Shockwave treatment for medial tibial stress syndrome: A randomized double blind sham-controlled pilot trial

Abstract

Objectives:
Up to 35% of runners develop medial tibial stress syndrome (MTSS) which often results in lengthy disruption to training and sometimes affects daily activities. There is currently no high quality evidence to support any particular intervention for MTSS. This study aims to investigate the effect of shockwave therapy for MTSS.

Design:
A randomized, sham-controlled, pilot trial in a university-based health clinic including 28 active adults with MTSS.

Methods:
Intervention included standard dose shockwave therapy for the experimental group versus sham dose for the control group, delivered during Week 1-3, 5 and 9. Main outcome measures were pain measured during bone and muscle pressure as well as during running using a numerical rating scale (0-10) and running was measured as pain-limited distance (m), at Week 1 (baseline) and Week 10 (post-intervention). Self-perception of change was measured using the Global Rating of Change Scale (-7 to +7) at Week 10 (post-intervention).

Results:
Pain (palpation) was reduced in the experimental group by 1.1 out of 10.0 (95% CI -2.3 to 0.0) less than the control group. There were no other statistically significant differences between the groups.

Conclusions:
Standard dose shockwave therapy is not more effective than sham dose at improving pain or running distance in MTSS. However, the sham dose may have had a clinical effect. Further investigation including a no intervention control is warranted to evaluate the effect of shockwave therapy in the management of MTSS.

Full text

Please
cite
this
article
in
press
as:
Newman
P,
et
al.
Shockwave
treatment
for
medial
tibial
stress
syndrome:
A
randomized
double
blind
sham-controlled
pilot
trial.
J
Sci
Med
Sport
(2016),
http://dx.doi.org/10.1016/j.jsams.2016.07.006
ARTICLE IN PRESS
G Model
JSAMS-1357;
No.
of
Pages
5
Journal
of
Science
and
Medicine
in
Sport
xxx
(2016)
xxx–xxx
Contents lists available at ScienceDirect
Journal
of
Science
and
Medicine
in
Sport
journal homepage: www.elsevier.com/locate/jsams
Original
research
Shockwave
treatment
for
medial
tibial
stress
syndrome:
A
randomized
double
blind
sham-controlled
pilot
trial
Phil
Newman∗,
Gordon
Waddington,
Roger
Adams
University
of
Canberra,
Research
Institute
for
Sport
and
Exercise,
Australia
a
r
t
i
c
l
e
i
n
f
o
Article
history:
Received
4
February
2016
Received
in
revised
form
19
June
2016
Accepted
13
July
2016
Available
online
xxx
Keywords:
Medial
tibial
stress
syndrome
Shin
splints
Extracorporeal
shockwave
therapy
a
b
s
t
r
a
c
t
Objectives:
Up
to
35%
of
runners
develop
medial
tibial
stress
syndrome
(MTSS)
which
often
results
in
lengthy
disruption
to
training
and
sometimes
affects
daily
activities.
There
is
currently
no
high
quality
evidence
to
support
any
particular
intervention
for
MTSS.
This
study
aims
to
investigate
the
effect
of
shockwave
therapy
for
MTSS.
Design:
A
randomized,
sham-controlled,
pilot
trial
in
a
university-based
health
clinic
including
28
active
adults
with
MTSS.
Methods:
Intervention
included
standard
dose
shockwave
therapy
for
the
experimental
group
versus
sham
dose
for
the
control
group,
delivered
during
Week
1–3,
5
and
9.
Main
outcome
measures
were
pain
measured
during
bone
and
muscle
pressure
as
well
as
during
running
using
a
numerical
rating
scale
(0–10)
and
running
was
measured
as
pain-limited
distance
(m),
at
Week
1
(baseline)
and
Week
10
(post-
intervention).
Self-perception
of
change
was
measured
using
the
Global
Rating
of
Change
Scale
(−7
to
+7)
at
Week
10
(post-intervention).
Results:
Pain
(palpation)
was
reduced
in
the
experimental
group
by
1.1
out
of
10.0
(95%
CI
−2.3
to
0.0)
less
than
the
control
group.
There
were
no
other
statistically
significant
differences
between
the
groups.
Conclusions:
Standard
dose
shockwave
therapy
is
not
more
effective
than
sham
dose
at
improving
pain
or
running
distance
in
MTSS.
However,
the
sham
dose
may
have
had
a
clinical
effect.
Further
investigation
including
a
no
intervention
control
is
warranted
to
evaluate
the
effect
of
shockwave
therapy
in
the
management
of
MTSS.
©
2016
Sports
Medicine
Australia.
Published
by
Elsevier
Ltd.
All
rights
reserved.
1.
Introduction
Medial
tibial
stress
syndrome
(MTSS)
is
a
common
and
debilitat-
ing
condition
associated
with
running
and
walking
activities.
Yates
and
White1(2004,
pg
777)
describe
MTSS
as
“pain
along
the
pos-
teromedial
border
of
the
tibia
that
occurs
during
exercise,
excluding
pain
from
ischaemic
origin
or
signs
of
stress
fracture”.
Athletes,
soldiers
and
casual
sports
participants
who
run
are
affected,
with
between
4%
and
35%
of
this
population
developing
the
condition
at
any
one
time.1,2 The
syndrome
is
thought
to
include
periostitis,
bone
stress
and/or
musculotendinous
breakdown,
though
there
is
uncertainty
as
to
which
of
these
elements
is
most
consistently
a
source
of
pain.
The
weight
of
evidence
currently
favours
incomplete
bone
remodeling.3–6 Left
untreated,
the
condition
may
progress
to
full
stress
fracture.7Measurable
reductions
in
bone
density
at
∗Corresponding
author.
Fax:
+61
62015727.
E-mail
address:
phillip.newman@canberra.edu.au
(P.
Newman).
the
site
of
injury
can
be
present
for
up
to
8
years
post
onset
of
symptoms.4
Recovery
times
for
symptom
resolution
in
this
condition
range
greatly,
but
tend
to
be
long—4
weeks
to
30
months,
with
many
sufferers
having
recurrence
of
episodes,
adding
to
the
costs
and
inconvenience
of
MTSS.
There
is
little
evidence
to
support
any
par-
ticular
intervention
aimed
at
treating
or
preventing
development
of
MTSS.8–14 Effective
therapy
for
MTSS
is
vital
for
optimizing
a
return
to
full
physical
function.
Extracorporeal
shock
wave
therapy
has
been
used
non-
invasively
in
the
management
of
insertional
tendonopathies
as
a
mechanism
to
reactivate
the
local
tissue
repair
response
following
application
of
short
burst
high
intensity
sound
waves.
It
has
high
level
evidence
as
a
therapy
in
a
number
of
anatomical
sites,
includ-
ing
the
plantar
fascia
and
Achilles
tendon
at
the
heel
and
the
biceps
and
supraspinatus
tendons
in
the
shoulder.
It
uses
intense
pulses
of
sound
delivered
to
targeted
tissues
to
trigger
a
repair
response,
and
has
a
very
low
adverse
side
effect
rate.
Shockwave
therapy
has
been
used
to
stimulate
bone
repair
and
remodelling
with
apparent
affect
in
both
human
and
animal
trials.15,16 It
is
feasible
http://dx.doi.org/10.1016/j.jsams.2016.07.006
1440-2440/©
2016
Sports
Medicine
Australia.
Published
by
Elsevier
Ltd.
All
rights
reserved.

Please
cite
this
article
in
press
as:
Newman
P,
et
al.
Shockwave
treatment
for
medial
tibial
stress
syndrome:
A
randomized
double
blind
sham-controlled
pilot
trial.
J
Sci
Med
Sport
(2016),
http://dx.doi.org/10.1016/j.jsams.2016.07.006
ARTICLE IN PRESS
G Model
JSAMS-1357;
No.
of
Pages
5
2
P.
Newman
et
al.
/
Journal
of
Science
and
Medicine
in
Sport
xxx
(2016)
xxx–xxx
Fig.
1.
Design
and
flow
of
participants
through
the
trial.
that
shockwave
therapy
will
stimulate
bone
remodelling
in
MTSS
sufferers.
To
date,
two
studies
have
reported
the
use
of
shockwave
therapy
in
the
treatment
of
MTSS.17,18 Moen
et
al.17 undertook
a
prospec-
tive
observational
controlled
study
to
compare
shockwave
therapy
plus
graded
running
against
graded
running
only
on
MTSS
symp-
toms,
and
measured
time
to
return
to
18
min
of
running.
Moen
et
al.
reported
a
significantly
faster
return
to
full
activity
in
the
com-
bined
shockwave
therapy
plus
running
group,
and
recommended
randomization
and
blinding
for
further
investigation
of
shockwave
therapy
as
an
intervention
for
MTSS.
The
second
study
by
Rompe
et
al.18 recruited
47
MTSS
sufferers
who
agreed
to
pay
for
a
series
of
shockwave
treatments.
These
participants
were
age
and
gen-
der
matched
retrospectively
to
a
control
group
who
chose
not
to
pay
for
shockwave
therapy
but
to
instead
receive
a
home
exercise
program.
Outcome
measures
included
a
numeric
rating
scale
and
rating
of
change.
The
authors
reported
a
significant
improvement
in
the
treatment
group
at
1
month
4
months
and
15
months
after
commencement
of
the
trial.
The
results
are
limited
by
lack
of
ran-
domization,
no
placebo
or
sham
therapy.
The
present
study
aims
to
investigate
the
effectiveness
of
shockwave
therapy
in
the
treat-
ment
of
MTSS
in
a
double-blind
randomized
sham
controlled
trial
in
order
to
improve
on
the
previous
studies.
2.
Methods
A
double-blind
randomized
sham
controlled
trial
investigating
the
effectiveness
of
shockwave
therapy
was
conducted
at
a
uni-
versity
clinic
in
Canberra,
Australia.
Participants
responded
to
local
advertising
and
were
recruited
from
the
general
community.
Par-
ticipants
were
recruited
over
a
period
spanning
May
2014–July
2015.
An
investigator
(RA),
independent
of
the
recruitment
of
par-
ticipants,
generated
the
allocation
sequence
in
blocks
of
four
using
a
computer-generated
random
number
programme.
Allocation
was
concealed
from
the
recruiter
and
participants.
Participants
identi-
fied
with
MTSS
were
randomly
allocated
into
one
of
two
groups;
the
experimental
group
received
standard
dose
shockwave
ther-
apy
and
the
control
group
received
a
sham
dose
shockwave
therapy
administered
by
GW.
Measures
were
taken
at
baseline
(Week
1),
and
at
one
week
after
intervention
(Week
10)
by
an
assessor
blinded
to
group
allocation
and
to
baseline
results
(PN).
Partici-
pants
received
treatment
at
weeks
1–3,
5
and
9.
Each
participant
was
asked
to
keep
their
activity
levels
as
unchanged
as
possible
during
the
course
of
the
trial.
The
design
of
the
trial
is
presented
in
Fig.
1.
A
researcher
analysed
results
whilst
remaining
blinded
to
group
allocations.
Ethical
approval
for
the
project
was
gained
from
the
University
of
Canberra
Human
Research
Ethics
Committee
Project
number
14-04.
Volunteers
were
included
if
they
had
pain
for
a
minimum
of
21
days
confined
to
the
distal
half
of
the
posteromedial
tibia
spread
over
an
area
of
more
than
5
cm
that
was
associated
with
running
based
activity,
pain
lasted
for
hours
or
days
after
exercise,
and
there
was
no
indication
of
paraesthesia.
This
was
in
accordance
with
the
description
of
MTSS
by
Yates
and
White1and
the
diagnostic
algorithm
by
Edwards
et
al.19 Diagnosis
was
determined
by
clini-
cal
examination
and
consultation
of
each
volunteer
with
a
sports
physiotherapist
with
more
than
20
years
clinical
experience.
Vol-
unteers
were
excluded
if
shockwave
therapy
had
been
used
for
treatment
of
their
symptoms
previously,
or,
if
they
had
another
concurrent
diagnosis
of
lower
limb
injury
such
as
compartment
syndrome,
stress
fracture
or
joint
sprain.
Imaging
was
not
per-
formed
in
addition
to
clinical
diagnosis,
as
findings
from
previous
studies
have
reported
relatively
high
rates
of
abnormal
findings
in
asymptomatic
individuals.20–22 Baseline
measures
of
height,
weight,
gender,
body
mass
index,
running
volume
and
modes
of
activity
currently
and
12
months
prior,
current
maximum
activity

Please
cite
this
article
in
press
as:
Newman
P,
et
al.
Shockwave
treatment
for
medial
tibial
stress
syndrome:
A
randomized
double
blind
sham-controlled
pilot
trial.
J
Sci
Med
Sport
(2016),
http://dx.doi.org/10.1016/j.jsams.2016.07.006
ARTICLE IN PRESS
G Model
JSAMS-1357;
No.
of
Pages
5
P.
Newman
et
al.
/
Journal
of
Science
and
Medicine
in
Sport
xxx
(2016)
xxx–xxx
3
Table
1
Baseline
characteristics
of
participants.
Characteristic
Randomised
(n
=
24)
Lost
to
follow-up
(n
=
4)
Exp
(n
=
12)
Con
(n
=
12)
Exp
(n
=
2)
Con
(n
=
2)
Age
(yr),
mean
(SD)
34
(11)
36
(9)
30
(8)
27
(4)
Gender,
n
females
(%)
7
(58)
7
(58)
2
(100)
2(100)
Height
(m),
mean
(SD) 1.71
(0.07) 1.78
(0.11) 1.65
(0.04) 1.70
(0.01)
Weight
(kg),
mean
(SD) 74.7
(10.4)
77.7
(9.7)
75.1(2.7)
70.2(3.6)
Distance
run
per
week
(km),
mean
(SD)
Currently
4
(6)
8
(16)
3
(4)
1
(1)
12
months
ago
8
(10)
5
(9)
2
(2)
1
(0)
Regular
running
experience
(yr),
mean
(SD)
9
(7)
9
(7)
6
(6)
6
(6)
Duration
of
shin
pain
(mths),
mean
(SD) 18
(11) 23
(9) 19
(16) 19
(16)
Exp
=
experimental
group,
Con
=
control
group
tolerance,
site
of
pain,
intensity
of
pain,
duration
of
symptoms
post
exercise,
and
chronicity
of
symptoms
were
recorded
to
describe
the
sample.
The
experimental
group
received
standard
dose
shockwave
therapy
progressively
increased
across
the
series,
as
per
Moen
et
al.17 The
dose
progressed
from
0.1
to
0.3
mJ/mm2(1000
pulses
at
0.1
mJ/mm2week
1,
1500
pulses
at
0.15
mJ/mm2week
2,
1500
pulses
at
0.20
mJ/mm2week
3,
1500
pulses
at
0.25
mJ/mm2week
5
and
1500
pulses
at
0.30
mJ/mm2in
week
9.
The
total
cumulative
dose
delivered
across
the
five
sessions
was
1450
mJ/mm2).
The
control
group
received
a
sham
dose
of
shock
wave
therapy,
i.e.,
the
lowest
dose
deliverable
at
0.01
mJ/mm2(1
×
1000
pulses
in
week
one
and
4
×
1500
pulses
thereafter,
with
a
total
cumulative
dose
delivered
of
70
mJ/mm2).
Outcomes
were
measured
at
the
impairment
level
(pain),
the
activity
limitations
level
(running)
and
the
participation
level
(self-
perception
of
change).
Pain
was
measured
during
bone
and
muscle
pressure,
as
well
as
during
running,
using
a
numerical
rating
scale
(NRS)
and
reported
as
a
score
between
0
and
10
where
0
represents
no
pain
and
10
represents
the
worst
pain
imaginable.
An
algome-
ter
[Baseline®model
12-0304]
was
used
to
exert
5
kg
of
pressure
over
the
most
tender
point
of
posteromedial
musculature
and
the
most
tender
point
of
posteromedial
tibial
surface
and
a
numeric
rating
scale
(NRS)
for
pain
was
recorded
for
each
point
and
on
each
leg.
When
symptoms
were
unilateral,
the
corresponding
anatom-
ical
area
was
chosen
for
testing
on
the
non
symptomatic
leg.
The
most
tender
5
cm
area
was
highlighted
with
a
pen
marker
on
each
effected
leg
to
indicate
the
site
for
targeting
the
intervention.
Running
was
measured
as
distance
run
when
pain
reached
a
specific
level
(4
out
of
10)
and
was
recorded
as
distance
in
metres.
Participants
ran
on
a
treadmill
at
7.5
km/h
for
2
min
and
then
at
10
km/h.
Participants
were
instructed
to
stop
running
when
pain
reached
a
level
of
4
out
of
10
on
a
NRS
or
at
a
maximum
of
18
total
minutes
of
running,
whichever
occurred
first.
At
Week
10,
self
perception
of
change
was
measured
using
the
global
rating
of
change
(GROC)
questionnaire
and
reported
as
a
score
between
−7
and
+7
where
−7
=
“A
very
great
deal
worse”,
−6
=
“A
great
deal
worse”,
−5
=
“Quite
a
bit
worse”,
−4
=
“Moderately
worse”,
−3
=
“Somewhat
worse”,
−2
=
“A
little
bit
worse”,
−1
=
“A
tiny
bit
worse”,
0
=
“About
the
same”,
+1
=
“A
tiny
bit
better”,
+2
=
“A
little
bit
better”,
+3
=
“Somewhat
better”,
+4
=
“Moderately
better”,
+5
=
“Quite
a
bit
better”,
+6
=
“A
great
deal
better”
and
+7
=
“A
very
great
deal
better”.
Using
an
intention
to
treat
approach
all
participant
data
was
included
in
the
analysis,
with
zero
change
being
recorded
for
those
who
did
not
complete
the
trial.
Descriptive
statistics
were
calcu-
lated
for
all
variables
over
the
two
time
periods
(Weeks
1and
10).
The
change
in
NRS
on
algometer
palpation
of
bone
and
muscle,
NRS
of
pain
associated
with
running,
treadmill
running
distance
to
pain,
and
global
rating
of
change
scores
were
analysed
using
repeated
measures
analysis
of
variance
(ANOVA)
to
determine
whether
there
were
significant
differences
in
the
change
within
and
between
the
groups
from
Week
1
to
10.
Results
were
reported
as
means
and
standard
deviation
or
means
and
95%
confidence
interval
(CI).
Anal-
yses
were
performed
using
SPSS,
version
21.0.0
for
Windows,
and
statistical
significance
was
set
at
0.05.
3.
Results
The
trial
included
28
participants
in
total,
18
females
and
10
males,
mean
age
34
years
(Table
1).
Duration
of
symptoms
ranged
from
2
to
30
months
(mean
20
months).
Current
average
running
frequency
and
distance
per
week
was
similar
to
12
months
prior
for
each
participant
(Table
1).
Running
experience
ranged
from
1
to
20
years
(mean
9
years).
Analysis
of
variance
in
baseline
characteristics
between
groups
revealed
no
significant
statistical
differences.
Four
participants
did
not
complete
the
trial;
2
moved
away
for
work
related
reasons,
2
could
not
attend
follow
up
appoint-
ments.
There
were
no
reports
of
adverse
effects
of
the
shockwave
therapy
across
all
participants.
One
participant
was
unable
to
com-
plete
the
Week
10
treadmill
run
due
to
a
recent
exacerbation
of
asthma.
By
Week
10,
the
control
group
had
1.1
out
of
10.0
points
(95%
CI
0.0–2.3)
less
pain
during
bone
pressure
than
the
experimental
group.
There
was
no
significant
difference
between
groups
in
pain
during
muscle
pressure
(MD
0.2
out
of
10.0,
95%
CI
−1.5
to
1.9)
or
during
running
(MD
−0.1
out
of
10.0,
95%
CI
−2.9
to
2.7)
(Table
2).
By
Week
10,
there
was
no
significant
difference
between
groups
in
the
pain-limited
distance
run
(MD
−583
m,
95%
CI
−1260
to
94).
By
Week
10,
there
was
no
significant
difference
between
groups
in
the
self-perception
of
change
(MD
−0.7
out
of
14,
95%
CI
−2.6
to
1.3).
4.
Discussion
This
pilot
study
of
comparison
between
standard
dose
shock-
wave
therapy
and
sham
shockwave
therapy
in
people
with
MTSS
show
no
differences
in
outcome.
This
is
in
contrast
to
previous
studies17,18 which
found
an
earlier
return
to
a
predetermined
running
distance17 and
improvements
in
patient
reported
measures
of
change18 in
MTSS
sufferers
treated
with
shockwave
therapy.
However,
the
observed
association
in
the
present
study
between
sham
therapy
and
improvement
in
bone
pain
on
palpation
merits
attention
in
the
context
of
the
observed
improvements
within
the
groups.
Post-hoc
analysis
revealed
a
significant
improvement
in
algometer
measurements
of
bone
pain
for
all
participants
between
week
1
and
week
10
(Mean
change
−1.1,
95%
CI
−1.6
to
−0.5,
p
<
0.01).
Intra-rater
reliability
of
pressure
algometry
used
on
the
tibia
has
been
reported
previously
to
be
moderate
to
excellent
(ICC

Please
cite
this
article
in
press
as:
Newman
P,
et
al.
Shockwave
treatment
for
medial
tibial
stress
syndrome:
A
randomized
double
blind
sham-controlled
pilot
trial.
J
Sci
Med
Sport
(2016),
http://dx.doi.org/10.1016/j.jsams.2016.07.006
ARTICLE IN PRESS
G Model
JSAMS-1357;
No.
of
Pages
5
4
P.
Newman
et
al.
/
Journal
of
Science
and
Medicine
in
Sport
xxx
(2016)
xxx–xxx
Table
2
Mean
(SD)
of
groups,
mean
(SD),
and
mean
(95%
CI)
difference
within
groups
and
difference
between
groups.
Outcome
GROUPS
Difference
within
groups
Difference
between
groups
Week
1
Week
10
Week
10
minus
Week
1
Week
10
minus
Week
1
Exp
(n
=
14)
Con
(n
=
14)
Exp
(n
=
12)
Con
(n
=
12)
Exp
Con
Exp
minus
Con
Pain
NRS
(0–10)
During
bone
pressure
5.9
(2.4)
5.5
(2.0)
5.3
(2.4)
3.6
(1.7)
−0.5
(−1.2
to
0.3)
−1.6
(−2.6
to
−0.6)
1.1
(0.0
to
2.3)
During
muscle
pressure 3.6
(2.5) 3.9
(1.8) 3.3
(1.6) 3.2
(1.8) −0.2
(−1.4
to
1.1) −0.3
(−1.7
to
1.0)
0.2
(−1.5
to
1.9)
During
running 6.9
(1.3)
6.6
(2.0)
3.2
(2.5)
2.9
(3.0)
−3.9
(−5.7
to
−2.1)
−3.8
(−6.2
to
−1.4)
−0.1
(2.9
to
−2.7)
Running
Pain-limited
distance
(m)
471
(281)
864
(772)
659
(520)
1754
(1103)
213
(−8
to
435)
797
(113
to
1480)
−583
(−1260
to
94)
Self-perception
of
change
GROC
(−7
to
+7)
2.6
(2.3)
3.3
(2.3)
−0.7
(−2.6
to
1.3)
Exp
=
experimental
group,
Con
=
control
group,
GROC
=
Global
Rating
of
Change
score.
0.53–0.90).23 There
was
no
significant
reduction
in
algometer
mea-
sures
of
muscle
pain
between
week
1
and
week
10
(mean
change
−0.3,
95%
CI
−1.1
to
0.6,
between
groups
mean
difference
−0.2,
95%
CI
−2.7
to
2.9).
Mean
NRS
for
bone
pain
in
the
sham
group
reduced
from
5.5
(sd
2.0)
to
3.6
(sd
1.7)
and
in
the
experimental
group
bone
pain
reduced
from
5.9
(sd
2.4)
to
5.3
(sd
2.5).
Whilst
both
groups
improved,
the
improvement
was
significantly
greater
in
participants
receiving
sham
shockwave
therapy
(mean
differ-
ence
between
groups
1.1,
95%
CI
0.0
to
−2.3,
p
=
0.05).
There
may
be
several
explanations
for
this
effect.
The
duration
of
symptoms
in
MTSS
tend
to
be
longer
than
10
weeks.
The
participants
in
this
trial
reported
their
symptoms
to
have
been
stable
for
a
median
period
of
30
months.
This
was
simi-
lar
to
the
duration
of
symptoms
reported
by
Magnusson
et
al.,429
months
(range
5
to
120)
indicating
this
is
a
highly
recalcitrant
con-
dition.
It
is
less
likely
for
MTSS
to
improve
in
only
10
weeks
without
participants
reducing
their
running
volume.
The
participants
in
this
trial
had
not
reduced
their
activity
levels.
Further,
on
analy-
sis
of
the
data,
there
was
no
correlation
between
reported
MTSS
symptom
duration
and
change
in
bone
pain
on
palpation,
indicat-
ing
that
improvements
observed
were
not
predictably
occurring
in
the
less
chronic
cases
as
one
might
expect
if
time
alone
brought
about
recovery.
Whilst
bone
pain
on
palpation,
pain
limited
run-
ning
distance,
pain
associated
with
running
and
self-perception
of
change
improved
significantly
between
week
1
and
week
10,
it
is
possible
that
the
effect
observed
is
simply
natural
improvement
of
the
condition
with
time.
If
this
was
the
case
then
it
would
fol-
low
that
standard
dose
shockwave
therapy
retards
or
lessens
the
natural
improvements
in
bone
pain
on
palpation.
If
the
improvements
observed
are
simply
a
placebo
response
we
would
expect
a
global
effect,
with
proportional
responses
in
palpation
testing
of
both
muscle
and
bone,
yet
algometer
readings
of
the
posteromedial
muscle
pain
did
not
improve
significantly.
The
posteromedial
musculature
palpated
and
the
posteromedial
tibial
bone
palpation
site
are
in
very
close
proximity
to
each
other.
The
treatment
probe
was
focussed
specifically
towards
bone
so
despite
being
very
close
to
the
muscle
palpation
site,
it
did
not
target
muscle
tissue.
Algometer
palpation
for
bone
pain
improved
significantly,
by
approximately
20%.
Muscle
injuries
generally
tend
to
heal
more
rapidly
than
injuries
in
bone,
so
these
results
do
not
follow
natural
healing
parameters
for
these
tissue
types.
The
shockwave
beam
for
both
groups
was
focussed
on
the
bone
rather
than
muscle,
so
if
there
is
an
effect
of
shockwave
therapy
then
it
is
consistent
with
the
site
of
application.
The
muscle
site
has,
in
effect,
served
as
a
control
site.
Shockwave
therapy
is
known
to
have
a
stimulatory
effect
on
bone.16,24,25 However
it
has
also
been
shown
to
be
destructive
to
bone
at
higher
intensities.26 It
is
possible
therefore
that
shockwave
therapy
has
a
stimulatory
effect
on
bone
that
is
dose
dependant,
and,
that
is
more
effective
at
very
low
dose.
Studies
of
bone
repair
and
remodelling
report
methods
for
iso-
lating
individual
cells
and
subjecting
them
to
mechanical
strain
by
passing
fluid
across
the
cell
at
known
rates
of
flow.
Osteocytes
are
known
to
respond
to
both
fluid
flow
and
vibration
by
releasing
the
many
factors
that
result
in
bone
repair
and
remodelling.27 These
studies
provide
a
good
model
for
how
shockwave
therapy
may
stimulate
bone
remodelling.
The
question
is,
how
much
mechan-
ical
energy
is
adequate
to
expect
a
response
from
the
osteocyte?
One
recent
study
has
shown
that
pulsatile
fluid
flow
of
13
kPa
can
stimulate
a
signalling
response
in
a
mouse
osteocyte.28 The
low
dose
therapy
applied
as
sham
in
this
trial
was
applied
in
a
focussed
beam
rather
than
a
pressure
wave,
but
in
energy
delivered
terms
it
equates
to
approximately
18
kPa
at
each
session.
The
mechani-
cal
stimulation
of
shockwave
therapy
in
tissues
at
the
cellular
level
is
conceivably
providing
an
equivalent
stimulus
to
the
osteocyte
as
seen
in
fluid
flow
studies.
Further
research
is
required
to
determine
the
threshold
for
response
in
osteocytes
exposed
to
various
doses
of
shockwave
therapy.
Minimally
important
differences
in
clinical
measures
vary
by
context,
population
and
the
nature
of
disease
.29 Many
studies
cor-
relate
NRS
vs
GROC
to
assist
in
determining
minimally
important
difference
values
for
a
given
disease
or
condition.30 Salaffi
suggests
determinations
of
clinical
significance
of
NRS
scores
made
in
this
way
are
least
problematic
when
the
mean
baseline
scores
are
closer
to
7
out
of
10,
as
opposed
to
a
population
or
disease
state
where
the
initial
NRS
score
is
<4.30 Salaffi
suggests
a
change
in
NRS
of
1
point
or
15%
change
is
a
minimally
important
difference
for
common
chronic
musculoskeletal
conditions,
and
improvement
in
NRS
of
2
points
or
33%
are
best
associated
with
the
concept
of
“much
better”.
A
recent
study
by
Winters31 identified
significant
responsiveness
of
an
NRS
for
“pain
while
performing
sporting
activities”
and
a
7
point
participant
perceived
improvement
scale
to
be
in
the
ratio
1
NRS:
−0.45
GROC.
Using
this
approach
it
could
be
surmised
that
a
reduc-
tion
in
pain
when
running
from
a
mean
of
6.8
at
week
1,
to
a
mean
of
2.7
at
week
10
(mean
change
−3.9,
95%
CI
−5.3
to
−2.5,
p
<
0.01)
would
result
in
a
perception
of
change
of
+1.9
=
“a
little
bit
better”.
The
participants
in
this
study
rated
their
improvement
on
average
at
+3
=
“Somewhat
better”.
Pain
limited
running
distance
improved
by
a
mean
of
505
m
from
week
1
to
week
10,
95%
CI
151.6
to
858.4,
p
<
0.01.
There
was
a
significant
positive
correlation
between
global
rating
of
change
scores
and
baseline
difference
in
patient
reported
pain
with
running
across
both
groups
(Pearson’s
r
=
0.44,
p
=
0.03).
Whilst
the
distance
improvement
is
not
large
on
the
scale
of
a
typ-
ical
distance
runner,
it
is
a
large
proportional
change
in
an
MTSS
population.
A
notable
limitation
of
this
pilot
trial
is
the
small
sample
size
of
28
participants.
The
difference
between
groups
in
bone
pain
on
palpation
approaches
significance,
with
a
moderate
effect
size
of
0.52.
A
larger
trial
is
indicated
to
evaluate
the
effect
of
shockwave
therapy
in
MTSS.
5.
Conclusion
This
study
has
established
that
there
is
no
benefit
of
standard
dose
versus
sham
dose
shockwave
therapy
in
the
treatment
of

Please
cite
this
article
in
press
as:
Newman
P,
et
al.
Shockwave
treatment
for
medial
tibial
stress
syndrome:
A
randomized
double
blind
sham-controlled
pilot
trial.
J
Sci
Med
Sport
(2016),
http://dx.doi.org/10.1016/j.jsams.2016.07.006
ARTICLE IN PRESS
G Model
JSAMS-1357;
No.
of
Pages
5
P.
Newman
et
al.
/
Journal
of
Science
and
Medicine
in
Sport
xxx
(2016)
xxx–xxx
5
MTSS,
however
the
low
dose
shockwave
therapy
utilized
as
the
sham
intervention
may
improve
bone
pain
on
palpation.
Further
research
that
includes
a
no
treatment
control
and
higher
numbers
of
participants
is
required
to
more
fully
understand
the
effec-
tiveness
of
no
treatment,
low
dose
and
standard
dose
shockwave
therapy
in
MTSS.
Practical
implications
•Standard
dose
shockwave
therapy
does
not
have
a
superior
effect
over
sham
shockwave
therapy
in
the
treatment
of
medial
tibial
stress
syndrome.
•There
may
be
an
effect
of
low
dose
shockwave
therapy
that
is
helpful
for
reducing
bone
pain
in
medial
tibial
stress
syndrome.
•Further
research
that
includes
a
no
treatment
control
and
higher
numbers
of
participants
is
required
to
determine
clinical
efficacy.
Funding
There
has
been
no
financial
assistance
associated
with
this
project.
Acknowledgements
Our
thanks
go
to
the
Faculty
of
Health
Clinics
and
to
our
volunteers.
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