Evaluating validity of various acupuncture device types: a random sequence clinical trial.

Autor:	Jungtae Leem, Jimin Park, Gajin Han, Seulgi Eun, Makary, Meena M., Kyungmo Park, Junhee Lee, Sanghoon Lee
Předmět:	ACADEMIC medical centers ACUPUNCTURE ANALYSIS of variance CONFIDENCE intervals HEART beat HYPODERMIC needles LONGITUDINAL method PLACEBOS QUESTIONNAIRES RESEARCH evaluation T-test (Statistics) DATA analysis EQUIPMENT & supplies RANDOMIZED controlled trials REPEATED measures design BLIND experiment DESCRIPTIVE statistics
Zdroj:	BMC Complementary & Alternative Medicine; 2/2/2016, p1-8, 8p, 1 Black and White Photograph, 2 Diagrams, 1 Chart
Abstrakt:	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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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