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Original article
Moen MH, Rayer S, Schipper M, et al. Br J Sports Med (2011). doi:10.1136/bjsm.2010.081992 1 of 5
Accepted 3 February 2011
A B S T R A C T
O b j e c t i v e The purpose of this study was to describe
the results of two treatment regimens for medial tibial
stress syndrome (MTSS); a graded running programme
and the same running programme with additional
shockwave therapy (extracorporeal shockwave therapy;
ESWT).
D e s i g n A prospective obser vational controlled trial.
S e t t i n g Two different sports medicine departments.
P a r t i c i p a n t s 42 athletes with MTSS were included.
I n t e r v e n t i o n Patients from one hospital were treated
with a graded running programme, while patients from
the other hospital were treated with the same graded
running programme and focused ESW T (fi ve sessions in
9 weeks).
Main Outcome Measures Time to full recover y (the
endpoint was being able to run 18 min consecutively
without pain at a fi xed intensity).
R e s u l t s The time to full recovery was signifi cantly
faster in the ESWT group compared with the patients
who only performed a graded running programme,
respectively 59.7±25.8 and 91.6±43.0 days (p=0.008).
C o n c l u s i o n s This prospective observational study
showed that MTSS patients may benefi t from ESWT in
addition to a graded running programme. ESWT as an
additional treatment warrants fur ther investigation in a
prospective controlled trial with the addition of randomi-
sation and double blinding.
Medi al t ibial str ess sy ndr ome (MTSS) is one of the
most common complaints of t he lower leg in the
athletic population.
1
Incidences between 4% and
35% have been reported in both military and ath-
letic studies.
2
–
4
Different aetiological mechanisms
have been proposed for MTSS. For years MTSS
was thought to be caused by traction-induced
periostitis.
5
–
7
Another aetiological theory is that
overloaded bone remodelling causes MTSS.
8
9
Recent studies showed that with overloaded
remodelling the cortex appears osteopaenic on
CT scans and that dual energy x-ray absorpti-
ometry scans reveal decreased bone densit y.
10
11
When MTSS symptoms subside the bone density
returns to normal values,
12
suggesting that MTSS
is related to mechanical overloading of the bone.
In the treatment of MTSS a therapy in which
bone cells are upregulated would possibly
enhance bone density and t hus decrease symp-
toms. Studies that tried to enhance the number of
bone cells in the treatment of stress fractures and
the non-union of fractures provided evidence for
the plausibility of this theory.
13
14
In those studies
extracorporeal shockwave therapy (ESWT) was
used to stimulate the bone.
At the time of planning the study no studies had
been published on the use of ESW T in MTSS. As
some idea of ef fect size is necessary to perform an
adequate power analysis for the proper planning
of a randomised controlled trial it was decided to
perform a prospective obser vational controlled
study that could be simply realised in the local
area. In two regional hospitals the treatment pro-
tocol used was different and this situation lent
itself to performing this observational study. The
effect on time to full recovery after ESWT and a
graded runn ing programme was compared with
a group of MTSS patients who performed only a
running programme. The aim of this study was
to describe the results of two different treatment
regimens on MTSS; one group was rehabilitated
with a running programme, whereas the other
group was rehabilitated with the same running
programme in combination with ESW T.
M E T H O D S
S u b j e c t s
Patients were included in two separate sports
medicine departments of large general district
hospitals by one sports medicine specialist. For
inclusion in the study the Yates and White
4
crite-
ria from 2004 were used.
Pain history
The pain was induced by exercise and could last for
hours or days after exercise. Pain was located on
the posteromedial border of the tibia. T here was no
history of paraesthesia or other symptoms indica-
tive of other causes of exercise-induced leg pain.
L o c a t i o n
The patients identifi ed pain along the posterome-
dial border of the tibia. The site had to be spread
over a min imum of 5 cm.
P a l p a t i o n
Palpation of the posteromedial border of the tibia
produced discomfort that was diffuse in nature
and confi ned to the posteromedial border of the
tibia.
Symptoms had to be present for at least 21 days
for patients to be included.
Exclusion criteria
Patients were excluded if there was a past history
of a tibial fracture and when ESWT had been used
previously for MTSS symptoms.
P r o c e d u r e
Patients were included in two different sports
medicine clinics by the same investigator. In
1 Rehabilitation and Sports
Medicine Depar tment,
University Medical Center
Utrecht, Utrecht, The
Netherlands
2 Department of Physical
Therapy, Rayer Health Care
Physical Therapy, Zoetermeer,
The Netherlands
3 Department of Sports
Medicine, Medical Center
Haaglanden, Leidschendam,
The Netherlands
Correspondence to
Dr M H Moen, Rehabilitation
and Sports Medicine
Department, University
Medical Center U trecht,
Heidelberglaan 100, 3508 CX
Utrecht, The Netherlands;
m . m o e n @ u m c u t r e c h t . n l
Shockwave treatment for medial tibial stress
syndrome in athletes; a prospective controlled study
M H M o e n , 1 S R a y e r , 2 M S c h i p p e r , 2 S S c h m i k l i , 1 A W e i r , 3 J L T o l , 3 F J G Backx 1
BJSM Online First, published on March 9, 2011 as 10.1136/bjsm.2010.081992
Copyright Article author (or their employer) 2011. Produced by BMJ Publishing Group Ltd under licence.
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Original article
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one clinic, patients were advised to start ESWT in combi-
nation with a running programme. In the other clinic, as
therapy, patients were advised to perform the same running
programme.
At inclusion, various baseline parameters were measured:
sex, weight, height, body mass index, kind of sport in
which the patient is involved, centimetres of pain on pal-
pation of the posteromedial border of the tibia, side of the
sy mptoms a nd nu mber of days with symptoms (see table 1 ).
The study was performed in compliance with the Helsinki
Declaration.
15
Running test
Before starting treatment, all patients performed a running
test. The test consisted of running on a treadmill at a fi xed
speed while wearing run ning shoes. Before the test, the
patient was shown a visual analogue scale (VAS, 1–10). It was
explained that a score of 4 on the analogue scale was associ-
ated with symptoms and pain that started to become annoy-
ing. With the onset of such leg symptoms by pointing at the
4 on the analogue scale, the running test would be stopped.
The test started at 7.5 km/h for 2 min. After this initial phase
of warming up, the distance was registered that could be run
at 10 km/h until a 4 on the VAS scale was indicated by the
patient. The distance ran at 7.5 km/h was subtracted from
the total metres run and was called ‘metres run on a treadmill
without pain’.
T r e a t m e n t
The treatment consisted of focused ESWT in combination
with a graded running programme or a running programme
only (see table 2 ).
Running programme
All patients performed a graded runn ing programme as part
of the treatment.
16
The programme consisted of six phases. In
the fi rst t wo phases the patient ran on a treadmill while in the
following phases the patient ran outdoors. A starting point
in the running programme was established using the results
from the running test. If ‘metres run on a treadmill without
pain’ was between 0 and 400 m, the patient was told to start
the running programme in phase 1. If 401– 800 m could be
run, the patient started in phase 2. With 801–1200 m, the
patient started in phase 3. If 1201–1600 m could be run, the
patient started in phase 4. At 1600 m or more, patients started
with phase 5. The running programme was not started if the
patient experienced pain during walking. In that case, t he
patient was advised to avoid symptoms by reducing loading
of the leg. Only after two consecutive days without pain dur-
ing walking, were they allowed to start the programme in
the fi rst phase. The programme was performed three times
per week. Instructions were given not to run on consecutive
days.
A new phase of the running programme could be com-
menced if the previous one could be fi nished without a pain
score of 4 or higher on the 1–10 VAS pain scale. A lso, if
pain (4 or more on the VAS scale) was experienced imme-
diately after the session of the running programme or 1
day after the session, the next phase was not commenced.
In that case, the next run ning session started in the same
phase with 2 min less to run. When phase 6 was fi nished,
we advised patients gradually to start their own sport. They
were instructed to practise sport and to adjust the intensity
and duration to keep their pain score at 4 or lower on the
1–10 VAS pain scale.
ESWT and running programme
In addition to the running programme, one group of patients
was treated with focused ESW T. All treatments were per-
formed by one of the authors (SR) without local anaesthesia. A
focuse d ESW T device (D uolith SD1; Storz M edical, Tä gerwi len,
Switzerland) was used in all patients. Five treatment sessions
were scheduled in the weeks 1, 2, 3, 5 and 9 after inclusion.
At the fi rst session, 1000 shocks were administered with an
energy fl ux density of 0.10 mJ/mm
2
with the patient supine
and the knees fl exed at 30°. The treatment frequency was 2.5
shocks per second. Before each treatment session, contact fl uid
was applied over the length of the posteromedial tibia. At the
start of the fi rst session, the part of the tibia that was painful
on palpation was treated with the ESW T device and also high-
lighted with a waterproof marker. The zone t hat was high-
lighted with the marker was also treated in the consecutive
sessions. At the second session (in the second week of treat-
ment), 1500 shocks were applied with an energy fl ux density
of 0.15 mJ/mm
2
and 2.5 shocks per second. The third session
took place in the third week of treatment; 1500 shocks were
applied with an energy fl ux of 0.20 mJ/mm
2
and 2.5 shocks
per second. At the fourth session (in week 5 of the treatment),
again 150 0 shocks were applied with an energy fl ux density of
0.25 mJ/mm
2
and 2.5 shocks per second. The last session was
in week 9 of the treatment. In this session, 1500 shocks were
applied with an energy fl ux density of 0.30 mJ/mm
2
and 2.5
shocks per second.
The treatment was performed along the painful area on
the posteromedial border of the tibia. No restrictions after
the treatment sessions were given. The running programme
started in the week of the fi rst treatment with ESWT.
Table 1 Baseline values for the treatment groups
Running programme
(N=20)
Running programme +
focused ESW T (N=22) p Value
Sex (% male) 35 73 0.029
Weight (kg) 68.5 (SD 8.6) 74.2 (SD 10.1) NS
Length (cm) 175.1 (SD 6.5) 178.5 (SD 10.3) NS
Body ma ss index (kg/ length in cm
2 ) 22.2 (SD 1.9) 23.2 (SD 2.2) NS
Age (year s) 22.7 (SD 7.2) 30.0 (SD 12.5) 0.027
Days with symp toms 189.3 (SD 339.8) 629.2 (SD 761.1) 0.022
Centimetres palpa tion pain on tibia 11.7 (SD 4.5) 11.3 (SD 6.4) NS
Metres run on t readmill without p ain 744.8 (SD 417.1) 1329.6 (SD 562.9) 0.001
ESWT, extrac orporeal shockwave ther apy; NS, not signifi cantly different (p>0.05).
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Outcome measure
The number of days from inclusion to completion of phase 6
of the running schedule (full recovery) was used as the pri-
mary outcome measure. When a patient did not fully recover
according to the graded runn ing programme, the Likert scale
was used to assess the status of the patient.
17
Scores varied on
a sca le from 1 t o 6 : 1, completely recovered; 2, much i mproved;
3, somewhat improved; 4, same; 5, worse; and 6, much worse.
Statistical analysis
After blinded, double, data entr y, all analyses were carried
out using SPSS version 17.0. To compare data between groups
and explore for possible confounding factors, χ
2
analysis and
analysis of variance (ANOVA) were used. Variables with a sig-
nifi cant difference between treatment groups using univariate
ANOVA or χ
2
analysis were considered as potential confound-
ers. Their univariate relation with the outcome parameter,
‘days to full recovery’ was expressed by the (corrected) amount
of variance explained using univariate ANOVA in the case of
ordinal or nominal confounders, or by means of univariate
regression analysis in the case of scale confounders.
All confounders were tested together in a multivariate
ANOVA, with scale confounders as covariate and nominal or
ordinal confounders as a random factor. All confounders were
also tested in interacting with the treatment status. Statistical
signifi cance was set at p≤0.05.
R E S U L T S
In total, 42 athletes were included in the study. The athletes
participated most frequently in recreational running (19.1%)
and soccer (13.2%). Other sports that at hletes practised were
fi eld hockey, tennis, basketball, athletics and dancing. The
baseline characteristics of the athletes are shown in table 1 .
One patient in the running programme group and t wo
patients in the running programme with focused ESWT did
not fi nish the last phase of the running programme due to
persisting symptoms. The patient in the running programme
group scored a 3 on the Likert scale (somewhat improved) on
quitting the study. In the running programme with ESWT
group two patients scored 4 on the Likert scale (same) on
quitting the study. In total, 39 athletes fi nished the running
programme.
Time to recovery
In the group of the running programme with ESWT the dura-
tion to full recovery was 59.7 (SD 25.8) days. In the group with
the running programme only, the duration was 91.6 (SD 43.0)
days. The means were signifi cantly different between the
groups (p=0.008), with treatment explaining 17.5% of the
total variance in the number of days to full recovery.
Multivariate risk factor analysis
Some baseline characteristics were different between the
treatment groups: sex (p=0.029), age (p=0.027), days with
symptoms (p=0.022) and metres run on a treadmill without
pain (p=0.001).
Apart from sex (p=0.039), no confounder could explain
a signifi cant percentage of the variance (corrected R
2
) in the
number of days to full recovery: age, less than 1%; days with
symptoms, less than 1%; metres run on a treadmill without
pain, 3%. Women needed more days to complete phase 6 than
men: 88.8 days (SD 38.4 days) versus 63.6 days (SD 35.1 days).
With treatment used as fi xed factor in a multivariate ANOVA
on the number of days to full recovery, none of potential con-
founders mentioned above infl uenced the outcome parameter
‘number of days to full recover y’. The use of ESWT was the
only variable that explained the difference between the two
groups.
DISCUSSION
This prospective observational controlled study described the
time to full recovery for two different treatment protocols.
The protocol in which ESWT was added to the running pro-
gramme showed a signifi cantly quicker recovery. This study is
limited as it was observational and no randomisation or blind-
ing was used. There are signifi cant differences in the baseline
characteristics between the groups, although on analysis these
did not sign ifi cantly affect the outcome. These results provide
support for the hypothesis that the treatment of MTSS with a
running programme combined with ESWT may be faster than
treatment with a running programme alone.
The results of this study are in keeping with a recently pub-
lished retrospective trial by Rompe et al ,
18
who studied the
effect of ESWT on MTSS retrospectively. The authors com-
pared this treatment with a control group that performed a
home training programme. They found that the group receiv-
ing ESWT did recover faster, and more patients recovered than
the control group. No studies were found that investigated
ESWT for MTSS prospectively.
Other prospective studies on the treatment of MTSS could
not fi nd a signifi cant difference comparing different treatment
options. Three randomised controlled trials were performed
in which the following interventions were investigated: ice
massage with ice massage and aspirin, ice massage and fenylb-
utazone; ice massage and heel-cord stretching and a walking
cast; active laser and placebo laser and a leg orthosis.
2
19
20
It
Table 2 Running programme
Running phase Surface Minutes Total (min) Speed/intensity
1 Treadmil l 2 2 2 2 2 2 2 2 16 2 = running at 10 km/h, 2 = walki ng at 6 km /h
2 Treadmil l 2 2 2 2 2 2 2 2 16 2 = running at 12 km/ h, 2 = walk ing at 6 k m/h
3Concrete3 2 3 2 3 2 3 2 20 Intensity 1–2 (*)
3 = running, 2 = walking
4Concrete3 2 3 2 3 2 3 2 20 Intensity 2– 3 (*)
3 = running, 2 = walking
5 Concrete Continu ous running 16 Inten sity 1–2 (*)
6Concrete Continuous running 18 Intensity 2–3 (*)
*Inten sity 1, ru nning speed: lig ht jogging; Intensity 2, ru nning speed: jog ging while able t o speak ; Inte nsit y 3, running speed:
jogging while speaking becomes dif fi cult.
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should be noted that the studies mentioned had serious meth-
odological shortcomings such as small numbers or the lack of
blinding.
ESWT was only used for MTSS in one retrospective study
by Rompe et al .
18
The ESWT device used in that study was
radial. One group was treated with ESW T, while the other
group received a home exercise programme (calf stretches,
heel raises and toe raises). As a primary outcome measure they
used a six-point Likert to assess recovery (1, completely recov-
ered; 6, much worse). They found that after 1, 4 and 15 months
the group that was treated with ESW T had signifi cantly better
L ik er t s co re s ( p< 0. 00 1). Ro mp e et al
18
did not str uctural ly report
the time to return to sport. They stated that time to return
to sport ranged from 6 weeks to 6 months. After 15 months,
85.1% of the athletes treated with ESW T had returned to their
preinjury sport, while 46.8% of the athletes in the exercise
group had returned to their preinjury sport.
This study did not measure time to return to sport, so a
comparison with the study by Rompe et al
18
is diffi cult. The
primary outcome measure in the current study was days to
complete a running programme (termed full recovery). This
was used to have an outcome measure that was the same for
all athletes, regardless of the type of sport and level of sport.
The time to full recovery in the running programme with
ESWT group was 59.7 (SD 25.8) days. Rompe et al
18
reported
that only 64% of their athletes with MTSS treated with ESWT
were completely recovered or much improved after 4 months.
The difference in outcome may be explained by the differ-
ing outcome measures. In the present study the patients had
to complete a running programme, whereas in the study by
Rompe et al
18
the patients had to have made a full return to
sport, which, for most athletes, would possibly involve more
tibial loading than the running programme. The difference
between the studies may also possibly be due to t he fact that
the present study used a focused ESW T instead of the radial
ESWT used by Rompe et al .
18
One study was found that com-
pared radial and focused shockwave while treating bone.
21
Differences in microcrack density and microcrack length were
found. What these differences mean for clinical practice is not
clear. The difference in outcome between our study and the
study by Rompe et al
18
could also be explained by the fact that
our study added a running programme to the ESWT. Waldorff
et al
22
showed a signifi cant decrease in microdamage in tibiae
over time following weightbearing or intermittent weight-
bearing compared with limb suspension.
Fina lly, baseline c haracter istics for age a nd duration of sym p-
toms were not the same between this study and the study by
Rompe et al .
18
This could also have infl uenced the outcome.
However, Moen et al
23
showed that days with symptoms (and
metres run on a treadmill without pain) were not prognostic
factors to predict time to full recovery.
Several recent studies investigated the impact and conse-
quences of ESWT on cortical bone.
13
14
24
–
27
Those studies
showed an increase in osteoblast activity and an increase in
bone matrix deposition in vitro.
26
–
28
Promising clinical results
of ESWT on bone healing were found in studies involving
humans.
13
14
24
25
In this study, at baseline, several baseline characteristics
were different between the groups, so these were considered
possible confounding factors (age, days with symptoms and
metres run without pain on a treadmill and sex). Univariate
ANOVA with sex as a random showed only a weak relation-
ship with days to fu ll recovery. This could have possibly infl u-
enced the results in this study, because more men were present
in the running programme with ESWT group. However, after
multivariate ANOVA and χ
2
analysis, no signifi cant relation-
ship was found between these parameters and days to full
recovery.
This study has several limitations. First, although the study
had a prospective design, it was not a randomised study. This
explains the difference in baseline characteristics. With a ran-
domised study the chance of unequal distributions of these
characteristics would be lower. The prospective observational
design of this study was chosen because of the limited avail-
abilit y of focused shockwave devices and the fact that the
pre-existing protocols were well suited to this observational
design to assess the possible effect size for future study plan-
ning. Also, the control group did not have contact with a phys-
ical therapist, whereas the patients in the treatment group
did. This could have infl uenced the time to complete the run-
ning programme. The physical therapists who performed the
ESWT were instructed to advise the patients as little as pos-
sible. However, the treatment in itself could have led to a pla-
cebo effect. In the future blinding would help eliminate this
shortcoming.
Another limitation of the study is its relatively small num-
ber of participants. However, even with the limited numbers
of participating athletes a signifi cant difference between the
two treatment groups was found. This allows for a good esti-
mation of effect size of the treatment, which can now serve
to perform a good power analysis for designing a randomised,
blinded trial.
C O N C L U S I O N
T he t im e t o f ul l r ec ove r y i n a th le tes w it h MTSS w it h a ru nn in g
programme and focused ESWT was signifi cantly (p=0.008)
faster in the running programme and ESWT group (59.7
days (SD 25.8) and 91.6 days (SD 43.0), respectively). These
results from this study provide a base for further research of
the treatment of MTSS with ESWT combined with a running
programme for the treatment for MTSS in a prospective, ran-
domised, blinded study.
Acknowledgements The authors would like to thank Eric Bakker, from the
Depar tment of Clinical Epidemiology, Biostatistics and Bioinformatics, for his
contributions to the ar ticle.
Competing interests N o n e .
Patient consent Obtained.
What is already known on this topic
▶ A retrospective study was conducted before on the treat-
ment of MTSS with shockwave.
▶ This study showed that shockwave was a good possible
treatment option for MTSS.
What this study adds
▶ This study prospectively investigated the effect of shock-
wave on MTSS and showed promising results.
▶ This is the fi rst prospective study on MTSS that was able
to fi nd a signifi cant difference on primary outcome mea-
sures between two treatment groups.
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Ethics approval This stud y was conducted with the approval of the Medical
Ethical Committee South West Holland.
Provenance and peer review Not commissioned; externally peer reviewed.
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doi: 10.1136/bjsm.2010.081992
published online March 9, 2011Br J Sports Med
M H Moen, S Rayer, M Schipper, et al.
controlled study
syndrome in athletes; a prospective
Shockwave treatment for medial tibial stress
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