bands, which was 2.70 mm. There were also significant differences in the thickness of the three plantar fascia bands in symptomatic patients. A plantar fascia index was established consisting of the ratio of the mean thickness of symptomatic medial, central, and lateral plantar fascia bands to that of asymptomatic bands; for this study, the index value is 1.98 (5.35/2.70 mm).

Your trial should include three arms:

(1) Patients before and after ESWT

(2) Patients before and after Placebo ESWT

(3) Patients before and after alternative treatment (i.e. corticosteroid injections)

Inclusion criteria as strict as possible, additional therapy as restrictive as possible, minimum follow-up 6 months. Ultrasound examinations not (!) by the treating physician.

Re: different ESWT technologies, my experiences

Donald Iain Scott on 10/06/03 at 05:05 (132399)

Dr Z,

Your ESWT lobby group should be very critical on studies and surveys that are incorrectly formulated. Publication of an article in most journals must go before a panel of peers to deem whether said article is worthy. I have not seen the Buchbinder paper in any other journal i.e American Podiatry Journal or ESWT Journals.

You have to co-operate and pull together for the betterment of the Podiatry and ESWT fraternity. As I have stated since posting on this board the make and model of your machine and whether you use low or high is irrelevant, all provide a dynamic treatment to the tendon affect with possitive results. Patient feed back is important on a case by case treatment. Sham groups prove nothing only to frustrate honest practitioner and consumer alike.

For those who have no success with ESWT have they had proper pre and post treatment advice.

Post studies are useless after 6 months due to possible other injuries a patient may do to themselves.

All health funds no matter what country we are in will always take the easy option to get out of paying rebates to patients who pay high premiums. They are into ivory towers and their shareholders profit.

Donald Iain Scott
Podiatrist
ESWT Therapist
Australia

Donald Iain Scott

Re: different ESWT technologies, my experiences

Ed Davis, DPM on 10/06/03 at 09:53 (132422)

Jan:

I am surprised that Vohra could differentiate, accurately, thickness of the different bands. I will need to look at his technique. For clinical purposes, the transducer is placed on the plantar surface of the heel, producing a lateral image. Since the central band is the thickest, it obscures accurate reading of the medial and lateral bands.

We look at the thickest part of the fascia on the lateral view which is just in front of the boney origin. On a given patient, we always go back to the same spot -- this is why I mentioned the greater significance of looking at individuals as opposed to populations. Consistency of measurement technique including location of measurement would be needed in the study. Although, clinically, I feel we are fairly consistently looking at the same spot plus or minus a couple of millimeters transposition proximally or distally along the fascia. The presence of a 'spur' causes the observer to move somewhat more distally in the measurement, although the area would stay consistent in that individual.
Ed

Re: different ESWT technologies, my experiences

Dr. Z on 10/06/03 at 10:10 (132423)

Dr. Rompf

I am talking about changing a fasciosis state to a normal vascularization ( fibroblastic activity) much similar to what happens with the changes that take place when ESWT is used for non-unions treatment. Since this is injury directly to the plantar fascia, due to the mechanical repetitive motion injury, I would think that healing this injury would be the goal which would reduce and or eliminate pain. If low energy eswt effects the pain receptors we still have damaged plantar fascia unless there is additional plantar fascia changes due to the pain receptor inter action with the plantar fascia. I agree with Dr Lemont and his fasciosis description. This has confirmed my original theory that the reason eswt works is due to the mechanical trauma that occurs with applications of eswt directly to the plantar fascia. This is my theory of why surgical release works. The trauma to the insertion creates a injury to induce re-vascularization. So why does low energy work if it only works on the pain receptors and does' have any impace with tissue quality improvement.

I do have some questions about the 13% from the active group. With the patients that were pain free how many developed additional pain that didn't require foot surgery and how many had a reduction in activity when after the ESWT treatment they had a return back to activity. I will read the article Thanks

Resolution of these types of questions can lead in the direction of resolve thing economic problems that ESWT is encountering in the USA. I would also like to thank you for your contribution to ESWT. Without you I would never have had the opportunity to use this wonderful treatment . Thanks

thanks

Dr. Zuckerman ( Dr. Z, David) . I really am a friendly guy,

Re: different ESWT technologies, my experiences

Ed Davis, DPM on 10/06/03 at 13:26 (132445)

Donald:

I wish we truly had an ESWT lobby. It has been disparate, competing groups that have been moving forward with this. Often those groups have hurt themselves in the process of criticizing competing technologies.
Healthtronics, with the Ossatron, has a very expensive treatment model and appeared to feel threatened by the less expensive technologies.
Ed

Re: different ESWT technologies, my experiences

Dr. JB on 10/06/03 at 13:39 (132447)

You are such an irresponsible doctor. What does Dornier pay you to sit and monitor this site? If you are such an authority on shockwaves, why haven't you published any of your data? Stop dispensing device as though you're the end all authority of shockwave technology. Publish your data, then talk.

Re: different ESWT technologies, my experiences

Dr. Z on 10/06/03 at 15:06 (132462)

Please join this discussion. Contribute. Tell us who your are. My name is David Zuckerman DPM . I am not the end all authority on ESWT however I CARE enought to discuss and learn as much as I can. Be the way all of the data that I am talking has been published. I am trying to get information that isn't

Re: different ESWT technologies, my experiences

Pauline on 10/06/03 at 15:36 (132470)

If a paper is published and considered flawed by others is there a protocol set in place to remove it from publication or does it just remain in print? Also what is the route that must be taken to get a paper (study) published in a respected medical journal? What are the steps taken and who must review it before it is accepted and published?

Re: different ESWT technologies, my experiences

Dorothy on 10/06/03 at 15:46 (132478)

Dr. Z ~ I encourage you to ignore those who only want to hurt or inflame or draw inordinate attention to themselves as centers of their own universes. They presume then that they will likewise be the center of everyone else's universe as well. I confess that I don't always know what you are talking about, but I think you are very nice and I like the fact that you contribute and post here. I derive some comfort from that.

Re: different ESWT technologies, my experiences

Ed Davis, DPM on 10/06/03 at 19:32 (132500)

Dr. JB:

I doubt that you really are a doctor but if you are, you realize that there are clinicians who spend most of their time treating patients and researchers who do the majority of the publishing. Dr. Z is a clinician who enjoys donating time here to provide information. There is plenty of published data to talk about. A clinician does not also have to be a researcher in order to 'talk.'

You are implying that Dr. Z has a conflict of interest when you state that he is being paid by Dornier. You have probably not been here long enough to know that he originally used another product before Dornier.

If you have information of value to contribute, then you are welcome to do so but please don't come here to anonymously bash a regular contributor.
Ed

Re: different ESWT technologies, my experiences

Ed Davis, DPM on 10/06/03 at 19:49 (132502)

Pauline:
Once a paper has been published, it cannot be removed -- journals come out monthly or less -- once something has been printed and distributed, that is it. A respected journal EARNS its respect by carefully screening the papers that are submitted to it and rejecting papers that fail to meet its standards. JAMA, which published the flawed Buchbinder study, damaged its own reputation by doing so. Why did it get published? One possibility is that the area is new enough that JAMA failed to obtain individuals with adequate expertise to properly review the paper. That is giving them the benefit of the doubt. Other reasons-- not sure but there were and are enough people out there trying to slow the development of this technology by giving third parties a reason not to reimburse for it.
It was astounding to see numerous third parties embrace this paper immediately and use it as a means to argue against reimbursement.
Ed

Re: different ESWT technologies, my experiences

Dr. Z on 10/06/03 at 22:18 (132528)

Thanks Dorothy,

I really had no idea what this person was even talking about. I have written,lectured, and trained hundreds of doctor to use ESWT.
All of the most recent information that I was talking about didn't come from Dr. Z personally. they came from the literature. What I was trying to determine was how low energy ESWT worked and what were the long term re-occurrenc rates. This is something that I feel is important and Dr. Rompf was very helpful in these areas ,

Re: different ESWT technologies, my experiences

Jan R. on 10/07/03 at 07:01 (132559)

Sir:

In my view there are not many clinical trials in the field of orthopaedics that are better designed than those done by Buchbinder (2002) or Haake (2003) or Speed (2003). Of course, none of the trials is perfect. However, there is no such thing like a perfect trial in my experience.

The Editorial Boards of JAMA and BMJ and J Orthop Res were well advised to accept these brilliant papers for publication.

Neither Dr. Buchbinder nor Dr. Haake nor Dr. Speed deserve criticism for their efforts, such as

'The study is a lesson in the axiom that while it is important to enlist the help of clinical trials experts and statisticians in designing a study protocol, it is equally important to ensure that participating clinicians are familiar with both the disorder being treated and (in the case of medical devices) with the technology being used.'
or
'I fear that the authors have found a device that they feel can be productive in helping them produce clinical studies that may expand their curricula vitae. However, carpenters should always first learn to use their tools. To undertake a clinical trial (especially involving a placebo control group) whose methodology is so flawed that meaningful conclusions cannot be made is, in my view, unethical.'

When planning a randomized placebo-controlled trial it is clear to everyone involved that the outcome cannot be predicted. Even more, 'the dark side of placebo' makes it quite likely that you do not find any clinical efficacy. There is an abundance of examples for this negative experience (i.e. Mosely et al. 2002, NEJM, on arthroscopic surgery for degenerative knee complaints)

What is a source for possible concern is that none of both undertook a pilot trial. Both relied on previously published data but did not adhere to the inclusion/exclusion and treatment protocols.

On the other hand, their trials showed very clearly, that ESWT is not effective under all circumstances. Even if you use an effective protocol you may end up in disaster if you do not select your patients individually.

What is necessary now is that somebody repeats a protocol reported as succesful in the frame of another RCT. If you have 2 RCTs from 2 independent institution showing comparably good results then you will have a high degree of evidence.

If this will solve all problems with reimbursement is a different question.

Re: different ESWT technologies, my experiences

dr ben pearl on 10/07/03 at 20:15 (132707)

David,
If you are not getting differences pre and post ESWT what is the basis for measuring the fascia thickness?
DRBP

Re: different ESWT technologies, my experiences

Dr. Z on 10/07/03 at 20:27 (132710)

Ben,
I measure pre-post eswt for pf . There are alot of patients that I do see pf thickness changes then there are some that I don't see any major change and still no pain and the patient is satisfied Could be that I need to wait longer to observe the changes

Re: different ESWT technologies, my experiences

Pauline on 10/07/03 at 21:29 (132725)

Dr. Rompe,
Thank you for posting your view on the criticism that hovers around the Buchbinder study on this board and for dissipating any negligence on the part of JAMA'S editoral board for accepting and publishing her paper.

Your insight is greatly appreciated.

Re: different ESWT technologies, my experiences

Dr. Z on 10/07/03 at 22:47 (132736)

Good point Pauline,
The negligence may be with the how the insurance companies use this information knowing very well that this study has nothing to do with the type of ESWT and patient population that they review for coverage.
How or why the AMA journal accepted a paper that talks about a non FDA approved procedure is beyond my understanding. However Dr. Rompf does make valid points
Quality papers always review the history of a procedure and the present applications before presenting new information. The AMA paper if I recall never concluded that the duration of the condition was a possible factor that concluded that ESWT was MORE effective then in the placebo group. In fact did the AMA paper ever refer to or reference Dr. Rompf earlier work and compared why this was a different conclusion. Anyway the AMA wasn't brilliant and didn't contribute anything but confusion due to the lack of reference to duration and factors that may have determine their conclusions.
In play English you mean to tell me that they never reviewed any of the papers already in pubication. Come up this is the AMA journal.

Re: different ESWT technologies, my experiences

Jan R. on 10/08/03 at 06:05 (132759)

Dr. Davis:

Have you read this paper? Hammer and co-workers just published what you intended to do.

Regards

Jan R.

Arch Orthop Trauma Surg. 2003 Oct 3 [Epub ahead of print].

Ultrasonographic evaluation at 6-month follow-up of plantar fasciitis after extracorporeal shock wave therapy.

Hammer DS, Adam F, Kreutz A, Rupp S, Kohn D, Seil R.

Orthopaedic University Hospital, 66421, Homburg/Saar, Germany.

INTRODUCTION. The aim of this study was to investigate the effect of extracorporeal shock wave therapy (ESWT) on the ultrasonographic appearance of chronically painful, proximal plantar fasciitis. MATERIALS AND METHODS. Twenty-two patients with a unilateral proximal plantar fasciitis were prospectively enrolled after unsuccessful conservative treatment lasting 6 months. The contralateral plantar fascia was used as the control. ESWT (3x3000 shock waves/session of 0.2 mJ/mm(2)) was performed at weekly intervals. The thickness of the plantar fascia was measured ultrasonographically about 2 cm distal of the medial calcaneal tuberosity. Pain estimation on a visual analogue scale (VAS) and the comfortable walking time were recorded. No local anaesthesia was applied. Follow-up was done at 6, 12 and 24 weeks. RESULTS. Before ESWT, the plantar fasciitis side was ultrasonographically significantly thicker than the control side ( p<0.05), whereas 6 months after ESWT, the thickness of the fascia was no longer significantly different. The decrease in thickness of the plantar fasciitis side was significant ( p<0.05). Pain during activities of daily living decreased by 79% according to the VAS, and the comfortable walking time increased, both significantly ( p<0.01). In patients with little pain (VAS<30), the thickness of the plantar fasciitis side was significantly less ( p<0.01) compared with patients who still suffered more pain (VAS>30). CONCLUSION. After ESWT, the thickness of the plantar fascia in patients with plantar fasciitis decreased, pain and walking time improved (all significantly).

Re: different ESWT technologies, my experiences

Jan R. on 10/08/03 at 06:16 (132760)

Dr. Davis:

Another just released article on ultrasonography for PF.

Regards,

Jan R.

Clin Imaging. 2003 Sep-Oct;27(5):353-7. Related Articles, Links

Ultrasonographic appearance of the plantar fasciitis.

Akfirat M, Sen C, Gunes T.

Department of Radiology, Faculty of Medicine, Gaziosmanpasa University, Tokat, Turkey. (email removed)

PURPOSE: To study high frequency sonographic in the examination of plantar fasciitis (PF), which is a common cause of heel pain. MATERIALS AND METHODS: Our study was done with 25 PF (21 unilateral, 4 bilateral) and 15 control cases of similar age, weight and gender. In this study, the plantar fascial thickness (mainly), fascial echogenity and biconvexity were examined using 7.5 MHz linear phase array transducer. Perifascial fluid collection, fascial rupture and fascial calcification that are rarely seen were also examined. RESULTS: The fascial thickness ranges for the PF cases: for the symptomatic heels: 3.9-9.1 mm (mean: 4.75 +/- 1.52 mm), for the asymptomatic heels: 2.0-5.9 mm (mean: 3.37 +/- 1.0 mm) and for the control group: 2.1-4.7 mm (3.62 +/- 0.68 mm). The results were significantly different in Group I for symptomatic heels and the control group statistically for PF (P < .05). The echogenity of plantar fascia and biconvexity of plantar fascia were the major criteria for symptomatic heels. In three heels (10%), perifascial fluid was diagnosed, in three heels (10%) fascial calcification, in one heel (3%) partial fascial rupture. Subcalcaneal spur was encountered sonographically in both cases of Groups I and II. CONCLUSION: Ultrasonography (US) is the first step for PF, because of its easy and quick performance, availability and high sensitivity of diagnosis, low-cost and free radiation.

Re: different ESWT technologies, my experiences

Ed Davis, DPM on 10/09/03 at 13:36 (133110)

Dr. Rompe:
Thank you very much.
I am awaiting a response from Dr. Norris per his paper.
Ed

Re: different ESWT technologies, my experiences

Ed Davis, DPM on 10/09/03 at 13:41 (133111)

Dr. Rompe:

The timing of this paper is good. The cost of diagnostic ultrasound equipment has dropped considerably over the past few years and more practitioners are taking a second look at available systems. We tend to take office x-rays more to rule out associated pathology with heel pain but with perhaps, limited utility in examining the plantar fascia itself.

Some say 'timing is everything' but , not to overuse an old cliche, this imformation could have a significant impact on our imaging habits. Thank you again.
Ed