RCT's—the right way forward in sports and exercise medicine research?
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Transcript of RCT's—the right way forward in sports and exercise medicine research?
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Editorial
RCT’s—the right way forward in sports and exercise medicine research?
Is it time to revisit the value of Randomised Control
Trials (RCTs) in Sports and Exercise Medicine (SEM)
Research? For some time now, the ‘gold standard’ for
testing a research hypothesis where an intervention is
involved has been a prospective, placebo RCT with
appropriate blinding. This is evidenced, for example, by
the Cochrane Database of Systematic reviews, a resource
commonly accessed by SEM professionals, which only
considers randomised and quasi-randomised trials. In my
view, however, this requirement for an RCT becomes self-
fulfilling and means that potentially important evidence that
might be available from studies employing alternative
methodologies is sometimes overlooked. Moreover, the
conclusions generated by the Cochrane reviews themselves
frequently state that there is insufficient evidence available
and recommend that more good quality RCT’s are carried
out (Linko, Harilainen, Malmivaara, & Seitsalo, 2005). Is
this the right message, or should we consider addressing the
lack of evidence in a different way?
We must remember that double blind, placebo RCT’s
have been widely used to prove the efficacy and safety of new
drugs. Is it appropriate therefore that these have been adopted
by other fields? One of the criticisms of SEM research is a
lack of numbers reducing the power of a study, and this raises
some important issues. Firstly can elite, professional athletes
be combined in a study with recreational athletes? Could
results obtained from a population of the former be
generalised to a population from the latter, and vice versa?
If ‘not necessarily’ is the answer, and I would suggest it is,
then by definition any study conducted on elite athletes will
necessarily have a small sample size
Extending the study period over a longer time frame can
enable more participants to be captured. However, a
potential problem with this is that approaches may change
over time. A good example is a pilot study on eccentric
exercise and chronic patella tendinopathy (Purdam,
Johnsson, Alfredson, Lorentzon, Cook, & Khan, 2004).
When the study was started the standard format was
eccentric training on a horizontal surface. Then during the
progress of the research, it became evident that training on
an angled decline might be a superior way of loading the
patella tendon, and this was substituted as the training for
subsequent recruits to the study. This should not be
1466-853X/$ - see front matter q 2005 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ptsp.2005.08.001
considered as a limitation to this particular study, and the
authors freely acknowledged that this occurred. Moreover it
demonstrates the dynamic progresses being made in this
field.
Another consideration is the pathology to be investi-
gated, as the time and sample population factors can become
prohibitive for an RCT involving less common pathologies.
Additionally, professional athletes involved in sports such
as track and field, swimming, tennis and golf are constantly
on the move during competition and training camps, and are
notoriously difficult to follow-up.
Sports which lend themselves to be more easily
investigated are the club-based team sports such as rugby.
However, whilst a critical mass of recruits is more readily
available, there is a dilemma in this situation about whether
it is it ethical and/or practical to deliver an intervention in a
manner that would fit an RCT. Not impossible, but difficult.
A good example of recent research conducted on a specific
team has recently been published (Verall, Slavotinek, &
Barnes, 2005). Having targeted hamstring injuries within an
Australian Rules football club and collected baseline data
over a 2 season period, a training programme aimed at
prevention was then instigated at the end of the second
season. The entire team participated and the incidence and
consequence of injury was evaluated over the subsequent 2
seasons. The results were impressive, with the number of
injuries and consequently games missed being dramatically
reduced. Whilst it would be easy to criticise this paper for
lack of controls/blinding/randomisation etc., it was a
pragmatic piece of research which set out to reduce the
incidence of hamstring injury within the club, and this was
achieved. Of course, this may not have been exclusively due
to the training prevention programme; other factors can
come into play when players are being more closely
screened. It would therefore be interesting to continue the
follow up at the club to see if results are maintained over
subsequent seasons and to investigate whether another club
of comparable level could achieve the same results
following the programme.
This paper reflects what many clinicians working
within a club are challenged with on a regular basis,
identification of a problem, application of an appropriate
prevention and/or treatment programme and evaluating the
effect of the intervention. And yet this study would not be
selected according to the criteria for systematic reviews,
Physical Therapy in Sport 6 (2005) 169–170
www.elsevier.com/locate/yptsp
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Editorial / Physical Therapy in Sport 6 (2005) 169–170170
and as a consequence, some valuable research would be
overlooked.
For all these reasons, I think we need to address the
appropriate methodologies for Sports and Exercise Medi-
cine Research and face the fact that one ‘model’ may not fit
all eventualities.
In this issue of Physical Therapy in Sport, Kim Bennell
presents a masterclass on the prevention and management of
stress fractures in athletes. The different factors that are
thought to contribute to this problem are discussed and the
evidence for their contribution along with management
strategies is explored.
Wobble boards have traditionally been the main stay of
rehabilitation following ankle injury with subsequent
functional instability (even though there has been a school
of thought that training on a wobble board just makes you
good at balancing on a wobble board). In a piece of original
research, Clark & Burden demonstrate how a 4-week
programme of wobble board training 3 times a week for
10 minutes improved the perception of functional stability
and decreased the muscle onset latency time in a group with
functional ankle instability compared to a control group with
functional ankle instability who underwent no training.
Whilst the authors acknowledge that this might not produce a
sufficient increase in torque to prevent future sprains, their
data contributes to the controversial area of muscle onset
latency around functionally unstable ankles.
Also in this issue is a piece of original research presented
by Mikesky which certainly lends itself to a double blind,
placebo RCT. Therapeutic static magnets can be worn to
reduce pain and enhance recovery it is thought by improving
blood flow. This study investigated the effects of magnetic
therapy in 20 subjects with eccentric elbow flexion induced
DOMS. Subjects were randomly assigned magnetic or
placebo therapy via an armband over a 7-day period. No
effects on pain or speed of recovery were found compared to
the placebo control. This study is restricted to acute pain
caused by DOMS induced in healthy subjects, and it is
acknowledged that this might not be the optimal model
since anecdotal evidence has suggested benefits of this
therapy in chronic and systemic pathology. Further research
could also explore the hypothesis of whether magnetic
therapy increases blood flow, which was beyond the scope
of this study and not evaluated.
Gatherer and Peek present an interesting case study of the
cervical rehabilitation of a professional rugby player
following a C7/T1 posterior microdiscectomy. The authors
describe the use of a Maximal Isometric Voluntary Muscle
Contraction (IVMC max) using a dynamometer as part of
the rehabilitation programme and outline the modifications
during the different phases of the rehabilitation process.
Readers should find this more unusual treatment method an
interesting read.
Sports Physiotherapy for All (SPA), alongside the
International Federation of Sports Physiotherapy (IFSP)
and their University partners have been developing
competencies and standards for sports physiotherapy, and
the initial competencies were published previously in
Physical Therapy in Sport (Bulley & Donaghy, 2005).
Following consultation, the final document combining
standards and competencies was voted on to be accepted
at the IFSP General meeting in Oslo, 21st June 2005. In this
issue Bulley & Donaghy present a paper on how the
standards for Sports Physiotherapy were developed.
The wide variety of articles included in this issue should
stimulate even the most cursory of readers!
References
Bulley, C., & Donaghy, M. (2005). Sports physiotherapy competencies:
The first step towards a common platform for specialist professional
recognition. Physical Therapy in Sport, 6, 103–108.
Linko, E., Harilainen, A., Malmivaara, A., & Seitsalo, S. (2005).
Surgical versus conservative interventions for anterior cruciate
ligament ruptures in adults. The Cochrane Database of Systematic
Reviews 3.
Purdam, C. R., Johnsson, P., Alfredson, H., Lorentzon, R., Cook, J. L., &
Khan, K. M. (2004). A pilot study of the eccentric decline squat in the
management of painful chronic patellar tendinopathy. British Journal of
Sports Medicine, 38, 395–397.
Verrall, G. M., Slavotinek, J. P., & Barnes, P. G. (2005). The effect of sports
specific training on reducing the incidence of hamstring injuries in
professional Australian Rules football players. British Journal of Sports
Medicine, 39, 363–368.
Zoe Hudson
Editor