Park and the colleagues, who developed, state that this device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects and inactive, where the specific needle sensation is taken as a surrogate measure of activity. However, due to the nature of minimal physiological activity required to achieve successful subject blinding in acupuncture trial, they emphatically call for caution in the application of sham acupuncture control and interpretation of the findings.
The Park Sham Device consists of 2 plastic tubes, one of which slides into the other. These are attached to a base, which is formed of a flat disc. On the bottom of this is a double sided sticky circle to facilitate placement on the skin. All the constituents’ part is manufactured in theRepublic of Korea. Acupuncture needles are supplied with the Park Sham Device. %0% of these are blunt sham needles. The others are normal acupuncture needles. These are registered in the European Union as CE 0120 and in theUnited States of America FDA License No.263.
The intended use is the investigation of the efficacy of acupuncture in the treatment of illness and pain. These will be disposed of after use in the usual way for used sharp medical products. They will be collected in a suitable “sharps container” and incinerated by a company licensed to deal with this kind of waste.
How to use the Park Sham Device. Currently, either real or sham needles are packed in a single guide tube in a blister package. To avoid compromising the sterilisation you could peel off only the top of the package to expose the handle of the needle. Then introduce that handle through the bottom of the plastic flange. After introducing the handle you tilt the needle and Park tube over to allow the needle to slide down to the other end of the tube. Then you will be able to hold the needle handle together with the top end of the Park tube. After this, peel off the cover of the double-sided sticky tape and place the device on the skin while keeping the needle handle projecting about 5 mm from the top of the Park tube.
Tap the needle gently to insert it about 5 mm followed by moving down the upper telescopic guide tube to allow sufficient exposure of the handle for manipulation of the needle. Manipulate the needle as desired. To remove: first, take out the needle and dispose of it safely, then peel the flange from the skin, with the guide tube in place. Doing this quickly will minimise discomfort.