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Pressing on the bottom of the heel- what does this mean

Posted by Dr. Z on 3/11/04 at 21:15 (146758)

Patients that undergo ESWT can have pain with physical pressing ( palpation) to the medial plantar aspect of the heel. What does this mean and does it denote success or failure of the procedure.
In my experience there are patients that still have some pain with physical examination but this in no way limits their ability to walk whether it is when they first get up in the morning or does it limit their ability to function. These patient would rate their treatment experience as either no complaint or an excellent outcome. These patient can participate in all of the activities that they desire.
A very interesting summary/conclusion in a subgroup of failed primary ossatron treated patient was that after a second treatment the evaluation with palpation was evaluated and it was noted that only 53.3% of the patients reported relief from their view but the doctor but only pressing on the area denoted 90% sucess rate. The conclusion was that the dissatified group must have had other problems. Maybe but maybe palpatoin to the area just isn't that important when evaluating just what success means.

In my practice success is always determined from the patient's view as it should be.

Re: Pressing on the bottom of the heel- what does this mean

elliott on 3/12/04 at 15:45 (146808)

Dr. Z, if, as you say, the heel pressure test is not a good one, why did Ossatron receive a PMA?

Re: Pressing on the bottom of the heel- what does this mean

Dr. Z on 3/12/04 at 16:42 (146813)

Because it was shown to be a safe and efficient procedure.

Re: Pressing on the bottom of the heel- what does this mean

dr ben pearl on 3/13/04 at 19:05 (146893)

Patients will tend to have less bias than an evaluation which would like to present the technology in the most favorable light.
DRBP

Re: Pressing on the bottom of the heel- what does this mean

Dr. Z on 3/13/04 at 20:29 (146897)

I agree 100% . That is why the R/M is the REAl test of success

Re: Pressing on the bottom of the heel- what does this mean

elliott on 3/13/04 at 22:52 (146909)

I personally cannot judge the merits of the heel pressure test. Ogden, et al., considered it their most important test and gave reasons why. I have not yet seen that officially repudiated. If you doctors are right and this test actually has little value, then, especially considering that of the 3 remaining Ossatron success criteria, two were not significant at all and one only slightly so, there is no disputing that Ossatron's success results would be put into question. And yet the FDA gave it approval based on those results. Then maybe FDA approval on the Dornier doesn't mean as much as you're making it to be out either.

Dr. Z, why does it follow that if the heel pressure test is not a good one that R/M alone is the real test of success?

Re: Pressing on the bottom of the heel- what does this mean

Dr. Z on 3/14/04 at 00:45 (146914)

The real test of success is the patients ability to function without pain.

Re: Pressing on the bottom of the heel- what does this mean

elliott on 3/14/04 at 09:29 (146930)

Dr. Z, here are my observations (which don't need FDA approval to be valid) on 4-point R/M as a sole measure of success as you have been using it on these boards:

1. At the 3-month mark, while the Dornier treatment group scored better in the 'Good' category than the placebo group, it did no better in 'Excellent'.

2. At the 3-month mark, many of the other endpoints showed no difference between treatment and placebo groups. If 4-point R/M in isolation is such a good indicator of overall improvement, one would expect the other endpoints to have been generally more positive.

3. Beyond the 3-month mark there is no placebo group to compare to, so boasting of a one-year 94% success rate in isolation gives a false impression as to the Dornier's power. Why stpo there? Use a 3-year endpoint; that should push it even closer to 100%, and with no control group to dispel the accomplishment. It would be nice also to see at the one-year mark how many of those were E and how many were G. If a big chunk were G, that puts more of a qualification on what 'success' means.

4. There was a study that kept the placebos (who had rather similar inclusion criteria as in the FDA study) blinded for a full year, the Haake study. At the 1-year mark they had a 76% success rate based on the exact same R/M criterion you use, even more impressive given one of the criticisms of the study was that it did not continue an adequate level of conservative treatment throughout. If you ask me, this puts a damper on your 94% figure. Your answer to this was that they must not have had adequate blocking of the waves. The burden of proof is on *you* that the FDA study's 'thin air cushion...placed on the therapy head' was far better than the Haake study's 'polyethylene foil filled with air...fixed with ultrasound gel in front of the coupling cushion', and in a study that had a lower level of energy than the FDA's.

I'm not saying ESWT is totally worthless. I've consistently thought it has a PF success rate of somewhere between 0 and 30%, and because I have an open mind when I look at the evidence, I consider the lower limit still a distinct possibility. And then we have to define 'success', which, the more I read, the weaker it seems to become. I feel you have given the readers on this site the impression for a long time that they have a 94% chance of being completely healed one year after getting blasted by the Epos. Sorry if they now think otherwise.

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Re: Pressing on the bottom of the heel- what does this mean

Dr. Z on 3/14/04 at 10:03 (146932)

So keep the mind open that it could be 94%. I am not the only ESWT provider in the USA that doesn't feel that the success rate of ESWT is 94% after one year is either correct or very close.
Readers who do meet the criteria that was outlined in the FDA inclusion protocol do have a very good chance of getting a good results with the dornier. The cross over group percentage after one year was 93% and these were patients that had pf pain very close to one year if not longer. Do you think that they would just have treatment if they weren't in pain.
If we took you entire thinking process and applied this to all treatments in medicine. I hate to think of the outcome.

Re: Pressing on the bottom of the heel- what does this mean

Dr. Z on 3/14/04 at 11:20 (146939)

Elliott,
The entire USA and International Society for Shockwave Therapy doesn't agree with your 30% sucess rate. The articles within the ESWT section are completely opposite to your view point with ESWT success.
Hey how about you lecturing your finding at the next Internatinal Society for Shockwave Therapy Group. I promise to be there to field questions

Re: Pressing on the bottom of the heel- what does this mean

Ed Davis, DPM on 3/15/04 at 21:24 (147091)

Elliott:
One needs to look at the aggregate of provider experience, studies which are not double blinded, studies which are. The aggregate suggests a relatively high success rate for ESWT.
Ed

Re: Pressing on the bottom of the heel- what does this mean

Ed Davis, DPM on 3/15/04 at 22:22 (147095)

I think if Dr. Z, myself and a few other providers with a modest number of patients pooled data we could show a unique population of individuals with multi-year histories of recalcitrant PF, having been through multiple modalities unsuccessfully but brought to resolution via ESWT in stark contrast to the questionable population of Buchbinder. What we have is an aggregate of very tough 'incurable' cases that only ESWT brought to resolution. There is no question in my mind whatsoever, that if ESWT could cure some of the toughest cases including surgical failures, that we have a modality of immense value and success, not to mention the infinitessimal downside to the performance of this procedure. I know of no procedure in my almost 22 years in practice that has fewer side effects or is safer. The reward to risk ratio is remarkable and unmatched by virtually any medical discovery in the last 22 years or more.
Ed

Re: Pressing on the bottom of the heel- what does this mean

Pauline on 3/16/04 at 07:54 (147107)

Dr. Ed,
I think the more treatment centers involved for your suggestion the better with both Orthopedic and Podiatric contributors. In addition I think the results would also have to also reflect other data to make a good comparison.

Total number of patients treated, how long they have had their pain, those that had no relief, those that have some and of course those that were left totally pain free and perhaps other data as well.

With so many variables and of course the consideration of natural healing process over time, I still don't know if the scientific community would be satisfied with the results.

I think the first hurdle would be developing a questionnaire that everyone would agree upon is reflective of all the necessary data that would make the results acceptable to the scientific community and others seeking such information.

Re: Pressing on the bottom of the heel- what does this mean

Pauline on 3/16/04 at 12:06 (147135)

Dr. Ed.,
Maybe acceptance and insurance coverage for ESWT for P.F.will come on the coat tail of elbow and shoulder treatment. Not that it should be that way, but maybe insurance companies will look more favorably at it because it can be useful in a variety of ways. Maybe what we imagine sooooo far off in the distance is just around the corner. Just a thought.

Re: Pressing on the bottom of the heel- what does this mean

Dr. Z on 3/16/04 at 13:00 (147138)

Ed,
I have found in our area on the east coast that FDA approved ESWT treatments for elbows still isn't covered. Maybe with more physician specialities what Pauline is saying could become a reality. I hope so

Re: Invitation for Australians, German colleagues and others to comment

Ed Davis, DPM on 3/16/04 at 21:11 (147157)

Pauline:
That is a very good point but keep in mind that the 'fathers' of ESWT never intended it to be a body region specific modality and no provider considers it to be a modality specific to the plantar fascia. The regional study and usage of this is an artificial creation of the FDA approval process. It is a modality designed to treat tissue quality problems of tendons and ligaments, not just the plantar fascia. The US is the only country in the world that has taken this unique geographic approach and the only valid reasons for doing so are political ones, not scientific concerns. I invite our Australian, German and other foreign colleagues to comment on this.
Ed