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Original Research
Shockwave treatment for medial tibial stress syndrome in military
cadets: A single-blind randomized controlled trial
Santiago Gomez Garcia
a
,
*
,
1
, Silvia Ramon Rona
b
, Martha Claudia Gomez Tinoco
c
,
Mikhail Benet Rodriguez
d
, Diego Mauricio Chaustre Ruiz
e
,
Francia Piedad Cardenas Letrado
f
,
Africa Lopez-Illescas Ruiz
g
, Juan Maria Alarcon Garcia
h
a
Orthopaedic Surgeon and Sports Medicine Physician, Military School of Cadets of the Colombian Army, Calle 80 No. 38-00, Bogot
a, Colombia
b
Director of Physical Medicine and Rehabilitation Department, Hospital Quir
on, Garcia Cugat Foundation CEU-UCH Chair of Medicine and Regenerative,
International University of Catalonia, Plaça d'Alfonso Comín, 5-7, 08023, Barcelona, Spain
c
Psychology Unit of the Academic Vice-Rectory, Military School of Cadets of the Colombian Army, Calle 80 No. 38-00, Bogot
a, Colombia
d
Research Director of the CAFAM University Foundation, Cra. 68 No. 90-88, Bogot
a, Colombia
e
Department of Physical Medicine and Rehabilitation, Central Military Hospital, Transversal 3 No.49-00, Bogot
a, Colombia
f
Physiotherapy Unit, Military School of Cadets of the Colombian Army, Calle 80 No. 38-00, Bogot
a, Colombia
g
Director of Physical Rehabilitation Unit, National Sports Medicine Center, Higher Sports Council, C/ Pintor El Greco S/N, 28040, Madrid, Spain
h
Director of Shockwave Service, Vithas Nuestra Se~
nora de Am
erica Hospital, Madrid, Spain
highlights graphical abstract
Medial tibial stress syndrome (MTSS)
is characterized by pain in the lower
leg, common in athletes and
militaries.
Although MTSS is often mild, it can
evolve to chronicity.
Optimal treatment for MTSS has yet
to be established.
Extracorporeal shockwave treatment
(ESWT) is a tool aimed at alleviating
symptoms and shortening recovery
time in MTSS.
A single focused ESWT combined
with a specific exercise program al-
lows faster recovery in military ca-
dets with MTSS.
article info
Article history:
Received 9 June 2017
Received in revised form
26 July 2017
Accepted 17 August 2017
Available online 5 September 2017
abstract
Medial tibial stress syndrome (MTSS) is a common injury in athletes and soldiers. Several studies have
demonstrated the effectiveness of extracorporeal shockwave treatment (ESWT) in athletes with MTSS.
Objective: To assess whether one session of focused ESWT is effective in the treatment of military cadets
with MTSS.
Design: A randomized, prospective, controlled, single-blind, parallel-group clinical study. Level of evi-
dence: Ib.
Setting: Military School of Cadets of the Colombian Army.
*Corresponding author. Calle Amparo L
opez Jean No 8, 5to Izquierda, CP: 15174, Culleredo, A Coru~
na, Spain.
E-mail addresses: sancubacfg@yahoo.es (S. Gomez Garcia), sramon@comb.cat (S. Ramon Rona), nanygomezt@hotmail.com (M.C. Gomez Tinoco), benetmikhail@gmail.com
(M. Benet Rodriguez), diegomchaustrer68@yahoo.com.co (D.M. Chaustre Ruiz), frapcl@hotmail.com (F.P. Cardenas Letrado), lopezillescas@gmail.com (
A. Lopez-Illescas Ruiz),
ondasdechoquealarcon@icloud.com (J.M. Alarcon Garcia).
1
Sports Medicine Physician. Clínica Cenit, C/ Pedro Ferrer, 3 Bajo, 15011, A Coru~
na, Spain.
Contents lists available at ScienceDirect
International Journal of Surgery
journal homepage: www.journal-surgery.net
http://dx.doi.org/10.1016/j.ijsu.2017.08.584
1743-9191/©2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
International Journal of Surgery 46 (2017) 102e109
Keywords:
Medial tibial stress syndrome
Shin splints
Shockwave
Shockwave treatment
Military injuries
Regenerative therapy
Methods: Forty-two military cadets with unilateral chronic MTSS were randomly assigned to either one
session of focused electromagnetic ESWT (1500 pulses at 0.20 mJ/mm
2
) plus a specific exercise pro-
gramme (muscle stretching and strengthening exercises) or the exercise programme alone.
The primary endpoint was change in asymptomatic running test (RT) duration at four weeks from
baseline. Secondary endpoints were changes in the visual analogue scale (VAS) after running and
modified Roles and Maudsley (RM) score also at four weeks from baseline.
Results: ESWT patients were able to run longer. Mean RT after four weeks was 17 min 33 s (SE: 2.36)
compared to 4 min 48 s (SE: 1.03) in the exercise-only group (p ¼0.000). Mean VAS after running was
2.17 (SE: 0.44) in the ESWT group versus 4.26 (SE: 0.36) in the exercise-only group (p ¼0.001). The ESWT
group had a significantly higher RM score, with excellent or good results for 82.6% of patients vs. 36.8% in
the exercise-only group (p ¼0.002). No significant adverse effects of ESWT were observed.
Conclusion: A single application of focused shockwave treatment in combination with a specific exercise
programme accelerates clinical and functional recovery in military cadets with MTSS.
©2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
1. Introduction
Medial tibial stress syndrome (MTSS), also known as shin splints
or tibial periostitis, is characterized by pain in the middle and lower
end of the tibia; the pain is usually elicited by practising sports or
other physical activities [1e3]. The criteria for diagnosis of MTSS
were established by Yates and White [4]. Although the prognosis of
MTSS is usually benign, it can evolve to chronicity and be disabling
[5]. It is a common cause of leg pain in military personnel and
athletes [6,7], with incidences ranging between 4% and 35% in these
populations [8,9]. Basic training can cause tibial periostitis in 4e10%
of recruits after 8e12 weeks [9,10]. In fact, 60e80% of cases are
associated with musculoskeletal overload [11]. Prolonged military
marching and physical activity involving excess training of the
lower limbs contribute to the stress reaction of the bone [12e15],as
confirmed by imaging studies [13,16e21]. This condition has been
considered a precursor stage for stress fracture, which, unlike
MTSS, presents more localized pain that is accentuated on per-
cussion [22] and has a different treatment and prognosis.
According to the theory of bone stress reaction introduced by
Moen et al. [23], oedema in the bone marrow is a sign of bone
remodelling secondary to overload in people subjected to repetitive
strain on the lower limbs. This may cause clinical signs and
symptoms when the load exceeds a certain threshold, due to
microscopic fatigue (microlesions), as explained in the mechano-
stat model [24].
To date, no in-depth studies have been carried out on specific
treatments for MTSS. Several forms of conservative treatment have
been applied in the acute phase, such as relative rest [25e29], anti-
inflammatory drugs, analgesics and cryotherapy [9], electrotherapy
[30], laser [31], acupuncture [32,33], orthotics [34,35], foot orthoses
[36], prolotherapy [37], compression [38], corticosteroid injections
[39] and kinesiotaping [40], with varying results. Fasciotomy of the
posterior superficial compartment of the leg has also been per-
formed [41e47], but no preferred therapeutic approach has been
identified yet. The clinical course is generally prolonged despite
treatment, with periods of relapse.
A therapeutic alternative is currently being studied aimed at
reducing pain and shortening recovery time in MTSS, using extra-
corporeal shockwave treatment (ESWT). Two studies from Rompe
[48] and Moen [49] have shown ESWT to be effective for MTSS,
whereas another study from Newman showed no benefit[50].
Furthermore, as literature has pointed the efficacy of 3 ESWT
sessions in MTSS, we studied if one ESWT session was effective in
this pathology as well.
The aim of this study was to evaluate the effectiveness of ESWT
in a military population with MTSS.
2. Materials and methods
We performed a single-blind randomized controlled study in 42
military cadets (33 men and 9 women) with MTSS from the Military
School of Cadets of the Colombian Army, between February and
April 2015.
Inclusion criteria were as follows: 1) patients of either sex, aged
over 18 years, diagnosed with MTSS per Yates and White criteria
[4], with pain during exercise in the posterior medial part of the
tibia, and an area of diffuse pain on palpation measuring at least
5 cm; 2) continuous pain that had appeared at least 3 weeks earlier;
3) pain elicited by exercise and occurring during and after exercise;
4) unilateral pain; 5) X-Ray were performed to rule out stress
fracture or other types of fracture.
Exclusion criteria were as follows: 1) patients with current or
prior radiological signs of stress fractures or other types of fracture;
2) local infection or osteomyelitis; 3) tumour in the region; 4)
compartment syndrome; 5) prior surgery on the same leg; 6) prior
use of shockwaves for MTSS; 7) prior or current rheumatic disease;
8) coagulation disorders; 9) pregnancy.
When all the inclusion criteria and none of the exclusion criteria
were met, MTSS patients were enrolled by the orthopaedic surgeon
once informed consent had been obtained. To ensure consistency of
data collection at baseline, a specially designed protocol was used
that included clinical variables, such as the visual analogue scale
(VAS), and functional variables, such as the running test (RT), which
consisted of running on a treadmill at a fixed speed (10 km/h). The
RT was stopped if the patient indicated that pain was too severe to
continue or in case of fatigue. Patient satisfaction with the treat-
ment was recorded using the Roles and Maudsley scale (RM).
Clinical assessments were performed at baseline and at a follow-up
4 weeks later by an orthopaedic surgeon blinded to patients'
treatment allocation.
Patients were randomly assigned to receive either a focused
ESWT plus a specific exercise programme (intervention group) or
the exercise programme alone (control group). Random allocation
was performed by the physiotherapist using Epidat 4.0. Allocation
was concealed from the recruiter and participants. The intervention
consisted of a single session of 1500 pulses at an energy flux density
(EFD) of 0.20 mJ/mm
2
and a frequency of 5 Hz generated by an
electromagnetic device (Duolith SD1 T-Top; Storz Medical), per-
formed by a physician specialized in rehabilitation and certified in
the use of shockwaves. ESWT was applied to the most painful
affected region on palpation in the tibia, without anaesthesia, with
S. Gomez Garcia et al. / International Journal of Surgery 46 (2017) 102e109 103
Table 1
Exercise programme for medial tibial stress syndrome patients.
Muscle stretching exercises Calf Stretch With Towel
Standing Calf Stretch
Anterior Compartment Stretch
Muscle strengthening exercises Strengthening Exercises for the Lower Leg muscles with Thera-band
®
:
Resisted Dorsiflexion Flexion
Resisted Plantar Flexion
Resisted Inversion
Resisted Eversion
Strengthening Exercises for the Lower Leg:
Heel Raises
Toe Raises: Sitting
Toe Raises: Standing
Strengthening of the stabilizing muscles of the hip and pelvis:
Pelvic bridge
Lateral leg lift extension
Lateral flexion leg lift: Clam exercise
Joint mobility exercises Active Range of Motion of the Ankle
Fig. 1. Consort diagram of participants flow through the trial.
Table 2
Description of the patients in the groups at the start of the study.
Variables Patient Group p
ESWT þexercise
(N ¼23)
Exercise
(N ¼19)
Mean SEM Mean SEM
Age 20.04 0.29 19.42 0.35 0.18
Body mass index 24.13 0.56 24.38 0.64 0.78
Number of clinical symptoms at the start 6.96 0.38 7.42 0.30 0.36
Number of overtraining items
a
15.78 2.02 19.11 2.15 0.27
Gender N % N % 0.15
Male 20 86.96 13 68.42
Female 3 13.04 6 31.58
a
Based on the questionnaire of the French Society for Sports Medicine [53]; SEM, standard error of the mean; N, number of patients.
S. Gomez Garcia et al. / International Journal of Surgery 46 (2017) 102e109104
the patient in the supine position and knee extended. Rest and
analgesics were prescribed for 24e48h if necessary. ESWT was
combined with an exercise programme (modified from that used
by Rompe et al. [48]) consisting of 40 min of exercise five days a
week for four weeks under the supervision of a physiotherapist
(Table 1).
Patients assigned to the control group received the exercise
programme only. In the control group but not in the ESWT group,
cryotherapy was applied to the affected part of the tibia after
completion of the exercises during 10 minuts, in order to avoid its
possible influence on the biological mechanism of ESWT.
The study design according to the Consort diagram [51] is
shown in Fig. 1.
Sample size calculations were based on normal approximation
Fig. 2. Pain based on visual analogue scale (VAS) at baseline and follow-up in both groups. Graph A shows VAS at rest; and graph B, VAS at the end of running.
S. Gomez Garcia et al. / International Journal of Surgery 46 (2017) 102e109 105
and bilateral contrast with continuity correction. To obtain a sam-
ple size ratio of 1:1 for both treatment groups, criteria were
a
¼0.05,
b
¼0.2, P1 ¼80.5 and P2 ¼65. We obtained a sample size
of 46 patients, i.e. 23 in each group. From this sample, 42 patients
met the inclusion criteria and none of the exclusion criteria.
Statistical analysis was performed using Windows SPSS version
17.0 software. Student's t-test and Chi-square test were used to
compare the two patient groups. Statistical significance was
established at p 0.05.
The research project was approved by the ethics and research
committee of Hospital Militar Central de Colombia (Ref. 7257/DIGE/
16/09/2014). The study was carried out in line with the Helsinki
Declaration and best clinical practice [52].
3. Results
The initial statistical analysis showed that both patient groups
were homogeneous and therefore comparable (Table 2). There
were no dropouts.
The ESWT group showed a significantly greater improvement
than the exercise-only group at the end of follow-up, in terms of
pain according VAS at rest (p ¼0.016) and at the end of running
(p ¼0.001) (Fig. 2).
All individuals in the ESWT group who had pain at rest 4 ac-
cording to VAS (16 patients), considered as moderate to high pain
levels [49], were asymptomatic or improved their pain on follow-
up. On the other hand, pain at rest also improved in the control
group. In addition, all patients in the control group suffering pain
before treatment, improved significantly at follow-up. Further-
more, 69.6% of the intervention group improved pain compared to
10.5% of those treated with exercise alone. (Table 3).
Moreover, patients in the ESWT group were able to run for
17 min 33 s (SE: 2.36) at the end of follow-up, compared to 4 min
48 s (SE: 1.03) in the exercise-only group (p ¼0.000) (Fig. 3). All
patients returned to activity and running in the militar academy at
4 weeks after treatment.
Patient satisfaction with the treatment according to the Roles
and Maudsley scale was excellent (“1”) or good (“2”) in 82.6% of
patients in the ESWT group at the end of follow-up, compared to
36.8% of patients in the exercise-only group. The difference was
statistically significant (p ¼0.002) (Fig. 4).
No complications or significant adverse effects were observed in
either group.
4. Discussion
Military cadets are regularly subjected to training regimes with
Table 3
Percent reduction of pain for both groups.
Group and variables Before treatment At the end of treatment
Frequency Percentage Frequency Percentage
ESWT þexercise
VAS at rest
High level of pain 16 69,6 0 0,0
Low level of pain 7 30,4 23 100,0
VAS at the end of running
High level of pain 23 100,0 7 30,4
Low level of pain 0 0,0 16 69,6
Exercise
VAS at rest
High level of pain 12 63,2 2 10,5
Low level of pain 7 36,8 17 89,5
VAS at the end of running
High level of pain 19 100,0 17 89,5
Low level of pain 0 0,0 2 10,5
Fig. 3. Running time in minutes in both groups.
S. Gomez Garcia et al. / International Journal of Surgery 46 (2017) 102e109106
intense periods of physical activity, overload of the lower limbs, and
sometimes with insufficient recovery periods, which may lead to
musculoskeletal lesions such as MTSS. Treatment of MTSS using
ESWT has been shown to be effective in athletes [48,49], but its
efficacy in military personnel has not been evaluated to date
(Table 4).
The main result of our study showsthat the use of focused ESWT
plus exercise in military cadets was more effective, as measured by
clinical and functional outcome measures, than exercise alone,
particularly in terms of pain experienced after running, running
time and patient satisfaction with the treatment according to the
Roles and Maudsley scale.
In our study, pain-free running time increased in both groups at
the end of follow-up and was significantly higher in the ESWT
group. Rompe et al. [48], in a non-randomized retrospective study,
showed pain alleviation in the radial shockwave group compared to
the control group, consisting of rest, cryotherapy and a regime of
therapeutic exercises carried out at home. They also demonstrated
that ESWT was associated with a faster return to sports activities: in
64% of athletes after 4 months of treatment and 85.1% after 15
months, compared to 46.80% of controls after 15 months.
In our study, patients in the ESWT group were able to run
without pain for 17 min 33 s at one month after treatment, much
longer than the 4 min 49 s in the exercise-only group.
Similarly, Moen et al. [49], in a non-randomized, non-blinded
observational study in MTSS, showed that 5 sessions of focused
ESWT significantly shortened recovery time to 59.7 days, compared
to 91.6 days for the patients in the control group.
We used the same device as Moen et al. [49] and Newman et al.
[50] to generate focused electromagnetic ESWT to treat MTSS, as
well as the same type of functional evaluation, the running test.
This test was chosen because running is one of the essential
training activities of military cadets.
Surprisingly, Newman et al. [50], in a randomized, double-blind
Fig. 4. Excellent or good results according Roles and Maudsley scale on last follow-up in both groups.
Table 4
Evidence on shockwaves in medial tibial stress syndrome.
Author
(year)
Type of Study
(No. of Patients)
Device No. of
Pulses
EFD Frequency
(Hz)
No. of
Sessions
Main Results
Rompe et al.
(2010)
[48]
Retrospective cohort, in athletes
N¼94
Radial 2000 2.5 bar 8 3 Recovery level:
Completely recovered or much improved: ESWT 76% vs. Control 37%.
Moen et al.
(2012)
[49]
Prospective observational, non-
randomized, in athletes
N¼42
Focused 1000
e1500
0.10
e0.30
a
2.5 5 Time to full recovery:
ESWT 59.7 days vs. Control 91.6 days.
Newman
et al.
(2017)
[50]
Prospective RCT, in athletes
N¼28
Focused 1000
e1500
0.10
e0.30
a
e5 - No significant differences between groups during muscle pressure,
during running.
- No differences in running pain-limited distance.
- Self-perception of change GROC: no significant difference between
groups.
Gomez et al.
(2017)
[58]
Prospective RCT, in military
personnel
N¼42
Focused 1500 0.20
a
5 1 - Lower pain (VAS) after running in ESWT þexercise programme of 2.17
vs. 4.26 in the exercise programme group.
- Faster running time in ESWT þexercise programme of 17.33 min vs.
4.49 in the exercise programme group.
- Excellent or good results in 86.2% in ESWT þexercise programme
compared to 36.8% in exercise programme group.
a
mJ/mm
2
; EFD, energy flux density; ESWT, extracorporeal shockwave treatment; RCT, randomized clinical trial; GROC, Global Rating of Change score.
S. Gomez Garcia et al. / International Journal of Surgery 46 (2017) 102e109 107
study in patients with MTSS treated with an electromagnetic de-
vice, found no significant differences between the treatment group
and the control group in terms of pain at rest, on muscle palpation,
while running or in pain-free running distance. These results are
different to our results and there are several possible causes for
this: 1) no complementary investigations were performed in MTSS
patients to rule out other conditions, such as stress fracture, which
require different treatment and longer recovery times; 2) the small
sample size of 28 patients initially and 24 at the final follow-up; 3)
non-adherence to ISMST standard [54], given that EFD was
increased from 0.1 to 0.3 mJ/mm
2
in each session, instead of a
specific therapeutic energy level; treatment was performed every
two weeks, instead of weekly; 4) the “sham”dose consisted of 1000
pulses of 0.01 mJ/mm
2
in each session, which may have had a
positive therapeutic effect. These circumstances may explain why
there were no differences in the ESWT group compared to the sham
group.
Standard electromagnetic ESWT parameters recommended are
1200e1500 pulses, EFD ¼0.18e0.25 mJ/mm2 and 3 or 4 treatment
sessions [55]. In our case, our ESWT protocol consisted of 1500
pulses, EFD 0.20 mJ/mm2 in a single session. Cadets with MTSS
were able to resume their activity in a safe and effective manner
within the shortest time possible. Other pathologies, such as
plantar fasciitis, have been treated with one session of electro-
magnetic ESWT with favorable results [56,57]. Unlike other studies,
we showed that a single session of focused shockwaves produced
excellent or good results in 82.6% of patients one month after
treatment [58]. In contrast, in the studies by Rompe et al. [48],
Moen et al. [49] and Newman et al. [50],(Table 4). MTSS patients
required, respectively, 3, 5 and 5 ESWT sessions. Shorter recovery
time is important in military personnel with MTSS, so that they can
return to their functional activities quickly. On the other hand,
compliance with the training exercise programme was confirmed
at the end of the study by all patients in both groups.
Another important aspect associated with this condition is the
body mass index. Unlike the study by Plisky [59], our study shows
no significant differences in this variable, probably due to the fact
that, in military training, the intense aerobic physical exercise
required by the cadets makes them more likely to be in good
physical condition and not overweight or obese. This observation
supports the hypothesis that the condition is due to repeated
overloading of the cadets' leg bones during the period of military
training, not to excess weight.
MTSS tends to become chronic and may lead to a stress fracture
of the tibia [5,22], which could end a patient's military career due to
the long time to functional recovery. A cost study would presum-
ably show that a single session of focused electromagnetic shock-
waves is more efficient in improving symptoms and reducing the
time to functional recovery than multiple physiotherapy sessions.
We therefore believe that focused shockwaves in MTSS are safe,
effective and efficient, shortening the time required to achieve
functional recovery compared to conventional therapies.
We must consider that the current study included military
personnel of both sexes and there were no age group differences.
Therefore, the findings of this study could be generalized to the
population of military cadets and patients with MTSS as well.
Limitations of our study are small sample size and short follow-
up. Further research is required to establish long-term ESWT cost-
effective interventions in MTSS patients for a safer and faster
functional recovery to their previous activities.
5. Conclusion
A single application of focused extracorporeal shockwave
treatment in combination with a specific exercise programme
accelerates clinical and functional recovery in military cadets with
MTSS, with a success rate of 82.6% at 4 weeks.
Conflicts of interest
Nothing to declare.
Funding
The authors have not received external funding for this study.
Storz Medical AG, lent the device Duolith SD1 T-Top for the study
period. No other potential conflicts of interest relevant to this
article were reported.
Ethical approval
The research project was approved by the ethics and research
committee of Hospital Militar Central de Colombia (Ref. 7257/DIGE/
16/09/2014). The study was carried out in line with the principles of
the Helsinki Declaration and best clinical practice.
Unique identifying number (UIN)
researchregistry2377.
Author contribution
Santiago G
omez García: coordination, design of the study, data
collection, interpretation of data, writing the article, tables, final
revision.
Silvia Ram
on Rona: writing, figures, tables, final revision.
Martha Claudia G
omez Tinoco: data collection, writing, final
revision.
Mikhail Benet Rodriguez: design of the study, statistical anal-
ysis, interpretation of data.
Diego Mauricio Chaustre Ruiz: data collection, revision.
Francia Piedad C
ardenas Letrado: data collection, revision.
Africa L
opez-Illescas Ruiz: final revision and correction.
Juan María Alarc
on García: final revision and correction.
Guarantor
Santiago G
omez García.
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