ArticlePDF Available

The medial tibial stress syndrome score: A new patient-reported outcome measure

Authors:
  • Onder de Knie
  • Royal Netherlands Army

Abstract and Figures

Background At present, there is no validated patient-reported outcome measure (PROM) for patients with medial tibial stress syndrome (MTSS). Aim Our aim was to select and validate previously generated items and create a valid, reliable and responsive PROM for patients with MTSS: the MTSS score. Methods A prospective cohort study was performed in multiple sports medicine, physiotherapy and military facilities in the Netherlands. Participants with MTSS filled out the previously generated items for the MTSS score on 3 occasions. From previously generated items, we selected the best items. We assessed the MTSS score for its validity, reliability and responsiveness. Results The MTSS score was filled out by 133 participants with MTSS. Factor analysis showed the MTSS score to exhibit a single-factor structure with acceptable internal consistency (α=0.58) and good test–retest reliability (intraclass correlation coefficient=0.81). The MTSS score ranges from 0 to 10 points. The smallest detectable change in our sample was 0.69 at the group level and 4.80 at the individual level. Construct validity analysis showed significant moderate-to-large correlations (r=0.34–0.52, p<0.01). Responsiveness of the MTSS score was confirmed by a significant relation with the global perceived effect scale (β=−0.288, R2=0.21, p<0.001). Conclusions The MTSS score is a valid, reliable and responsive PROM to measure the severity of MTSS. It is designed to evaluate treatment outcomes in clinical studies.
Content may be subject to copyright.
The medial tibial stress syndrome score: a new
patient-reported outcome measure
Marinus Winters,
1
Maarten H Moen,
2,3
Wessel O Zimmermann,
4,5
Robert Lindeboom,
6
Adam Weir,
7
Frank JG Backx,
1
Eric WP Bakker
6
Additional material is
published online only. To view
please visit the journal online
(http://dx.doi.org/10.1136/
bjsports-2015-095060).
1
Department of Rehabilitation,
Nursing Science & Sports,
University Medical Centre
Utrecht, Utrecht,
The Netherlands
2
Bergman Clinics, Naarden,
The Netherlands
3
The Sports Physician Group,
St Lucas Andreas Hospital,
Amsterdam, The Netherlands
4
Department of Training
Medicine and Training
Physiology, Royal Netherlands
Army, Utrecht, The Netherlands
5
Uniformed Services University
of the Health Sciences,
Bethesda, Maryland, USA
6
Division of Clinical Methods
and Public Health, Academic
Medical Centre, University of
Amsterdam, Amsterdam,
The Netherlands
7
Aspetar Orthopedic and
Sports Medicine Hospital,
Doha, Qatar
Correspondence to
Marinus Winters, Department
of Rehabilitation, Nursing
Science & Sports, University
Medical Centre Utrecht, P.O.
Box 85500, Utrecht 3508 GA,
The Netherlands;
marinuswinters@hotmail.com
Accepted 1 October 2015
To cite: Winters M,
Moen MH,
Zimmermann WO, et al.Br J
Sports Med Published Online
First: [please include Day
Month Year] doi:10.1136/
bjsports-2015-095060
ABSTRACT
Background At present, there is no validated patient-
reported outcome measure (PROM) for patients with
medial tibial stress syndrome (MTSS).
Aim Our aim was to select and validate previously
generated items and create a valid, reliable and
responsive PROM for patients with MTSS: the MTSS
score.
Methods A prospective cohort study was performed in
multiple sports medicine, physiotherapy and military
facilities in the Netherlands. Participants with MTSS lled
out the previously generated items for the MTSS score
on 3 occasions. From previously generated items, we
selected the best items. We assessed the MTSS score for
its validity, reliability and responsiveness.
Results The MTSS score was lled out by 133
participants with MTSS. Factor analysis showed the
MTSS score to exhibit a single-factor structure with
acceptable internal consistency (α=0.58) and good test
retest reliability (intraclass correlation coefcient=0.81).
The MTSS score ranges from 0 to 10 points. The
smallest detectable change in our sample was 0.69 at
the group level and 4.80 at the individual level.
Construct validity analysis showed signicant moderate-
to-large correlations (r=0.340.52, p<0.01).
Responsiveness of the MTSS score was conrmed by a
signicant relation with the global perceived effect scale
(β=0.288, R
2
=0.21, p<0.001).
Conclusions The MTSS score is a valid, reliable and
responsive PROM to measure the severity of MTSS. It is
designed to evaluate treatment outcomes in clinical
studies.
INTRODUCTION
The medial tibial stress syndrome (MTSS) is one of
the most common exercise-induced leg injuries
among running and jumping athletes and military
personnel.
1
It is dened as exercise-induced pain
along the posteromedial border of the tibia, and
when pain is additionally provoked by palpation
over ve or more consecutive centimetres.
2
A recent systematic review showed that there is
no conclusive evidence for any effective interven-
tion in the management of MTSS.
3
The absence of
a specic outcome measure for patients with MTSS
disables a valid measurement of injury severity and
intervention effects. Studies investigating the effects
of interventions in participants with MTSS have
used a wide range of outcome measures to quantify
their results, for example, time to recovery, visual
analogue scales, Likert scale and numeric rating
scale.
46
Differing denitions for the same outcome
measure such as time to recoveryare often
used.
67
A standardised assessment instrument that enables
a valid and reliable assessment of treatment effects
in patients with MTSS is needed.
3
The patients per-
spective has become increasingly important in the
context of determining treatment effects.
8
Patient-reported outcome measures (PROMs) are
recommended to evaluate effectiveness in clinical
settings and randomised controlled trials.
9
Recently,
items for a new PROM for patients with MTSS
were generated using a Delphi procedure.
10
The
objective of this study was to test the methodo-
logical properties of these items, select the best ones
to form the MTSS score, and assess the MTSS
scores validity, reliability and responsiveness.
METHODS
Design and objective
A prospective cohort design was used to select the
best items for the MTSS score and to assess its val-
idity, reliability and responsiveness. We followed
the consensus-based standards for selection of
health measurement instruments (COSMIN) guide-
lines while validating the MTSS score.
11
Participants
Between 1 January 2013 and 1 January 2015, 13
healthcare centres (including 5 sports medicine
facilities, 1 military medical centre, 5 sports physio-
therapy practices and 2 military physiotherapy
centres) in The Netherlands assessed possible eli-
gible participants for study participation. Sports
physicians and sports physiotherapists working in
the participating facilities assessed potential candi-
dates by applying our inclusion and exclusion cri-
teria. Participants (16 year) with MTSS for at
least 3 weeks were considered eligible for inclusion.
MTSS was dened as activity-related pain along the
posteromedial tibial border and tenderness on the
same site over a length of at least ve or more con-
secutive centimetres.
2
Participants were excluded
when a history of tibial fracture, clinical suspicion
of chronic compartment syndrome or stress frac-
ture was present, or when coexisting injuries were
present.
12
Participants with concurrent lower
extremity symptoms and participants with spoken
or written Dutch language comprehension dif-
culty were excluded. Participants who met the
inclusion criteria were informed about the study
purpose and participated after signing informed
consent. The medical ethics committees of
Zuid-West Holland (12092) and Utrecht (12542/
C), The Netherlands, provided approval before the
studys initiation.
Winters M, et al.Br J Sports Med 2015;0:18. doi:10.1136/bjsports-2015-095060 1
Original article
BJSM Online First, published on October 28, 2015 as 10.1136/bjsports-2015-095060
Copyright Article author (or their employer) 2015. Produced by BMJ Publishing Group Ltd under licence.
group.bmj.com on October 28, 2015 - Published by http://bjsm.bmj.com/Downloaded from
Procedure
Participants were asked to ll out questionnaires on three occa-
sions. At baseline (T1), participants were asked to ll out a form
relating demographic information, preliminary items of the
MTSS score, the RAND 36-item Health Survey and to answer
questions relating to their sports activities. After 1 week (T2),
the primary investigator (MW) contacted participants by tele-
phone and requested them to ll out the preliminary items of
the MTSS score again in an online environment. The nal meas-
urement was administered at 3 months (T3). Participants were
approached by telephone to ll out the MTSS scores prelimin-
ary items, a global perceived effect (GPE) scale and to answer
questions relating to their weekly sports activities in an online
environment. During the study, participants continued standard
medical care at their facility. Figure 1 shows the study ow and
the administered measures for each occasion.
Measures
Items for the MTSS score
Experts developed items for the MTSS score by means of a
Delphi study. These items were then appraised by a total of 20
patients with MTSS who did not participate in the validation
study. We reported on the item generation process elsewhere.
10
All items were generated in Dutch. In total, 15 items were gen-
erated, assessing limitations in sporting activities, pain while per-
forming sporting activities, pain while performing activities of
daily living (ADL) and pain at rest. Items have four response
options with descriptors for each response category. Higher
item scores indicate a more severe pain or limitation and hence
more severe MTSS symptoms. Participants were asked to ll out
the MTSS score with their most painful shin in mind, in case of
bilateral symptoms.
Items of the RAND 36-item Health Survey
We used items of the Dutch version of the RAND 36-item
Health Survey for assessment of construct validity.
13
The
RAND-36 is widely used to measure a variety of domains,
including pain and limitations while performing ADL, and also
in musculoskeletal and sports medicine-related research.
1416
Of
specic interest to this study were items 3G, 3H and 7. Item 3G
measures the limitation while walking >1 km. Item 3H mea-
sures the limitation while walking 0.5 km. Low non-
standardised scores indicate that the activity is more limited for
both items. Item 7 of the RAND-36 evaluates the degree of pain
in the past week, with higher non-standardised scores indicating
less pain.
Transition scale
At T2, the transition scale assesses the perceived change since
T1. Participants could indicate if their condition had improved,
worsened or remained unchanged.
11
Those participants whose
condition had remained unchanged were considered stable
participants.
GPE scale
The GPE scale assesses the participants perceived condition at
follow-up (T3) compared with T1; completely recovered,
much improved,slightly improved,not changed,slightly
worsened,much worsenedor worse than ever.
17
Change in intensity and volume of sporting activities
At baseline, participants indicated the number of hours they
were able to perform sporting activities, and how much they
had reduced their training volume since the onset of their
MTSS symptoms. We labelled the difference as volume change
in sporting activities in hours. In addition, we asked to what
degree the intensity of their exercise had changed since the
onset of their symptoms (severely diminished,diminished,
my exercise intensity has remained unchanged,my exercise
intensity increased,I am unable to perform any type of exer-
cise due to my shin pain). We labelled this as intensity change
in sporting activities.
Data analysis and statistics
All data were analysed with SPSS (V.20.0, IBM SPSS Inc,
Chicago, USA) by one author (MW). Missing data were handled
by imputing item medians of the sample investigated for all ana-
lyses. Demographic data were presented with appropriate mea-
sures of central tendency and dispersion.
Preliminary data analysis and item reduction
We planned to reduce the item set to have one item for all rele-
vant domains (limitations in sporting activities, pain while per-
forming sporting activities, pain while performing ADL and
pain at rest). We used the reliability and responsiveness analysis
to identify the best items for the nal version of the MTSS
score.
We selected the best item for each domain:
For limitation in sporting activities: item current sporting
activities,current amount of sporting activitiesor current
content of sporting activities;
Figure 1 Flow diagram (GPE, global perceived effect; MTSS, medial
tibial stress syndrome).
2 Winters M, et al.Br J Sports Med 2015;0:18. doi:10.1136/bjsports-2015-095060
Original article
group.bmj.com on October 28, 2015 - Published by http://bjsm.bmj.com/Downloaded from
For pain while performing sporting activities: item pain
while performing sporting activities,time to onset of pain
during sporting activities, pain throughout sporting activities
1,pain throughout sporting activities 2or pain after sport-
ing activities;
For pain while performing ADL: item pain while standing,
pain while walking,pain while walking up or downstairs
or pain while performing common daily activities;
For pain at rest: item pain at rest,pain at nightor pain to
touch.
We used the following analyses to select the best items:
Te s t retest reliability as calculated with intraclass correlation
coefcients (ICCs);
Association between item change scores and the GPE scale.
Testretest reliability
We used the data of stable participants, collected at T1 and T2,
for evaluation of the MTSS scores items and subscale reliability.
Te s t retest reliability was assessed with a two-way random
effects, consistency, single measures ICC for all items. ICCs
were presented with their 95% CIs.
18
ICC values of <0.50
were regarded as insufcient, ICCs between 0.50 and 0.75 were
considered acceptable, and ICCs>0.75 were labelled as good.
19
Item responsiveness
We used the data collected at T1 (MTSS score) and T3 (MTSS
score and GPE scale) for this analysis. We assessed the relation
between each item change score (independent variable) and the
GPE scale (dependent variable) in a linear regression analysis.
We calculated change scores for each item subtracting T3 from
T1 for each item of the MTSS score. The β-coefcient and the
R
2
expressed the direction and magnitude of the relation
between each item and the GPE scale. These measures were
used to select the best items for the MTSS score. We considered
a p value <0.1 as a signicant relation. We hypothesised a
greater change to be negatively correlated with GPE (the lower
the GPE score, the greater the improvement).
All items were discussed for relevancy and importance by
four authors (MW, AW, MHM and EWPB) until consensus was
reached on which items should be selected for the nal MTSS
score. However, when consensus could not be met, we voted
for selection of an item. Items were selected when a majority of
the authors (3/4) favoured selection. When no majority was
reached, a fth author (FJGB) made the decision.
Further methodological testing of the nal MTSS score and
statistics
We further assessed the remaining item set for its:
Structural validity and internal consistency;
Construct validity;
Responsiveness of the total score;
Te s t retest reliability of the total score.
In addition, we calculated:
Measurement error and smallest detectable change (SDC);
Minimal important change.
We present a summary of item variation at T1 and T3 to
further address the interpretability of the MTSS score.
Structural validity and internal consistency
To investigate the structural validity of the MTSS score, we ran
a factor analysis on the MTSS score data collected at T1. We
estimated the amount of common variance by estimating com-
munality values for all variables using the maximum-likelihood
method (MLM) with direct oblique rotation. MLM enables
generalisation of the results beyond the studys population.
Direct oblique rotation assumes that underlying (latent) factors
of the MTSS score are related.
20
Kaisers criterion (eigenvalues
1) and a scree plot ( point of inexion) assisted in identifying
relevant factors.
21 22
Items with factor loadings of >0.4 were
thought to be important for the factor being studied.
23
We
checked the item-rest correlations for the items that were main-
tained in the MTSS score at T1. Item-rest correlations >0.3
were considered to measure the same construct. We addressed
the internal consistency of the item set by calculating
Cronbachsα(CA). We considered CA around 0.6 as acceptable,
and above 0.75 as good.
24 25
Construct validity
We assessed the relationships between items of the MTSS score
with three items of the RAND-36, and volume and intensity
change in sporting activities, collected at T1. After the item selec-
tion process, we formulated a hypothesis for each item of the
MTSS score. Spearmans Rank tests were used to assess correla-
tions between items. We regarded correlation coefcients around
0.1 as small, around 0.3 as moderate and those around or above
0.5 as large.
26
We recoded item scores of items 3G and 3H
(recoded: higher scores indicate more limitation) for this analysis.
Responsiveness of the MTSS score
To determine item responsiveness, we calculated the change in
MTSS scores between T1 and T3 (ie, T1T3). We performed a
linear regression analysis with these change scores as the inde-
pendent variable and the GPE as the dependent variable. The
β-coefcient and the R
2
expressed the direction and magnitude
of the relationship between the MTSS score and the GPE scale.
We considered a p value <0.05 as a signicant relationship. We
hypothesised a greater change to be negatively correlated with
GPE (the lower the GPE score, the greater the improvement).
Testretest reliability, measurement error and SDC of the MTSS
score.
We used the data of stableparticipants, collected at T1 and
T2, for evaluation of the MTSS scores reliability. Testretest
reliability of the total MTSS score was assessed in the same way
as individual items. We expressed measurement error by the
standard error of measurement (SEM). The SEM was calculated
as SEM ¼SDmeasurement 1þ2ffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi
1ICC
p.
18
The SDC was calculated
at both the individual SEM 1:96 ffiffiffi
2
p

and group level
SEM 1:96 ffiffiffi
2
p=ffiffiffi
n
p

.
18 27
Minimal important change
We used the data of those participants who indicated that their
condition had slightly improvedor slightly worsenedon the
GPE scale at T3. The same change scores were used here as in
the responsiveness analysis. We considered the mean change
score of those participants who indicated slightly improvedor
slightly worsenedto be the minimal important change.
Interpretability
To enhance the interpretability of the MTSS score, we present
the means, SDs and distributions of the MTSS score at T1 and
T3. Floor or ceiling effects were considered to be present when
15% or more of the participants scored the lowest or highest
possible MTSS score.
11 28
Cross-cultural translation
We translated all items of the preliminary MTSS score into
English. This translation process contained a forward and
Winters M, et al.Br J Sports Med 2015;0:18. doi:10.1136/bjsports-2015-095060 3
Original article
group.bmj.com on October 28, 2015 - Published by http://bjsm.bmj.com/Downloaded from
backward translation. As for item generation, we report on the
cross-cultural translation process elsewhere.
10
We present here
the nal (Dutch) MTSS score and its English cross-cultural
translation.
Sample size
We calculated the required sample size for testretest reliability
analysis and exploratory factor analysis, before the studys start.
For testretest reliability, a sample size of 51 stable participants
was required, as well as constructing a two-sided 95% CI and
assuming an ICC of 0.80 with a lower limit of 0.70.
29
For
exploratory factor analysis, a minimum of 100 participants is
advised; however, others suggest including 10 participants for
each item tested in the analysis.
30
RESULTS
Prospective cohort study
A total of 133 participants met the inclusion criteria and agreed
to participate in this prospective cohort study. The study com-
prised 73 men and 60 women, the mean age was 24.2
(SD=7.9), and the mean body mass index was 23.0 (SD=3.0).
Forty-six participants (35%) were military personnel and 87
(65%) were athletes. Eighty-two per cent of the participants had
bilateral MTSS, and18% had unilateral MTSS. Table 1 provides
further demographic information on our participants.
All 133 participants completed the MTSS score, the
RAND-36 and questions concerning their exercise volume and
intensity at T1. Seventy participants completed the MTSS score
at T2 (the median number of days post T1 was 9 (range 520)),
of whom 48 were stable. At T3, the MTSS score was com-
pleted by 66 individuals, whereas the GPE was completed by 63
participants (median number of days post T1 was 70 (range 44
120)).
Missing items
For items of the MTSS score, few data were missing: at T1 2%,
at T2 1.25%, while at T3 no data were missing. At T1, 7.25%
of the data of the three items of the RAND-36 were missing. A
minority of the participants did not provide information on
sports volume (5.6%) and sports intensity change (6.8%) at T1.
No data were missing for the transition scale at T2 or the GPE
scale at T3.
Preliminary data analysis and item selection
Testretest reliability on item level
Forty-eight participants indicated that their symptoms had
remained unchangedat T2. We used their data, collected at T1
and T2, to estimate the two-way random effects, consistency,
single measures ICCs for all items of the MTSS score. Table 2
provides ICC values for all preliminary items of the MTSS
score. All ICCs were acceptable or good, except for items pain
to touch,pain while performing common daily activities,
pain throughout sporting activities 1and pain throughout
sporting activities 2. These items exhibited low testretest reli-
ability (ICC<0.50).
Item responsiveness on item level
Change scores between T1 and T3 were calculated for all items
of the MTSS score. The change score item pain at night
showed an inverse relation with the GPE scale at T3 and was
therefore considered invalid. All other change score items
showed a relation with the GPE scale at T3; however, this rela-
tionship was only signicant for items pain while standing,
pain while walking,current sporting activities,current
content of sporting activities,pain while performing sporting
activities,time to onset of pain during sporting activitiesand
pain after sporting activities.
Item selection
Limitation in sporting activities
The item current sporting activitieswas selected for limitation
in sporting activities. The item current content of sporting
activitiesshowed comparable testretest reliability (ICC=0.80
vs 0.84) and association with the GPE scale (β=0.43 vs
0.38); however, we considered the rst to reect this domain
best.
Pain while performing sporting activities
The item pain while performing sporting activitiesshowed the
best relation with the GPE scale and exhibited the best test
retest reliability (see table 2) and was therefore selected.
Pain while performing ADL
The item pain while walkingwas selected for pain while per-
forming ADL. Although the items pain while standingand
pain while walking up or downstairswere equally reliable and
related to the GPE scale (see table 2), we considered walking
more relevant and feasible than standing and walking up or
downstairs. More specically, standing and walking up or down-
stairs are activities that not all possible participants with MTSS
would engage in on a daily basis. Pain while performing
common daily activitiesexhibited a low testretest reliability
(ICC=0.48), but one author considered this item the most rele-
vant to measure this domain. Therefore, the steering committee
further discussed item selection for this domain (see Steering
committee section).
Table 1 Demographic information
Demographic variable
Participants
(N=133)
Male/female, n 73 (55%)/60 (45%)
Age in years, mean±SD 24.2±7.9
Length in cm, mean±SD 177±10
Weight in kg, mean±SD 74±13
BMI in kg/m
2
, mean±SD 23±3
Sports athletes/military personnel, n (%) 87 (65%)/46 (35%)
Sports category, n (%)
Running 35 (26%)
Fitness 21 (16%)
Hockey 14 (11%)
Soccer 14 (11%)
Athletics (non-distance running) 7 (5%)
Volleyball 6 (4%)
Cycling 5 (4%)
Other 31 (23%)
Hours of exercise a week at T1, median with range
(minimummaximum)
4.0 (030)
Duration of symptoms in months, median with range
(minimummaximum)
18 (0.75144)
Side of symptoms, n (%)
Both legs 109 (82%)
Only left leg 11 (8%)
Only right leg 13 (10%)
BMI, body mass index; T1, baseline.
4 Winters M, et al.Br J Sports Med 2015;0:18. doi:10.1136/bjsports-2015-095060
Original article
group.bmj.com on October 28, 2015 - Published by http://bjsm.bmj.com/Downloaded from
Pain at rest
The item pain at restwas considered the best item for pain at
rest´. Pain at nightexhibited an inverse relation with the GPE
scale (β=0.22) and was therefore considered invalid. The item
pain to touchexhibited a low testretest reliability
(ICC=0.50).
Steering committee
Selection was made on the basis of consensus for all items,
except for pain while performing activities of daily life.On
this domain, no consensus was reached; we voted for the item
pain while performing common daily activitiesor pain while
walking. A majority (3/4 authors) voted for pain while
walking.
Methodological testing of the nal MTSS score
Structural validity and internal consistency analysis
Data collected at T1 from all 133 participants were used to
assess the structural validity of the item set. One factor yielded
an eigenvalue of 1, explaining 44.4% of the variance in the
item set. The scree plot conrmed the unidimensionality of the
item set. All items loaded on this factor satisfactorily (>0.4). We
checked the item-rest correlation for each subscale. Item-rest
correlations were adequate, r0.3. CA showed acceptable
internal consistency, α=0.58. Table 3 depicts all results of the
factor and the internal consistency analyses.
Construct validity
We checked whether the remaining items of the MTSS score at
T1 were associated with items of the RAND-36 and sports
volume and intensity change.
We hypothesised that:
1. Item current sporting activitieswould show a
moderate-to-large positive correlation (r=0.30.5) with
volume change in sporting activities.
A positive correlation of r=0.34 (95% CI 0.17 to 0.50,
p<0.01) was found.
2. Item pain while performing sporting activitieswould
exhibit a moderate to large positive correlation with inten-
sity change in sporting activities (r=0.30.5).
We found a positive correlation of r=0.34 (95% CI 0.17 to
0.50, p<0.01).
Table 2 Item selection for the MTSS score
Theoretical domain Item
Testretest reliability Responsiveness analysis*
ICC (95% CI) β-coefficient R
2
p Value
Limitation in sporting activities
Current sporting activities 0.80 (0.67 to 0.88) 0.43 0.065 0.04
Current amount of sporting activities 0.76 (0.61 to 0.86) 0.03 0.001 0.78
Current content of sporting activities 0.84 (0.73 to 0.91) 0.38 0.114 <0.01
Pain while performing sporting activities
Pain while performing sporting activities 0.63 (0.43 to 0.78) 0.45 0.129 <0.01
Time to onset of pain during sporting activities 0.72 (0.56 to 0.84) 0.44 0.201 <0.01
Pain throughout sporting activities 1 0.44 (0.19 to 0.65) 0.11 0.018 0.31
Pain throughout sporting activities 2 0.34 (0.07 to 0.57) 0.15 0.031 0.18
Pain after sporting activities 0.74 (0.58 to 0.85) 0.20 0.048 0.09
Pain while performing activities of daily life
Pain while standing 0.72 (0.55 to 0.84) 0.55 0.098 0.01
Pain while walking 0.82 (0.70 to 0.90) 0.50 0.089 0.02
Pain while walking up or downstairs 0.86 (0.76 to 0.92) 0.18 0.008 0.48
Pain while performing common daily activities 0.48 (0.23 to 0.67) 0.52 0.107 <0.01
Pain at rest
Pain at rest 0.60 (0.39 to 0.76) 0.21 0.019 0.28
Pain at night 0.91 (0.85 to 0.95) 0.22 0.023 0.22
Pain to touch 0.50 (0.26 to 0.69) 0.19 0.059 0.06
Items in italics were selected for use in the MTSS score.
*As assessed with linear regression analysis. βindicates how the GPE scale changes for each extra unit of the item; R
2
represents the magnitude of the relation between the GPE scale
and each item.
ADL, activities of daily living; GPE, global perceived effect; ICC, intraclass correlation coefficient; MTSS, medial tibial stress syndrome.
Table 3 Factor analysis and internal consistency analysis
Items
Factor analysis Internal consistency analysis
Factor loadings Item-rest correlations Cronbachsα
MTSS score 0.58
Item 1 Current sporting activities 0.40 0.3
Item 2 Pain while performing sporting activities 0.52 0.4
Item 3 Pain while walking 0.64 0.4
Item 4 Pain at rest 0.48 0.3
Factor analysis and internal consistency analysis of definitive items in the MTSS score.
MTSS, medial tibial stress syndrome.
Winters M, et al.Br J Sports Med 2015;0:18. doi:10.1136/bjsports-2015-095060 5
Original article
group.bmj.com on October 28, 2015 - Published by http://bjsm.bmj.com/Downloaded from
3. Item pain while walkingwould show a moderate-to-large
positive correlation (r=0.30.5) with items 3G and 3H
(degree of limitation while walking >1 km and walking
around 0.5 km, respectively).
A large positive correlation was found with items 3G
(r=0.58, 95% CI 0.43 to 0.70, p<0.01) and 3H (r=0.48,
95% CI 0.32 to 0.63, p<0.01).
4. Item pain at restwould show a moderate-to-large correl-
ation (r=0.30.5) with item 7 (degree of pain in the past
week) of the RAND.
Item 1 showed a large positive correlation (r=0.53, 95% CI
0.39 to 0.64, p<0.01).
Responsiveness of the MTSS score
A signicant negative relation conrmed the responsiveness of
the total MTSS score: β=0.288, R
2
=0.21, t=3.962,
p<0.001.
Testretest reliability of the total MTSS score
The total MTSS score showed good testretest reliability:
ICC=0.82 (95% CI 0.70 to 0.89, F=9.95, p<0.001).
Measurement error, SDC and minimal important change
We assessed the measurement error by calculation of the SEM
and the SDC at the group and individual patient level. The
SEM was 1.73. The SDC on the individual level was 4.80. The
SDC and the minimal important change at the group level were
both 0.69. This means that the MTSS score can measure the
minimal important change.
Interpretability
The MTSS score is provided in Dutch and English (cross-
culturally translated version) and available online as supplemen-
tary material. In addition, tables 46provide information on
scoring distributions, means and medians of the MTSS score at
T1 and T3. We conclude that oor or ceiling effects are not
present for the MTSS score at T1 and T3.
The lowest possible MTSS score is 0, indicating that no
MTSS symptoms are present, whereas 10 is the maximum
score. This indicates the highest severity of MTSS symptoms. In
our study, the mean MTSS scores were 4.58 (±1.88) and 3.72
(±2.08) at T1 and T3, respectively.
DISCUSSION
This is the rst study to assess a PROM for patients with MTSS
for reliability, validity and responsiveness. We selected the best
items from an item pool generated by a group of experts to be
used in the nal MTSS score. This new MTSS score is a simple
four-item scale that addresses pain at rest, pain while perform-
ing ADL, limitations in sporting activities and pain while per-
forming sporting activities. The MTSS score specically
measures pain experienced along the shin and limitations due to
shin pain. Its items exhibit four response options with descrip-
tors for the degree of shin pain and limitations. The variation in
items, from low-demand activities (resting/walking) to high-
demand activities (sports activities), also contributes to the spe-
cicity of this new instrument.
Rigorous clinimetric evaluation
A previously performed Delphi study supports the content val-
idity of the MTSS score, as shown by consensus among a group
of experts in the eld of MTSS. In addition, those items were
appraised by a patient panel and were found to be valid, read-
able and comprehensive.
10
Structural analysis conrmed the uni-
dimensionality of the MTSS score. In addition, the MTSS score
showed good construct validity when compared with items of
the RAND-36 and the participantsvolume and intensity change
in sporting activities. The MTSS scores overall scale reliability
and responsiveness conrmed the suitability for its use in scien-
tic research. Taken together, this study shows that the MTSS
score is a valid, reliable and responsive PROM for the evalu-
ation of the injury severity in patients with MTSS.
In addition to reliability, validity and responsiveness, low
measurement error is important for the MTSS scores utility. We
found quite a large SDC (4.8, almost 50% of the possible score
Table 4 Interpretability; item variation of the MTSS score at T1 (N=133)
Item
number Item name
Answer option 1,
n (%)
Answer option 2,
n (%)
Answer option 3,
n (%)
Answer option 4,
n (%) Mean Median
Missing values
n (%)
1 Current sporting activities 16 (12.0) 48 (36.1) 57 (42.9) 8 (6.0) 1.44 2 4 (3.0%)
2 Pain while performing
sporting activities
4 (3.0) 65 (48.9) 52 (39.1) 8 (6.0) 1.50 1 4 (3.0%)
3 Pain while walking 41 (30.8) 71 (53.4) 20 (15.0) 1 (0.8) 0.86 1 0 (0.0%)
4 Pain at rest 48 (36.1) 69 (51.9) 14 (10.5) 2 (1.5) 0.77 1 0 (0.0%)
MTSS, medial tibial stress syndrome.
Table 5 Interpretability; item variation of the MTSS score at T3 (N=66)
Item number Item name
Answer option 1,
n (%)
Answer option 2,
n (%)
Answer option 3,
n (%)
Answer option 4,
n (%) Mean Median
Missing values
n (%)
1 Current sporting activities 13 (19.7) 25 (37.9) 24 (36.4) 4 (6.0) 1.29 1 0 (0.0%)
2 Pain during sporting activities 9 (13.6) 37 (56.1) 15 (22.7) 5 (7.6) 1.24 1 0 (0.0%)
3 Pain while walking 31 (47.0) 30 (45.4) 5 (7.6) 0 (0.0) 0.61 1 0 (0.0%)
4 Pain at rest 31 (47.0) 31 (47) 4 (6.0) 0 (0.0) 0.59 1 0 (0.0%)
MTSS, medial tibial stress syndrome.
6 Winters M, et al.Br J Sports Med 2015;0:18. doi:10.1136/bjsports-2015-095060
Original article
group.bmj.com on October 28, 2015 - Published by http://bjsm.bmj.com/Downloaded from
range) at the individual level. However, analysis at the group
level showed that the SDC was equal to the minimal important
change (both 0.69 points). This suggests that the MTSS score is
an appropriate measure to compare tendencies across different
groups, such as in RCTs into the effectiveness of different inter-
ventions in the treatment of MTSS.
Another outcome measure for exercise-induced lower leg pain
has been validated recently. This outcome measure aims to
measure functional impairment and limitation in sports ability
in runners.
31
In our opinion, the MTSS score is more valid and
feasible for patients with MTSS. Most of the activities that can
be scored in the outcome measure developed by Nauck et al
31
may not be relevant to all patients (such as taking off and
landing while jumping). In addition, our study suggests that
pain at rest and ADL are important limitations to patients with
MTSS and should therefore be part of an outcome assessment
tool.
Clinical utility of the new MTSS score
Many of the patients in our study had a long duration of symp-
toms prior to enrolling in our study. This suggests that current
interventions and routine care for MTSS are not very effective.
The MTSS scores at T1 and T3, and GPE scale at T3, showed
that little improvement was made after participants sought
medical care in centres with a large clinical experience. This
highlights the necessity for new approaches to treating MTSS.
The MTSS score can be used in several ways to enhance better
treatment outcomes. First, the MTSS score allows for determin-
ation of treatment effects as reported by the patient in contrast
to determination of treatment effects by the assessor or by
physical parameters. Second, the MTSS score is able to reliably
and validly track changes in groups. This is predominantly
important in randomised clinical trials. Finally, a possible
future application could be if the MTSS score was able to
predict a window for time to recovery (prognosis). We note
that in a 2015 systematic review of risk factors for MTSS,
there was no mention of certainty of the clinical diagnosis or
any variation in severity of the condition.
32
If adopted, our
instrument will allow the broad condition of MTSSto be sub-
categorised according to level of severity of the condition. This
instrument may be limited for monitoring individual patients
with MTSS.
Strengths and limitations
A strength of the present study is the inclusion of a broad
variety of participants with MTSS, athletes and military person-
nel with short-standing and long-standing symptoms. This
strengthens the studys external validity. The MTSS score is a
practical outcome measure; the patient can ll out the MTSS
score without any help from a physician or physiotherapist, and
it takes little time for the patient to do so.
Our study also has limitations. First, we followed the classical
test theory for all analyses, whereas the item response theory
would have been more appropriate. Item response theory ana-
lyses, however, require large sample sizes, up to 200500 parti-
cipants, depending on the type of analysis.
28
This was not
possible within our network of healthcare providers and budget.
Another limitation is the sample size in relation to the
number of statistical tests performed. We acknowledge that 18
tests is a large amount. Statistically, this may have introduced
one signicant result due to chance. Our methods were,
however, in accordance with the COSMIN guidelines, a
methods criterion in this eld of research.
11
The MTSS score exhibits one factor (it is unidimensional)
which explained 44% of the variance in the item set.
Some would regard this as moderate or low. However, to the
best of our knowledge, no hard cut-off values for when this
value is sufcient exist in the eld of clinimetrics.
The MTSS score yielded a value similar to those of other
PROMs successfully validated in the eld of musculoskeletal
pain.
3335
We used the CA statistic to assess for internal consistency. The
MTSS scores CA was 0.58 and we considered this as acceptable.
Other classication systems may rate this as moderate or poor.
28
Cortina
36
showed that a high number of items may inate CA
and a low number of items may deate CA. Given the relatively
low number of items in the MTSS score (N=4), we are con-
dent that the internal consistency is acceptable, also given the
sufcient item-rest correlations (all 0.3).
With regard to testretest reliability, there are some methodo-
logical issues to address: rst, 70 of the 133 participants lled
out the MTSS score at T1 and T2. Although we attempted to
contact all participants for the second measurement, we have
not succeeded in reaching them all. It is unclear how this may
have affected the testretest reliability results exactly. However,
we were still able to nd sufcient testretest reliability levels
for all items of the MTSS score as well as for the overall MTSS
score. Second, we used ICCs for categorical data instead of
weighted κ. Among the many advantages of ICC over weighted
κ, the most important ones are that ICC is able to deal with
(the presence or absence of ) various sources of error and with
missing values.
37
Therefore, it is most likely that the MTSS
scores testretest reliability is estimated more precisely with
ICCs, and consequently, conclusions can be drawn more
robustly. The direction and magnitude of the β-coefcient and
R
2
of the linear regression analysis were used to select the most
responsive items. In view of the moderate sample size used in
this analysis (N=66), we set the threshold for signicance to
<0.1 to avoid missing true signicant relations between the
GPE and MTSS change score.
38
Finally, the cross-cultural
English translation should be validated in English-speaking
MTSS populations.
We conclude that the MTSS score is a valid, reliable and
responsive PROM to evaluate injury severity in patients
with MTSS. We recommend its use in studies of MTSS
treatment.
Table 6 Interpretability; MTSS score at T1 (n=133), T3 (n=66) and MTSS change score (T1T3, n=66)
Mean SD 95% CI Median Range Absolute minimum Absolute maximum
Floor effects,
n (%)
Ceiling effects,
n (%)
MTSS score at T1 4.58 1.88 4.26 to 4.90 5 1 to 10 0 10 2 (1.5) 1 (0.8)
MTSS score at T3 3.72 2.08 3.22 to 4.24 4 0 to 9 0 10 3 (2.3) 0 (0.0)
MTSS change score at T1T3 1.00 1.56 0.62 to 1.38 1 2to5 10 10 0 (0.0) 0 (0.0)
MTSS, medial tibial stress syndrome.
Winters M, et al.Br J Sports Med 2015;0:18. doi:10.1136/bjsports-2015-095060 7
Original article
group.bmj.com on October 28, 2015 - Published by http://bjsm.bmj.com/Downloaded from
What are the ndings?
The medial tibial stress syndrome (MTSS) score is a new
patient-reported outcome measure that measures injury
severity in a practical way.
The MTSS score has been shown to be valid, reliable and
responsive.
The MTSS score can detect relevant group tendencies.
Acknowledgements The authors would like to thank all sports medicine
physicians and sports physiotherapists who assisted with including patients for this
study: Carl Barten, Sandra Chung, Jan-Willem Dijkstra, Frank Franke, Simon
Goedegebuurne, Pieter Graber, Floor Groot, Nick van der Horst, Nienke Hulsman,
Hilde Joosten, Wout van der Meulen, Robert Oosterom, Victor Steeneken, Karin
Thys, Peter van Veldhoven, Joost Vollaard, Niels Wijne and Rahmon Zondervan.
Contributors EWPB and MHM conceived the idea for the study. MW drafted the
manuscript. MW, MHM, RL, AW and EWPB were responsible for the study concept
and design. MW, MHM, WOZ, FJGB and EWPB collected the data. MW, RL and
EWPB were responsible for analysis and interpretation of the data. All the authors
critically revised the manuscript.
Competing interests None declared.
Ethics approval The medical ethics committees of Zuid-West Holland (12-092)
and Utrecht (12-542/C), The Netherlands, provided approval before the studys
initiation.
Provenance and peer review Not commissioned; externally peer reviewed.
REFERENCES
1 Taunton JE, Ryan MB, Clement DB, et al. A retrospective case-control analysis of
2002 running injuries. Br J Sports Med 2002;36:95101.
2 Yates B, White S. The incidence and risk factors in the development of medial tibial
stress syndrome among naval recruits. Am J Sports Med 2004;32:77280.
3 Winters M, Eskes M, Weir A, et al. Treatment of medial tibial stress syndrome:
a systematic review. Sports Med 2013;43:131533.
4 Johnston E, Flynn T, Bean M, et al. A randomized controlled trial of a leg orthosis
versus traditional treatment for soldiers with shin splints: a pilot study. Mil Med
2006;171:404.
5 Rompe JD, Cacchio A, Furia JP, et al. Low-energy extracorporeal shock wave
therapy as a treatment for medial tibial stress syndrome. Am J Sports Med
2010;38:12532.
6 Moen MH, Rayer S, Schipper M, et al. Shockwave treatment for medial tibial stress
syndrome in athletes; a prospective controlled study. Br J Sports Med
2012;46:2537.
7 Nissen LR, Astvad K, Madsen L. Low-energy laser treatment of medial tibial stress
syndrome. Ugeskr Laeger 1994;156:732931.
8 World Health Organization. Regional Ofce for Europe. Patient outcome measures
in mental health: report on a WHO consensus meeting, Stockholm, 2324
November 1995. Copenhagen WHO Regional Ofce for Europe, 1996.
9 Davidson M, Keating J. Patient-reported outcome measures (PROMs): how should I
interpret reports of measurement properties? A practical guide for clinicians and
researchers who are not biostatisticians. Br J Sports Med 2014;48:7926.
10 Winters M, Franklyn M, Moen MH, et al. The MTSS-score: item generation for a
new patient reported outcome measure. [In press]
11 Mokkink LB, Terwee CB, Knol DL, et al. The COSMIN checklist for evaluating the
methodological quality of studies on measurement properties: a clarication of its
content. BMC Med Res Methodol 2010;10:22.
12 Edwards PH Jr, Wright ML, Hartman JF. A practical approach for the
differential diagnosis of chronic leg pain in the athlete. Am J Sports Med
2005;33:12419.
13 van der Zee K, Sanderman R. Het meten van de algemene gezondheidstoestand
met de RAND-36. Een handleiding. Groningen: NCG, 1993.
14 Thorborg K, Hölmich P, Christensen R, et al. The Copenhagen Hip and Groin
Outcome Score (HAGOS): development and validation according to the COSMIN
checklist. Br J Sports Med 2011;45:47891.
15 Christensen CP, Althausen PL, Mittleman MA, et al. The Nonarthritic Hip Score:
reliable and validated. Clin Orthop Relat Res 2003;406:7583.
16 Martin RL, Kelly BT, Philippon MJ. Evidence of validity for the Hip Outcome Score.
Arthroscopy 2006;22:130411.
17 Kamper SJ, Ostelo RW, Knol DL, et al. Global Perceived Effect scales provided
reliable assessments of health transition in people with musculoskeletal disorders,
but ratings are strongly inuenced by current status. J Clin Epidemiol
2010;63:7606.
18 Weir JP. Quantifying test-retest reliability using the intraclass correlation coefcient
and the SEM. J Strength Cond Res 2005;19:23140.
19 Portney LG, Watkins MP. Foundations of clinical research: applications to practice.
3rd edn. Upper Saddle River, NJ: Pearson/Prentice Hall, 2009.
20 Costello AB, Osborne J. Best practices in exploratory factor analysis: four
recommendations for getting the most from your analysis. Pract Assess Res Eval
2005;10:19.
21 Kaiser HF. The application of electric computers to factor analysis. Educ Psychol
Meas 1960;20:14151.
22 Cattell RB. The scientic analysis of personality. Chicago: Aldine, 1966.
23 Stevens JP. Applied multivariate statistics for the social sciences. 4th edn. Hillsdale,
New York: Erlbaum, 2002.
24 Davis FB. Educational measurements and their interpretation. Belmont, California,
USA: Wadsworth, 1964.
25 Nunnally JC. Psychometric theory. 1st edn. New York: McGraw-Hill, 1967.
26 Cohen J. Statistical power analysis for the behavioural sciences. 2nd edn. New York:
Academic Press, 1988.
27 de Vet HC, Terwee CB, Knol DL, et al. When to use agreement versus reliability
measures. J Clin Epidemiol 2006;59:10339.
28 Streiner DL, Norman GR. Health measurement scales. A practical guide to their
development and use. 4th edn. New York: Oxford University Press, 2008.
29 Bonett DG. Sample size requirement for estimating intraclass correlations with
desired precision. Stat Med 2002;21:13315.
30 Field A. Discovering Statistics. Using SPSS. 3rd edn. London: Sage Publications Inc,
2009.
31 Nauck T, Lohrer H, Padhiar N, et al. Development and validation of a questionnaire
to measure the severity of functional limitations and reduction of sports ability in
German-speaking patients with exercise-induced leg pain. Br J Sports Med
2015;49:11317.
32 Hamstra-Wright KL, Bliven KC, Bay C. Risk factors for medial tibial stress
syndrome in physically active individuals such as runners and military
personnel: a systematic review and meta-analysis. Br J Sports Med
2015;49:3629.
33 Waddell G, Newton M, Henderson I, et al. A Fear-Avoidance Beliefs Questionnaire
(FABQ) and the role of fear-avoidance beliefs in chronic low back pain and
disability. Pain 1993;52:15768.
34 Wheeler AH, Goolkasian P, Baird AC, et al. Development of the Neck Pain and
Disability Scale. Item analysis, face, and criterion-related validity. Spine (Phila Pa
1976) 1999;24:12904.
35 Roos EM, Roos HP, Ekdahl C, et al. Knee injury and Osteoarthritis Outcome
Score (KOOS)validation of a Swedish version. Scand J Med Sci Sports
1998;8:43948.
36 Cortina JM. What is coefcient alpha? An examination of theory and applications.
J Appl Psychol 1993;78:98104.
37 Berk RA. Generalizability of behavioral observations: a clarication of interobserver
agreement and interobserver reliability. Am J Ment Dec1979;83:46072.
38 Altman DG. Practical statistics for medical research. 1st edn. London: Chapman &
Hall, 1999.
8 Winters M, et al.Br J Sports Med 2015;0:18. doi:10.1136/bjsports-2015-095060
Original article
group.bmj.com on October 28, 2015 - Published by http://bjsm.bmj.com/Downloaded from
new patient-reported outcome measure
The medial tibial stress syndrome score: a
Lindeboom, Adam Weir, Frank JG Backx and Eric WP Bakker
Marinus Winters, Maarten H Moen, Wessel O Zimmermann, Robert
published online October 28, 2015Br J Sports Med
http://bjsm.bmj.com/content/early/2015/10/28/bjsports-2015-095060
Updated information and services can be found at:
These include:
Material
Supplementary
DC1.html
http://bjsm.bmj.com/content/suppl/2015/10/28/bjsports-2015-095060.
Supplementary material can be found at:
References
#BIBL
http://bjsm.bmj.com/content/early/2015/10/28/bjsports-2015-095060
This article cites 26 articles, 9 of which you can access for free at:
service
Email alerting box at the top right corner of the online article.
Receive free email alerts when new articles cite this article. Sign up in the
Collections
Topic Articles on similar topics can be found in the following collections
(205)Physiotherapy (152)Physiotherapy (49)Statistics and research methods
Notes
http://group.bmj.com/group/rights-licensing/permissions
To request permissions go to:
http://journals.bmj.com/cgi/reprintform
To order reprints go to:
http://group.bmj.com/subscribe/
To subscribe to BMJ go to:
group.bmj.com on October 28, 2015 - Published by http://bjsm.bmj.com/Downloaded from
... MTSS was defined as exercise-induced pain at the medial side of de tibia [46]. The registration form indicating no complaints and 10 indicating maximal complaints) was calculated [74]. ...
... Most studies in MTSS used clinical diagnosis of the MTSS, this methodological difference helps to explain the lower incidence of MTSS in the literature compared to our study. We attempted to minimise self-evaluation errors by using a validated questionnaire [74] and a clear definition [46]. Nevertheless, the self-evaluation procedure of MTSS complaints may be the primary explanation for the higher MTSS incidence in our study. ...
... Therefore, a follow-up study investigated the incidence of MTSS more indepth (chapter 3). Students were monitored during the academic year (i.e., 40-weeks) using the Dutch version of the MTSS-score questionnaire [74]. In total, 25% of the students developed MTSS during follow-up, where women (39%) were more likely to develop MTSS then men (21%). ...
... Although Likert scales are sensitive indicators of clinical trial endpoints [37], the lack of specificity could at least partly explain the limited treatment effect for these outcomes. Since this study was conducted there are 3 validated patient outcome scores are now available [42][43][44], one is specific for MTSS [42]. ...
... Although Likert scales are sensitive indicators of clinical trial endpoints [37], the lack of specificity could at least partly explain the limited treatment effect for these outcomes. Since this study was conducted there are 3 validated patient outcome scores are now available [42][43][44], one is specific for MTSS [42]. ...
Article
Full-text available
Background: Medial tibial stress syndrome (MTSS) is one of the most common lower leg injuries in sporting populations. It accounts for between 6 and 16% of all running injuries, and up to 53% of lower leg injuries in military recruits. Various treatment modalities are available with varying degrees of success. In recalcitrant cases, surgery is often the only option. Objective: To evaluate whether ultrasound-guided injection of 15% dextrose for treatment of recalcitrant MTSS decreases pain and facilitates a return to desired activity levels for those who may otherwise be considering surgery or giving up the sport. Method: The study design was a prospective consecutive case series involving eighteen patients: fifteen male and three female; (mean age = 31.2 years) with recalcitrant MTSS. They were referred from sports injury clinics across the UK, having failed all available conservative treatment. Intervention: An ultrasound-guided sub-periosteal injection of 15% dextrose was administered by the same clinician (NP) along the length of the symptomatic area. Typically, 1 mL of solution was injected per cm of the symptomatic area. Main outcome measures: Pain was assessed using a 10-cm visual analog scale (VAS) at baseline, short-term, medium-term (mean 18 weeks), and long-term (mean 52 weeks) follow-up. Symptom resolution and return to activity were measured using a Likert scale at medium and long-term follow-up. Statistical analyses were performed using SPSS for Mac version 19.0.0 (IBM, New York, NY, US). The Shapiro-Wilk test was used to evaluate the normality of the distribution of data. Friedman's non-parametric test was used to compare the within-patient treatment response over time. Post-hoc Wilcoxon signed-rank tests with Bonferroni corrections were performed to determine VAS average pain response to treatment over five paired periods. Results: Patients reported a significant (p < 0.01) reduction in median VAS pain score at medium and long-term follow-up compared to baseline. Median improvement per patient was 4.5/10. Patients rated their condition as 'much improved' at medium-term follow-up and the median return to sports score was 'returned to desired but not pre-injury level' at medium-term and long-term follow-up. No adverse events were reported. Conclusions: Ultrasound-guided 15% dextrose prolotherapy injection has a significant medium-term effect on pain in MTSS. This benefit may be maintained long-term; however, more robust trials are required to validate these findings in the absence of controls. Clinical relevance: Clinicians should consider the use of ultrasound-guided injection of 15% dextrose as a viable treatment option to reduce pain and aid return to activity for patients with recalcitrant MTSS.
... The MTSS scale shows good test-retest reliability (intraclass correlation coefficient 5 0.81) and internal consistency (a 5 0.58), and has a moderate to large validity (r 5 0.34-0.52). 26 ...
... The perceived therapeutic efficacy at the sixth week by the ASFO and SFO groups was 18.5% and 13.5%, respectively, which is equivalent to "somewhat better." In addition, the combination of ASFO and the multimodal therapeutic intervention led to a 2-point change on an 11-point perceived therapeutic scale, not seen in the multimodal intervention per se, which is a clinically meaningful improvement by ASFO. 25 Because a 0.35 MTSS score is the smallest significant detectable change for patients with MTSS, 26 the reduction in MTSS score by 1.6 in the ASFO group versus 0.8 in the SFO group in the sixth week indicates a significant improvement in treatment outcomes with ASFO. This indicates that adding ASFO to the multimodal therapeutic intervention achieved a greater therapeutic success, particularly at 6 weeks after start of the treatment. ...
Article
Objective: Our aim was to assess the effects of adding arch-support foot-orthoses (ASFO) to a multimodal therapeutic intervention on the perception of pain and improvement of recovery from medial tibial stress syndrome (MTSS) in recreational runners. Design: A prospective randomized controlled trial. Setting: Sport training and medical centers. Participants: Fifty female recreational runners with MTSS were randomized into 2 groups. Interventions: Runners either received ASFO or sham flat noncontoured orthoses. Both groups received a multimodal therapeutic intervention, including ice massage, ankle muscle exercises, and extracorporeal shockwave therapy. Main outcome measures: Pain during bone pressure using a numerical Likert scale (0-10), MTSS severity using an MTSS scale, perceived treatment effect using the global rating of change scale, and quality of life using the short Form-36 questionnaire were determined at week 6, 12, and 18. Results: Pain intensity and MTSS severity were lower, and the perceived treatment effect and physical function were better in the ASFO than in the sham flat noncontoured orthoses group at week 6 and week 12. Cohen's dz effect size for between-group differences showed a medium difference. However, arch-support foot-orthoses did not add to the benefits of multimodal therapeutic intervention on pain, MTSS severity and perceived treatment effect at week 18. Conclusions: Adding ASFO to a therapeutic intervention leads to an earlier diminishment of pain and MTSS severity, and improved PF and perceived therapeutic effects.
... Although Likert scales are sensitive indicators of clinical trial endpoints (37), the lack of speci city could at least partly explain the limited treatment effect for these outcomes. Since this study was conducted there are 3 validated patient outcome scores are now available (42,43,44), one is speci c for MTSS (42). ...
... Although Likert scales are sensitive indicators of clinical trial endpoints (37), the lack of speci city could at least partly explain the limited treatment effect for these outcomes. Since this study was conducted there are 3 validated patient outcome scores are now available (42,43,44), one is speci c for MTSS (42). ...
Preprint
Full-text available
Background: Medial tibial stress syndrome (MTSS) is one of the most common lower leg injuries in sporting populations. It accounts for between 6%-16% of all running injuries, and up to 53% of lower leg injuries in military recruits. Various treatment modalities are available with varying degrees of success. In recalcitrant cases, surgery is often the only option. Objective: To evaluate whether ultrasound-guided injection of 15% dextrose for treatment of recalcitrant MTSS decreases pain and facilitates a return to desired activity levels for those who may otherwise be considering surgery or giving up the sport. Method: The study design was a prospective consecutive case series involving eighteen patients: fifteen male and three female; (mean age=31.2 years) with recalcitrant MTSS. They were referred from sports injury clinics across the UK, having failed all available conservative treatment. Intervention: An ultrasound-guided sub-periosteal injection of 15% dextrose was administered by the same clinician (NP) along the length of the symptomatic area. Typically, 1 mL of solution was injected per cm of the symptomatic area. Main Outcome Measures: Pain was assessed using a 10-cm visual analog scale (VAS) at baseline, short-term, medium-term (mean 18 weeks), and long-term (mean 52 weeks) follow-up. Symptom resolution and return to activity were measured using a Likert scale at medium and long-term follow-up. Statistical analyses were performed using SPSS for Mac version 19.0.0 (IBM, New York, NY, US). The Shapiro-Wilk test was used to evaluate the normality of the distribution of data. Friedman's non-parametric test was used to compare the within-patient treatment response over time. Post-hoc Wilcoxon signed-rank tests with Bonferroni corrections were performed to determine VAS average pain response to treatment over five paired periods. Results: Patients reported a significant (p<0.01) reduction in median VAS pain score at medium and long-term follow-up compared to baseline. Median improvement per patient was 4.5/10. Patients rated their condition as 'much improved' at medium-term follow-up and the median return to sports score was 'returned to desired but not pre-injury level' at medium-term and long-term follow-up. No adverse events were reported. Conclusions: Ultrasound-guided 15% dextrose prolotherapy injection has a significant medium-term effect on pain in MTSS. This benefit may be maintained long-term; however, more robust trials are required to validate these findings in the absence of controls. Clinical Relevance: Clinicians should consider the use of ultrasound-guided injection of 15% dextrose as a viable treatment option to reduce pain and aid return to activity for patients with recalcitrant MTSS.
... The validated medial TSS score survey was adapted from the standard 15-item questionnaire to 4 items. 17 The mini-TSS consisted of 4 questions regarding the ability to perform sporting activities, pain during sporting events, pain during walking, and pain at rest. For each question, participants selected one of 4 responses. ...
Article
Context: Tibial stress syndrome (TSS) is an overuse injury of the lower extremities. There is a high incidence rate of TSS among military recruits. Compression therapy is used to treat a wide array of musculoskeletal injuries. The purpose of this study was to investigate the use of compression therapy as a treatment for TSS in military service members. Design: A parallel randomized study design was utilized. Methods: Military members diagnosed with TSS were assigned to either a relative rest group or compression garment group. Both groups started the study with 2 weeks of lower extremity rest followed by a graduated running program during the next 6 weeks. The compression garment group additionally wore a shin splints compression wrap during the waking hours of the first 2 weeks and during activity only for the next 6 weeks. Feelings of pain, TSS symptoms, and the ability to run 2 miles pain free were assessed at baseline, 4 weeks, and 8 weeks into the study. Results: Feelings of pain and TSS symptoms decreased during the 8-week study in both groups (P < .05), but these changes were not significantly different between groups (P > .05). The proportion of participants who were able to run 2 miles pain free was significantly different (P < .05) between the 2 groups at the 8-week time point with the compression garment group having a significantly increased ability to complete the run without pain. Conclusions: Although perceptions of pain at rest were not different between groups, the functional ability of running 2 miles pain free was significantly improved in the compression garment group. These findings suggest that there is a moderate benefit to using compression therapy as an adjunct treatment for TSS, promoting a return to training for military service members.
... Pain in the medial part of tibia is one of the clinical signs of MTSS, which is indicated as frequent injury in cadets. Medial tibial stress syndrome (MTSS) (M76.80 according to the ICD-10) is an overuse injury of the lower limbs [14]. This pathology mostly occurs in sportsmen, in particular, athletes (from 13.6% to 20%) and military members (from 7.2% to 35%) and can significantly limit their ability to perform professional physical activities [15]. ...
Article
Full-text available
Aim: The purpose of the study was to substantiate the relevance of the introduction of physiotherapy for prevention and rehabilitation for medial tibial stress syndrome in cadets by analyzing of their injuries experience. Materials and Methods: 256 cadets took part in the retrospective study. The study was conducted in a survey form. The specially prepared questionnaire included questions about injuries and pain syndromes with an emphasis in the manifestation of symptoms of medial tibial stress syndrome. Results: 59.5% of respondents reported on the occurrence of injuries and pain syndromes during training in higher military educational institutions. The first year was pointed out as the most traumatic by the cadets of all year of studying. Out of all respondents 62% of the first year cadets, 37.8% of the second years, and 32.2% of the third years pointed the first year as the most traumatic. 83.2% of respondents indicated having an experience of injuries and pain syndromes in the lower limbs during training. It was found that 13.6% of injuries and pain syndromes in cadets occur in the lower limbs; among them 62.1% have the localization of pain on the medial surface. Conclusions: The highest number of injuries and pain syndromes in cadets occurs in the first year of studying. The most common are injuries and pain syndromes of the lower limbs, a third part of which are the injuries of the tibiae area. More than half of all injuries and pain syndromes of the lower limbs are localized on the medial surface, which means the risk of development of MTSS. The obtained results determine the relevance of research on the development and analysis of the effectiveness of using physiotherapy interventions to prevent and treat the MTSS in cadets
... 56%) of clinically diagnosed cases with MTSS (39). Furthermore, periosteal and bone marrow oedema are often present in healthy asymptomatic athletes (40,41) which suggests it is not an adequate characteristic to identify those with MTSS. As a result, we may have missed relevant cases with MTSS with negative MRI ndings. ...
Preprint
Full-text available
Background: Medial tibial stress syndrome (MTSS) is one of the most common lower leg injuries in sporting populations. It accounts for between 6%-16% of all running injuries, and up to 53% of lower leg injuries in military recruits. Various treatment modalities are available with varying degree of success. In recalcitrant cases, surgery is often the only option. Objective: To evaluate whether ultrasound-guided injection of 15% dextrose for treatment of recalcitrant Medial Tibial Stress Syndrome decreases pain and facilitates a return to desired activity levels for those who may otherwise be considering surgery or giving up sport. Design: Prospective case series Setting: Private specialist Centre Patients: Eighteen patients: fifteen male and three female; (mean age=31.2 years) with MTSS were referred from sports injury clinics across the UK, having failed all available conservative treatment. Intervention: An ultrasound-guided sub-periosteal injection of 15% dextrose was administered by the same clinician (NP) along the length of the symptomatic area. Typically, 1 mL of solution was injected per cm of symptomatic area. Main Outcome Measures: Pain was assessed using a 10-cm visual analogue scale (VAS) at baseline, short-term, medium-term (mean 18 weeks) and long-term (mean one year) follow-up. Symptom resolution and return to activity were measured using a Likert scale at medium and long-term follow-up. Results: Patients reported a significant (p<0.01) reduction in median VAS pain score at medium and long-term follow-up compared to baseline. Median improvement per patient was 4.5/10. Patients rated their condition as ‘much improved’ at medium-term follow-up and median return to sport score was ‘returned to desired but not pre-injury level’ at medium-term and long-term follow-up. No adverse events were reported. Conclusions: Ultrasound-guided 15% dextrose prolotherapy injection has a significant medium-term effect on pain in MTSS. This benefit may be maintained long-term. More robust trials are required to validate these findings. Clinical Relevance: Clinicians should consider the use of ultrasound-guided injection of 15% dextrose as a viable treatment option to reduce pain and aid return to activity for patients with recalcitrant Medial Tibial Stress Syndrome.
Article
Medial tibial stress syndrome (MTSS) is characterized by the presence of diffuse pain in the posteromedial portion of the medial border of the tibia. Current evidence from the literature has not established an effective treatment and has not been able to demonstrate effectiveness of numerous modalities commonly used to treat MTSS pain. Case Description This report describes an 18-year-old male collegiate soccer player who presented with pain along the distal medial tibial border bilaterally consistent with the diagnosis of medial tibial stress syndrome (MTSS). Treatment focused on correcting clinical and kinesiological findings likely contributing to the patient’s condition including fascial mobilization, interferential currents (IFC), strengthening and stretching exercises. After 10 sessions over 10 weeks the patient was able to return to training and competition without pain.
Thesis
Full-text available
Exercise related leg pain in the military. Treatment of MTSS and CECS, with an emphasis on gait retraining.
Article
Full-text available
BACKGROUND: There is no valid and reliable instrument that evaluates injury severity and treatment effects for medial tibial stress syndrome (MTSS) patients. OBJECTIVE: The aim was to generate items for the MTSS score, a new patient-reported outcome measure for patients with MTSS. METHODS: The authors consulted experts in the fi eld of MTSS to generate items that measure the severity of MTSS and to reach consensus on the relevance of items for the MTSS score. This research consisted of a pilot study and two Delphi rounds. The Delphi approach entails the consultation of experts about a topic for which no evidence is available during which consensus is sought on this topic. Additionally, 20 MTSS patients appraised the MTSS score on readability and comprehension. RESULTS: Nineteen experts consented to participate, 13 of whom reached consensus. Generated items address the following domains: 'limitation in sporting activities', 'pain while performing sporting activities', 'pain while performing activities of daily living' and 'pain at rest. Patients with MTSS confirmed the good readability and comprehension of the items. CONCLUSION: This study supports the importance of items in the aforementioned domains while evaluating treatment effects in atients with MTSS.
Article
Full-text available
Background: There is no valid and reliable instrument that evaluates injury severity and treatment effects for medial tibial stress syndrome (MTSS) patients. Objective: The aim was to generate items for the MTSS score, a new patient-reported outcome measure for patients with MTSS. Methods: The authors consulted experts in the field of MTSS to generate items that measure the severity of MTSS and to reach consensus on the relevance of items for the MTSS score. This research consisted of a pilot study and two Delphi rounds. The Delphi approach entails the consultation of experts about a topic for which no evidence is available during which consensus is sought on this topic. Additionally, 20 MTSS patients appraised the MTSS score on readability and comprehension. Results: Nineteen experts consented to participate, 13 of whom reached consensus. Generated items address the following domains: ‘limitation in sporting activities’, ‘pain while performing sporting activities’, ‘pain while performing activities of daily living’ and ‘pain at rest’. Patients with MTSS confirmed the good readability and comprehension of the items. Conclusion: This study supports the importance of items in the aforementioned domains while evaluating treatment effects in patients with MTSS.
Article
Full-text available
Medial tibial stress syndrome (MTSS) is a common injury in runners and military personnel. There is a lack of agreement on the aetiological factors contributing to MTSS, making treatment challenging and highlighting the importance of preventive efforts. Understanding the risk factors for MTSS is critical for developing preventive measures. The purpose of this systematic review and meta-analysis was to assess what factors put physically active individuals at risk to develop MTSS. Selected electronic databases were searched. Studies were included if they contained original research that investigated risk factors associated with MTSS, compared physically active individuals with MTSS and physically active individuals without MTSS, were in the English language and were full papers in peer-reviewed journals. Data on research design, study duration, participant selection, population, groups, MTSS diagnosis, investigated risk factors and risk factor definitions were extracted. The methodological quality of the studies was assessed. When the means and SDs of a particular risk factor were reported three or more times, that risk factor was included in the meta-analysis. There were 21 studies included in the systematic review and nine risk factors qualified for inclusion in the meta-analysis. Increased BMI (weighted mean difference (MD)=0.79, 95% CI 0.38 to 1.20, p<0.001), navicular drop (MD=1.19 mm, 95% CI 0.54 to 1.84, p<0.001), ankle plantarflexion range of motion (ROM; MD=5.94°, 95% CI 3.65 to 8.24, p<0.001) and hip external rotation ROM (MD=3.95°, 95% CI 1.78 to 6.13, p<0.001) were risk factors for MTSS. Dorsiflexion and quadriceps-angle were clearly not risk factors for MTSS. There is a need for high-quality, prospective studies using consistent methodology evaluating MTSS risk factors. Our findings suggest that interventions focused on addressing increased BMI, navicular drop, ankle plantarflexion ROM and hip external rotation ROM may be a good starting point for preventing and treating MTSS in physically active individuals such as runners and military personnel.
Article
Psychological research involving scale construction has been hindered considerably by a widespread lack of understanding of coefficient alpha and reliability theory in general. A discussion of the assumptions and meaning of coefficient alpha is presented. This discussion is followed by a demonstration of the effects of test length and dimensionality on alpha by calculating the statistic for hypothetical tests with varying numbers of items, numbers of orthogonal dimensions, and average item intercorrelations. Recommendations for the proper use of coefficient alpha are offered.
Article
Study Design. The development and testing of a new comprehensive measure of neck pain and disability, the Neck Pain and Disability Scale. Objectives. To provide an initial evaluation of the Neck Pain and Disability Scale’s reliability and validity. Summary of Background data. Although several measures exist for generalized pain and disability, none is specific for neck pain. More specific measurements should improve assessment of treatments and clinical research aimed at cervical pain syndromes. Methods. The Neck Pain and Disability Scale was designed using the Million Visual Analogue Scale as a template and consists of 20 items that assess neck pain. In this study, 100 patients with neck pain, 52 patients with lower back and leg pain, and 27 pain-free volunteers were rated by the Neck Pain and Disability Scale. In addition, a subset of the 47 patients with neck pain were rated by several other established psychometric instruments. Results. An item analysis showed a high degree of internal consistency among the 20 items on the Neck Pain and Disability Scale (r = 0.93), and face validity was established by comparing patients who had neck pain as well as lower back and leg pain with a pain-free group. The Neck Pain and Disability Scale scores correlated with the Oswestry Disability Questionnaire, the Pain Disability Index, and psychological measures of depression and neuroticism. Conclusions. The results suggest a highly reliable instrument for evaluating neck pain with at least four underlying dimensions. Further work to address the predictive validity of this new tool are under way.
Book
Clinicians and those in health sciences are frequently called upon to measure subjective states such as attitudes, feelings, quality of life, educational achievement and aptitude, and learning style in their patients. This fifth edition of Health Measurement Scales enables these groups to both develop scales to measure non-tangible health outcomes, and better evaluate and differentiate between existing tools. Health Measurement Scales is the ultimate guide to developing and validating measurement scales that are to be used in the health sciences. The book covers how the individual items are developed; various biases that can affect responses (e.g. social desirability, yea-saying, framing); various response options; how to select the best items in the set; how to combine them into a scale; and finally how to determine the reliability and validity of the scale. It concludes with a discussion of ethical issues that may be encountered, and guidelines for reporting the results of the scale development process. Appendices include a comprehensive guide to finding existing scales, and a brief introduction to exploratory and confirmatory factor analysis, making this book a must-read for any practitioner dealing with this kind of data.