Does military personnel suffering from MTSS benefit from early intervention with ESWT?
A multicentre randomised trial

In physically active population Medial Tibial Stress Syndrome (MTSS) is a
common overuse injury of the lower leg(s). It is often reported among military
personnel and runners. The incidence rates in military personnel are ranging
from 7.2% to 35% and in runners from 13.6% to 20% . In the military this injury
can lead to withdrawal from the basic military training (Algemene Militaire
Opleiding (AMO)) or even discharge from the Royal Netherlands Army (RNLA) if
treatment isn*t successful.
MTSS is characterised by pain, sometimes with swelling, on the medial border of
the mid and distal third of the tibia. This occurs with physical activities as
well as in rest. Treatment and prevention of MTSS are difficult due to lack of
understanding of its aetiology. One of the hypothesis is that there is tibial
periostitis in conjunction with cortical bone oedema and microtrauma .
Risk factors for MTSS have been studied in many studies Potential risk factors
are Body Mass Index (BMI), gait kinematics, Range of Motion (ROM) of the ankle
and hip, navicular drop and many others. However, the exact way of how these
factors contribute to the development or maintenance of MTSS is still not clear
.
Due to the aetiology of MTSS being unknown and a range of potential risk
factors, there are many treatment options, but the evidence for effectiveness
of these treatments is very weak or absent .
Extracorporeal shock wave therapy (ESWT) is the application of short burst high
intensity sound waves. It has been used in the management of insertional
tendinopathies as a mechanism to reactivate the local tissue repair response.
For MTSS therapeutic use and effectiveness of ESWT is hypothesised to stimulate
bone remodelling or to reduce pain signalling to the brain and breaking down
calcium deposits. Evidence of the effectiveness of ESWT is weak to moderate,
but it appears to be more effective or more promising than other non-surgical
treatments for reducing pain in lower extremity disorders
ESWT treatment is usually effective with little treatment sessions. Ideally
treatment of MTSS should be as short as possible, as the consequences for
military deployment or finishing the basic military training can be dramatic,
as it can lead to be declared not fit for duty and possible discharge of the
RNLA .
A different part of treatment for MTTS is adjustment in training and exercise.
In the RLNA a guideline for lower leg complaints is used for treatment of MTSS.
In the RNLA both treatments are usual care. Both of them are used separately as
treatment or complementary.
The goal of this study is to examine the effect of both treatment strategies on
the running distance of the Defensie Conditie Proef (DCP) and on the time of a
5k march, as these are important indicators whether the soldiers are fit for
duty. The goal is to establish whether one of these treatment strategies will
lead to longer (painfree) running distances en faster (painfree) marching
times after the first 3 weeks. And if so, will these effects remain after a
follow up period of 12 weeks.
If one of the strategies leads to better outcome values, this will lead to
possible change of best practice and care for military personnel suffering from
MTSS.

The goal of this study is to examine the effect of both treatment strategies on
the running distance of the Cooper*s test, a part of the Defensie Conditie
Proef (DCP) and on the time of a 5k march, as these are important indicators
whether the soldiers are fit for duty. The goal is to establish whether one of
these treatment strategies will lead to longer running distances en faster
marching times after the first 3 weeks. And if so, will these effects remain
after a follow up period of 12 weeks. We want to investigate this with the
following research parameters:
Primary Objective:
* Covered running distance in 12 minutes ( Cooper*s test, a part of the
Defensie Conditie Proef (DCP) with a NPRS score of maximum 3.
Secondary Objective(s):
* Time to complete a 5 kilometres march; with a NPRS score of maximum 3 and a
maximum time of 60 minutes
* The MTSS score specifically measures the pain along the inside of the shin
and the limitations arising from this shin pain. The score ranges from 0 (no
limitation) to 10 (full limitation)
* Pain in general is measured with the Numeric Pain Rating Scale (NPRS). The
score ranges from 0 (no pain) tot 10 (worst pain imaginable)
* The perceived effect of treatment and satisfaction with the treatment are
measured with Global Perceived Effect questionnaire (GPE). These scores range
for the perceived effect from *very much improved* to *very much deterioration*
and for satisfaction from *Absolutely satisfied* to *Absolutely dissatisfied*.

Pilot Multicentre Randomised Clinical Trial

Trainings GeneeskundeTrainings Fysiologie (TGTF) guideline for MTSS (Annex 1)
versus Focussed ESWT (3x, max 1x week) added to this TGTF guideline in the
first 3 weeks.

After the eligibility test, participants come to the health centre at the
barracks for treatment during a 16-week period.
In addition to the normal physiotherapeutic information that is mandatory in a
treatment file, the following additional information is collected:
* Height and weight are measured in week 1
* The shock wave treatments take place weekly in weeks 1 to 3.
* In the first, 3rd, 15th week a Cooper*s test is performed as well as a 5 km
march.
* Two questionnaires (NPRS and MTSS ) are completed in week 1, after 3 and 15
weeks. The GPE is added in the 3rd and 15th week.

During this research the usual care for MTSS is being evaluated. The provided
care (di-agnostics, intervention and guidance) does not differ from the care
that subjects would receive if they chose not to participate in this research.
ESWT as well as exercise pro-grams are effective for treating pain and
improving function for MTSS complaints. Occa-sionally, patients do not (fully)
recover. Shockwave treatment can be experienced as painful.
The recommended ISMST focussed ESWT parameters for MTSS are 1500-2500 pulses,
energy flux density (EFD) 0.10-0.25 mJ/mm²(pain-adapted dosing) and standard up
to 3 max. 5 treatments with an interval of 1-2weeks.
From data used in previous studies combined with consensus of professional
experience from treatment of MTSS we will be using 1500 pulses with EFD 0.10
and 0.25 mJ/ mm² and 3 treatment sessions. As shockwave treatment can be as
experienced as painful, the subject, together with the therapist, chooses an
intensity between EFD 0.10 and 0.25 mJ/ mm² that can be maintained during the
1500 pulses. In addition to short-term redness of the skin, no side effects
have been reported from shockwave