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Another RCT

Posted by Jan D. Rompe on 8/20/03 at 10:34 (127391)

I would like to focus your attention on the following article:

Speed CA, Nichols D, Wies J, Humphreys H, Richards C, Burnet S, Hazleman BL. Extracorporeal shock wave therapy for plantar fasciitis. A double blind randomised controlled trial.
J Orthop Res. 2003 Sep;21(5):937-40.

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: Another RCT

David L on 8/20/03 at 12:11 (127398)

SONOREX Response to Speed Publication

'Extracorporeal shock wave therapy for plantar fasciitis-a double blind randomised controlled trial' by C. A. Speed et al. was recently published in the Journal of Orthopaedic Research 2003; 21:937-940. The conclusion was that their 'regime of moderate dose ESWT has no significant treatment effect in patients with chronic plantar fasciitis compared with placebo.' These findings differ significantly with other studies that employ different treatment technique and patient inclusion criteria. One should not, therefore, generalize that their results would be expected to occur in patients with such different selection criteria or those treated with a much different treatment protocol. In fact, the authors clearly state that 'efficacy may be highly dependent upon the hardware, treatment protocols, and specific condition being treated.'

Speed's findings differ sharply with those of Rompe et al. who recently published a study demonstrating very good results in running athletes who have chronic plantar fasciitis. Rompe treated patients with chronic plantar fasciitis of longer duration with a significantly different treatment protocol. Recent publications by both Buchbinder and Haake which also reported no significant improvement in plantar fasciitis patients treated with ESWT versus placebo, also are remarkable for their different patient selection criteria and/or their marked difference in treatment technique. Thus, all three of these unfavorable studies have common differences which we believe likely accounts for their less favorable results.

With respect to selection and inclusion criteria, Speed et al. accepted patients with symptoms of only three months duration. In our experience, and in a separate pilot protocol with the Siemens Sonocur, those patients with less chronic symptoms (less than six months) are likely to improve whether or not they have ESWT. For this reason, we believe any credible study must limit patient selection to those who have symptoms for at least six (6) months.

Our most significant concern is with the treatment technique employed and the intervals at which shock waves were applied. In almost all studies which demonstrate positive effects of ESWT with lower energy, repetitive treatments are applied at once weekly intervals rather than on a monthly schedule which was employed by Speed. At least 2000 shocks should be applied per session and success should be evaluated at twelve (12) weeks after the last treatment session. Most importantly, great attention should be given to the 'clinical focusing' technique. Speed indicates that focusing was done initially by ultrasound. This is of no or little value when trying to locate a painful site. One cannot image pain and plantar fascial changes on ultrasound are not consistently related to symptoms. Speed also indicates that shock wave focus obtained by ultrasound was 'altered according to the site of maximum reproduction of local pain by the subject at initiation of treatment.' While we applaud this effort, clinical focusing is only effective if continual intra-procedural refocusing is accomplished every 200300 shocks. It is only by this method that one can be sure the painful site is accurately and precisely treated. Frequently, only 1-2 millimeters of movement is necessary to move away from the painful site which can result in an ineffective treatment. Speed indicates that all actively treated patients were treated with shock wave energies of 0.12 mJ/mm2. Most patients who have shock waves precisely focused on the painful site cannot tolerate this energy level. In view of the above, it seems logical to conclude that shortly after initiation of treatment the focus of shock waves may well have moved away from the most painful area of pathology.

This study further illustrates, along with the Buchbinder and Haake studies, how important attention to proper patient selection and treatment technique (clinical focusing, weekly interval treatments, adequate shock numbers) is to achieving positive clinical results. We look forward to additional clinical studies which will affirmatively illustrate these points.

Rompe JD, et al. Shock wave application for chronic plantar fasciitis-a prospective, randomized, placebo-controlled trial. Am J Sports Med 31:268-275,2003
Buchbinder R, et al. Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis. JAMA 288: 1364-1372,2002
Haake M. et al. Extracorporeal shock wave therapy for plantar fasciitis: randomized controlled multicentre trial. BMJ 327: 75-79,2003

Re: Another RCT - Dr. Rompe....your comments?

David L on 8/20/03 at 12:18 (127399)

Dr Rompe,
Do you have any comments on the article by Speed that you just posted? Could you address why your studies show ESWT is effective, but Speed, Buchbinder and Haake's articles result in ineffectiveness?

Re: Another RCT - Dr. Rompe....your comments?

Peter R on 8/20/03 at 15:10 (127418)

David L
Would you care to stae your qualifications that would establish credibility to your analysis of the study you critiqued?

Re: Another RCT - Dr. Rompe....your comments?

Ed Davis, DPM on 8/20/03 at 19:32 (127465)

Peter:

David L. is David Lowy (I believe -- unless he prefers to remain anonymous for purposes of this board), the director of the Sonocur Treatment Center in Vancouver, BC. His center has successfully treated large numbers of patients.
Ed

Re: Another RCT - Dr. Rompe....your comments?

Dr. Z on 8/20/03 at 20:08 (127479)

Ed,

I think he is more important then just a director. I believe he is the CEO of Sonnex. Anyway he is a great guy and an important leader in the ESWT industry

Re: Another RCT - Dr. Rompe....your comments?

David L on 8/20/03 at 22:00 (127499)

Gentlemen.....I am honored by your kind remarks. I am the VP for the Western United States & all of Canada, based in Vancouver. We started with one Sonocur in Vancouer in 1999. The CEO of Sonorex is a urologist who was very instrumental in popularizing lithotripsy on a widespread basis across the United States. It was basically taking technology that was clinically proven in Europe and popularizing it across the US. Today, lithotripsy is common practice. In the mid 80s, many considered it 'investigational'. I see some parallels here with the introduction of ESWT. Ultimately though, there are exponentially more tendinopathies each year in the US vs. kidney stones. The 'Sonorex Response', posted above, was written by an orthopaedic surgeon with very extensive knowledge of ESWT.
Again, thank you for your very kind words and I am particularly humbled that an eminent clinician such as Dr. Z refers to me as an 'important leader in the ESWT industry'

Re: Another RCT - Dr. Rompe....your comments?

Jan D. Rompe on 8/22/03 at 03:05 (127624)

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 trial2 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 0.012 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 trial2 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:

1. 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?

2. 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?

3. 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:

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

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

3. 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?

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

5. 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.

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: Another RCT - Dr. Rompe....your comments?

dr ben pearl on 8/22/03 at 05:49 (127628)

A well thought out synopsis.
Is your sense that lower energy values in your runners study than other published studies was a signifigant factor in determining different conclusions on efficacy? ( your reference to the Buchbinder study) If so , does this shape your opinion of higher energy single dose machines.

DRBP