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Nature of TMD Interventions
Most clinicians treating
TMD patients would like to know if specific therapeutic modalities
are superior to the current treatment regimens. These treatment
regimens usually consist of multi-modal treatment, including giving
patients information about their condition, showing them self-care
treatments, administering or recommending medications, etc. However,
few of the existing trials have compared multi-modal treatment
groups to new forms of treatment in addition to previous modalities.
Although single modality
RCT's can help to simplify and identify which aspects of treatment
may be especially valuable, one has to question their relevance
since these therapies may change in their overall value once they
are mixed in with other forms of treatment commonly used.
Figure 11.1 below shows
two types of treatment groups:
- RCT #1 - the treatment
group has a new treatment in addition to usual and customary
treatment
- RCT #2 - the treatment
group has only the new treatment, as compared to usual and customary
treatment in the control group
Figure
11.1 Treatment and Control Groups in TMD Trials
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The design
of RCT #1 answers whether the new treatment is better over and
above standard treatment, while in RCT #2, the design answers
whether the new treatment by itself is better than usual and customary
treatment.
When deciding upon
what types of interventions to include in a trial, it is best
to consider modalities that have shown promise with TMD or other
pain conditions in published research, and are the least likely
to demonstrate adverse effects. Interventions may be novel to
TMD, and thus are usually evaluated in an efficacy trial, or under
idealized conditions with only subjects that are likely to be
highly compliant with the treatment protocol. Efficacy can be
defined as an intervention that does more good than harm to those
that receive it.
Later on, with more
proven treatments, the question of whether the intervention can
be used under less stringent conditions is usually tested in effectiveness
trials, where the practical use of the intervention can also be
studied.
Most clinical trials
are efficacy trials since the risk for an inconclusive trial is
more likely with an effectiveness trial. To see other distinctions
of different types of clinical trials, see Max, M., Chapter 1,
The Design of Clinical
Trials for Treatment of Pain for explanations and examples
of explanatory and pragmatic trials.
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