The paper introduces an innovative integrated high-thermal insulated placebo warming acupuncture device.The device includes a true warming moxibustion unit and a sham warming moxibustion unit, both of which are visually identical and consist of isolation bowl, aluminum nitride plate and tripod, with the tripod equipped with sterile double-sided silicone rubber pads. During the operation of warming acupuncture technique, the true warming acupuncture moxibustion unit generates heat conduction, and the needle tip can be inserted into the skin, while the sham unit provides thermal insulation and its blunt needle tip is lifted immediately after contacting the skin, which merely simulates the sensation of skin penetration, so as to obtain the blinding of subjects, and simultaneously isolate the effects of acupuncture and moxibustion.Twenty healthy subjects were recruited and divided into the true warming moxibustion group (10 cases) and the sham warming moxibustion group (10 cases). The true warming moxibustion unit and the sham warming moxibustion unit were respectively used for moxibustion at the Shousanli (LI10) point on the right side. YM-HW-I medical infrared thermography system was used to capture infrared thermal images of the right upper limb of the healthy subjects to observe the changes in the surface temperature of the area where Shousanli (LI10) is located. The results showed that compared with baseline (before warming acupuncture operated), in the true warming moxibustion group, the temperature at the right Shousanli (LI10)increased during the initial 9 minutes following the operation, and the mean temperature in the area within a diameter of 1 cm rose from the first 1 minute to 8 minutes after needling (P<0.05). In the sham warming moxibustion group, except that the temperature at the acupoint and the mean temperature in the area within the diameter of 1 cm was elevated after the first 3 minutes following needling and after the first 4 minutes respectively (P<0.05), the increase of temperature at the other time points was not significant (P>0.05). These findings indicate that the sham warming moxibustion device can effectively isolate most of the heat generated during moxibustion combustion, block the photothermal effects of moxibustion and basically eliminates its therapeutic effects, thereby meeting the design requirements of placebo warm needling device. 介绍一款创新设计的一体式高隔热安慰温针灸装置。该装置包括真温灸器与假温灸器,两者外观完全一致,均由隔离碗、氮化铝板及三角脚撑组成,三角脚撑配备带无菌双面胶垫的硅橡胶脚蹼。施温针灸时,真温灸器导热,针尖可以刺入皮肤;假温灸器隔热,钝头针尖抵皮肤后立即抬起,仅模拟针刺破皮感,以对受试者设盲,同时隔绝针刺与艾灸效应。招募20例健康受试者,分为真温针灸组(10例)和假温针灸组(10例),分别使用真温灸器、假温灸器于右侧手三里施灸,采用YM-HW-I医用红外热像仪拍摄健康受试者右上肢红外热成像图,观察右侧手三里穴区域体表温度变化。结果显示:与温针灸前比较,真温针灸组健康受试者在温针灸第0~9分钟时右侧手三里穴点温度、第1~8分钟时直径1 cm区域内平均温度均升高(P<0.05);假温针灸组除温针灸第3分钟时右侧手三里穴点温度、第4分钟时直径1 cm区域内平均温度升高外(P<0.05),其余时间点均无明显升高(P>0.05)。表明假温灸器能有效隔绝艾灸燃烧时的大部分热量,阻断艾灸的光热效应,基本排除其治疗效果,从而满足安慰温针灸的设计要求。.