RESEARCH JUSTIFICATION
Study Design
A pilot study was the design choice. This was primarily due to the
absence of any evidence for DFM on tendinopathies in isolation.
By using this study design(ThabaneandMaetal.,2010,p.1) explains
that any undesirable results can be observed , it will provide
knowledge of the requirements for a larger study design and will
allow one to gage how viable the interventions are by analyzing
the outcomes.
The internal validity of randomization through sealed envelopes
has been questioned with regard to potential meddling. However
Sealed envelopes are commonly used and are a basic way of
allocating different interventions. (TorgersonandRoberts,1999,pp.375
376)
With clinicians as well as patients having knowledge of various
treatments it is very challenging to have a study with double
blinding and so the study will be single blinded. (Lijmer et al,
1999).
The samples in the studies will be stratified by gender.
Kvist 1994 explains that males are more likely to get achilles
tendinopathies than females.
Outcomes of the study will be related more to the general
population when the sample is stratified.
Having a small sample size due to the trial being a pilot study
could decrease the surety of the results being caused by the
interventions. (ross et al 1999)xxx
Methodology
There is a big percentage of the population who are of
black ethnicity alone with a large percentage of white
British. (office for national statistics 2006). To ensure
culture variety and create added validity to the study this
is taken into consideration and 12 boroughs of south
London shall be used in recruitment .
Real time ultrasound or MRI will not be used for diagnostic purposes for ATs.
Structural damage seen on the images does not essentially correlate with pain.
(FukutaandMasakietal.,2002,pp.287291)
Interventions
Alfredson et al (1998) created the heavy-load eccentric calf muscle
training protocol which will be carried out in this study for eccentric
exercises. AlfredsonandPietil\"Aetal.,1998,pp.360366) States that
this is gold standard.
The non-symptomatic side is employed after the affected side is
eccentrically lowered.
This is important as this removes any concentric contractions and
in a study by (LorenzandReiman,2011,p.27) it explains how eccentric
exercises in isolation has more successful outcomes.
Pain experienced in eccentric contractions has been proven to be
more beneficial than when compared to the exercise done without
pain.(AlfredsonandPietil\"Aetal.,1998,pp.360366). Although painful
exercises are quite frequently criticized, patients will be told that is
it ok to continue through painful symptoms.
Patients will be assessed by either 1 of 2 physiotherapists
Van triffel et al 2010 suggests that between therapists
performance in assessments differ.
DATA COLLECTION
(Haywood,2006,pp.187203)states that a key aspect in conducting a
study is choosing an appropriate outcome measure. Reliability is
defined by joppe 2000 as The extent to which results are
consistent over time and are an accurate representation of the
total population under study. He also explains that validity
determines whether the research truly measures that which it
was intended to measure or how truthful the research results
are. Joppe, M. (2000). [Link] February 25, 1998, from [Link]
When choosing an outcome measure these aspects of validity and reliability should be
implemented. (Roach,2006,pp.812)
With tendinopathies it has been proven that pain is not always experienced. ((Rees
andStrideetal.,2013)). However despite this it is still the symptom that is reported
most with these injuries and so pain and function will be measured.
A common pain scale used is the Visual analogue scale. Comparing it with the NRS,
the NRS has been reported by (Lundeberg et al, 2001) to have more sensitivity along
with having secure test re-test reliability .
Despite variations in reliability amongst functional outcome measures for ATs studies
have began to more commonly use the VISA questionnaire. Robinson et al (2001)
DATA ANALYSIS
To find which test will be used the sample size needs to be looked at
BraceandKempetal.,2006)With the sample size used in this study the shapriowilk test will be used to look for a normal distribution of the subjects.
To know if there is a Normal distribution a significant value of 0.05 will be shown.
Using intention to treat analysis means that subjects will
be analysed should they receive treatment or not for
whatever reason. This should prevent any issues in the
interventionaffectingoutcomes. (Lewis et al, 1993).
PARTICIPANTS TO BE STUDIED
To achieve the most accurate results the number of subjects used needs to
be taken into consideration. This study is the first to look into DFM for
Achilles tendinopathies and so there are no statistical figures able to be
drawn from other studies. Generally the sample size for pilot studies is 30
subjects in each group. Browne 1995.
The occurrence of population tendinopathies can be used to propose a
sample size. Woodley et al 2007 state that 1-2% of the population have
tendinopathies of some sort.
In using this figure this will cover the sample count produced by browne.
With subjects potentially dropping out throughout the trial, 36 patients
will be recruited for each group. (could add inhere a ref from Rompe et al (2007) talking about having a
leeway either side for drop outs.)
The sample size can also be gauged using a projected confidence
level and margin of error
Field 2013 states that there is improved accuracy of results With a
5% margin of error and 95% confidence interval.
Field, A. P. (2013). Discovering statistics using IBM SPSS Statistics: and sex and drugs and
rock 'n' roll (fourth edition). London: Sage publications.
SELECTION CRITERIA
Insertional tendinopathies were omitted from the study as (Kvist,
1994) states that when compared to midportion injuries they are
less common by 4 fold. To ensure the tendon injury is chronic the
patient must have had symptoms lasting for at least 3 months.( with
evidence suggesting that insertional AT responds less favourably to eccentric protocols. )--- if space add but change
words.
(Villemure and Stokes, 2009, pp. 17931803 states that a subject
may be at risk of linear and torsional stress if growth cartilage is
present. Below the age of 19 there can be growth cartilage found.
This is why patients that are 19 or younger will not be selected.
Longo et al 2009 states that there is no relationship between getting
older and AT despite the fact some research shows that tendons that
are older can withstand just as much load as younger ones. With
the former research stating there is no relationship between age and
AT this is why anyone above 19 can attend the trial.
Longo UG, Ronga M, Maffulli N. Achilles tendinopathy. Sports Med Arthrosc. 2009;17:112
126.
In carrying out the eccentric exercises benefits and outcomes will
be distorted if there is a phase of concentric contraction. If both
Achilles tendons are injuries this could be a likely occurrence.
it has been shown in an article by (AlfredsonandCook,2007,pp.211216
that pain is reduced in tendinopathies after an injection of corticosteroids. For this
reason results could be inaccurate if patients had been injected prior to attending the
study.
Neurological conditions can often result in spasticity -
Spasticityafterstroke:Physiology,
assessmentandtreatment
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AuroreThibaut ,CamilleChatelle ,ErikZiegler ,MarieAure lieBruno ,StevenLaureys ,&OliviaGosseries
ComaScienceGroup,CyclotronResearchCentre,UniversityandUniversityHospitalofLie`ge,Lie`ge,Belgium
2
and CyclotronResearchCentre,UniversityofLie`ge,Lie`ge,Belgium
Spastictythatcanoccurinthegrastroneumiusandsoleuscouldhaveanaffect
[Link]
neurologicalconditionswillnotbeallowedtoparticipate.
