898461

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FAIXXX10.1177/1071100719898461Foot & Ankle InternationalPinitkwamdee et al

Article

Foot & Ankle International®

Effectiveness of Extracorporeal Shockwave

2020, Vol. 41(4) 403­–410
© The Author(s) 2020
Article reuse guidelines:
Therapy in the Treatment of Chronic sagepub.com/journals-permissions
DOI: 10.1177/1071100719898461
https://doi.org/10.1177/1071100719898461

Insertional Achilles Tendinopathy journals.sagepub.com/home/fai

Siwadol Pinitkwamdee, MD1 , Sukij Laohajaroensombat, MD1 ,

Jakrapong Orapin, MD1, and Patarawan Woratanarat, MD, PhD1

Abstract
Background: Extracorporeal shockwave therapy (ESWT) has been proposed as a conservative treatment for insertional
Achilles tendinopathy from limited evidence without placebo controls. Our objective was to assess the effectiveness of
ESWT compared with sham controls in chronic insertional Achilles tendinopathy.
Methods: A double-blind, randomized sham-controlled trial was conducted between 2016 and 2018. The inclusion
criteria were patients aged 18 to 70 years diagnosed with chronic insertional Achilles tendinopathy who failed standard
conservative treatment. After computerized randomization, patients were allocated into either low-energy ESWT or
sham control. Pain, function, and other complaints were assessed using visual analog scale (VAS) and VAS foot and ankle
(VAS-FA) at preintervention and weeks 2, 3, 4, 6, 12, and 24. Intention-to-treat analysis and repeated measurement were
performed using STATA 15.0.
Results: Sixteen patients in ESWT and 15 patients in sham control groups had nonsignificant different baseline characteristics
with preintervention VAS (6.0 ± 2.6 vs 5.2 ± 2.2) and VAS-FA (64.8 ± 16.6 vs 65.3 ± 12.7). There was no significant
difference in VAS, VAS-FA, and its domains in the long term between the 2 groups. In addition, the ESWT group had
significant improvement in VAS (2.9 ± 2.2) at weeks 4 to 12, and sham controls group had significantly improved VAS (2.3
± 2.6) at weeks 12 to 24. Complications were found only after ESWT treatment.
Conclusion: There was no difference at 24 weeks with the use of low-energy ESWT for chronic insertional Achilles
tendinopathy, especially in elderly patients. However, it may provide a short period of therapeutic effects as early as weeks
4 to 12.
Level of Evidence: Level I, randomized controlled study.

Keywords: chronic insertional Achilles tendinopathy, extracorporeal shockwave therapy

Achilles tendinopathy is one of the most common conse-
quences from overuse injury and often causes posterior heel
pain. The effects of Achilles tendinopathy are decreased
sports or even normal activity of daily living such as walk-
ing on slopes or upstairs.3 In general, 31% of patients who
had Achilles tendinopathy were in the normal population
and did not participate in sports or vigorous activities.15 It
accounts for 5% to 18% of running injuries. Also, in an ath-
letic population with Achilles problems, 23% had inser-
tional Achilles tendinopathy.1,8
The etiology and pathogenesis of Achilles tendinopathy
have not yet been scientifically clarified. Some authors
hypothesized that it can be caused by intrinsic factors such as
age, sex, body weight, tendon temperature, systemic disease,
previous injuries, anatomic malalignment, blood supply, or
genetics and extrinsic factors such as drugs (fluoroquino-
lones), overuse, or microtrauma.11 The most common histo-
pathologic finding is a degenerative process characterized by
disorganized collagen, abnormal neovascularization, necro-
sis, and mucoid degeneration.8,17
Khan et al,7 Maffulli et al,9,10 and Sayana and Maffulli18
popularized the term Achilles tendinopathy to describe the
1
Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi
Hospital, Mahidol University, Bangkok, Thailand
Corresponding Author:
Siwadol Pinitkwamdee, MD, Department of Orthopedic Surgery, Faculty
of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI
Road Ratchathewi, Bangkok, 10400, Thailand.
Email: ouan_edmund85@hotmail.com
404
triad of tendon pain, swelling, and impaired performance.
The location of pathology in Achilles tendinopathy is
important in terms of diagnosis and management; it has
been divided into 2 groups: insertional group and noninser-
tional group (2-6 cm proximal to Achilles insertion).11
Insertional Achilles tendinopathy is typically associated
with a prominent posterosuperior calcaneal tuberosity
(Haglund’s prominence) and/or radiographically apparent
calcification at the tendon’s insertion, which indicates it is
in a chronic stage.4
Nonoperative treatment options for insertional Achilles
tendinopathy have been proposed. Apart from general con-
servative treatment options (medications, immobilization,
activity and shoe wear modification, calf stretching, eccen-
tric strengthening, and corticosteroid injection), extracorpo-
real shockwave therapy (ESWT) seems to be an effective
supplement to other noninvasive therapies.6
In the literature, 3 studies specifically evaluated the
effect of ESWT on insertional Achilles tendinopathy. A
level III case-control study by Furia5 compared high-energy
ESWT single shot plus anesthesia with nonoperative ther-
apy; the outcome showed significant improvement in pain
scores in the ESWT group. This study also suggested that a
local anesthesia field block done prior to the application of
the shockwaves may decrease the effectiveness. A level I
randomized controlled trial (RCT) study by Rompe et al16
compared a low-energy ESWT group with an eccentric
exercise group. While on average, the outcome measures
and pain scores improved for both groups, the low-energy
ESWT group had significantly more favorable results than
the eccentric loading group. Another study was a case series
by Pavone et al13 that included 40 patients who had chronic
insertional Achilles tendinopathy and failed a 3-month pro-
gram of eccentric exercise alone to receive a combination
treatment of eccentric exercise and low-energy ESWT. The
results were significant improvement in pain and function;
thus, the authors recommended treating chronic insertional
Achilles tendinopathy with eccentric exercise and low-
energy ESWT. However, these studies did not include a
sham treatment group. Therefore, the contribution of a pla-
cebo effect to the shockwaves was not assessed. A limited
number of studies in the literature provide insufficient evi-
dence to support the use of ESWT in the treatment of inser-
tional Achilles tendinopathy.
In this article, we conducted a double-blind, randomized
sham-controlled trial to assess the effectiveness of low-
energy ESWT on insertional Achilles tendinopathy.
Methods
We conducted a double-blind, randomized sham-controlled
trial at our orthopedic outpatient clinic between December
2016 and June 2018. After institutional review board
approval, patients aged 18 to 70 years who were clinically
Foot & Ankle International 41(4)
and radiographically diagnosed with insertional Achilles
tendinopathy by foot and ankle specialists, had symptoms
of pain and swelling at the Achilles insertion for more than
6 months, failed other standard conservative treatment for
3 months (ie, rest, medication, activity modification,
stretching exercise, and heel lift orthosis), were able to
complete questionnaires, and were willing to participate
were enrolled. Patients who received a corticosteroid injec-
tion at the Achilles insertion within 4 weeks, had a nonin-
sertional Achilles tendinopathy, had a neurological deficit,
had a history of foot and ankle infection or trauma, had a
foot and ankle deformity, had a history of foot and ankle
surgery on affected side, or had a contraindication for
shockwaves such as hemophilia, coagulopathy, or foot and
ankle malignancy were excluded from the study. This study
was processed according to Consolidated Standards of
Reporting Trials (CONSORT) standards.
Study Protocol
A computerized block of 4 random numbers was generated
from www.randomization.com into 2 groups: ESWT and
placebo (sham) group. Investigators concealed the treat-
ment allocation by sequential sealed opaque envelopes.
After informed consent, patients were asked to avoid any
cointervention and pain-provoking activities such as run-
ning or doing vigorous activities. If the patient had break-
through pain, the rescue drugs were naproxen 750 mg/d or
acetaminophen 2000 to 4000 mg/d. Patients were asked to
complete a questionnaire on baseline characteristics (age,
sex, body mass index [BMI]), duration of symptoms,
affected side, sport activities, underlying disease, and previ-
ous conservative treatment. All eligible patients were
treated in a prone position with the affected ankle at the
edge of the bed. In this position, they were unable to see the
application of intervention (ie, were blinded). The sealed
opaque envelops were opened just before the assigned treat-
ment began.
Shockwave Group
Two foot and ankle specialists used a radial shockwave
device (Swiss DolorClast Classic; EMS, Munich, Germany)
without anesthesia (Figure 1). A radial shockwave probe
(blue) with a 15-mm diameter metal applicator was applied
at the point of maximum tenderness at the Achilles tendon
insertion (not more than 2 cm) and with a thin layer of ultra-
sound gel. The settings of the device were 2.5 to 3.5 bars of
air pressure (equal to an energy flux density 0.12-0.16 mJ/
mm2), which was grouped as low-energy shockwave,12
2000 pulses with 8 to 12 Hz. The total energy flux density
was 240 to 320 J/mm2, which has had a positive effect on
tendon cellularity and pain relief.12 We provided the ESWT
once weekly for 4 times along with standard conservative
Pinitkwamdee et al
Figure 1. The activated probe in the extracorporeal
shockwave therapy group.
treatment (rest, medication, activity modification, stretch-
ing exercise, and heel lift orthosis).
Placebo (Sham) Group
According to the ESWT protocol, we used the blue-colored
radial shockwave probe on the same location of the Achilles
tendon insertion with ultrasound gel. However, we discon-
nected the blue-colored radial shockwave probe from the
machine and connected a red-colored focus shockwave probe
(Figure 2); the setting was the same as the shockwave group.
We started the machine, which activated the red-colored
focus shockwave probe (which did not contact the patient’s
heel) to generate the shockwave sound. The blue-colored
radial shockwave probe that contacted the heel was not
active, but the patient could hear a sound of the shockwave
machine. We gave the same number of sessions of sham
ESWT and the same standard conservative treatment.
Outcome Assessment
The outcome assessment in this study was 7 times: preinter-
vention and weeks 2, 3, 4, 6, 12, and 24. The patients com-
pleted a VAS and VAS-FA Thai version, which had been
validated with the SF-36 Thai version,2 at every follow-up.
The outcome assessor was blinded. Baseline characteristics
were collected. The primary outcome was VAS (0 to 10
scale, from worst to excellent) and the secondary outcome
was VAS-FA Thai version (0 to 100 scale, from very bad to
excellent), which had 3 categories: pain (4 questions;
405
Figure 2. The activated probe (horizon) touching the
inactivated probe (vertical) in sham controls.
frequency and intensity of pain at rest and with physical
activities), function (11 questions; gait, climbing stairs,
occupation, driving a car, standing, standing on 1 leg, walk-
ing, running, daily activities, traveling, and walking on
uneven ground), and other complaints (5 questions; weak-
ness, callous, range of motion, footwear, and sensation).14
Possible complications, including pain, swelling, ecchymo-
sis, numbness, bleeding, and changing decision to surgery,
were also collected.
Demographics
Thirty-four patients were recruited. Three of them were not
willing to participate, leaving 31 patients enrolled in the
study as shown in the CONSORT flow diagram (Figure 3).
After randomization, 16 patients were in the ESWT group,
and 15 patients were assigned to sham controls. No patients
were lost to follow-up. All of them remained in the random-
ized groups and analyzed on an intention-to-treat basis. The
mean (SD) age of the 2 groups was 56.5 (7.9) and 61.4 (5.9)
years old, and 66% and 87% of them were female (Table 1).
Average BMI was 28 kg/m2. In total, 12% to 13% were
involved in sports activities, and 60% to 68% had underly-
ing diseases. Haglund deformity was 68.8% in the ESWT
group and 64.3% in the sham group. All patients had inser-
tional calcific tendinopathy. Previous treatments were med-
ication, rehabilitation, acupuncture, and injection. Mean
(SD) VAS of the 2 groups was 5.0 (2.2) and 6.2 (2.6), and
average VAS-FA was 65. Baseline characteristics of both
groups were not significantly different.
406
Figure 3. Flowchart of the trial. ESWT, extracorporeal shockwave therapy.
Statistical Analysis
We used mean and standard deviation for continuous vari-
ables and frequency (percent) for categorical data. For non-
normally distributed variables, median and range were
presented. Continuous data of both interventions was com-
pared using either unpaired t test or Mann-Whitney U test
based on normal distribution while categorical data were
compared using the Fisher exact test. Repeated measures
with Bonferroni post hoc analysis was applied for each
intervention according to times of follow-up and between
groups. The Bartlett test for equal variance checked the
assumption before using analysis of variance. If the data did
not meet the assumption, nonparametric Kruskal-Wallis
was performed. We used STATA 15.0 (StataCorp LP,
College Station, TX) for all statistical analysis. P values
less than .05 were defined as significant.
Sample Size
Sample size was estimated using STATA 15.0 based on an α
error of 0.05, a β error of 0.2, mean VAS in controls of 5.0,
Foot & Ankle International 41(4)
mean VAS in the intervention group of 3.5, a standard devi-
ation (SD) in both groups of 2.3,5 a preintervention assess-
ment for 1 time, a postintervention assessment for 6 times,
and a correlation between the first and the last VAS assess-
ment of 0.8. The calculated sample size was 12 per group.
With a 20% increment for loss of follow-up, the final sam-
ple size was 15 per group.
Results
From Table 2, ESWT showed significant improvement in
VAS from 6.0 ± 2.6 to 2.9 ± 2.2, 3.0 ± 2.3, and 2.3 ± 2.5
at weeks 4, 6, and 12, respectively. VAS among sham con-
trols was also significantly reduced from 5.2 ± 2.2 to 2.3 ±
2.6 and 2.0 ± 2.6 at weeks 12 and 24, respectively. For
VAS-FA, there was no significant improvement according
to time in both groups. Pain was the only domain that had
statistically significant improvement in sham controls at
weeks 12 and 24 (from average score of 47.3 to 77.8). After
repeated measurement analysis, even though times were
significantly related to VAS and VAS-FA, there was no
Pinitkwamdee et al 407

Table 1. Baseline Characteristics.a

Variables ESWT (n = 16) Sham Controls (n = 15) P Value

Age, mean (SD), y 61.4 (5.9) 56.5 (7.9) .0591
Female 14 (87.5) 10 (66.7) .220
Body weight, mean (SD), kg 68.9 (10.2) 70.7 (12.7) .6536
Height, mean (SD), cm 156.2 (5.6) 158.7 (8.2) .3336
BMI, mean (SD), kg/m2 28.2 (4.3) 28.0 (3.9) .8646
Duration of symptoms, median 7.5 (6 to 120) 12 (6 to 48) .6068
(range), mo
Right side 9 (56.3) 8 (53.3) 1.000
Bilateral 6 (37.5) 1 (6.7) .083
Haglund deformity 11 (68.8) 10 (66.7) 1.000
Insertional calcification 16 (100) 15 (100) —
Sports activities 2 (12.5) 2 (13.3) 1.000
Exercise, median (range), h 3.3 (0-60) 3.5 (0-14) .9683
Underlying disease 10 (68.8) 9 (60.0) .036
Diabetes 2 (12.5) 4 (26.7) .394
Hypertension 8 (50.0) 6 (42.9) .722
Dyslipidemia 1 (6.25) 4 (26.7) .172
Knee osteoarthritis 1 (6.25) 0 1.000
Breast cancer 1 (6.25) 1 (6.7) 1.000
Aortic regurgitation 0 1 (6.67) .484
Obstructive sleep apnea 0 1 (6.7) .484
Medication 9 (56.3) 9 (60.0) 1.000
Rehabilitation 2 (12.5) 4 (26.7) .394
Acupuncture 2 (12.5) 0 .484
Injection 0 3 (20.0) .101
VAS, mean (SD) 6.0 (2.6) 5.2 (2.2) .3126
VAS-FA, mean (SD) 64.8 (16.6) 65.3 (12.7) .9362
Pain 54.4 (24.8) 47.5 (34.7) .4132
Function 60.1 (20.8) 66.6 (20.1) .3872
Other complaints 80.0 (15.1) 83.9 (12.6) .4375

Abbreviations: BMI, body mass index; ESWT, extracorporeal shockwave therapy; VAS, visual analog scale; VAS-FA, visual analog scale for foot and
ankle; —, data could not be calculated.
a
Values are presented as number (%) unless otherwise indicated.

significant difference in these 2 outcomes between groups
(Table 3).
Table 4 showed no significant difference in the amount
of rescue drug usage according to time. There was also no
different usage between groups (P = .5851 for naproxen
and P = .6661 for paracetamol). Complications occurred
with pain during ESWT in 2 patients and failed ESWT at
the end of follow-up in another 2 patients. Both of them
requested surgical treatment at the end of the study. There
was no complication detected in the sham controls. P value
from the Fisher exact test comparing these complications
between 2 groups was .484.
Discussion
Chronic insertional Achilles tendinopathy has been treated
with various methods. Low-energy shockwave therapy
could reduce pain and inflammation, but its effect still has
to be proven. This double-blind, randomized controlled
trial compared low-energy ESWT with sham controls. The
results showed no difference at 24 weeks between ESWT
and sham controls in the treatment of chronic insertional
Achilles tendinopathy, although it did improve VAS at
weeks 4, 6, and 12, while sham controls also significantly
reduced pain at weeks 12 and 24. The effect of ESWT was
faster but of shorter duration than those of the sham group.
VAS-FA was better at various time intervals in both groups,
but the differences were not statistically significant.
However, sham controls improved in pain domain at weeks
12 and 24 significantly. There was no difference in rescue
drug usage between both groups. The complications were
found in only the ESWT group; 2 patients felt pain during
the intervention, and the other 2 were scheduled for
surgery.
408 Foot & Ankle International 41(4)

Table 2. Repeated Measurement of Intervention Groups According to Time.

Follow-up Time, Mean (SD), wk

Outcomes Preintervention 2 3 4 6 12 24 P Value

VAS
ESWT 6.0 (2.6) 4.6 (3.1) 3.7 (3.0) 2.9 (2.2)a 3.0 (2.3)a 2.3 (2.5)a 2.8 (3.3) .0034
Sham 5.2 (2.2) 2.9 (1.9) 3.1 (2.3) 2.6 (2.2) 3.7 (2.9) 2.3 (2.6)a 2.0 (2.6)a .0144
VAS-FA
ESWT 64.8 (16.6) 69.7 (19.6) 73.3 (16.6) 79.3 (15.1) 77.2 (19.6) 80.0 (23.5) 77.2 (23.0) .2614
Sham 65.3 (12.7) 70.8 (17.1) 79.5 (17.1) 79.3 (15.6) 78.6 (17.8) 82.0 (19.2) 82.7 (17.8) .0726
Pain
ESWT 54.4 (24.8) 57.7 (29.0) 63.3 (26.8) 73.7 (21.7) 72.0 (21.4) 76.0 (30.8) 70.1 (30.1) .1687
Sham 47.3 (21.9) 58.2 (26.4) 68.5 (22.7) 70.7 (23.5) 71.4 (25.9) 77.8 (25.3)a 77.8 (26.0)a .0157
Function
ESWT 60.1 (20.8) 66.4 (23.5) 71.0 (20.6) 77.1 (21.1) 74.9 (23.3) 78.2 (24.6) 76.0 (27.8) .2716
Sham 66.6 (20.1) 70.5 (23.0) 78.9 (20.9) 79.2 (18.6) 77.4 (21.5) 79.9 (22.2) 82.5 (17.9) .3811
Complaint
ESWT 80.0 (15.1) 84.9 (12.6) 85.8 (11.2) 89.8 (9.2) 84.9 (17.6) 85.9 (19.2) 85.8 (15.1) .7261
Sham 83.9 (12.6) 83.8 (13.6) 89.1 (11.9) 87.9 (10.1) 87.0 (13.8) 88.3 (14.9) 87.9 (17.8) .9009

Abbreviations: ESWT, extracorporeal shockwave therapy; VAS, visual analog scale; VAS-FA, visual analog scale for foot and ankle.
a
Significant P value less than .05 compared with preintervention data.

Table 3. Repeated Measurement According to the Intervention Groups and Time.

Variables Degrees of Freedom Mean Square Adjusted R Square F Test P Value

VAS 0.1278
Group 1 14.5 2.22 .1378
Time 6 37.8 5.78 <.0001a
VAS-FA 0.0604
Group 1 258.5 0.81 .3686
Time 6 1007.4 3.16 .0055a
Pain 0.0792
Group 1 10.6 0.02 .8973
Time 6 2591.5 4.07 .0007a
Function 0.0432
Group 1 981.9 2.10 .1491
Time 6 1097.5 2.34 .0329a
Complaint –0.0071
Group 1 124.4 0.64 .4234
Time 6 158.3 0.82 .5565

Abbreviations: VAS, visual analog scale; VAS-FA, visual analog scale for foot and ankle.
a
Significant P value <.05.

ESWT has been used for 30 years and more recently
has been proposed for chronic insertional Achilles tendi-
nopathy.5 The previous studies were confounded with
high-energy shockwave, local anesthesia,5 and eccentric
exercise.13,16 This study revealed no long-term benefit of
low-energy ESWT in the treatment of chronic insertional
Achilles tendinopathy, but a short period of therapeutic
effect started by 4 weeks after treatment and lasted up to 3
months. The results were different from the study by
Furia.5 A single high-energy ESWT treatment had effects
up to 12 months, but 5 patients had pain during the inter-
vention, transitory reddening, or 24-hour numbness.
Rompe et al16 reported pain improvement at 4 months
after low-energy ESWT weekly for three times.
Nevertheless, only 16 of 25 patients had successful results.
ESWT provides mechanotransduction, stimulating nitric
oxide. This mechanism helps reduce pain, inflammation,
and substance P and induces tenocyte proliferation.5 On
the other hand, ESWT may injure tendons, leading to pain
and other complications.16
Pinitkwamdee et al 409

Table 4. Rescue Drug Usage.

Follow-up Time, Median (Range), wk

Drug Preintervention 2 3 4 6 12 24 P Value

Naproxen
ESWT — 0 (0-250) 0 (0-500) 0 (0-500) 0 (0-3500) 0 (0-750) 0 (0) .9727
Sham — 0 (0-500) 0 (0-500) 0 (0-750) 0 (0-750) 0 (0) 0 (0) .9909
Paracetamol
ESWT — 0 (0-1000) 0 (0-1000) 0 (0-1000) 0 (0-2500) 0 (0-1500) 0 (0) .6169
Sham — 0 (0-1000) 0 (0-1000) 0 (0-3500) 0 (0-3500) 0 (0) 0 (0) .9398

Abbreviations: ESWT, extracorporeal shockwave therapy; —, data could not be calculated.

Our study is a double-blind, randomized sham-controlled 2. Angthong C, Chernchujit B, Suntharapa T, Harnroongroj T.

trial. We used this rigorous methodology to balance prog-
nostic factors between intervention groups, conceal the ran-
domized sequences, control for measurement biases,
complete follow-up, and perform intention-to-treat analy-
sis. The sample size was adequate to detect a significant
difference in the primary outcome (VAS) as small as 1.5.
The limitations of our study are as follows: (1) older age of
the participants (60 years) may not apply to the whole popu-
lation, (2) median follow-up time was only 6 months, and
(3) the sample size could detect a VAS-FA difference
between groups of only 12.0 or more.
In conclusion, low-energy ESWT had no significant ben-
efit at 24 weeks, but it may relieve pain for the first 3 months
after treatment in chronic insertional Achilles tendinopathy,
but it was not significantly better than sham controls.
However, this result may apply mainly to the elderly.
Further studies to evaluate the efficacy of shockwave in a
younger population could be helpful.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this arti-
cle. ICMJE forms for all authors are available online.
Funding
The author(s) received no financial support for the research,
authorship, and/or publication of this article.
ORCID iDs
Siwadol Pinitkwamdee, MD, https://orcid.org/0000-0002-2211-
6579
Sukij Laohajaroensombat, MD, https://orcid.org/0000-0002-
1119-968X
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