Study Title: The use of RCTs in manual therapy – Are we trying to fit a square peg into a round hole?
Author(s): Milanese S
Publication Information: Manual Therapy 2011; 16: 403-405.
Study Title: The use of RCTs in manual therapy – Are we trying to fit a square peg into a round hole?
Author(s): Milanese S
Publication Information: Manual Therapy 2011; 16: 403-405.
In this instalment of Research Review Corner, I wish to combine some personal opinion with discussion points from a recent editorial published in Manual Therapy about the difficulty in studying manual therapy (MT) in a randomized controlled trial (RCT) design.
You are likely aware that RCTs are considered the gold standard in clinical research. Randomization, control group comparisons, treatment standardization and patient/doctor blinding are all considered strengths of RCTs, where each patient in a particular study group receives (in theory) exactly the same intervention. When the RCT has been published, those of us in practice are tasked with finding the study, reading and understanding it, then integrating results into our patient care. Simple, right? Well, as we all know, not really.
One reason for this is that, unfortunately, some of the strengths of RCTs that are seen as requisite components of “high level” research are difficult, or impossible, to achieve fully when studying MT. These study design components are better suited for medical trials utilizing pharmaceutical treatment, yet manual therapists are often held to the same procedure by the health-care community. Essentially, studying what we do to our patients isn’t as simple as administering drug X for disease Y and comparing it to a placebo pill.
Standardizing hands-on interventions in a research setting is very difficult, and not always representative of “real life.” Let’s use spinal manipulation as an example. We clinicians are all different sizes and have different skills – the size of our hands, our touch, speed, force development, set-up techniques, patient instructions, etc., are widely variable among us – not to mention the variability in our patients! Also, we touch our patients, listen to them, and interact with them during each treatment. We develop supportive relationships with them. The effects of these elements are difficult to quantify, but they can certainly have a positive effect on treatment outcome. Further, RCT designs normally dictate that each patient receives a predetermined number of treatments. In practice, however, we should be constantly evaluating progress and modifying treatment as needed. Other RCT design components can be problematic as well, in MT, such as patient and doctor blinding. Such limitations often result in MT research being graded as “low quality” in systematic reviews and clinical practice guidelines, with little consideration given to these factors.
Does this mean we should abandon the RCT and ignore the results of such studies? Obviously not. RCTs represent a very important research design that we must continue to pursue. But, useful information can also be gleaned from other study formats such as cohort studies, case-control studies and pragmatic clinical trials.
Personally, I feel pragmatic trials have a lot of potential for MT, including chiropractic. This is because they can, to some degree, account for the limitations of RCTs discussed above. In this type of study, interventions are evaluated as they occur in normal, day-to-day practice.1 Clinicians treat individual patients as they see fit, perhaps utilizing a multi-modal approach. This type of study can demonstrate the effectiveness of a particular treatment or approach, but cannot establish the exact contributions of individual treatment modalities (i.e., why did the patient get better – was it the spinal manipulation, the rehabilitative exercise or the soft tissue therapy?).
While staying current with our discipline’s body of literature, we must keep the limitations of each type of study in mind. That way, we can continue to rationally integrate research findings into our patient care, remembering that clinical experience and patient preference are the other important “pillars” of evidence-based medicine.
ADDITIONAL REFERENCE
MacPherson H. Pragmatic clinical trials.Complimentary Therapies in Medicine 2004; 12: 136-140.
Dr. Shawn Thistle is the founder and president of Research Review Service Inc., an online, subscription-based service designed to help busy practitioners to integrate current, relevant scientific evidence into their practice. Shawn graduated from CMCC and holds an Honours Degree in Kinesiology from McMaster University. He also holds a certificate in Contemporary Medical Acupuncture from McMaster University, and is a Certified Active Release Techniques (ART®) Provider. For more information about the Research Review Service, visit www.researchreviewservice.com.
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