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English podiatists not amused by ESWT..

Posted by Yasmin on 10/23/03 at 08:57 (135125)

Hi

I live in the UK, and have been trying to find a eswt therapist here (found a few only). I contacted all the podiatry schools here. Some of them have got back to me. Their responses were: firstly, they've never heard of shockwave therapy and secondly, that recent studies show there is no evidence that this therapy works. The head of podiatry (form Manchester univercity) talked to a Dr Keith Rome, on my behalf and he informed her about a recent study he did on eswt and said shockwave therapy 'was a waste of money and time'.

I am confused, why do these studies show that eswt does not work, and others that it does. Surely if many people have benefitted from this therapy, why are they not in these studies? Can you let me know about any recent studies show that shows the opposite of what these podiatists are saying?

I've included one of the studies the senoir lecturer in podiatry at Queen Margaret's univercity in Edinburgh sent me:

Author(s): Speed CA ; Nichols D ; Wies J ; Humphreys H ; Richards C ; Burnet S ; Hazleman BL Affiliation: Department of Medicine, Rheumatology, Sports and Exercise Medicine, Addenbrooke's Hospital, Hills Road, Cambridge, CB2 2QQ, UK. (email removed)

Title: Extracorporeal shock wave therapy for plantar fasciitis. A double blind randomised controlled trial.
Source: J Orthop Res (Journal of orthopaedic research : official publication of the Orthopaedic Research Society.) 2003 Sep; 21(5): 937-40Additional Info: United States

Standard No: ISSN: 0736-0266; NLM Unique Journal Identifier: 8404726

Language: English

Abstract:
BACKGROUND: Extracorporeal shock wave therapy (ESWT) is an increasingly popular therapeutic approach in the management of a number of tendinopathies. Benefit has been shown in calcific tendinitis of the rotator cuff, but evidence for its use in non-calcific disorders is limited. AIMS: To perform a double blind randomised controlled trial of moderate dose shock wave therapy in plantar fasciitis. METHODS: Adults with plantar fasciitis for at least 3 months were randomised to receive either active treatment (0.12 mJ/mm(2)) or sham therapy, monthly for 3 months. Pain in the day, nocturnal pain and morning start-up pain were assessed at baseline, before each treatment and 1 and 3 months after completion of therapy.

RESULTS: Eighty-eight subjects participated and no differences existed between the groups at baseline. At 3 months, 37% of the subjects in the ESWT group and 24% in the sham group showed a positive response (50% improvement from baseline) with respect to pain. Positive responses in night pain occurred in 41% and 31% in the ESWT and sham groups, respectively. Positive responses in start-up pain occurred in 37% and 36% in the ESWT and sham groups, respectively. Both groups showed significant improvement over the course of the study, but no statistically significant difference existed between the groups with respect to the changes were seen in any of the outcome measures over the 6-month period. CONCLUSIONS: There appears to be no treatment effect of moderate dose ESWT in subjects with plantar fasciitis. Efficacy may be highly dependent upon machine types and treatment protocols. Further research is needed to develop evidence based recommendation for the use ESWT in musculoskeletal complaints.

Re: English podiatists not amused by ESWT..

Dr. Z on 10/23/03 at 13:03 (135162)

Hi

effect of moderate dose ESWT in subjects with plantar fasciitis. Efficacy may be highly dependent upon machine types and treatment protocols. Further research is needed to develop evidence based recommendation for the use ESWT in musculoskeletal complaints.
Posted in Category
The problem with studies are they include different doses of ESWT energy, different patient population.
In the USA our protocol for FDA approved machines is much higher energy, the patient must have the pf pain for six months with at three failed failed
IF you treat a patient population with an average of six weeks or three months there is a very good chance that with conservative treatment the problem will get better and the pain will leave.
We use ESWT in the USA to treat pf pain that is chronic . So in summary as the article stated different protocol , different machines and different patient population.
I hope that this helps you

Re: English podiatists not amused by ESWT..

Donald Iain Scott on 10/24/03 at 06:51 (135234)

Yasmin,
Was the study carried out in UK done with ESWT or RSWT. There is a big difference.
Also the study says that an active treatment was done at .12mJ/mm2. If that was the case then the required 1,500 mJ/mm2 was not attained and therefore NO healing can take place. The treatment was done over a three month period. This ia also wrong, low dose is done on a weekly basis for three weeks. High dose treatment (USA ONLY) 1 treatment at Level 9 or 4200 Pulses at .36mJ/mm2
The Podiatrists in UK are probably not actively involved with ESWT due to the cost of machines @ 150,000 Pounds. I am the only Podiatrist in Australia using ESWT.
There are a few so called experts out there are debunking ESWT, WHY? Double blind tests do NOT work all the time, and for ESWT this is the case. There are so many variable when treating an individual for plantar fasciitis, height, weight, age, gender, duration of pain, type of pain, thickness of Plantar fascia, size of spur/no spur.
After 6 months other factors encroach on the treatment, re-injury, non compliance post treatment

Yasmin, do not give up, are you able to contact anyone in Europe - Germany is the best starting point

Donald Iain Scott
Wollongong
Australia

Re: English podiatists not amused by ESWT..

Yasmin on 10/24/03 at 18:45 (135393)

Thanks to both docs who have answered to my mail.

No I am not in contact with anyone in Europe, Do you have any ideas or can you point me towards the right direction for treatment?

Thanks in advance.

Re: English podiatists not amused by ESWT..

BrianG on 10/24/03 at 23:21 (135426)

Hi Yasmin,

Check out this link, I think it's probably what your looking for. You probably got sidetracked if you were looking for information from the Pod's over there. Most of the European ESWT is low energy, performed by MD's. They have been at it a lot longer than most of the world.

http://www.ismst.com/literature.htm

Good luck
BrianG,

Re: Thanks Brian for the info

BrianG on 10/25/03 at 21:40 (135572)

Your welcome. There is a lot of good ESWT info at this web site, you just have to poke around to find it. I've even written a couple e-mails to these doctors, and all of them were answered!!!

Good luck
BrianG

Re: English podiatists not amused by ESWT..

Donald Iain Scott on 10/25/03 at 22:34 (135578)

Yasmin,
There are at least 3 ESWT units in UK- Chelsea is one, another unit is run by a Mr John Tanner but I have no idea of his location in the UK
ISMST may be able to help a practitioner. You could try (Google) and then ESWT UK, Evotron.
Good Luck

Donald Iain Scott
Australia

Re: English podiatists not amused by ESWT..

Yasmin on 10/26/03 at 09:09 (135599)

Hi Donald

I know the one in Chelsea, the guy who runs the clinic is a physiotherapist, I have seen Dr Tanner, he uses the reflectron machine, but he gave a very low percentage of improvement - 50%.

Also have asked ISMST for help, they gave me another docs name, but was charging more than the first two put together. There doesnt seem to be a lot docs that practice this here, also I am really looking for someone who really knows what they are doing!

Thanks

Yasmin

Re: English podiatists not amused by ESWT..

Jan R. on 10/30/03 at 07:14 (135994)

This is my comment on the study published by Speed and co-workers:

Prof. J.A. Buckwalter, MD
Editor
The Journal of Orthopaedic Research
Department of Orthopaedic Surgery
The University of Iowa Hospitals and Clinics
200 Hawkins Drive
Iowa City, IA 52242-1088
USA

August 13, 2003

Letter to the Editor:
'Extracorporeal shock wave therapy for plantar fasciitis – a double blind randomised controlled trial' by C.A. Speed et al., J Orthop Res 2003; 21:937-940

Sir,

I read with interest the article in the Journal of Orthopaedic Research entitled 'Extracorporeal shock wave therapy for plantar fasciitis – a double blind randomised controlled trial' by C.A. Speed et al.(1)

I congratulate them for the well-conducted randomised controlled trial, the negative results of which contrast with our and others recently published experience (2,6) and confirm data of the Australian multi-center study (3) and of the German multi-center study.(4)

All four randomised controlled trials (2,3,4,6) were not included in the discussion of their article.

In the trial from our department (2) forty-five running athletes with intractable plantar heel pain were enrolled in a randomized single-blind trial with a parallel-group design and blinded independent observer, to evaluate the efficacy of three applications of 2000 impulses of low-energy shock waves (Group I) compared with sham treatment (Group II). Followup examinations were done at six months, and at one year after extracorporeal shock wave application. Symptoms had been present from one year to six years. The primary efficacy endpoint was reduction of subjects´s self-assessment of pain on first walking in the morning on a visual analog scale (range, 0 - 10 points) at six months after shock wave application. After six months self-assessment of pain on first walking in the morning as primary efficacy endpoint showed a significant reduction from an average 6.9 to 2.1 points in Group I, and from an average 7.0 to 4.7 points in Group II on the visual analog scale. The mean difference between both groups was 2.6 points. After twelve months pain on first walking in the morning showed a further reduction in both groups, to an average 1.5 points in Group I, and to 4.4 points in Group II . In conclusion, this study showed that three treatments with 2100 impulses of low-energy shock waves were a safe and effective non-surgical method for treating chronic plantar fasciitis in long-distance runners after a followup of six months.

This study sharply contrasted with the Australian multi-center trial published by Buchbinder et al. in JAMA 2002.(3) They enclosed 166 patients in a double-blind, randomized, placebo-controlled trial. Patients were randomly assigned to receive either ultrasound-guided ESWT given weekls for 3 weeks to a total dose of at least 1J/mm² or identical placebo to a total dose of 0.006 /mm². After significant improvements in both groups, the between- group difference of improvement was only 0.6 on a 100 mm visual analog scale. There was no evidence of ESWT over placebo. The study of Buchbinder was of excellent quality but there were clear differences regarding our trial. First, patients in the active group did not receive identical treatment (either 2000 or 2500 shock waves per treatment of energy levels varying between 0.02 mJ/mm² and 0.33 mJ/mm²) contrary to the current study.4 Second, the mean dose in the active group was 1407 mJ/mm², 500mJ/mm² more than in the current study. In the experience of the author of the current study patients will not tolerate such a high dose unless the treatment area of maximal pain is missed. Accordingly, third, Buchbinder did not focus on the area of maximal pain like in the current study, but on the area of maximal thickness of the plantar fascia. Fourth, a potent analgetic drug was allowed for the duration of the study. Fifth, patients were enrolled with a pain history as short as 6 weeks, contrary to 12 months in the current study. Sixth, there was no real placebo group, but sham therapy consisted of application of 100 shock waves of 0.02 mJ/mm².

With regard to the German multicenter trial published by Haake et al.(4) in the BMJ the study design is excellent. It was a randomised, blinded, multicenter trial with parallel group design. 272 patients with chronic plantar fasciitis recalcitrant to conservative therapy for at least six months were enrolled: 135 patients were allocated extracorporeal shock wave therapy and 137 were allocated placebo. 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. 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. No difference was found in the secondary end points. Few side effects were reported. In conclusion, extracorporeal shock wave therapy was ineffective in the treatment of chronic plantar fasciitis. However, Haakes´s treatment regimen is clearly different from the regimen applied in our trial (2) regarding shock wave device, number of shock waves, energy flux density, technique of focussing, period between application, permission of additional pain medication, simultaneous application of local anesthesia.

A possible influence of simultaneous local anesthesia has been discussed particularly. Auersperg et al.(5) reported they had enrolled fifty-one patients with a chronic plantar fasciitis in a randomized controlled observer-blinded trial. Patients were randomly assigned to receive either active ESWT without local anesthesia, given daily for 3 days (Group I, n=25; 3 x 1500 pulses, total energy flux density 0.04 mJ/mm2) or identical ESWT with local anesthesia (Group II, n=26). Main outcome measures were: Pain during first step in the morning (measured on a 0-10 point visual analog scale), and no further therapy needed, measured at six weeks after the last ESWT. At six weeks, there was significant improvement in pain during first steps in the morning in both groups, by 4.4 points in Group I, and by 2.6 points in Group II. The mean between-group difference of improvement was statistically significant. In Group I 19/25 (76%) patients didn´t need any further therapy compared with 9/26 (35%) patients in Group II. In conclusion, at six weeks success rates after low-energy ESWT with local anesthesia were significantly lower than after identical low-energy ESWT without local anesthesia.

Buch et al.(6)presented results of a US-based prospective randomised placebo-controlled double-blind multicenter trial. 150 patients with persistent heel pain were enrolled. 76 patients received a single active treatment (3800 pulses, 0.36 mJ/mm², local anesthesia of the posterior tibial nerve), 74 received a single sham treatment. A reduction of heel pain at first step in the morning was observed in both groups at 3-month follow-up, by 4.4 points in the active group, and by 3.6 points in the placebo group. The between-group difference was significant. The Roles and Maudsley score also showed a significant difference between the groups, with 61.6% good or excellent results in the active group, and 39.7% in the placebo group. The data presented in this study led to FDA approval of the shock wave device in January 2002.

Now, Speed et al.(1) present another treatment concept. They performed a double blind randomised trial of moderate shock wave therapy in plantar fasciitis of at least 3-month duration. 88 patients either received active treatment (1500 pulses of 0.12 mJ/mm², given 3x in monthly intervals) or placebo treatment. At three months from baseline, that is at one month after completion of treatment, 37% of the subjects in the ESWT group, and 24% in the sham group showed a >50% improvement from baseline with respect of pain. In conclusion, there appeared to be no treatment effect of moderate dose ESWT. Clearly, Speed´s treatment regimen is different from the regimen applied in our trial (2) regarding number of shock waves (3x 1500 vs. 3x 2000), energy flux density (0.12 mJ/mm² vs. 0.18 mJ/mm²), period between application (1 month vs. 1 week), and time of follow-up (1 month after completion of treatment vs. 6 months). The technique of focusing was similar to ours, and they did not use a local anesthesia.

Some questions remain to be answered by Dr. Speed and his co-authors:

·88 patients were in the study. Was it a pilot study? Was there any sample size calculation prior to starting the trial. If so, which data were the basis of this calculation? Or was selection of treatment parameters just empirical, with emphasis on a feasible regime?

·The primary endpoint relied on assessment of heel pain during the day. It remains unclear how patients rate a pain over a 24-hour period. Concerning difference between groups: What was the statistical power of the analysis?

·As I read there was no statistically significant difference between both groups concerning the visual analog pain scores one month after treatment. What was the statistical power of the analysis? Maybe the power was too small to detect a clinically relevant difference between the groups?

All authors made clear in the discussion of their papers (1,2,3,4,6) that 'the results were only valid for the therapeutic variables applied'. Therefore I fully agree with Dr. Speed that differences between different studies may be related to differences in study populations, heterogeneity of treatment parameters, different placebos and different machine designs.

So, many questions still remain to be answered by future prospective randomized controlled trials:

·What roles do treatment intervals and follow-up periods play?

·Has a local anesthetic an adverse effect on the clinical outcome after repetitive low-energy ESWT? What about performing the treatment under regional anesthesia?

·Is there an adverse effect of additional pain medication on the clinical outcome after repetitive low-energy ESWT? If so, why and to which extent?

·Is clinical outcome after repetitive low-energy ESWT comparable with results after high-energy ESWT performed under regional anesthesia?

·What clinical results are observed when exactly repeating treatment protocols which have reportedly been successful?

All these issues warrant further research in order to develop evidence-based recommendations for the use of ESWT in musculoskeletal disorders. I strongly disagree with Haake (4) in whose opinion the diverging results of the existing RCTs justify a ban on further research. On the contrary, these diverging data are a magnificent basis for future trials according GCP and ICH criteria.

Sincerely yours,

Jan R.

References

1.Speed CA, et al. Extracorporeal shock wave therapy for plantar fasciitis – a double blind randomised controlled trial. J Orthop Res 21:937-940, 2003
2.Rompe JD, et al. Shock wave application for chronic plantar fasciitis in running athletes – a prospective, randomized, placebo- controlled trial. Am J Sports Med 31:268-275, 2003
3.Buchbinder R, et al. Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis. JAMA 288: 1364-1372, 2002
4.Haake M, et al. Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial. BMJ 327:75-79, 2003
5.Auersperg V, et al. Influence of simultaneous local anesthesia on the outcome of repetitive low-energy shock wave therapy for chronic plantar fasciitis. Presentation at the 3rd Tri-National Meeting of the Austrian, Swiss, and German Societies for ESWT, Munich 2003
6.Buch M, et al. Extracorporeal shockwave therapy in symptomatic heel spurs. Orthopäde 31:637-644, 2002

Re: English podiatists not amused by ESWT..

Pauline on 11/01/03 at 08:42 (136120)

Dr. Rompe,
Was your comment published in their August issue? Did it generate any response?

Re: English podiatists not amused by ESWT..

Jan R. on 11/04/03 at 10:06 (136340)

The Letter has been accepted for publication.

I have not been informed about the exact date or issue of the J Orthop Res.

For details please turn to Dr. Buckwalter.