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A reminder....

Posted by Ed Davis, DPM on 11/11/04 at 22:35 (163645)

PubMed

PubMed Citation
Articles by Rompe, J. D.
Articles by Nafe, B.

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Track and field

The American Journal of Sports Medicine 31:268-275 (2003)
© 2003 American Orthopaedic Society for Sports Medicine

Shock Wave Application for Chronic Plantar Fasciitis in Running Athletes
A Prospective, Randomized, Placebo-Controlled Trial
Jan D. Rompe, MD*, Jens Decking, MD, Carsten Schoellner, MD and Bernhard Nafe, MD
From the Department of Orthopaedics, Johannes Gutenberg University School of Medicine, Mainz, Germany

* Address correspondence and reprint requests to Jan D. Rompe, MD, Department of Orthopaedics, Johannes Gutenberg University School of Medicine, Langenbeckstrasse 1, D-55131 Mainz, Germany

Background: Recent articles have reported success with repeated low-energy shock wave application for treatment of chronic plantar fasciitis in runners.

Hypothesis: Shock wave treatment for chronic plantar fasciitis is safe and effective.

Study Design: Prospective, randomized, placebo-controlled trial.

Methods: Forty-five running athletes with intractable plantar heel pain for more than 12 months were enrolled; half were assigned to a treatment group that received three applications of 2100 impulses of low-energy shock waves, and half received sham treatment. Follow-up examinations were performed at 6 months and at 1 year by a blinded observer.

Results: After 6 months, self-assessment of pain on first walking in the morning was significantly reduced from an average of 6.9 to 2.1 points on a visual analog scale in the treatment group and from an average of 7.0 to 4.7 points in the sham group. The mean difference between groups was 2.6 points. After 12 months, there was a further reduction of pain in both groups, to an average 1.5 points in the treatment group, and to 4.4 points in the sham group.

Conclusion: Three treatments with 2100 impulses of low-energy shock waves were a safe and effective method for treatment of chronic plantar fasciitis in long-distance runners.

Re: Our honred poster, Dr. Rompe has been a very busy man...

Ed Davis, DPM on 11/11/04 at 22:48 (163646)

Rompe JD Tierexperimentelle und klinische Ergebnisse der Stosswellentherapie am Knochen. 1997 Siebert W, Buch M (Hrsg), Stosswellenanwendung am Knochen - Klinische und experimentelle Erfahrungen, Dr. Kovac, Hamburg: 38-39

Rompe JD Extrakorporale Stosswellentherapie - Grundlagen, Indikation, Anwendung. 1997 Chapman & Hall GmbH, London Glasgow Weinheim New York Tokio Melbourne Madras
(ISBN 3-8261-0138-3)

Rompe JD Stosswellentherapie: therapeutische Wirkung bei spekulativem Mechanismus. 1996 Orthopädie, 134: 13-19

Rompe JD Die Auswirkung extrakorporaler Stosswellen unterschiedlicher Energiedichten auf knochennahes Sehnengewebe - tierexperimentelle und klinische Studien. 1996 Habilitationsschrift, Johannes Gutenberg-Universität Mainz

Rompe JD Overview of Tennis Elbow Treated with Shockwaves 2000 Coombs R, Schaden W, Zhou S (eds), Musculoskeletal Shockwave Therapy, Greenwich Medical Media Ltd, London: 131-135

Rompe JD, Bohl J, Riehle HM, Schwitalle M, Krischek O Überprüfung der Läsionsgefahr des Nervus ischiadicus des Kaninchens durch die Applikation niedrig- und mittelenergetischer extrakorporaler Stosswellen. 1998 Zeitschrift für Orthopädie, 136: 407-411

Rompe JD, Burger R, Hopf C, Eysel P. Shoulder function after extracorporeal shock wave therapy for calcific tendinitis. 1998 Shoulder Elbow Surg 1998; 7: 505-509

Rompe JD, Decking J, Schoellner C, Nafe B Shock wave application for chronic plantar fasciitis in running athletes – a prospective, randomized, placebo-controlled trial. 2001 Persönliche Mitteilung, 2001

Rompe JD, Eysel P, Hopf C, Vogel J, Küllmer K Extrakorporale Stosswellenapplikation bei gestörter Knochenheilung - eine kritische Bestandsaufnahme. 1997 Unfallchirurg, 100: 845-849

Rompe JD, Eysel P, Küllmer K, Vogel J, Kirkpatrick CJ, Bürger R, Nafe B, Heine J Extrakorporale Stosswellentherapie in der Orthopädie - aktueller Stand. 1996 Orthopädische Praxis, 8: 558-561

Rompe JD, Hopf C, Eysel P, Heine J, Witzsch U, Nafe B Extrakorporale Stosswellentherapie des therapieresistenten Tennisellenbogens - erste Ergebnisse von 150 Patienten. 1995 Chaussy C, Eisenberger F, Jocham D, Wilbert D (Hrsg), Die Stosswelle - Forschung und Klinik, Attempto Verlag, Tübingen: 147-152

Rompe JD, Hopf C, Küllmer K, Heine J, Bürger R Analgesic effect of extracorporeal shock-wave therapy on chronic tennis elbow. 1996 Bone Joint Surgery, 78 B: 233-237

Rompe JD, Hopf C, Küllmer K, Heine J, Bürger R, Nafe B Low-energy extracorporeal shock wave therapy for persistent tennis elbow. 1996 International Orthopaedics, 20: 23-27

Rompe JD, Hopf C, Küllmer K, Witzsch U, Nafe B Extrakorporale Stosswellentherapie der Epicondylopathia humeri radialis - ein alternatives Behandlungskonzept. 1996 Orthopädie, 134: 63-66

Rompe JD, Hopf C, Nafe B, Bürger R Low-energy extracorporeal shock wave therapy for painfull heel: a prospektiv controled single-blind study. 1996 Archives of Orthopaedic and Trauma Surgery, 115: 75-79
Rompe JD, Hopf C, Rumler F 2 Jahre extrakorporelle Stosswellentherapie (ESWT) in der Orthopädie - Indikationen und Resultate ? 1994 Orthopädie Mitteilungen, 173

Rompe JD, Kirkpatrick CJ, Küllmer K, Schwitalle M, Krischek O Dose-related effects of shock waves on rabbit tendo Achillis. 1998 Bone Joint Surgery 80 B: 546-552

Rompe JD, Küllmer K, Eysel P, Riehle HM, Bürger R, Nafe B Niedrigenergetische extrakorporale Stosswellentherapie beim plantaren Fersensporn. 1996 Orthopädische Praxis, 4: 271-275

Rompe JD, Küllmer K, Riehle HM, Herbsthofer B, Eckardt A, Bürger R, Nafe B, Eysel P Effektiveness of low-energy extracorporeal shock waves for chronic plantar fasciitis. 1996 Foot Ankle Surgery, 2 : 215-221
Rompe JD, Küllmer K, Vogel J, Eckardt A, Wahlmann U, Eysel P, Hopf C, Kirkpatrick CJ, Bürger R, Nafe B Extrakorporale Stosswellentherapie - experimentelle Grundlagen, klinischer Einsatz. 1997 Orthopäde, 26: 215-228

Rompe JD, Riedel C, Betz U, Fink C Chronic lateral epicondylitis of the elbow (tennis elbow) – Prospective comparison of low-energy shock wave therapy with low-energy shock wave therapy plus manual therapy of the cervical spine. 2001 Arch Phys Med Rehabil 2001; 82: 578-582
Rompe JD, Rosendahl T, Schöllner C, Theis C High-energy extracorporeal shock wave treatment of nonunions 2001 Clinical Orthopaedics and Related Research, 387: 102-111

Rompe JD, Rumler F, Hopf C, Eysler P Shoulder function after extracorporeal shock wave therapy (ESWT) for calcifying tendinitis. 1997 Shoulder and Elbow Surgery

Rompe JD, Rumler F, Hopf C, Nafe B, Heine J Extracorporeal shock wave therapy for calcifying tendinitis of the shoulder. 1995 Clinical Orthopaedics and Related Research, 321: 196-201

Rompe JD, Schoellner C, Nafe B Evaluation of low-energy extracorporeal shock-wave application for treatment of chronic plantar fasciitis 2002 Bone Joint Surg [Am] 2002;84:335-41

Rompe JD, Zöllner J, Eysel P, Heine J Surgical Treatment Versus High Energy Shockwaves for Calcifying Tendonitis 2000 Coombs R, Schaden W, Zhou S (eds), Musculoskeletal Shockwave Therapy, Greenwich Medical Media Ltd, London: 145-150

Rompe JD, Zöllner J, Riedel C, Schöllner C, Freitag C Importance of the elimination of the calcium deposit in patients treated with extracorporeal shockwaves for calcifying tendinitis of the shoulder 2000 3rd Congress of the ISMST - Naples, Abstracts:24

Rompe JD, Zoellner J, Nafe B Shock wave therapy versus conventional surgery in the treatment of calcifying tendinitis of the shoulder 2001 Clinical Orthopaedics and Related Research, 387: 72-82

Isn't it great to know something about the expertise of the man giving you advise?
Ed

Re: Our honred poster, Dr. Rompe has been a very busy man...

Jan R. on 11/12/04 at 04:29 (163671)

So, let us talk data!

Re: A reminder....

john on 11/12/04 at 06:35 (163678)

Dr Davis,

Dr Rompe is a leading contributer to the field of ESWT. I hope that his research will be helpful at getting insurance coverage here and in Europe.

You missed his recent article in the November 19, 2003 JAMA. The article was titled 'Extracorporeal Shock Wave Therapy for the Treatment of Chronic Calcifying Tendonitis of the Rotator Cuff'

Re: Our honred poster, Dr. Rompe has been a very busy man...

john on 11/12/04 at 07:44 (163682)

Dr Rompe,

I would like to talk data. I have a question about your own research and its findings.

In your JAMA article, Extracorporeal Shock Wave Therapy for the Treatment of Chronic Clacifying Tendonitis of the Rotator Cuff, Gerdesmeyer et. al., Journal of the AMA, Volume 290, November 19, 2003, pp2573-2580, it was concluded that:

'Both high-energy and low-energy ESWT appeared to provide a beneficial effect on shoulder function, as well as on self-rated pain and diminished size of calcifications, compared with placebo. Furthermore, high-energy ESWT appeared to be superior to low-energy ESWT'

Dr Davis has claimed that treatment by ESWT should be the same for all sites, e.g., shoulder, elbow, knee, foot, etc... and that approval for each site in unnecessary.

Based on your study and Dr Davis's claim, am I correct in concluding high-energy ESWT is superior to low-energy ESWT for all sites? If not, what is the difference in applying ESWT to the rotator cuff as opposed to applying ESWT to the plantar fascia?

Re: Our honred poster, Dr. Rompe has been a very busy man...

Jan R. on 11/12/04 at 08:35 (163684)

Sir:

I disagree with Dr. Davis insofar that I do not think it wise to treat different pathologies in the same way.

For recalcitrant tendinosis (or fasciosis) my recommendation is: repetitive 'low'-energy ESWT.

In calcifying tendinitis, you have a differing pathology with large calcium deposits within the tendon. With ESWT I aim a dissolving these deposits - therefore we apply 'high'-energy ESWT. What you need is an extremely good focusing device: you intend to treat the deposit, not the surrounding tendon.

As you have a rather high number of rotator cuff tears in this elderly population: I never do high-energy ESWT before having checked the integrity of the supraspinatus tendon. With high-energy ESWT, you may produce partial or complete ruptures of an already weakened tendon.

Best wishes

Re: Our honred poster, Dr. Rompe has been a very busy man...

john on 11/12/04 at 09:19 (163687)

Dr Rompe,

Thank you for your reply.

I agree with you and believe that each pathology needs its own protocol that has been proven to work. This is probably the reason that the FDA requires approval for each pathology.

Is there any literature, other than the plantar fasciitis Ossatron study, that shows partial of complete ruptures of weakened tendons using high energy ESWT? In your opinion, if the integrity of the supraspinatus tendon is poor is any form of ESWT indicated?

Re: mis-information

Ed Davis, DPM on 11/12/04 at 10:28 (163697)

Dr. Rompe and John:
I NEVER stated that ESWT should be the 'same' for all sites but quite the opposite. I have repeatedly stated that the optimal energy application and technique is not known for all sites in the body. What I specifically have objected to is the region by region (tendon by tendon, ligament by ligament) approval process of the FDA. Either ESWT has a physicologic effect on tendinopathies or enthesopathies or it does not. I fully expect that technique and success rates to vary by body region due to differences in technique and unique aanatomic conditions. For example, the low success rate on medial epicondylitis compared to lateral epicondylitis may have something to do with the broader attachement of at the medial epicodyle and the proximity of the ulnar nerve which may be causing the user to aim 'broad' of the tendon.
Ed

Re: A reminder....

Ed Davis, DPM on 11/12/04 at 10:31 (163698)

John:

Would you feel as good if Dr. Rompe's research leads to insurance acceptance of low energy protocols as high energy protocols?

John, how do you explain Sunny Jacob and David Lowy's high success rates treating plantar fasciittis in Canada via low energy?
Ed

Re: Our honred poster, Dr. Rompe has been a very busy man...

Ed Davis, DPM on 11/12/04 at 10:55 (163706)

John:
See my post below on the misinformation in your post. Please don't lie about what I have said!
Ed

Re: mis-information

john on 11/12/04 at 14:09 (163726)

Dr Davis,

In many posts you have said that both low energy and high energy work equally well. My question remains. Given that high energy works better than low energy for rotator cuff, are you willing to grant that high energy might work better for other parts of the body? If not, do you think that there is something unique about the rotator cuff article?

Wouldn't the situation be better if Seimans had just sought FDA approval for plantar fasciitis? I don't buy the argument that FDA approval is too expensive for Seimans. Seimans is one of the leading manufacturers of medical equipment in the world. They are larger than Healthtronics and Dornier combined. Maybe the conspiracy is that the FDA does not have the stomach to go after Seimans for off-label marketing of ESWT because Seimans is so large and so well connected? Just a thought.

Re: mis-information

Ed Davis, DPM on 11/12/04 at 14:21 (163727)

john:
I have stated that low energy works for PF as does high energy. I have stated many times (keep in mind I have been on this board for years and you can go back in history as far as you wish with the archive feature) that we will eventually refine techniques and establish the optimal technique and energy level for the various tendons and ligaments in the body. That will be much harder to do if we don't have a body wide indication. I certainly agree that Siemens should have tried to obtain FDA approval for PF -- they are a big enough company that one would assume they have the capital to do so. Why would the FDA want to go after Siemens for off label use when the device is SAFE. That is the prime directive of the FDA -- safety of drugs and devices. Again, when it comes to efficacy, I ask you the same question for the third time in 2 days: Why do Sunny Jacobs and David Lowy have such an excellent cure rate for PF using the Siemen's Sonocur with low energy? The Seattle area I live in is only about 2 1/2 hours from Vancouver, B.C so I can vouch for David Lowy's success rate personally. Beyond that I have had conversations with Sunny Jacob and feel that he is quite straightforward and honest about his results.
Ed

Re: A reminder....

Jan R. on 11/13/04 at 03:54 (163799)

Dr. Davis:

Please, let´s talk data, not advertisement.

Where are the data of 'Sunny Jacob and David Lowy's high success rates treating plantar fasciitis in Canada via low energy'?

How to get access to their results?

If they managed to publish their data wouldn´t they have to declare their financial interests?

Bhandari et al. just released the following article in CMAJ:

Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials.

CMAJ 2004; 170:477-80.

BACKGROUND: Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings. In this study, we examine the association between industry funding and the statistical significance of results in recently published medical and surgical trials.
METHODS: We examined a consecutive series of 332 randomized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals. Each eligible study was independently reviewed for methodological quality using a 21-point index with 5 domains: randomization, outcomes, eligibility criteria, interventions and statistical issues. Our primary analysis included studies that explicitly identified the primary outcome and reported it as statistically significant. For studies that did not explicitly identify a primary outcome, we defined a 'positive' study as one with at least 1 statistically significant outcome measure. We used multivariable regression analysis to determine whether there was an association between reported industry funding and trial results, while controlling for study quality and sample size.
RESULTS: Among the 332 randomized trials, there were 158 drug trials, 87 surgical trials and 87 trials of other therapies. In 122 (37%) of the trials, authors declared industry funding. An unadjusted analysis of this sample of trials revealed that industry funding was associated with a statistically significant result in favour of the new industry product (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.3-3.5). The association remained significant after adjustment for study quality and sample size (adjusted OR 1.8, 95% CI 1.1-3.0). There was a nonsignificant difference between surgical trials (OR 8.0, 95% CI 1.1-53.2) and drug trials (OR 1.6, 95% CI 1.1-2.8), both of which were likely to have a pro-industry result (relative OR 5.0, 95% CI 0.7-37.5, p = 0.14).
INTERPRETATION: Industry-funded trials are more likely to be associated with statistically significant pro-industry findings, both in medical trials and surgical interventions.

So, let Mr. Jacobs and Mr. Lowy release their data, and state possible financial interests. Then, I will be happy to check the results and give you my impression.

Regards

Re: A reminder....

Ed Davis, DPM on 11/13/04 at 10:34 (163821)

Jan:

I cannot speak for those two. Clinicians are not researchers as we spend the vast majority of our time treating patients. It would be my sincere hope that Sonorex has compiled data from its work throughout the years and will ask them.

Keep in mind, that as a clinician, I am very interested in reviewing the literature but place credibility on the cumulative experience gained by hundreds of practitioners in an area, experiential information. Quite frankly, that is how much of it is done in the area of surgery and I have asked many a time, why surgical treatment trends are based so strongly on experiential results compared to the non-surgical area.

I find your data on the differences between industry funded statistics and independent studies to be interesting. If you have a chance, take a look at the controversy over the safety of Aspartame, in which you will see a very significant difference between safety studies funded by Searle, the manufacturer and private, independent studies.
Regards,
Ed

Re: A reminder....

J. P. (Sunny) Jacob on 11/13/04 at 14:45 (163837)

PainFree ESWT Clinic is privately owned and operated. We do not have any direct or indirect financial or other relationship with ‘Sonorex' (who I assume is a clinical operator and clinic financier dedicated to a specific equipment model), or any other corporation.
We acquire our equipment directly from the manufacturer. However, we do not endorse any particular manufacturer or engage in ‘fee-splitting' arrangements with anyone.
This is part of our corporate policy and we adhere to it in all clinical modalities.
It gives us full independence to purchase the best medical equipment available in the market at a given time. It is also our policy to provide the best service at a most reasonable cost to our patients.
Regarding our treatment data, - our best success is the treatment outcome based on thousands of treatments since 1996 using ‘low energy' ESWT. As all our patients pay directly, they are also the most demanding for good results. An annual patient growth of approx. 30% speaks for itself. Our proprietary treatment polices and procedures were developed internally. We do collect extensive treatment data, not only for PF but also for tendonitis treatment and in our urology section for Peyronie's disease.
I do not wish to share this information on chatrooms and message boards. It will be presented and published at the appropriate time via credible professional forums.

Re: Our honred poster, Dr. Rompe has been a very busy man...

J. P. (Sunny) Jacob on 11/13/04 at 14:52 (163838)

Re.: Effect of ‘low' energy ESWT on calcium deposits:
In the PainFree ESWT Clinic, Toronto, we successfully treat Peyronie's Disease (Induratio penis plastica) with ‘low energy' ESWT.
We developed our own clinical policies and procedures for Peyronie's after performing a series of trial treatments using ‘low energy' ESWT. During the last 16 months this procedure is performed in our clinic on a routine basis by an experienced urologist and an academic like yourself, affiliated to a university.
The calcified plaque size in the patients treated varies from 1 cm to more than 3 cm in diameter.
As you have mentioned, direct focusing with in-line ultrasound is a must. No anesthesia or analgesics are required. The procedure is documented with pre- and post treatment photos and ultrasound documentation. All patients undergo three sessions and some receive a fourth treatment. If there are multiple plaques, each location has to be treated individually.
Fibrous tissues with partially calcified plaque is a common occurrence with Peyronie's patients. This condition is also successfully treated with the same procedure. The majority of our patients are referred by their urologist and a few from family physicians. All patients undergo a thorough consultation by our urologist prior to approving ESWT treatment, due to occasional misdiagnosed patients arriving for ESWT.
Post treatment follow-up is done during the 3rd, 6th and 12th week after treatment. According to our internal data to date, the success rate for this treatment is 63%. Without other effective alternatives available, almost all of our patients are very appreciative of the improvement in their condition, i.e. decreased curvature and substantially reduced pain and related symptoms.

Re: A reminder....

Ed Davis, DPM on 11/13/04 at 15:02 (163839)

Sunny:
I realize that we will need to wait for your finished public paper but would you consider providing us with an approximate success rate for your treatment of plantar fasciitis. As you can see from this board, the issue has been high vs. low energy ESWT. I have tried Ossatron, Dornier and Sonocur and while my numbers are low on the Ossatron, I do not perceive any difference in results. Discussions with colleagues who have similar experiences seem to agree. Of course, we are speaking of experiential information as opposed to 'structured' studies. It appears to me that the 'attack' on low energy is motivated in large part because low energy is a lower cost alternative. FDA approval or lack of is being used as the primary 'weapon' against low energy. Of course the FDA represents only one country, the US and has a spotty track record of judging efficacy since it is so heavily politicized.
Ed

Re: Why have some industries felt that the cost of studies was too great...

Ed Davis, DPM on 11/13/04 at 15:30 (163844)

Jan:
A number of industries which could not see a sufficient financial retrun for providing the studies may be hesitant to fund studies considering potential costs. See the following article:

http://www.cato.org/pubs/pas/pa-235.html

Ed

Re: Why have some industries felt that the cost of studies was too great...

Ed Davis, DPM on 11/13/04 at 15:31 (163845)

In other words, a high rate of financial return is needed to justify FDA approval and that drives the cost of medical care to great heights.
Ed

Re: US, Canadian and European approval of medical devices...

Ed Davis, DPM on 11/13/04 at 15:45 (163848)

http://www.fdareview.org/devices.shtml

Re: A reminder....

J. P. (Sunny) Jacob on 11/13/04 at 16:17 (163855)

Most of our PF patients arrive with a pain level between 7 and 9 on a VAS scale.
What we call ‘success' is when the patient's pain level is reduced to level 3 or lower during inactivity within 12 weeks after a 3-session treatment.
Approximately 8 to 10% of patients may require a second course of treatment if they do not achieve the expected success level (see above) 12 weeks after the first 3 treatment sessions. If this is required,we do not charge any additional fee for the 2nd course of treatments.
The majority of the patients who undergo a second treatment course achieve substantial pain relief after the second round of treatment sessions. Those who do not get pain relief even after the second course of treatment, we may not be able to help.
Our success rate to date for PF is 86% and this has been fairly constant for the past seven years. As you know, we have refined our treatment protocol over the years.
My recollection of European treatment data for ‘low energy' treatment for PF is a success rate of 72%.
We treat primarily chronic PF patients who have undergone conventional treatment without success and who do not wish to undergo surgery. Some of our patients with successful treatment outcome had previously undergone ESWT treatment elsewhere without success. We maintain separate statistical clinical data for that group.

All 3 major manufacturers, Ossatron (HMT), Dornier and Siemens were using multiples sessions with ultrasound imaging in Europe. In USA, due to certain restrictions for the use of ultrasound imaging, all of them changed their protocol. Their marketing approach influenced the clinical trials for single treatment with high energy. In Europe, Dornier was performing PF treatment using multiple sessions at 0.24 mJ/mm2 with ultrasound imaging. To compete in the US market with Ossatron, they also went into single session treatment.
Irrespective of all these changes made in USA, I agree that overall, all of these equipments perform well to provide satisfactory PF treatment. Still, one of the most important elements for successful treatment outcome is the experience of the therapist.

Re: US, Canadian and European approval of medical devices...

Dorothy on 11/14/04 at 00:35 (163875)

It's amazing, isn't it.

Re: A reminder....

john on 11/14/04 at 10:52 (163884)

Sunny,

With all due respect, Dornier has stated that they entered the US market with high energy because after years of experience they came to believe that a single treatment, high energy protocol was more successful than multiple low energy treatments.

As you must realize, Dornier could have sought FDA approval for either high or low energy.

Re: A reminder....

J. P. (Sunny) Jacob on 11/14/04 at 21:26 (163941)

In the early ‘90s when ESWT was introduced in Germany, patients who had the treatment and the physicians who treated them were surprised with the positive result. It was no surprise that many scientists called it a placebo effect.
If I am right, the German national health care calls it placebo effect (for specific reasons) even today, irrespective of high or low energy, though there are thousands of satisfied patients in Germany. If the situation has changed, someone please correct me.
If a certain special interest group wishes to categorize successful low energy ESWT treatment outcomes as a placebo effect, then so be it.
From my standpoint, if the low energy experience of the past 7 years with a high success rate and satisfied patients is called a placebo effect, then the many low energy ESWT providers around the world are providing a successful placebo treatment in the annals of placebo treatment.
Interesting enough this is achieved by not even using anesthetic or analgesia and without side effects. Personally, I will take such a placebo treatment at any time for a pain relief until someone proves that it is harmful.
Other: In which country did Dornier do 'years' of single treatment and during which period of time?
It does not seem to make a lot of sense to supply an equipment with the ability for high and low energy set-up and then suggest that the treatment protocol is only for high energy, - especially when low energy is being claimed as giving only a placebo effect.

Re: A reminder....

Dr. Z on 11/14/04 at 21:54 (163942)

Sunny,
Have you seen the post by the podiatrist Scott from Australia? He describes a three session repetitive High energy protool without anesthesia. The device used is the Dornier. I think it is very interesting, however the non use of anesthesia seems very unusual. It would appear that the repetitive use with increasing power settings with weekly spaced treatments is the key for using without anestheisa. Your comments would be appreciated.

Re: A reminder....

J. P. (Sunny) Jacob on 11/15/04 at 07:23 (163951)

Dr. Z,
I also recall reading about the energy protocol used by Scott in Australia.
I am not certain that the models sold in Australia and the U.S. are the same. The only way to find that is to compare the technical literature and data provided by the manufacturer. However, it is difficult for me to understand that level settings in the U.S. and Australia in mJ/mm2 are the same.
Even on Sonocur, the maximum level a patient can take without anesthesia is level 7, i.e. 0.47 mJ/mm2 for calcified plaque. The average level used for PF is between 3 and 4, i.e. 0.28 to 0.33 mJ/mm2. During the 2nd and 3rd session the patients usually cannot take a higher level than what I stated above. Many patients start at a lower level during the first session.
Dr. Z, you would be in a perfect situation to do a comparison study of low multiple session without anesthesia (may be off label) and high energy single treatment for PF using your Dornier Epos.

Re: A reminder....

Dr. Z on 11/15/04 at 13:34 (163989)

Sunny,
I am confused. Isn't 0.33mj/mm2 high energy range.