Int J Osteopath Med
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Int J Osteopath Med · Mar 2024
Meta-epidemiologic review: blinding and sham treatment in clinical trial design for osteopathic manipulative treatment research.
To analyze the consistency of study designs in osteopathic manipulative treatment (OMT) research, focusing on blinding protocols and the use of sham treatments. ⋯ Strict double-blinding is achievable for OMT clinical research by blinding the subjects and data collectors/analyzers rather than the osteopaths providing the actual treatment. The use of questionnaires to determine the success of blinding should be considered. Additionally, including OMT-naïve subjects is preferred to enhance blinding success. When designing a sham treatment, careful consideration should be given to blinding the data collector, accounting for the placebo effect, and incorporating an additional no-treatment control group to improve the rigor of the study design.