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

Abstract

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 (P < 0.05) 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.

Introduction of two novel devices for investigating the influence of non-mechanical components such as therapeutic qi in acupuncture

“…Thus, tools like placebo needles have been invented to investigate whether penetrating the skin has any effect on outcome parameters in patients or healthy volunteers while blinding the patients [8,33] . Some of these placebo needles are designed in such a way that the acupuncturist himself can be blinded [9,28,[34][35][36] . Mechanical factors are proposed to be responsible for the therapeutic effect of acupuncture [10] , and methods have been developed to quantify the displacement and rotation during needling [12] .…”

“…Traditional Chinese medicine (TCM) diagnosis, TCM pattern [1][2][3] Meridians [4][5][6] Acupuncture points [1,4,6,7] Needle insertion (except for laser acupuncture) [8,9] Needle stimulation (mechanical or electrical or laser) [1,[10][11][12] De qi (perceived by patient) [1,[13][14][15][16] Needle grasp (perceived by acupuncturist) [10] Number of needles [17] Needle retention time [1,14] Non-specific for acupuncture Patient's expectations or belief [14,18,19] Acupuncturist's expectations or belief [18,20] Acupuncturist's intention [21] Communication [22][23][24] Therapeutic relationship [22] Acupuncturist's skills and experience [1,23] Cultural background [25] Number or frequency of treatments [1] Placebo effects [26,27] Journal of Integrative Medicine intensively moving the needle handle, the movement of the needle on the inside of the Veliusator was monitored by the sensor.…”

“…Two common strategies for investigating the specific effects of inserting needles at acupuncture points are placebo needles, and sham needling. Researchers invented placebo needles [8,9,28] , whereby the needles appear to penetrate the subject's skin upon use, but in fact they do not actually penetrate the skin. Sham points, or so-called nonacupuncture points, do not lie on meridians and have been used as controls.…”

The N-of-1 Clinical Trial: A Timely Research Opportunity in Homeopathy

“…The authors attributed the modest effects to the small dose of Valerian investigated. 52 Several articles have reported the use of N-of-1 trials in Traditional Chinese Medicine (TCM) [53][54][55][56][57] and in Japanesestyle acupuncture. 58,59 The TCM studies variously addressed the difficulties of optimising treatment and washout periods, 55,56 autocorrelation, repeated-measures analysis, and acute exacerbation of symptoms.…”

The Essential Guide to N-of-1 Trials in Health

“…Recently several articles have been published by Chinese groups about using N-of-1 trials for Traditional Chinese Medicine (TCM) Huang et al 2014 ). They may be suitable for trials of acupuncture using a sham needle (Lee et al 2012 ). N-of-1 trials are uniquely suited to the individualized nature of TCM, though limited information about the half-lives of some of these medicines make estimating the length of each treatment period and washout periods, and therefore trial length, diffi cult.…”