Published in:
Open Access
01-12-2015 | Study protocol
Evaluating validity of various acupuncture device types: a random sequence clinical trial
Authors:
Jungtae Leem, Jimin Park, Gajin Han, Seulgi Eun, Meena M. Makary, Kyungmo Park, Junhee Lee, Sanghoon Lee
Published in:
BMC Complementary Medicine and Therapies
|
Issue 1/2016
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Abstract
Background
Although 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/Design
The 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.
Discussion
This trial will evaluate the relevance of using placebo acupuncture devices as controls using a validation test procedure.
Trial registration
Clinical Research Information Service:
KCT0001347.