[Design and development of integrated high-thermal insulated placebo warming acupuncture device]

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.