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 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 1466-853X/$ - see front matter q 2005 Elsevier Ltd. All rights reserved. doi:10.1016/j.ptsp.2005.08.001

Transcript of RCT's—the right way forward in sports and exercise medicine research?

Page 1: RCT's—the right way forward in sports and exercise medicine research?

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

Page 2: RCT's—the right way forward in sports and exercise medicine research?

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