Abstract
BackgroundAlthough various placebo acupuncture devices have been developed and used in acupuncture research, there is controversy concerning whether these devices really serve as appropriate placebos for control groups.Methods/DesignThe proposed study is a single-center prospective random sequence participant- and assessor-blinded trial with two parallel arms. A total of 76 participants will be randomly assigned to Group 1 or Group 2 in a 1:1 ratio. Group 1 will consist of Sham Streitberger’s needle, Real Streitberger’s needle, and Phantom acupuncture session. Group 2 will consist of Park Sham device with real needle, Park Sham device with sham needle, and no treatment session. Participants will have a total of three acupuncture sessions in a day. The primary endpoint is blinding test questionnaire 1. Secondary endpoints are the Bang’s blinding index, the Massachusetts General Hospital Acupuncture Sensation Scale index, and physiological data including heart rate, heart rate variability, and skin conductance response.DiscussionThis trial will evaluate the relevance of using placebo acupuncture devices as controls using a validation test procedure.Trial registrationClinical Research Information Service: KCT0001347.
Highlights
Various placebo acupuncture devices have been developed and used in acupuncture research, there is controversy concerning whether these devices really serve as appropriate placebos for control groups
This trial will evaluate the relevance of using placebo acupuncture devices as controls using a validation test procedure
This trial was designed to investigate if various placebo acupuncture devices are appropriate for control groups in acupuncture research
Summary
This trial was designed to investigate if various placebo acupuncture devices are appropriate for control groups in acupuncture research. Streitberger et al performed a validation study that investigated if acupuncture- naïve healthy participants (n = 60) could feel the difference between a real acupuncture needle and a placebo acupuncture device [3]. They found that PSD was indistinguishable and inactive (in terms of de-qi), it is a valid placebo control for acupuncture research These previous two devices touch the skin and induce a physiological effect. By measuring blinding, de-qi sensation, and various physiological parameters such as HR, HRV, and SCR, we will investigate if placebo acupuncture techniques are indistinguishable from real acupuncture and physiologically inert This trial will evaluate the relevance of using placebo acupuncture devices in control groups using a validation test of various placebo acupuncture devices that have been used in acupuncture research.
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