The aim of this prospective cohort study is threefold: (1) for a better understanding of MTSS' underlying pathophysiology, (2) to assess the QU's reliability in healthy subjects and subjects with MTSS and (3) to assess the validity of QU…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of MTSS
Local tibial bone health as expressed in "Speed of Sound" (meters / seconds)
Secondary outcome
Those subjects that develop MTSS are asked to fill out the newly developed
patient reported outcome measure "The MTSS-score". This outcome measure
consists of items that evaluate pain, pain and limitation in activities of
daily life and sports activities.
Reliability study:
Intraclass correlation coefficient for intra-rater and inter-rater reliability
Standard error of measurement
Smallest detectable change on the individual and group level.
Background summary
Medial tibial stress syndrome (MTSS) is the most frequently seen lower leg
injury in athletes and military personnel . MTSS is defined as
"exercise-induced diffuse pain along the posteromedial border of the tibia"
that is provoked by palpation over a length of 5 or more consecutive
centimetres.
Presently, MTSS is thought to be caused by bony overload .This theory is based
on a case-control and a follow-up study by Magnusson et al.. They found a
reduced bone mineral density in the tibia in chronic MTSS patients (mean
duration of complaints: 31 months) compared with healthy athletic controls. On
follow-up, when symptoms had disappeared, the bone mineral density was restored
. In contrast with these results, Özgürbüz et al. found no differences in bone
mineral density between MTSS patients with a short period of complaints (mean
duration: 5 weeks) and active controls. As subjects' tibial bone health has
never been studied prior to and during the onset of MTSS, it remains unclear
how MTSS is related to changes in local tibial bone health. For treatment and
prevention, it could be important to clarify MTSS' pathophysiology.
Quantitative Ultrasound (QU) is a commonly used device for measuring bone
health. A probe, with a transmitter and receptor, sends (and receives) sound
waves through bone tissue. The speed on which the wave travels through bone is
called Speed of Sound and is an indication of bone health. In osteoporosis
research it has been shown to accurately predict the onset of osteoporosis and
fractures. QU is a good technique to use as it is a non-invasive, safe
technique without radiation. Therefore, it could be used frequently to monitor
local tibial bone health. QU has shown to be reliable and valid in osteoporosis
research. As MTSS's pathophysiology is hypothesized as of bony origin, QU may
be of predicting value for healthy populations at risk for MTSS.
If MTSS appears be associated with a decreased local tibial bone health and QU
is able to measure changes in tibial bone health relevant to MTSS, preventative
and curative interventions could be better targeted.
Study objective
The aim of this prospective cohort study is threefold: (1) for a better
understanding of MTSS' underlying pathophysiology, (2) to assess the QU's
reliability in healthy subjects and subjects with MTSS and (3) to assess the
validity of QU in predicting MTSS. In addition, a reliability study will be
performed in which inter-rater and intra-rater reliability of the quantitative
ultrasound device will be assessed. For this part of the study 20 subjects will
be invited to be measured 3 times on one day by two physiotherapists.
Study design
Prospective cohort study. Participants are followed for 4 months. During these
months their local tibial bone health is measured every two weeks.
Study burden and risks
MTSS is a common injury among students of the *academie voor lichamelijke
opvoeding*. Many of the students are between 16 and 18 years of age. To aim
preventative and curative interventions, it is highly important to clarify
MTSS' pathophysciological nature. Furthermore, this study is not accompanied by
any risks or harms. This is an observational design. No measurements could
affect participants' (emotional) well-being. Participants are subjected to 9
measurements, each taking 5 minutes of the students' time. For those student
participating in the reliability study, two additional measurements will be
performed on, each taking 5 minutes for each measurement.
Rijksweg 69
Naarden 1411 GE
NL
Rijksweg 69
Naarden 1411 GE
NL
Listed location countries
Age
Inclusion criteria
All healthy students (>=16 years), without a history of cruris fractures, will be eligible for inclusion. Those students having lower leg pain within a week prior to study's commencement, will be excluded.
Exclusion criteria
History with crural fractures; lower leg pain within a week prio to study's commencement
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49488.100.14 |