[ evidence in practice ]

STEVEN J. KAMPER, PhD1

Control Groups:
Linking Evidence to Practice
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J Orthop Sports Phys Ther 2018;48(11):905-906. doi:10.2519/jospt.2018.0706

D
espite the fact that a randomized controlled trial (RCT), by This means that the trial compares out-
definition, can’t exist without one, the control group is the comes from treatment A to outcomes
forgotten stepchild of the RCT. Most of the time, what’s in from a range of interventions. A further
challenge involves generalizability, be-
it doesn’t even make it into the study title. Nevertheless,
cause usual care in one location might be
it is not possible to interpret the results of an RCT unless we really very different from usual care in another.
understand what is happening to the people in the control group. But there is a payoff for these challenges.
Copyright © 2018 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

The place of the RCT near the top
of the treatment-effectiveness evidence
hierarchy to some extent rests on the
presumption that you can only know the
benefit of an intervention by comparing
it to something else. The control group
in an RCT is the “something else.” So, in
the context of an RCT, the effectiveness
of an intervention is the difference be-
Journal of Orthopaedic & Sports Physical Therapy®
ent sorts of research questions that go
with each type.
No Treatment or Waiting List
Sometimes, the people who get treatment
A are compared to a group that gets noth-
ing or is on a waiting list. All the same
outcome measures are collected, at the
same time points, but controls receive
These studies answer a very pragmatic
and clinically relevant question: should
we leave the current health care situa-
tion (for that condition) as is, or roll out
a new standard of care in a particular
place? When done well, these studies
can have powerful clinical and policy
implications.

tween what happens to the people who
get the intervention of interest (treat-
ment A) and what happens to the people
who get the control treatment. It follows
that interpretation of the effectiveness of
treatment A, as reported in any particular
RCT, also depends on the effectiveness of
the control treatment.
Obviously, not all control groups are
equally effective. The key point to under-
stand is that different control interven-
tions answer different research questions.
For example, an RCT that compares an
exercise program for shoulder pain to
sham ultrasound answers a different
question from that of an RCT that com-
pares the same exercise program to a
joint mobilization treatment.
Although there are an almost lim-
itless number of different control in-
terventions, we can group them into
similar types, and consider the differ-
no treatment. The aim of this study is to
compare the effect of treatment A to the
natural course of the condition. Answer-
ing this question might be especially rel-
evant when the health condition is acute
or is characterized by recurrent episodes
that come and go with time. This can
inform decisions about whether the ben-
efits of treatment A are worth the costs,
risks, and inconvenience beyond natural
recovery.
Usual Care
Here, treatment A is compared to a
group of controls who receive whatever
care they would normally get if they
weren’t involved in a study, sometimes
called the “clinical course” of the condi-
tion. These studies can be challenging
to interpret because it may be that—just
like in real life—not everyone in the con-
trol group receives the same treatment.
Placebo or Attention Control
A placebo, or sham intervention, may
be designed for a particular study. The
broad idea is that the people in the con-
trol group think they are getting a real
treatment, but really they are not. The
classic placebo in medical studies is the
sugar pill; in physical therapy trials, it
might be something like deactivated
electrotherapy, fake acupuncture where
the needles don’t penetrate the skin,
or taping that serves no structural pur-
pose. A special type of placebo is called
an attention control, which is sometimes
used in trials testing education or advice
interventions. This is where the control
group receives the same amount of inter-
action with clinicians as the treatment
group, but the interaction has no specific
therapeutic purpose. This might involve
general discussion about the condition
without specific advice, education, or

School of Public Health, University of Sydney, Camperdown, Australia; Centre for Pain, Health and Lifestyle, Australia. t Copyright ©2018 Journal of Orthopaedic & Sports Physical
1

Therapy®

journal of orthopaedic & sports physical therapy | volume 48 | number 11 | november 2018 | 905
 [ evidence in practice
information. Note that placebos consti-
tute a complex and in-depth topic, and
there isn’t space to go into all the issues
here. Placebo-controlled trials are de-
signed to isolate and measure the effect
of a specific proposed mechanism re-
lated to treatment A. For example, con-
sider an RCT comparing real therapeutic
Downloaded from www.jospt.org at University of Sydney on November 1, 2018. For personal use only. No other uses without permission.
difference estimates the effect of the ac-
tual transmission of soundwaves to the
injured tissue. The placebo intervention
“controls” for information provided by
the clinician, rubbing of the ultrasound
head over the skin, and nonspecific ef-
fects of the therapeutic encounter.
]
monly given for that condition. In this
case, the people in both groups get a real
treatment, so the effect is the difference
in outcome between the group that got
treatment A and the group that got treat-
ment B. For example, people with back
pain might be randomized to receive ei-
ther a specific spinal stabilization exer-

ultrasound to deactivated therapeutic Other Interventions cise or a general aerobic fitness program.
ultrasound for improvement of swelling Treatment A might also be compared These trials seek to answer a question
after an ankle sprain. The between-group to another intervention that is com- about whether it is better to offer patients
one treatment or another.
Treatment A RCT 1 RCT 2 RCT 3 RCT 4
Spinal manipulative Summary
therapy Almost by definition, treatment A is the
headline act in any RCT, but the part
Control 1
Waiting list played by the control group is critically
important, so design of the control in-
tervention requires careful thought and
Randomization
Copyright © 2018 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

Sample
Control 2 planning. The nature of the control group
Patients with
Care determined by
acute neck in part determines the research question
the treating clinician
pain that the RCT answers (FIGURE), and only
Control 3 by understanding the precise question
Hand contact without can the results be sensibly interpreted.
manipulation Given that RCTs always measure relative
effectiveness of the treatment and control
Control 4
Range-of-motion interventions, it is important that inter-
exercise program pretation reflects this. That means that
Journal of Orthopaedic & Sports Physical Therapy®

conclusions that a treatment is effective

FIGURE. Four RCTs that answer different questions regarding the effectiveness of spinal manipulative therapy for should always state, “compared to the
acute neck pain. Abbreviation: RCT, randomized controlled trial. control intervention.” t

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906 | november 2018 | volume 48 | number 11 | journal of orthopaedic & sports physical therapy