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Evidence-Based Complementary and Alternative Medicine
Volume 2012 (2012), Article ID 507937, 7 pages
Research Article

Validation Study of Kim's Sham Needle by Measuring Facial Temperature: An N-of-1 Randomized Double-Blind Placebo-Controlled Clinical Trial

1Division of Standard Research, Acupuncture, Moxibustion and Meridian Research Center, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
2Department of Acupuncture and Moxibustion, Wonkwang University Oriental Medicine Hospital, Gwangju, Republic of Korea

Received 7 September 2011; Revised 7 November 2011; Accepted 18 November 2011

Academic Editor: Vitaly Napadow

Copyright © 2012 Sanghun Lee et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Introduction. In 2008, Kim's sham needle was developed to improve the quality of double-blinded studies. The aim of this study is to validate Kim's sham needle by measuring facial temperature. Methods. We designed “N-of-1” trials involving 7 smokers. One session was composed of 2 stimulations separated by a 2 h washout period. Six sessions were applied daily for all subjects. Infrared thermal imaging was used to examine the effects of acupuncture (HT8, KI2) on facial temperature following smoking-induced decrease. Results. All subjects demonstrated decreased temperatures after sham needle treatment, but 5 of the 7 subjects showed increased temperatures after real needle treatment. 6 of the 7 subjects showed a significant difference between treatments with real and sham needles. Thus, the physiological stimulation of Kim's sham needle is different from that of a real needle, suggesting that Kim's sham needle is a potential inactive control intervention.