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The Effectiveness of ESWT in Lower Limb Tendinopathy: Response

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The American Journal of Sports
http://ajs.sagepub.com/content/43/10/NP44
The online version of this article can be found at:
DOI: 10.1177/0363546515609179
2015 43: NP44Am J Sports Med
Dylan Morrissey, Sethu Mani-Babu and Christian Barton
The Effectiveness of ESWT in Lower Limb Tendinopathy: Response
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The Effectiveness of ESWT
in Lower Limb Tendinopathy:
Letter to the Editor
DOI: 10.1177/0363546515608114
Dear Editor:
We read with interest the recent paper entitled ‘‘The
Effectiveness of Extracorporeal Shock Wave Therapy in
Lower Limb Tendinopathy: A Systematic Review’’ by
Mani-Babu et al
4
in the March 2015 issue.
The use of extracorporeal shock wave therapy within
sports medicine professionals is rising globally, and there-
fore this systematic review represents an important paper
that allows evidence-based prescription of this intervention.
On close inspection of the raw data used to generate the
described effect sizes, we suspect a few errors that have
influenced the ultimate outcomes as calculated and reported
may have inadvertently crept in to the final analyses.
The authors have used dichotomous classifications (ie,
Roles and Maudsley score and 6-point Likert scale) of
treatment outcome (success/failure) as reported in the
studies reviewed to classify outcomes of complete recovery
and much improvement (success) compared to somewhat
improved, same, worse, and much worse (failure).
We suspect that in several instances these classifica-
tions have been reversed, and the unfavorable outcomes
were used for effect size calculation. The differences that
were observed between the systematic review and the orig-
inal papers in successful outcomes for effect size calcula-
tions are presented in Table 1.
We have also included a snippet from the original
papers referenced in this article for your comparison (see
the Appendix at http://ajsm.sagepub.com/supplemental).
Vasileios Korakakis, PhD
Rodney Whiteley, PhD
Doha, Qatar
TABLE 1
Differences Observed Between the Systematic Review
and the Original Papers in Successful Outcomes
Used for Effect Size Calculations
a
Figure 2, C and D
4
(greater trochanteric pain syndrome)
Roles and Maudsley score: successful outcomes
Mani-Babu et al (2015)
4
Furia et al (2009)
3
ESWT Controls ESWT Controls
1st month 16/33 25/33 17/33 8/33
3rd month 7/33 24/33 26/33 9/33
12th month 7/33 21/33 26/33 12/33
Likert scale (1-6): successful outcomes
Mani-Babu et al (2015)
4
Rompe et al (2009)
8
ESWT CS ESWT HT ESWT CS ESWT HT
1st month 68/78 18/75 68/78 71/76 10/78 56/75 10/78 5/76
4th month 25/78 37/75 25/78 45/76 53/78 38/75 53/78 31/76
(continued)
TABLE 1
(continued)
Figure 2, C and D
4
(greater trochanteric pain syndrome)
15th month 20/78 39/75 20/78 15/76 58/78 36/75 58/78 61/76
Figure 3C
4
(patellar tendinopathy)
Roles and Maudsley score: successful outcomes
Mani-Babu et al (2015)
4
Peers et al (2003)
5
ESWT Surgery ESWT Surgery
.12 months 4/14 5/12 10/14 7/12
Mani-Babu et al (2015)
4
Wang et al (2007)
9
ESWT Controls ESWT Controls
.12 months 3/30 12/24 27/30 18/24
Figure 4, C and D
4
(Achilles tendinopathy)
Roles and Maudsley score: successful outcomes
Mani-Babu et al (2015)
4
Furia et al (2008)
1
ESWT Controls ESWT Controls
1st month 10/34 27/34 24/34 7/34
3rd month 5/34 25/34 29/34 9/34
.12 months 5/34 25/34 29/34 9/34
Mani-Babu et al (2015)
4
Furia et al (2006)
2
ESWT Controls ESWT Controls
1st month 22/35 21/33 13/35 12/33
3rd month 6/35 20/33 29/35 13/33
.12 months 6/35 20/33 29/35 13/33
Likert scale (1-6): successful outcomes
Mani-Babu et al (2015)
4
Rompe et al (2007)
7
ESWT ECC Wait ESWT ECC Wait
4th month 12/25 10/25 19/25 13/25 15/25 6/25
Mani-Babu et al (2015)
4
Rompe et al (2008)
6
ESWT ECC ESWT ECC
4th month 9/25 18/25 16/25 7/25
Mani-Babu et al (2015)
4
Rompe et al (2009)
8
Ecc-ESWT ECC Ecc-ESWT ECC
4th month 6/34 15/34 28/34 19/34
a
CS, CS, corticosteroid injection; Ecc, eccentric loading; Ecc-ESWT,
eccentric loading plus extracorporeal shock wave therapy; ESWT, extracor-
poreal shock wave therapy; HT, home training; Wait, wait-and-see policy.
The American Journal of Sports Medicine, Vol. 43, No. 10
Ó2015 The Author(s)
NP43
by guest on January 13, 2016ajs.sagepub.comDownloaded from
Address correspondence to Korakakis Vasileios, PhD (email:
Vasileios.Korakakis@aspetar.com).
The authors have declared no conflicts of interest in the
authorship and publication of this contribution.
REFERENCES
1. Furia JP. High-energy extracorporeal shock wave therapy as a treat-
ment for chronic noninsertional Achilles tendinopathy. Am J Sports
Med. 2008;36:502-508.
2. Furia JP. High-energy extracorporeal shock wave therapy as a treat-
ment for insertional Achilles tendinopathy. Am J Sports Med.
2006;34:733-740.
3. Furia JP, Rompe JD, Maffulli N. Low-energy extracorporeal shock
wave therapy as a treatment for greater trochanteric pain syndrome.
Am J Sports Med. 2009;37:1806-1813.
4. Mani-Babu S, Morrissey D, Waugh C, Screen H, Barton C. The
effectiveness of extracorporeal shock wave therapy in lower limb
tendinopathy: a systematic review. Am J Sports Med. 2015;43:752-
761.
5. Peers KHE, Lysens RJJ, Brys P, Bellemans J. Cross-sectional out-
come analysis of athletes with chronic patellar tendinopathy treated
surgically and by extracorporeal shock wave therapy. Clin J Sport
Med. 2003;13:79-83.
6. Rompe JD, Furia J, Maffulli N. Eccentric loading compared with shock
wave treatment for chronic insertional achilles tendinopathy: a ran-
domized, controlled trial. J Bone Joint Surg Am. 2008;90:52-61.
7. Rompe JD, Nafe B, Furia JP, Maffulli N. Eccentric loading, shock-
wave treatment, or a wait-and-see policy for tendinopathy of the
main body of tendo Achillis: a randomized controlled trial. Am J Sports
Med. 2007;35:374-383.
8. Rompe JD, Segal NA, Cacchio A, Furia JP, Morral A, Maffulli N. Home
training, local corticosteroid injection, or radial shock wave therapy for
greater trochanter pain syndrome. Am J Sports Med. 2009;37:1981-
1990.
9. Wang CJ, Ko JY, Chan YS, Weng LH, Hsu SL. Extracorporeal shock-
wave for chronic patellar tendinopathy. Am J Sports Med.
2007;35:972-978.
The Effectiveness of ESWT
in Lower Limb Tendinopathy:
Response
DOI: 10.1177/0363546515609179
Authors’ Response:
Thank you for the opportunity to respond to this
communication.
We thank the authors of the letter for their questions and
commend them on their attention to detail. To paraphrase,
the question seems to be whether we have entered the data
incorrectly into the graph-generating software (RevMan), as
it appears that the responders and nonresponders are
reversed, therefore giving an incorrect clinical message.
In short, the answer is that the data have been entered
correctly, hence the results being consistent with the liter-
ature. However, in order to align scales that may have dif-
ferent vectors (eg, the Victorian Institute of Sport
Assessment Questionnaire–Achilles runs from 0 to 100
with the latter optimal, while the opposite is true on
a visual analog scale [VAS] from 0 to 10), it was decided
to multiply a scale by 21 or to invert the responders/
nonresponders with dichotomized data in order to ensure
that there was consistency of display of a given outcome
on the same side of any given graph.
For example, when entering pain VAS scores into Rev-
Man for this review, plots to the left (lower scores) indicate
that extracorporeal shock wave therapy (ESWT) is the
favored intervention. When entered in their raw form,
other variables evaluated in the literature (eg, dichoto-
mized data from Likert scales of perceived success) do
not present the same in forest plots—that is, results favor-
ing ESWT will lead to a plot on the right of the graph.
Therefore, nonresponders were entered instead, meaning
these plots favoring ESWT align to the left, consistent
with VAS scores. You may have noted that the graphical
representation of findings, along with the conclusions in
our review, are reflective of the results and conclusions
reported in original studies.
As a specific example, please consider Table 4 in the Furia
et al
1
(2009) paper relating to treatment of greater trochanter
pain syndrome. The VAS is entered in its original form and
correctly shows an outcome in favor of ESWT at 1 month,
with the VAS being reduced from 8.5 to 5.1, as compared to
a smaller reduction from 8.5 to 7.6 in the control group.
The Harris Hip Score improves by increasing from 49.6 to
69.8 in the shockwave group, whereas the control group
moves from 50.4 to 54.4. We have therefore multiplied the
Harris score by 21 to make it align appropriately on the
graph. The Roles and Maudsley score has higher values as
being worse pathology as per the Harris Hip Score. However,
as it is dichotomized, the solution was to reverse the numbers
of responders and nonresponders. These measures give cor-
rect estimates of treatment success and align scores that
have opposite vectors of severity.
Ofcourse,asthestatisticofchoice was a Mantel-Haenszel
fixed-effects risk ratio, the effect sizes and negative confi-
dence intervals are visually different to what they would be
if positive.
It could reasonably be argued that we could have made
this clearer in the methods, or perhaps the legends of the
relevant figures, and we will certainly consider that for
future work. Nonetheless we hope that our review will
assist to stimulate further research evaluating the effec-
tiveness of ESWT, with focus on identifying what the
most effective protocols are, which patients are most likely
to benefit, and how ESWT may interact with other effica-
cious interventions such as tendon loading programs.
Once again, we thank our colleagues for their letter.
NP44 Letter to the Editor The American Journal of Sports Medicine
by guest on January 13, 2016ajs.sagepub.comDownloaded from
Dylan Morrissey, PhD
Sethu Mani-Babu, MBBS
Christian Barton, PhD
London, UK
Address correspondence to Dylan Morrissey, PhD (email:
d.morrissey@qmul.ac.uk).
One or more of the authors has declared the following potential
conflict of interest or source of funding: The authors of the article
referenced in this letter received funding for a clinical trial and
mechanisms study from the UK government via the Engineering
and Physical Sciences Research Council that also has an element
of funding from a manufacturer of ESWT devices (Spectrum
technology). This statement applies to Professor Maffuli, Dr
Screen, Dr Morrissey, and Dr Waugh. This did not fund this study
directly.
REFERENCE
1. Furia JP, Rompe JD, Maffulli N. Low-energy extracorporeal shock
wave therapy as a treatment for greater trochanteric pain syndrome.
Am J Sports Med. 2009;37:1806-1813.
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Article
Full-text available
Background: The anatomy of hip is widely complex and several anatomical structures interact and contribute to its functioning. For position and role, hip and the surrounding tendons, which have their insertion around, are overstressed and often overloaded, especially in athletes. This could lead to the developing of several tendinopathies, among which the differential diagnosis is often complicated. Many conservative treatments are used in clinical practice, while actually, no defined conservative protocol is recommended. Methods: This is a review article. The aim of this manuscript is to evaluate the current evidences about the effectiveness of conservative management in hip tendinopathies. Conclusion: Conservative treatment is effective in the management of hip tendinopathies and may be considered the first-line approach for patients affected. However, there is lack of evidences about which is the most effective treatment. Exercise therapy seems to provide long-term pain relief, but the literature is still lacking about the correct type, dose, posology, intensity of exercise prescribed. Further studies about different local approaches, as PRP or hyaluronic acid injections, may be encouraged. Level of evidence: I.
Article
Full-text available
Background: The anatomy of hip is widely complex and several anatomical structures interact and contribute to its functioning. For position and role, hip and the surrounding tendons, which have their insertion around, are overstressed and often overloaded, especially in athletes. This could lead to the developing of several tendinopathies, among which the differential diagnosis is often complicated. Many conservative treatments are used in clinical practice, while actually, no defined conservative protocol is recommended. Methods: This is a review article. The aim of this manuscript is to evaluate the current evidences about the effectiveness of conservative management in hip tendinopathies. Conclusion: Conservative treatment is effective in the management of hip tendinopathies and may be considered the first-line approach for patients affected. However, there is lack of evidences about which is the most effective treatment. Exercise therapy seems to provide long-term pain relief, but the literature is still lacking about the correct type, dose, posology, intensity of exercise prescribed. Further studies about different local approaches, as PRP or hyaluronic acid injections, may be encouraged. Level of evidence: I.
Article
Full-text available
There are no controlled studies testing the efficacy of various nonoperative strategies for treatment of greater trochanter pain syndrome. Hypothesis The null hypothesis was that local corticosteroid injection, home training, and repetitive low-energy shock wave therapy produce equivalent outcomes 4 months from baseline. Randomized controlled clinical trial; Level of evidence, 2. Two hundred twenty-nine patients with refractory unilateral greater trochanter pain syndrome were assigned sequentially to a home training program, a single local corticosteroid injection (25 mg prednisolone), or a repetitive low-energy radial shock wave treatment. Subjects underwent outcome assessments at baseline and at 1, 4, and 15 months. Primary outcome measures were degree of recovery, measured on a 6-point Likert scale (subjects with rating completely recovered or much improved were rated as treatment success), and severity of pain over the past week (0-10 points) at 4-month follow-up. One month from baseline, results after corticosteroid injection (success rate, 75%; pain rating, 2.2 points) were significantly better than those after home training (7%; 5.9 points) or shock wave therapy (13%; 5.6 points). Regarding treatment success at 4 months, radial shock wave therapy led to significantly better results (68%; 3.1 points) than did home training (41%; 5.2 points) and corticosteroid injection (51%; 4.5 points). The null hypothesis was rejected. Fifteen months from baseline, radial shock wave therapy (74%; 2.4 points) and home training (80%; 2.7 points) were significantly more successful than was corticosteroid injection (48%; 5.3 points). The role of corticosteroid injection for greater trochanter pain syndrome needs to be reconsidered. Subjects should be properly informed about the advantages and disadvantages of the treatment options, including the economic burden. The significant short-term superiority of a single corticosteroid injection over home training and shock wave therapy declined after 1 month. Both corticosteroid injection and home training were significantly less successful than was shock wave therapy at 4-month follow-up. Corticosteroid injection was significantly less successful than was home training or shock wave therapy at 15-month follow-up.
Article
Introduction There is accumulating evidence for the effectiveness of extracorporeal shock wave therapy (ESWT) when treating lower limb tendinopathies including greater trochanteric pain syndrome (GTPS), patellar tendinopathy (PT) and Achilles tendinopathy (AT). The aim of this study was to evaluate the effectiveness of ESWT for lower limb tendinopathies Methods PubMed (Medline), Embase, Web of Knowledge, Cochrane and CINAHL were searched from inception to February 2013 for studies of any design investigating the effectiveness of ESWT in GTPS, PT and AT. Citation tracking was performed using PubMed and Google Scholar. Animal and non-English language studies were excluded. Quality assessment was performed by two independent reviewers and effect size calculations were completed where sufficient data were provided. Results 20 studies were identified with 13 providing sufficient data to complete effect size calculations. The energy level, number of impulses, number of sessions, and the use of local anaesthetic varied between studies. Evidence is limited by low participant numbers and methodological weaknesses including inadequate randomisation. Moderate evidence indicates ESWT is more effective than home training and corticosteroid injection in the short (<12 months) and long (>12 months) term for GTPS. Limited evidence indicates ESWT is more effective than alternative conservative managements including non-steroidal anti-inflammatory drugs, physiotherapy and an exercise programme and equal to patellar tenotomy surgery in the long term for PT [Furia, 2013]. Moderate evidence indicates ESWT is more effective than eccentric loading for insertional AT and equal to eccentric loading for mid-portion AT in the short term. Additionally, there is moderate evidence that combining ESWT and eccentric loading in mid-portion AT may produce superior outcomes to eccentric loading alone [Rompe, 09] (Figure 1). Discussion ESWT can play a role in treatment of patients with lower limb tendinopathy alongside progressive load and flexibility management. Both forms of treatment serve to induce tendon regeneration with rehabilitation exercise tending to be carried out over a period of many weeks, whereas ESWT treatment is typically administered weekly for 3 weeks. A suitable pathway would be using ESWT as an initial starting treatment to be followed by an exercise programme, with some evidence that combined treatments confer additional benefit the effect is even greater. More robust RCTs with larger sample sizes and control groups that include objective functional tests are needed to build upon the limited/moderate evidence that currently exists for ESWTs effectiveness in lower limb tendinopathy. Additionally, further RCTs specifically comparing the different elements of ESWT – energy levels, number of applications and number of days between applications are needed to identify the optimum protocol. References Furia et al. Knee Surg Sports Traumatol Arthrosc. 2013;21:346–50 Rompe et al. Am J Sports Med. 2009;37:463–70
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Article
Few randomized controlled trials compare different methods of management in chronic tendinopathy of the main body of tendo Achillis. To compare the effectiveness of 3 management strategies-group 1, eccentric loading; group 2, repetitive low-energy shock-wave therapy (SWT); and group 3, wait and see-in patients with chronic tendinopathy of the main body of tendo Achillis. Randomized controlled trial; Level of evidence, 1. Seventy-five patients with a chronic recalcitrant (>6 months) noninsertional Achilles tendinopathy were enrolled in a randomized controlled study. All patients had received unsuccessful management for >3 months, including at least (1) peritendinous local injections, (2) nonsteroidal anti-inflammatory drugs, and (3) physiotherapy. A computerized random-number generator was used to draw up an allocation schedule. Analysis was on intention-to-treat basis. At 4 months from baseline, the Victorian Institute of Sport Assessment (VISA)-A score increased in all groups, from 51 to 76 points in group 1 (eccentric loading), from 50 to 70 points in group 2 (repetitive low-energy SWT), and from 48 to 55 points in group 3 (wait and see). Pain rating decreased in all groups, from 7 to 4 points in group 1, from 7 to 4 points in group 2, and from 8 to 6 points in group 3. Fifteen of 25 patients in group 1 (60%), 13 of 25 patients in group 2 (52%), and 6 of 25 patients in Group 3 (24%) reported a Likert scale of 1 or 2 points ("completely recovered" or "much improved"). For all outcome measures, groups 1 and 2 did not differ significantly. For all outcome measures, groups 1 and 2 showed significantly better results than group 3. At 4-month follow-up, eccentric loading and low-energy SWT showed comparable results. The wait-and-see strategy was ineffective for the management of chronic recalcitrant tendinopathy of the main body of the Achilles tendon.
Article
Chronic patellar tendinopathy is an overuse syndrome with pathologic changes similar to tendinopathies of the shoulder, elbow, and heel. Extracorporeal shockwave was shown effective in many tendinopathies. Extracorporeal shockwave therapy may be more effective than conservative treatment for chronic patellar tendinopathy. Randomized controlled clinical trial; Level of evidence, 2. This study consisted of 27 patients (30 knees) in the study group and 23 patients (24 knees) in the control group. In the study group, patients were treated with 1500 impulses of extracorporeal shockwave at 14 KV (equivalent to 0.18 mJ/mm(2) energy flux density) to the affected knee at a single session. Patients in the control group were treated with conservative treatments including nonsteroidal anti-inflammatory drugs, physiotherapy, exercise program, and the use of a knee strap. The evaluation parameters included pain score, Victorian Institute of Sports Assessment score, and ultrasonographic examination at 1, 3, 6, and 12 months and then once a year. At the 2- to 3-year follow-up, the overall results for the study group were 43% excellent, 47% good, 10% fair, and none poor. For the control group, the results were none excellent, 50% good, 25% fair, and 25% poor. The mean Victorian Institute of Sports Assessment scores were 42.57 +/- 10.22 and 39.25 +/- 10.85, respectively, before treatment (P = .129) and 92.0 +/- 10.17 and 41.04 +/- 10.96, respectively, after treatment (P < .001). Satisfactory results were observed in 90% of the study group versus 50% of the control group (P < .001). Recurrence of symptoms occurred in 13% of the study group and 50% of the control group (P = .014). Ultrasonographic examination showed a significant increase in the vascularity of the patellar tendon and a trend of reduction in the patellar tendon thickness after shockwave treatment compared with conservative treatments. However, no significant difference in the appearance, arrangement, and homogeneity of tendon fibers was noted between the 2 groups. There were no systemic or local complications or device-related problems. Extracorporeal shockwave therapy appeared to be more effective and safer than traditional conservative treatments in the management of patients with chronic patellar tendinopathy.
Article
High-energy extracorporeal shock wave therapy has been shown to be an effective treatment for chronic insertional Achilles tendinopathy. The results of high-energy shock wave therapy for chronic noninsertional Achilles tendinopathy have not been determined. Shock wave therapy is an effective treatment for noninsertional Achilles tendinopathy. Case control study; Level of evidence, 3. Thirty-four patients with chronic noninsertional Achilles tendinopathy were treated with a single dose of high-energy shock wave therapy (shock wave therapy group; 3000 shocks; 0.21 mJ/mm(2); total energy flux density, 604 mJ/mm(2)). Thirty-four patients with chronic noninsertional Achilles tendinopathy were treated not with shock wave therapy but with additional forms of nonoperative therapy (control group). All shock wave therapy procedures were performed using regional anesthesia. Evaluation was by change in visual analog score and by Roles and Maudsley score. One month, 3 months, and 12 months after treatment, the mean visual analog scores for the control and shock wave therapy groups were 8.4 and 4.4 (P < .001), 6.5 and 2.9 (P < .001), and 5.6 and 2.2 (P < .001), respectively. At final follow-up, the number of excellent, good, fair, and poor results for the shock wave therapy and control groups were 12 and 0 (P < .001), 17 and 9 (P < .001), 5 and 17 (P < .001), and 0 and 8 (P < .001), respectively. A chi(2) analysis revealed that the percentage of patients with excellent ("1") or good ("2") Roles and Maudsley scores, that is, successful results, 12 months after treatment was statistically greater in the shock wave therapy group than in the control group (P < .001). Shock wave therapy is an effective treatment for chronic noninsertional Achilles tendinopathy.
Article
Nonoperative management of chronic tendinopathy of the Achilles tendon insertion has been poorly studied. With the recently demonstrated effectiveness of eccentric loading and of repetitive low-energy shock wave therapy in patients with midsubstance Achilles tendinopathy, the aim of the present randomized, controlled trial was to verify the effectiveness of both procedures exclusively in patients with insertional Achilles tendinopathy. Fifty patients with chronic (six months or more) recalcitrant insertional Achilles tendinopathy were enrolled in a randomized, controlled study. All patients had received treatment, including local injections of an anesthetic and/or corticosteroids, a prescription of nonsteroidal anti-inflammatory drugs, and physiotherapy, without success for at least three months. A computerized random-number generator was used to draw up an allocation schedule. Twenty-five patients were allocated to receive eccentric loading (Group 1), and twenty-five patients were allocated to treatment with repetitive low-energy shock wave therapy (Group 2). Analysis was on an intention-to-treat basis. Primary follow-up was at four months, and afterward patients were allowed to cross over. The last follow-up evaluation was at one year after completion of the initial treatment. The patients were assessed for pain, function, and activity with use of a validated questionnaire (the Victorian Institute of Sport Assessment-Achilles [VISA-A] questionnaire). At four months from baseline, the mean VISA-A score had increased in both groups, from 53 to 63 points in Group 1 and from 53 to 80 points in Group 2. The mean pain rating decreased from 7 to 5 points in Group 1 and from 7 to 3 points in Group 2. Seven patients (28%) in Group 1 and sixteen patients (64%) in Group 2 reported that they were completely recovered or much improved. For all outcome measures, the group that received shock wave therapy showed significantly more favorable results than the group treated with eccentric loading (p = 0.002 through p = 0.04). At four months, eighteen of the twenty-five patients from Group I had opted to cross over, as did eight of the twenty-five patients from Group 2. The favorable results after shock wave therapy at four months were stable at the one-year follow-up evaluation. Eccentric loading as applied in the present study showed inferior results to low-energy shock wave therapy as applied in patients with chronic recalcitrant tendinopathy of the insertion of the Achilles tendon at four months of follow-up. Further research is warranted to better define the indications for this treatment modality.