Massage & Bodywork

March/April 2010

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SOMATIC RESEARCH usually less than 50. A pilot study is an opportunity to see if the study design was effective in answering the question posed in the hypothesis. Once the protocol (intervention or techniques) and methods (the selection of participants, the application of the protocol, the measurement tools, etc.) are tested and refined, a comparison trial or RCT may be conducted. Bias is slightly less in pilot studies than in case reports. The participants are recruited from outside: they are not from inside the practitioner's existing clientele, nor do they select the practitioner. But with only one intervention provided in the study, they are agreeing to receive a known treatment, tending toward bias. Pilot studies are more generalizable and have less bias than case reports, and therefore have a higher level of evidence. the client's sleep improves and the practitioner decides to write up the results for publication. The information takes the form of a case report and contributes to the body of knowledge of our profession, informing other practitioners, referring caregivers, educators, and researchers. Case reports are a mechanism for recording information on typical and atypical clinical interactions, and may focus on anything from the interview questions, assessment techniques, and treatment, to client demographics and clinical settings. While the results are not generalizable to a larger population (the results only show how one person reacted to the intervention of one practitioner) they offer a perspective on what is possible and suggest what might warrant further study. Case reports can inform and shape a potential hypothesis for a larger study. Bias is inherent in case reports. The client has already chosen the practitioner and the type of treatment, so he or she is invested in the success of the treatment more so than being randomized into an unknown protocol with an unknown practitioner. Case reports are a low level of evidence. The data is not generalizable and bias is inherent. PILOT STUDIES Once an interest is identified (for example, sleep disturbances in older adults) and a hypothesis is formed (can massage therapy improve sleep in older adults), a pilot study can be used to test the hypothesis on a larger group of people and identify the feasibility of, and refinements for, further study. A pilot study does not include a comparison or control group and often uses a small set of participants: more than one, but 118 massage & bodywork march/april 2010 RANDOMIZED CONTROLLED TRIALS RCTs typically compare two or more clinical interventions to determine which treatment is best for an identified population. RCTs involve recruiting a large number of participants with a particular condition (sleep disturbances), and a computer program or other blinded selection process randomly funnels them into one of a few different arms of a research project (music therapy, aromatherapy, massage therapy). In randomized trials, the participants do not select the type of treatment nor do they select the practitioner, thereby limiting bias. The term controlled often refers to a placebo treatment: something that looks like the intended intervention but doesn't contain any healing properties. Placebos are difficult to design for somatic therapies. One problem is that we have yet to identify which component of massage therapy—the one-on-one interaction, the healing

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