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education SOMATIC RESEARCH Clinical Trials Foundations for the Strongest Studies By Jerrilyn Cambron Clinical trials are a type of experimental research. They may also be described as randomized clinical trials or randomized controlled trials (RCTs), controlled clinical trials, and randomized controlled clinical trials. Whatever name you give them, clinical trials are considered the most meaningful type of study because the investigators have so much control over what happens to the subjects. In other study designs, the subjects make the final decision as to what exposures or treatments they receive. In clinical trials, however, the subjects agree to being placed in a group and to follow the instructions of the researcher. CONTROL OVER TREATMENT AND SUBJECTS Clinical trials are designed with strict protocols in place. Researchers use specific recruitment processes in order to enroll a specific type of subject. For example, some studies have open recruitment in which researchers will recruit from the general public through newspaper and radio advertisements. 54 massage & bodywork january/february 2014 Other researchers will recruit through local physicians' offices, particularly ones that specialize in the condition being studied. Once subjects are recruited, they go through a baseline examination to determine if they are eligible for the study. Predesigned inclusion and exclusion criteria are assessed by the clinician. These criteria help narrow the type of subject in the study. For example, perhaps a study will focus only on subjects whose lowback pain is chronic rather than acute. Or perhaps one of the criteria would be that people cannot have other comorbidities because the other conditions might affect the way the subject responds to the treatment. The measures that will be used to determine the outcomes are set prior to the start of the study as well. Researchers tend toward using outcome measures that have already gone through testing to determine validity and reliability, so they are truly measuring what they think they are measuring, and doing it with accuracy. For example, the Visual Analog Scale (VAS) is known as a valid and reliable outcome measure and has been used by many researchers and clinicians. New measures can be developed, but if they are not tested prior to utilization, they might give spurious outcomes and affect the results. It is important that quality outcome measures are used. In clinical trials, treatment protocols are frequently developed as well. Protocols for a clinical trial on the benefits of massage might include the type of massage, the body areas treated, the duration of each session, the number of sessions, and the take-home instructions. There is usually quite a bit of rigor when it comes to treatment protocols and these sometimes take the longest to develop.