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Is ESWT ineffective for plantar fasciitis?

Posted by Jan Rompe on 7/18/03 at 02:32 (124693)

The full text of the following abstract is available at http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=12855524

or at http://bmj.com/cgi/content/full/327/7406/75 .

BMJ. 2003 Jul 12;327(7406):75.

Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial.

Haake M, Buch M, Schoellner C, Goebel F, Vogel M, Mueller I, Hausdorf J, Zamzow K, Schade-Brittinger C, Mueller HH.

Orthopadische Klinik, Universitat Regensburg, 93077 Bad Abbach, Germany. (email removed)

OBJECTIVE: To determine the effectiveness of extracorporeal shock wave therapy compared with placebo in the treatment of chronic plantar fasciitis. DESIGN: Randomised, blinded, multicentre trial with parallel group design. SETTING: Nine hospitals and one outpatient clinic in Germany. PARTICIPANTS: 272 patients with chronic plantar fasciitis recalcitrant to conservative therapy for at least six months: 135 patients were allocated extracorporeal shock wave therapy and 137 were allocated placebo. MAIN OUTCOME MEASURES: Primary end point was the success rate 12 weeks after intervention based on the Roles and Maudsley score. Secondary end points encompassed subjective pain ratings and walking ability up to a year after the last intervention. RESULTS: The primary end point could be assessed in 94% (n=256) of patients. The success rate 12 weeks after intervention was 34% (n=43) in the extracorporeal shock wave therapy group and 30% (n=39) in the placebo group (95% confidence interval - 8.0% to 15.1%). No difference was found in the secondary end points. Few side effects were reported. CONCLUSIONS: Extracorporeal shock wave therapy is ineffective in the treatment of chronic plantar fasciitis.

Re: Is ESWT ineffective for plantar fasciitis?

Peter R on 7/18/03 at 07:52 (124699)

Treatment application in this study does not conform to currently applied therapy using Dornier Epos Ultra. Treatment in the study was applied at the lowest energy level(.08mJ/mm2), level 1, on the Dornier Epos. Total energy delivered by Rhompe was 960 mJ/mm2 in 3 treatments vs. current method of 1300mJ/mm2 in 1 treatment. This probably why the results showed the modality to ineffecive. Just another excuse for the ins. co's to deny coverage.

Re: Is ESWT ineffective for plantar fasciitis?- Question

Dr. Z on 7/18/03 at 09:26 (124702)

This was a low energy multiple treatment protcol. What I would like to know is the following information. 0.08 mj/mm2 ( level three) is usually delivered at 120 shocks per minute. The faster the rate per minute the greater the cavitation effect which causes the biological damage to tissue. What was the rate per minute in this study. Was the purpose to create tissue biological damage or to induce analgesic effects on the pain receptors. Any help is appreciated

Re: Is ESWT ineffective for plantar fasciitis?

Dr. Z on 7/18/03 at 09:50 (124708)

I just read the complete abstract article. Why couldn't these clinic's use the FDA approved protocol for the dornier Epos Ultra. This was a great opportunity to use the exact protocol and then report their results. There was a local anesthetic used . So why didn't they use the Dornier Epos protocol. We need repetitive studies using the FDA approved protocol. This would really serve the public and the insurance industry.

Re: Is ESWT ineffective for plantar fasciitis?

Peter R on 7/18/03 at 10:14 (124711)

I stand corrected. .08mJ/mm2 on the Dornier is level 3. What I would like to know is 'Who funded this study' Could it have been an insurance comapny?

Re: Is ESWT ineffective for plantar fasciitis?- Question

Peter R on 7/18/03 at 10:17 (124712)

If we find out the sponsor of the study we may then know the purpose of the study.

Re: to : Jan Rhompe Re: Is ESWT ineffective for plantar fasciitis?

Peter R on 7/18/03 at 10:19 (124713)

Who sponsored the study and why wasn't it done according to the standard Dornier protocal for high energy ESWT?

Re: to : Jan Rhompe Re: Is ESWT ineffective for plantar fasciitis?

David on 7/18/03 at 10:49 (124718)

One should examine the differences in protocol and ask the question of Haake et al why Dr. Rompe's study, published earlier this year, shows positive results in the treatment of pf

Am J Sports Med. 2003 Mar-Apr;31(2):268-75. Related Articles, Links

Shock wave application for chronic plantar fasciitis in running athletes: a prospective, randomized, placebo-controlled trial.

Rompe JD, Decking J, Schoellner C, Nafe B.

Department of Orthopaedics, Johannes Gutenberg University School of Medicine, 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.

PMID: 12642264 [PubMed - in process]

Re: Read here Sponsor information !!

BrianG on 7/18/03 at 13:29 (124736)

Peter R,

You may not have read far enough down the report, but it does tell who the sponsor of the study was. If you read below, you will see that is was NOT completed by a special interst group! It looks to me like this is the type of trial that we have all been wating for. It was completed by medical specialists, in the field, who wanted a good, up to date, trial. I have a feeling this study will carry a lot of weigt, and will be even more trouble for the people who are waiting for the isurance companies to pick up the ESWT bills. It also may explain why two Dornier Epos treatments have not worked for me !!!!!

Regards
BrianG

Cut & Pasted, from the Study:

What is already known on this topic
Observational trials recommend extracorporeal shock wave therapy as treatment for recalcitrant chronic plantar fasciitis
No evidence exists of its efficacy from well designed randomised clinical trials
What this study adds
Extracorporeal shock wave therapy is ineffective in the treatment of chronic plantar fasciitis
No clinically relevant difference was found in success rates between therapy and placebo after 12 weeks and a year
Three quarters of patients improved 12 months after intervention, irrespective of treatment
Tables and criteria for inclusion or exclusion of patients appear on bmj.com
We thank I R König, H Wolf, C Wöhner, O Maier-Boerries, and C Riemert who helped with the conduct of the trial or recruited patients, our colleagues in the participating centres without whom this study could not have been carried out, and the participants.
Contributors: MH was the principal investigator and will act as guarantor for the paper. MB, MH, and HHM designed the study. HHM was the biostatistician. CSB coordinated the study. HHM and KZ analysed the data. MH, HHM, CSB, and KZ prepared and finalised the paper. All authors interpreted the results, commented on the first draft, and approved the final version.

Funding: This trial was supported by the Deutsche Forschungsgemeinschaft (grant No 1079/2-1), the German Association for Orthopaedics and Orthopaedic Surgery, and the Association for Promoting Science and Research at the Rehberg Clinic, Germany. Dornier Medizintechnik Germany provided us with the shock wave equipment. They had no involvement in, or control over, the conduct of the study or the content of this paper.
Competing interests: None declared.
Ethical approval: The study protocol was approved by the local ethics committees of the principal investigator (approval No 83/98) and the participating centres.

Re: Dr. Rompe -- please comment as to the methodology...

Ed Davis, DPM on 7/18/03 at 14:31 (124740)

Dr. Rompe:

Thank you for the post. Could you please comment on the methodology used in the study, how it compares to your methodology and why results are different.
Ed

Re: Is ESWT ineffective for plantar fasciitis?- Question

Ed Davis, DPM on 7/18/03 at 14:44 (124741)

Peter:

It can be a little harder than that to find the 'smoking gun' you are looking for as 'sponsors' will be careful to keep their names off such studies. Sponsors may, on the other hand, be active in funding research via foundations they have set up of by some other indirect financial support of researchers. Some studies, such as the Buchbinder study, appeared to me, to have 'fingerprints' all over it considering the questionable methodology and the surprising publicity it recieved -- the mere fact that such a flawed study was published by a reputable journal set off a lot of flashing lights. This study certainly looks cleaner so we will need to look at it more carefully.
Ed

Re: Is ESWT ineffective for plantar fasciitis?

Ed Davis, DPM on 7/18/03 at 14:49 (124742)

Dr. Z:
That is a logical first question. At this point, the argument is not between protocols but a question of overall efficacy. If the overall efficacy is going to be questioned, research must use the protocols in current use.
Ed

Re: Is ESWT ineffective for plantar fasciitis?

Ed Davis, DPM on 7/18/03 at 14:54 (124743)

Peter:

There is obviously a level of total energy delivered, below which, ESWT will have no beneficial effect. This study may have simply help define that level.
Ed

Re: Dr. Rompe -- please comment as to the methodology...

Jan D. Rompe on 7/19/03 at 02:59 (124776)

Read our response to the Haake publication at:

http://bmj.com/cgi/content/full/327/7406/75

Re: Dr. Rompe -- please comment as to the methodology...

Ed Davis, DPM on 7/19/03 at 17:28 (124802)

Dr. Rompe:

Thank you for your assessment. I think a number of us were amused by a couple of remarks in the paper -- criticsm by the authors of the quality of prior studies and the suggestion that no further studies need be performed.
Ed

Re: Dr. Rompe -- please comment as to the methodology...

Peter R on 7/20/03 at 08:46 (124823)

Why was this study done as low energy?? Why did Dornier participate in a low energy study when their protocall uses 1 high energy treatment? Did they know that the study would not be done by their high energy protocall? What insurance company(s) where secretly funding this study in order to sabotage ESWT so they don't have to pay for it? Jan Ronpe-why don't you do the exact same study using 1 high energy treatment with the Dornier EPOS?
I smell something very bad here and it's not an unwashed sweaty foot.

Re: Dr. Rompe -- please comment as to the methodology...

BrianG on 7/20/03 at 19:49 (124851)

Hi Peter,

I have e-mailed Dr. Rompe in the past. He told me that he only works with low energy ESWT applications. He had nothing to do with the FDA trials which chose to do one, high energy treatment. Why do you flame him, tying to bait him about using one high energy treatment, when he has never done so in the past?

The high energy protocal you talk about has nothing to do with Rompe, it's an FDA / American thing (Rompe and colleagues are from Europe), apples and oranges!!! Sure the Dornier was used by both the FDA, and Rompe's group, but that is what it was designed to do (both high ad low treatments). Personally, I think the FDA has done a great dis-service to us here in the US, as I believe the patients pcked for the trials could have probably been healed by conventional methods anyway.

The only thing 'bad here' I see is unnecessary flaming, which I will report to ScottR.

BrianG

PS: By the way Peter R, I probably missed it, but are you a Pod?

Re: Dr. Rompe -- please comment as to the methodology...

Dr. Z on 7/20/03 at 21:09 (124854)

Brian

I asked Peter in the past if he was a Pod and he told me no. I do wonder why no high energy studies are being done in Europe. There are high energy studies done in Taiwan. There are few articles on the ESWT section on this board which report high energy studies.

I am not sure of Peter reasoning for asking this question but it is one I would like to know the answer. There has to be a good answer

Re: Is ESWT ineffective for plantar fasciitis?

dr j wilner on 7/21/03 at 21:48 (124931)

this just goes to show only high energy shockwave systems are effective
and only a high energy machine such as the ossatron delivers the necessary
energy to cross the critical mass threshold to cause neovascularization
all other systems and / or lower energy levels simply do not work

Re: Dr. Rompe -- please comment as to the methodology...

dr j wilner on 7/21/03 at 21:52 (124932)

dr rompe

what have been your results with high energy machines such as the ossatron?? you need to compare apples to apples...your low energy machines simply will not work---that is a fact....try the same study and parameters with the ossatron as we are doing and you will see that it does indeed work and work quite well i invite you to contact me

Re: Dr. Rompe -- please comment as to the methodology...

Dr. Z on 7/22/03 at 00:14 (124940)

Hi
Could you point me in the direction for the 1000 case study for the ossatron . I have read the abstract just can't find the actual study. IS if a one two or three year study. I have a major insurance company willing to approve ESWT. I came across a patient who just happen to be one of the founder of one of the largest insurance companies in the USA. I did ESWT on his heel for pf and he is cured. This could a big break if I could only find a USA high energy single treatment with either the dornier or ossaton. Any help

Re: Dr. Rompe -- please comment as to the methodology...

dr ben pearl on 8/12/03 at 20:53 (126807)

You cannot draw any conclusion regarding the efficacy of high energy treatment based on Dr. Rompe's latest study.

drbp