Systematic Review Protocol for Sham Acupuncture Validation Research

Abstract

Background: Streitberger and Park sham needles have been developed and used as non-penetrating sham acupuncture needles that can be blinded in randomized controlled clinical trials assessing the efficacy of acupuncture. Ideal sham acupuncture should not be distinguishable from an actual acupuncture treatment provided to the experimental group to ensure patient blinding; additionally, it should not have any physiological or biological effect. Providing evidence for such sophisticated sham acupuncture devices is critical, as control settings in clinical studies are based on research verifying their validity.Methods: Three core electronic databases - PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials - will be used to search for validity verification studies of sham acupuncture devices. Clinical studies that verify the validity of non-penetrating sham acupuncture devices will be included in the review.Results: The study design, participant information, experimental and control groups, study population’s experience with acupuncture, outcome variables, and results of studies that verify the validity of sham acupuncture devices will be systematically reviewed.Conclusion: This systematic review of validity verification studies of sham acupuncture devices is expected to help the development of more sophisticated sham acupuncture, as well as the design of studies verifying its validity in the future.