Issue link: https://www.massageandbodyworkdigital.com/i/296580
I t p a y s t o b e A B M P C e r t i f i e d : w w w. a b m p . c o m / g o / c e r t i f i e d c e n t r a l 55 The usual care group did not receive any massage within the study and received their typical medical care, if and when desired. Using a predetermined massage protocol in a study helps the reader know exactly what was done during the session. This control over the study design is one of the main benefits of a clinical trial: we know exactly how the massage was performed on every subject in that group. It also allows therapists in the field to replicate the massage in their own practices. However, a structured massage format is not true to life. Every massage therapist approaches their massage practice differently, and every client has varied needs. What might be beneficial to one client may not help another. This trial included one group where the massage was predetermined and one group where the treatment was based on specific client needs, so the study actually had the best of both designs, although for different forms of massage care. Comparative effectiveness studies are like any clinical trials in that they need to specify the treatment rendered. When reviewing a study, ask yourself if you are able to replicate the treatment or at least have a good sense of what was done with the subjects. If this information is not available, applying the study results to your practice may be difficult. SUBJECTS Most massage therapists are willing to treat any person who is in need of care. Comparative effectiveness trials are different: to participate in the study, subjects must meet a pre-set list of criteria. The subjects in the Cherkin study were 20 to 65 years old, had outpatient diagnoses suggesting nonspecific chronic low-back pain lasting at least three months without two or more pain-free weeks, and their back pain bothered them at a rating of at least 3 on a scale of 0 to 10. Potential subjects were excluded from the study if they had specific causes of back pain such as cancer, fractures, or spinal stenosis; complicated back problems such as sciatica, back surgery in the past three years, or medicolegal issues; conditions making treatment difficult, such as paralysis or psychoses; conditions that might confound treatment effects or interpretation of results, such as severe fibromyalgia or rheumatoid arthritis; inability to speak English; having received a massage within the past year; or had plans to visit a provider for back pain. With each criteria, the group of people who are eligible for the study becomes smaller and smaller. The reason researchers create so many criteria is to decrease any factors that might confound the trial's results. For example, subjects who are over 65 years old might respond slower than those who are younger. Spinal fractures might lead to a need for modification of the massage treatment protocol. People with psychosis might complete outcome measures inaccurately. The inclusion and exclusion criteria within a comparative effectiveness trial work to standardize the subject base. However, when applying what we have learned from the research results, we have to ask ourselves if the study's subjects are anything like our own clients. For example, study results from adult subjects may not directly apply to teenage clients. When reading the literature, paying attention to the inclusion and exclusion criteria will help you better understand to whom the results may apply. OUTCOME MEASURES The outcome measures used in a comparative effectiveness trial are based on what the researchers are interested in assessing. Some studies might be biomechanical in nature, with range of motion or gait measures being the main outcomes. Other studies may include anxiety or depression measures. The outcome measures in the Cherkin study included pain (measured by the bothersomeness scale) and disability (measured by the Roland Disability Questionnaire). These measures are paper-based, easy to use, and free, When reviewing a study, ask yourself if you are able to replicate the treatment or at least have a good sense of what was done with the subjects.