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Brian maybe you were correct in your thinking

Posted by Pauline on 9/11/03 at 22:18 (129674)

Enough studies to keep your head spinning. Here is another one. Was this one posted before?

Copyright 2003, BMJ Publishing Group Ltd.
BMJ. 2003 July 12; 327 (7406): 75

Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial
Michael Haake, associate assistant professor,1 Mathias Buch, assistant medical director,2 Carsten Schoellner, senior resident,3 Felix Goebel, senior resident,4 Martin Vogel, senior resident,5 Ingo Mueller, senior resident,6 Jörg Hausdorf, senior registrar,7 Karin Zamzow, data manager,8 Carmen Schade-Brittinger, head of coordinating centre for clinical trials,9 Hans-Helge Mueller, senior biostatistician10

1 Orthopädische Klinik, Universität Regensburg, 93077 Bad Abbach, Germany 2 Orthopädische Klinik Kassel, 43131 Kassel, Germany 3 Orthopädische Klinik, Johannes Gutenberg Universität Mainz, 55131 Mainz, Germany 4 Klinik für Orthopädie, Martin Luther Universität Halle, 06097 Halle, Germany 5 Rehbergklinik St Andreasberg, 37444 St Andreasberg, Germany 6 Orthopädische Klinik, Christian-Albrechts-Universität Kiel, 24105 Kiel, Germany 7 Orthopädische Klinik, Ludwig Maximilians Universität München, 81377 München, Germany 8 Medizinische Biometrie und Epidemiologie, Philipps-Universität Marburg, 35033 Marburg, Germany 9 Koordinierungszentrum Klinische Studien, Philipps-Universität Marburg 10 Medizinische Biometrie und Epidemiologie, Philipps-Universität Marburg

Correspondence to: M Haake (email removed)

Accepted April 15, 2003.

Top
Abstract
Introduction
Materials and methods
Results
Discussion
References
Abstract

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.

Top
Abstract
Introduction
Materials and methods
Results
Discussion
References
Introduction

Plantar fasciitis is a common cause of heel pain, affecting 10% of the general population.1 It may be due to injury at the origin of the plantar fascia or to biomechanical abnormalities of the foot.2 3 A heel spur may be present, but has also been reported in up to 27% of patients without symptoms.1

Standard treatment for plantar fasciitis is conservative, but about 10% of patients fail to respond.4 Surgery is recommended eventually, but is unsuccessful in 2% to 35% of patients.5 For both conservative and surgical methods there is only limited evidence for a short term reduction of pain from local treatment with corticosteroids.6

Extracorporeal shock wave therapy is well established for the treatment of urolithiasis.7 It was introduced in the early 1990s for the treatment of insertion tendinopathies.8 Extracorporeal shock wave therapy for orthopaedic diseases is thought to provide long lasting analgesia and stimulate the healing process. It has been recommended as treatment for chronic plantar fasciitis in patients unresponsive to conservative treatment.913 Two shock wave devices are currently approved by the Food and Drug Administration.12 13

The efficacy of extracorporeal shock wave therapy in plantar fasciitis cannot be ascertained owing to the poor quality of methods in previous studies.14 We aimed to determine its effectiveness in chronic plantar fasciitis.

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Abstract
Introduction
Materials and methods
Results
Discussion
References
Materials and methods

Our study was a randomised, blinded, multicentre trial with a two sample parallel group design. Central randomisation and independent monitoring was conducted according to the Committee for Proprietary Medicinal Products and International Conference on Harmonisation guidelines for good clinical practice and statistical principles in clinical trials.

Patients were recruited in seven university hospitals, two clinics, and one practice in Germany (see bmj.com for inclusion and exclusion criteria). In cases where the clinical diagnosis was uncertain, the centres were advised to perform additional diagnostic tests, such as electromyography. Signed informed consent was obtained from all patients before randomisation.

Patients were randomised to receive either extracorporeal shock wave therapy (135 patients) or placebo (137 patients). The study doctor was told by telephone what treatment had been allocated to his or her patient when the patient turned up for the first intervention. Random permuted blocks of sizes six and four were used to provide each centre with a separate computer generated list of random treatment assignments.

Intervention
Extracorporeal shock wave therapy was provided by a Dornier Epos Ultra lithotripter (Dornier Medizintechnik, Wessling, Germany) equipped with an outline 7.5 MHz linear array ultrasound positioning system. Before recruitment of patients, the study doctors were given training in the diagnosis of plantar fasciitis and treatment with extracorporeal shock wave therapy or placebo.

Extracorporeal shock wave therapy comprised 4000 impulses of a positive energy flux density (0.08 mJ/mm2) under local anaesthesia with 2 ml mepi-vacaine 1%. Therapy was applied every two weeks plus or minus two days (3 × 4000 impulses). The head of the lithotripter was docked medially to the heel, and the ultrasound transducer from plantar to the insertion of the fascia. A cross hair on the monitor of the ultrasound guidance system constantly indicated the focus of the shock wave at the heel spur at the insertion of the fascia. The parameter positive energy flux density (ED+) is generally assumed to be the primary variable for physical and biological effects, and it was chosen to assure uniform treatment.15 The total positive dose was 0.96 J/mm2, the energy flux density was 0.22 mJ/mm2, and the positive pressure was 13.7 MPa. The appropriate execution of the intervention was controlled for each centre.

Patients in the control group received the same regimen of placebo therapy under local anaesthesia. A polyethylene foil filled with air was fixed with ultrasound gel in front of the coupling cushion to reflect the shock waves. The set up in both groups was identical, and the sound created by the lithotripters was similar.

Blinding
Patients were blinded to their particular treatment allocation, and only the caregiver performing the intervention knew the treatment. Study doctors were not informed until assessment of the primary end point. The caregiver was not involved in follow up and was not allowed to decide about further treatment.

The clinical outcome was assessed by observers blinded to treatment allocation. The extent to which patients' remained blinded was assessed after the last intervention. Unblinding was possible after the assessment of the primary end point and only if the patient required further therapy.

End points and side effects
Follow up examinations were carried out at six and 12 weeks and at one year after the last intervention. The primary end point was the success rate after 12 weeks; success was defined by a Roles and Maudsley score of 1 or 2 and if the patient received no additional treatment. Additional treatment was allowed after assessment of the primary end point, and the amount was recorded. The modified Roles and Maudsley score is a patient administered scoring system (see table A on bmj.com).16 We used the German version, which is clinically relevant in plantar fasciitis and has been applied in major studies on extracorporeal shock wave therapy.9 10

Secondary end points encompassed the Roles and Maudsley score and pain intensities (pain at rest, pain at night, pain at pressure, morning pain) on visual numeric rating scales (0 for no pain to 10 for unbearable pain), walking ability, and the need for additional treatments for one year after the last intervention. Side effects were noted.

Statistics
We carried out a two sided Fisher's exact test to compare the success rates at an overall significance level of 5%. Patients were included according to the intention to treat principle. Absolute differences were calculated for the success rates, odds ratios, and exact 95% confidence intervals. In addition we performed a stratified analysis by centre for verification of robustness of results. The secondary end points were analysed descriptively. An interim analysis was performed at α=0.005 after examination of half the patients. The final analysis was performed at α=0.048. The sample size of 272 patients was calculated with the aim of detecting a minimal clinically relevant difference of 20% in the success rates (placebo: 35%; extracorporeal shock wave therapy: 55%) with a power of 80%, allowing for a dropout rate of 20%. Analyses were conducted with the validated programs SAS 8.2 and StatXact 5.0.

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Abstract
Introduction
Materials and methods
Results
Discussion
References
Results

Overall, 272 patients were randomised between March 1999 and February 2001 (figure). Personal characteristics were similar in both groups (table 1).

The required number of pulses and energy level for treatment was reached in all cases. Three patients in the placebo group accidentally received three sessions of extracorporeal shock wave therapy, and one patient in the therapy group received placebo. In the therapy group, one patient received no treatment because of a dorsal heel spur, one patient turned up for the first session only, and one patient missed the last session. One patient in the placebo group received no further intervention after the first session because of a deep vein thrombosis.

Blinding of the patients was successful: 95 (74%) patients in the therapy group and 89 (69%) patients in the placebo group thought they had been treated with extracorporeal shock wave therapy, the difference being less than 6%.

End points
The primary end point could be assessed in 94% of the patients (table 2). The difference in success rates was 3.6% (- 8.0% to 15.1%; P=0.5927) and the odds ratio was 1.18 (0.675 to 2.07). Despite two centres recruiting only nine and seven patients, none of the observed differences reached the minimal clinically relevant difference of 20%. The odds ratio remained robust when data were stratified by centre (1.20, 0.674 to 2.13).

At the one year follow up, 91 of 113 (81%) patients in the therapy group and 87 of 115 (76%) in the placebo group had a Roles and Maudsley score of 1 or 2 (table 3). Additional treatment was sought by 41 (36%) patients in the therapy group and 64 (56%) patients in the placebo group. The number of conservative treatments was comparable between the groups except for the use of extracorporeal shock wave therapy (13 (12%) patients in therapy group, 44 (38%) patients in placebo group). One in each group had undergone surgery (see table B on bmj.com).

Side effects
Few side effects occurred during and after the treatment. More side effects were reported by the therapy group than by the placebo group (24 (18%) v 12 (9%)). Side effects were skin reddening (16 (12%) in therapy group; 5 (4%) in placebo group), pain (7 (5%) in therapy group; 2 (2%) in placebo group), and local swelling (3 (2%) in therapy group; 0 (0%) in placebo group). Less often reported were haematoma, nausea, dizziness, hair loss, and sleep disturbance. These were valued as non-serious effects, which in no case resulted in discontinuation of treatment. We expected a higher risk for side effects in the therapy group than in the placebo group (odds ratio 2.26, 1.02 to 5.18). We considered the case of deep vein thrombosis in the placebo group as not related to the treatment.

Top
Abstract
Introduction
Materials and methods
Results
Discussion
References
Discussion

We found no meaningful improvement of clinical outcome in patients treated with extracorporeal shock wave therapy for chronic plantar fasciitis compared with placebo, unlike previous studies. Although the success rates in patients with excellent or good results for the Roles and Maudsley score three months (45.7%) and one year (80.5%) after intervention were comparable to former trials, similar results could be achieved with placebo.10 12 17

About three quarters of the patients in both groups had a good outcome one year after intervention. Reasons for the observed improvement could have been a spontaneous remission of plantar fasciitis, additional conservative treatment, or a sustained placebo effect. Despite this, we found no evidence of additional benefits from extracorporeal shock wave therapy.

Most of the newly reported trials on extracorporeal shock wave therapy for plantar fasciitis that were not included in a former systematic review14 also show deficiencies in the quality of the methods (for example, lack of a control group,18 19 small sample size,18 20 unblinded design17 20 21). Therefore these trials only provide limited evidence for the effectiveness of extracorporeal shock wave therapy.

We are aware of only three published randomised, blinded, placebo controlled trials. Two of them show benefits from extracorporeal shock wave therapy for plantar fasciitis.12 13 However, the absolute difference of 17% in the first trial was not statistically significant and would not have met our definition of a clinically relevant result.12 The authors did not, however, report the method of randomisation. Different types of anaesthesia were used (foot block for extracorporeal shock wave therapy versus subcutaneous injection for placebo). Problems in the analysis and presentation of the data of this study have been published.22 These factors may have influenced the results.

One study reported the alleviation of pain in the morning,13 but according to the Roles and Maudsely score, the American Orthopaedic Foot and Ankle Society score, and pain scores, the findings were negative and comparable to our results. We do not believe that the only positive variable in that trial is a clinically relevant finding.

The negative findings of our study support the conclusion of the recently published third trial, although the treatment protocols of the studies differ slightly (mean total dose 1.4 J/mm2).23 In contrast to our study the authors applied a minimal shock wave dose without anaesthesia (3 × 100 impulses; 0.02 mJ/mm2) instead of a sham therapy in the control group. This may have minimised a clinically relevant effect between both treatment groups.

Our results are only valid for therapeutic variables applied. This might not be a limitation, as the variables we tested reflect the true setting of extracorporeal shock wave therapy. The total energy of shock waves was higher in our trial than in most of the previous studies.9 10 17 Despite this, the use of different treatment variables might lead to different overall results, but the evidence for this could only be obtained from clinical trials with adequate study designs. We cannot recommend specific applications of extracorporeal shock wave therapy to be tested in further clinical studies because all major trials, using different shockwave variables and types of lithotripters, showed negative results.

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


Footnotes

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.

Top
Abstract
Introduction
Materials and methods
Results
Discussion
References
References

De Maio M, Paine R, Mangine RE, Drez D. Plantar fasciitis. Orthopedics 1993;16: 1153-63. [PubMed]

Kuhns JC. Changes in elastic adipose tissue. J Bone Joint Surg (Am) 1949;31: 541-8.

Gill LH. Plantar fasciitis: diagnosis and conservative management. J Am Acad Orthop Surg 1997;5: 109-17. [PubMed]

Davis PF, Severud E, Baxter DE. Painful heel syndrome: results of non-operative treatment. Foot Ankle Int 1994;15: 531-5. [PubMed]

Schepsis AA, Leach RE, Gorzyca J. Plantar fasciitis. Etiology, treatment, surgical results, and review of the literature. Clin Orthop 1991;266: 185-96. [PubMed]

Crawford F, Atkins D, Edwards J. Interventions for treating plantar heel pain. Cochrane Database Syst Rev 2000;3: CD000416.

Chaussy C, Eisenberger F, Wanner K. The use of shock waves for the destruction of renal calculi without direct contact. Urol Res 1976;181: 352-7.

Dahmen GP, Meiss L, Nam VC, Skruodies B. Extrakorporale Stosswellentherapie (ESWT) im knochennahen Weichteilbereich an der Schulter. Extracta Orthopaedica 1992;11: 25-7.

Rompe JD, Hopf C, Nafe B, Bürger R. Low-energy extracorporeal shock wave therapy for painful heel: a prospective controlled single-blind study. Arch Orthop Trauma Surg 1996;115: 75-9. [PubMed]

Rompe JD, Küllmer K, Riehle MH, Herbsthofer B, Eckardt A, Bürger R, et al. Effectiveness of low energy extracorporeal shock waves for chronic plantar fasciitis. Foot Ankle Surg 1996;2: 215-21.

Krischek O, Rompe JD, Herbsthofer B, Nafe B. Symptomatic low-energy shockwave therapy in heel pain and radiologically detected plantar heel spur. Z Orthop Ihre Grenzgeb 1998;136: 169-74. [PubMed]

Ogden JA, Alvarez R, Levitt R, Cross GL, Marlow M. Shock wave therapy for chronic proximal plantar fasciitis. Clin Orthop 2001;387: 47-59. [PubMed][Full Text]

Buch M, Knorr U, Fleming L, Theodore G, Amendola A, Bachmann C, et al. Extracorporeal shock wave therapy in plantar fasciitis: a review. Orthopäde 2002;31: 637-44.

Böddeker IR, Schäfer H, Haake M. Extracorporeal shock-wave therapy (ESWT) in the treatment of plantar fasciitis a biometrical review. Clin Rheumatol 2001;20: 324-30. [PubMed][Full Text]

Granz B, Kohler G. What makes a shock wave efficient in lithotripsy? J Stone Dis 1992;4: 123-8. [PubMed]

Roles NC, Maudsley RH. Radial tunnel syndrome: resistant tennis elbow as a nerve entrapment. J Bone Joint Surg [Br] 1972;54: 499-508.

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

Alvarez R. Preliminary results on the safety and efficacy of the OssaTron for treatment of plantar fasciitis. Foot Ankle Int 2002;23: 197-203. [PubMed]

Wang CJ, Chen HS, Chen WS, Chen LM. Treatment of painful heels using extracorporeal shock wave. J Formos Med Assoc 2000;99: 580-3. [PubMed]

Hammer DS, Rupp S, Kreutz A, Pape D, Kohn D, Seil R. Extracorporeal shockwave therapy (ESWT) in patients with chronic proximal plantar fasciitis. Foot Ankle Int 2002;23: 309-13. [PubMed]

Weil LS Jr, Roukis TS, Weil LS, Borrelli AH. Extracorporeal shock wave therapy for the treatment of chronic plantar fasciitis: indications, protocol, intermediate results, and a comparison of results to fasciotomy. J Foot Ankle Surg 2002;41: 166-72. [PubMed]

Beckman KD, Letter to the editor. Clin Orthop 2002;398: 267-8. [PubMed][Full Text]

Buchbinder R, Ptasznik R, Gordon J, Buchanan J, Prabaharan V, Forbes A. Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis: a randomized controlled trial. JAMA 2002;288: 1364-72. [PubMed][Full Text]

Figures and Tables

Figure 1. Flow of patients through trial

Table 1. Characteristics of patients randomised to receive either extracorporeal shock wave therapy or placebo for chronic plantar fasciitis. Values are numbers (percentages) of patients unless stated otherwise

Table 2. Success rate of treatment for chronic plantar fasciitis six and 12 weeks and one year after extracorporeal shock wave therapy or placebo. Values are numbers (percentages) of patients unless stated otherwise

Table 3. Intensity of pain from chronic plantar fasciitis six and 12 weeks and one year after extracorporeal shock wave therapy or placebo

Re: Brian maybe you were correct in your thinking

Dr. Z on 9/12/03 at 13:57 (129721)

I believe this is ALL low energy studies for chronic insertional plantar fasciitis. Most chronic pf cases are done with High energy ESWT not low energy in the USA.

Re: Brian maybe you were correct in your thinking

BrianJ on 9/12/03 at 17:33 (129764)

Dr. Z --

The test group patients in the study were treated with the Dornier Epos Ultra. That's a high energy machine, isn't it?

Re: Brian maybe you were correct in your thinking

Dr. Z on 9/12/03 at 17:39 (129765)

This is a different dornier epos. The energy level are all low. There is no high energy system in the one used in this study. The high energy model is only made for the USA. At one time I had the opportunity to buy a used dornier epos and when I spoken with the USA dornier people they explained to me the difference.

Re: Brian maybe you were correct in your thinking

BrianG on 9/12/03 at 17:42 (129766)

Hi Dr. Z,

I was able to find the strength in the article. It is 4000 pulses at (0.08 mj/mm2) I take it this is low energy? If it is low energy, and your attubuting the low success rate to that fact, why are some of the doctos posting here, using both? If fact one Pod here reports that the low energy is working just as well as the high energy. Also, for the longest time, we have seen a lot of low energy treatments coming out of Canada. This is the first 1 year study that I have seen, and it is saying that ESWT is not any more effective in healing, than a placebo. In fact the healing rate is less than 50%,

I know that you have said the 1 year follow ups show that the Dornier Epos high energy treatments, have a success rate of over 90%. Could you share with us where you got your one year information from?

Regards
BrianG

Re: Brian maybe you were correct in your thinking

BrianG on 9/12/03 at 17:47 (129769)

I believe that the Epos can be used at either hgh, or low energy. The FDA has only approved high energy use.

BrianG

Re: Brian maybe you were correct in your thinking

Dr. Z on 9/12/03 at 17:48 (129770)

The 0.08mg/mm2 is low energy. There are alot of factors for sucessful ESWT
You can get low energy to work but you have to use more treatments in many cases. The technique for low energy is very different then high energy treatment. Patient feed back is used with low energy. I will get the one year year article from Dr. Zingas ( Pauline favorite orthopedic doctor)
and post it hear for you to read.

Re: Brian here is the informaton about the one year follow-up

Dr. Z on 9/12/03 at 17:52 (129772)

Shockwave Therapy for Plantar Fasciitis of the Eposcorporus Dornier
Authors: Christopher Zingas, David Collon, Kyle Anderson
Institution: Henry Ford Health System William Clay Ford Center for Athletic Medicine
The study is designed to assess the safety and efficacy of musculoskeletal shock wave therapy in the treatment of chronic plantar fasciitis. The authors hypothesize that shock wave therapy will be useful in the treatment of chronic plantar fasciitis which has failed conventional conservative methods.
Preliminary twelve month results indicate that shock wave therapy may provide an effective alternative treatment for chronic plantar fasciitis with minor transient adverse effects.
One hundred and fifty patients with chronic plantar fasciitis were enrolled in a randomized, 1:1 allocated, placebo-controlled, prospective, double blind clinical study with two groups: one receiving Extracorporeal Shock Wave Therapy (ESWT) with Dornier Epos Ultra and the other receiving sham treatment. All 150 patients had failed at least six months of physician supervised conventional conservative methods and would have been considered surgical candidates by guidelines set forth by the AOFAS. All patients were greater than 18 years of age with unilateral single site plantar medial heel pain, and had a visual analog score of >5 (scale 1-10) for the first few minutes of morning walking. There were 119 women and 31 men enrolled. The mean age was 50 years (26-69) for the active group and 53 years (31-72) for the sham group. Each active treatment patient was subjected to a single 20 minute ESWT session which delivered approximately 1300mJ/mm2 to the treatment area. The control group patients went through the identical treatment procedure without shock wave penetration. All patients were evaluated 3-5 days, 6 weeks, 3 months, 6 months, and 1 year post-treatment. Patients were assessed using the Visual Analog Score (VAS) during the first few minutes of walking and the Roles and Maudley score. The participants were unblinded at 3 months post-treatment. Patients in the sham treatment group who did not improve at 3 months were offered active ESWT and were considered the 'Crossover Group'.
The VAS for the first few minutes of walking at 3 months post-treatment showed a 45% success rate in the sham treatment group and 56% success in the active group. The Roles and Maudsley scoring showed a 40% success rate in the sham group and 62% success rate in the active group at 3 months. The VAS for the first few minutes of walking at 12 months post-treatment showed a 94% success rate in the active group. The Roles and Maudsley scoring showed also 94% success rate in the active group at 12 months. The crossover group at 12 months had a VAS score 63% success and Roles and Maudsley scoring of 93% success.
There were 17 active, 19 sham, 11 crossover mild transient complications seen. These included ecchymosis, edema, hypesthesia, paresthesia, petechiae, rash, neuralgia, injections site hemorrhage, nonpalpable pulse (sham treatment), and infection. These all resolved within a few days post-treatment. There was 1 permanent minor complication of paresthesia. No

Re: Brian here is the informaton about the one year follow-up

BrianG on 9/12/03 at 18:21 (129774)

Thank you. I really wish that the authors of these studies would very simply state at the beginning of the article, if the study is high, or low, energy. It would certainly help the patients that do not have all the technical knowledge.

BrianG

Re: High compared to Low Energy figures

Jen L on 9/13/03 at 10:31 (129846)

As indicated in the above postings, the high energy figure is 1300mj/mm2, and the low is 0.08mj/mm2, then the high energy is astonishingly 16,250 times of the low energy!
As a layperson who remebers how it felt when the heels were hit by the low energy Sonocur waves -it was not intolerable but by no means pleasurable, I can't imagine a force 16250 times as high as that landing on my feet! Although your feet will be numbed by anesthesia, still it's scary. Doctors, can these technical figures be compared this way? Why is there such a huge difference between high and low energy?
Excuse me if these questions do not make any sense.

Jen

Re: High compared to Low Energy figures

Dr. Z on 9/13/03 at 10:41 (129847)

Hi

The 1300mj/mm2 is the total energy for the entire treatment. It isn't the
specific energy level per treatmentsession . Here is how you define low vs high
energy levels below 0.28 mj/mm is low energy
energy between 0.28 and 0.6mj/mm is medium energy some classfiy this as high and don't separate a mid or medium level.
energy levels above 0.6 mj/mm is high energy

Re: High compared to Low Energy figures

Jen L on 9/13/03 at 10:57 (129851)

Then can you tell what is the energy level per treatment if the total is 1300mj/mm2?
Thanks Dr.Z.

Re: High compared to Low Energy figures

Dr. Z on 9/13/03 at 11:07 (129852)

When we use the dornier epos ultra we are using 0,36mj/mm2. The total amount of pulses is 3800 at at rate of 240 per minute
In low energy they do three treatment sessions to obtain a TOTAL of 1300mj/mm . In high energy they obtain the total in one session.
The low energy session energy rate with the dornier I am not sure of but it is usually 0.08 mj/mm . The amount of pulses is between 2000 and 2500 depending on the patient toleration.

Re: High compared to Low Energy figures

Peter R on 9/14/03 at 10:06 (129956)

3 treatments of 2500 pulses @ .08mj/mm2 is only 600mj/mm2 total unless there is a new math that I don't know about. At that rate it would take almost 7 sessions to achieve 1300mj/mm2.

Re: High compared to Low Energy figures

Peter R on 9/14/03 at 10:33 (129958)

Simple calculation:

(#of pulses)(energy level/pulse in mj/mm2)(#of treatments)=total energy appled in mj/mm2

The Dornier has a range of .03 - .57 mJ/mm2
Ossatron .09 - .34
Sonocur .016 - .22

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 11:15 (129960)

Another very important factor is that you need a cavitation effect with ESWT to produce micro-trauma. You can't get this effect at the .08mj/mm2 energy level. Another factor is the rate per minutes. With the dornier we are using 240 per minutes. I have no idea what the rate is with low energy. I do know the faster the rate per minute the greater the cavitation effect.

Trying to compare the low and the high energy treatment in this matter doesn't make sense to me.

Re: High compared to Low Energy figures

Peter R on 9/14/03 at 11:28 (129962)

I think the effectiveness of ESWT be it with low or high energy, single of multiple treatments, with or without ultrasound or any type of anesthetic is an argument that loses it's importance in the light of the determined effort by the insurance bandits to avoid paying for it. The economic insentive for companies to continue providing this modality will deteriorate if the patient has to bear the cost.

However thinking of Lasik and it's offshoots- I may prove me wrong - I hope I am

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 13:06 (129969)

Time is going to tell. i predict in the next one year we will know where ESWT stands with the insurance companies.

Re: High compared to Low Energy figures

Ed Davis, DPM on 9/14/03 at 13:11 (129970)

Peter:

I like the Lasik comparison. One difference is that Lasik is done for vanity (although that could be argued) and ESWT out of necessity which changes the value of the service in the mind of the public.

We have gone though an entire generation of someone other than the patient paying for medical care. That third party could be governemnet or the employer purchased insurance plan. There has developed an expectation, on the part of the public, that someone else is going to pay for their medical care. On the other hand, the public is accustomed to paying big bucks for things like cosmetic surgery, cosmetic dentistry, Lasik and so on.

He who pays the piper calls the tune and right now, it is the insurance industry. The only way to fix this issue and the whole mess is to cut the insurance companies out of the loop. That can be done via medical Savings Accounts where employees spend there own savings and THUS MAKE THEIR OWN DECISIONS on what is going to be payed for and how much (via the action of competition in the market place). The insurance companies will be there provideing high deductible policies to act as a stop loss for the MSA's or for catastrophic illness. In other words -- they will act as real insurance companies, not mincromanagers of patient care.
Ed

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 13:56 (129974)

Ed,
Have you found local union plans paying for ESWT??

Re: High compared to Low Energy figures

Peter R on 9/14/03 at 14:06 (129978)

I have been told in talks with aquaintances that some unions in the NYC area are paying for the procedure.
The union that has building workers, 39BJ, and healthcare workers, 1199 I believe pay for ESWT. I think that SAG also covered a procedure. One union has a yearly max for podiatric care- you apply it as needed. I believe that one was a union covering auto dealer techs.

Re: High compared to Low Energy figures

Peter R on 9/14/03 at 14:35 (129980)

Cavitation occurs when gas filled hollow bdies in a liquid medium are subjected to incresed external pressure causing the bubble to shrink and absorb part of the sonic energy.If the forces are large enough the bubble collapses and releases some of the absorbed energy into the medium as a new acoustic wave. This can also occur, to some lesser extent, during the negative phase of the acoustic wave if the energy wasn't enough to cause the collapse.
The extent of the high pressure jet would be directly related to the amount of high pressure energy during the positve cycle of the pulse. Positive Pulse pressures can be as low as 10 MPa or as high as 100 Mpa and this energy would effect the extent of cavitaion during the collapse of the hollow body or during the negative phase of the acoutic wave.
The effect of cavitation however may be slight due to the fact that the sonic energy of the collapsing bubble mayn be as little as 1/1000 of the excitant sonic wave.
One of the reasons that limits the maximum ESWT pulse frequency is the interaction of the cavitation with the following shock waves.

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 14:50 (129981)

But this doesn't occur with any low energy ESWT

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 14:52 (129982)

I have also found that unions will pay for ESWT in accordance with medical necessity

Re: High compared to Low Energy figures

David L on 9/14/03 at 18:30 (129998)

Dr Z....
How do the machines that Dornier ships to locations in Europe differ from the machines that they ship to the United States?

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 18:50 (129999)

The power levels are different. Level 9 isn't the same level 9 in the USA.
Why this is I have no idea.

Re: High compared to Low Energy figures

shock man on 9/14/03 at 20:51 (130018)

hey Z

maybe one of these days u will know that only the ossatron works
and dornier is truly no better than a sham tx....notice there are no
studies refuting the only true high energy system...the hmt ossatron

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 20:55 (130019)

Do you know why there aren't any low energy studies refuting the ossatron?

Re: High compared to Low Energy figures

shock man on 9/14/03 at 20:55 (130020)

hey z and peter

you guys dont get it..of course your dornier isnt any better than a sham
its becuz it dont work only a HIGH energy system like the ossatron works
all your other stuff like sonorex dornier etc DONT WORK just like the articles bear out......trying to pawn off your systems is a disservice to your pts.....timae to wake up and smell the coffee

Re: High compared to Low Energy figures

shock man on 9/14/03 at 20:56 (130021)

only the ossatron works!!!!

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 20:58 (130023)

Do you know what company invented the sparkgap ESWT system.?

Re: High compared to Low Energy figures

Ed Davis, DPM on 9/14/03 at 21:01 (130025)

Dr. Z:

In my area, the First Choice PPO is the umbrella for a number of union plans. A modest number are paying for ESWT.
Ed

Re: High compared to Low Energy figures

Ed Davis, DPM on 9/14/03 at 21:06 (130026)

shlockman:
Dornier can be used as a high or low energy machine. There are scores of articles that support the success of low and high energy ESWT and thousands of patient success stories. Low energy is the primary modality used for ESWT in Europe so do you think that thousands of Europeans are being cured by the power of suggestion?
Ed

Re: High compared to Low Energy figures

Ed Davis, DPM on 9/14/03 at 21:08 (130027)

shockman:
Why is HMT now mainly manufacturing the low energy Reflectron as opposed to the Ossatron?
Ed

Re: High compared to Low Energy figures

Ed Davis, DPM on 9/14/03 at 21:12 (130029)

Peter:
It is hypothesized that cavitation is necessary for ESWT to work but not proven. One area to consider is a variation of ESWT called radial shock wave therapy in which no cavitation occurs. If you go back in the archives, we had a poster who maintained that radial shockwave therapy should not even be allowed to be called ESWT due to the lack of cavitation.
Ed

Re: High compared to Low Energy figures

shock man on 9/14/03 at 21:16 (130030)

THAT IS A MOOT POINT...ONLY THE OSSATRON IS AUTHORIZED AND APPROVED
FOR TX OF PF WHO CARES ABOUT THE REFLECTRON THE OSSATRON IS THE ONLY EFFECTIVE TREATMENT AVAILABLE FOR PF AND ACHILLES......PERIOD

Re: Swiss Dolorclast

Ed Davis, DPM on 9/14/03 at 21:18 (130032)

Peter:

The Swiss Dolorclast, available in Canada and Europe, is an example of RSWT.
Ed

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 21:19 (130033)

Dr. Ed,

Whether it is cavitation or shearing force you do need a microtear to induce fibroblast activity or in bone osteoblastic tissue formation. I can't seen to find any articles that show that low energy does induce fibroblastic healing. I only find information which show hyperstimulation which stop the pain cycle.

Re: High compared to Low Energy figures

Ed Davis, DPM on 9/14/03 at 21:21 (130034)

shockman:
The Dornier EPOS is approved for treatment of plantar fasciitis in the US and the Sonocur for treamtnet of lateral epicondylitis.

Do you think the Europeans are all wrong?

Ed

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 21:22 (130035)

Where are you getting this information from.?

Re: High compared to Low Energy figures

Ed Davis, DPM on 9/14/03 at 21:25 (130036)

Sr. Z:
But is cavitation necessary to induce fibroblast activity? The total amount of energy delivered still seems to be the most important factor.
Ed

Re: High compared to Low Energy figures

Dr. Z on 9/14/03 at 21:47 (130039)

I think you need cavitation or shearing forces. Is there any animal studies that you know of that show fibrobastic activity with multiple low energy treatments?

Re: High compared to Low Energy figures

Donald Iain Scott on 9/15/03 at 05:21 (130044)

To All,
We are LITTLE fish in a big pond, see Finding Nemo, Dornier developed the technique some 10 years ago, they have treated 10 of thousands of patients in Europe.

Read the Blue book, if you don't have it, get it. Get Professional.

Low energy works from Level -1 to Level -9 over a three treatment protocol
with between 1,000mJ/mm2 - 1,500mJ/mm2 6,000 pulses minimum
After each treatment Heat pack and only heat packs to be applied to aid in revascularisation. Under NO circumstances will you use ice, that is a NO NO.

High energy works at Level -9 using GA or LA, there is NO patient feedback as to the exact treatment site, but only with the aid of previous recorded ultrasound to confirm.

There is a three (3) month period when it is expected for healing to take place. The PATIENT MUST be honest to inform the practitioner that they have complied with all of their instructions and not done something STUPID to jeopardise the treatment outcome.

My personal opinion of the Buchbinder study is that it was flawed from the begining, No postural, biomechanical, footwear or prior medical examinations were performed.

This is a great informative site Scott, have the leading manufacturers of shockwave machines come forward and put the record/s straight?

As I have stated several times before you Yanks are not the centre of the known universe, now get a grip and get on with it.

Don Scott
Australia

Re: High compared to Low Energy figures-- Blue Book

Ed Davis, DPM on 9/15/03 at 09:09 (130055)

Donald:

You and others have mentioned a 'Blue Book' on this site but I have never seen such a publication. Please let us know the exact name of that publication and how one can obtain a copy. Pleae contact me at (email removed)

Don, if you have read some of my prior posts, I have jested with those who place their entire opinion on ESWT efficacy on the actions of the FDA, totally ignoring the experience of the rest of the world. There has been some concern about what may be interpreted as the 'marketing' of non-FDA approved technologies in the US and that has limited manufacturer participation on this board. Restriction of information is not or should not be the function of the FDA.
Ed

Re: High compared to Low Energy figures

Ed Davis, DPM on 9/15/03 at 09:37 (130060)

Dr. Z:
That goes back to the basic research, pre-dating human trials and would need to look into that.
Ed

Re: High compared to Low Energy figures-- Blue Book

Scott D. on 9/15/03 at 12:32 (130075)

Ed,

The 'blue book' is a publication named 'ESWT and Ultrasound Imaging of the Musculoskeletal System'. I know that you can find it at Amazon.com.

Re: High compared to Low Energy figures-- Blue Book

Ed Davis, DPM on 9/15/03 at 12:33 (130076)

Scott:
Thank you.
Ed

Re: just got the last one.....

Ed Davis, DPM on 9/15/03 at 13:04 (130077)

Scott:
Just got online with Amazon and ordered the last one they had in stock ... thanks again.
Ed

Re: just got the last one.....

Scott D. on 9/15/03 at 19:53 (130124)

Ed,

It's a great reference, hope you get as much from it as I have!

Scott

Re: just got the last one.....

Peter R on 9/16/03 at 16:20 (130251)

Get it from Barnes and Noble.com $20 cheaper than Amazon ISBN # 3-7985-1252-3

Re: just got the last one.....

Ed Davis, DPM on 9/16/03 at 20:59 (130295)

Peter:
Thanks for the tip. Amazon is based just up the road from me so it may already have arrived at my office; this was my day away from the office to train residents.
Ed

Re: High compared to Low Energy figures

BGCPed on 9/17/03 at 23:06 (130403)

D Scott. Thanks for the end all post on this. Sorry but some of the Yanks on here are thick headed and dont get it. They need to watch a few episodes of Steve Irwin the Croc Hunter to get a real taste of how arrested we are development wise and how advanced the land down under is.

G'Day Mate