Objective : To develop a sham needle, which is applicable to clinical trials on acupuncture and test its credibility.
Methods : The Park Sham Needle' unit was developed. The apparatus consists of a blunt needle, the shaft of which telescopes into the handle when tapped, so that while the needle appears to have been inserted, it does not actually pierce the skin, and a Park Tube' that is composed of a standard guide tube and an oversize guide tube with a plastic flange at one end which adheres to the skin with double-sided sticky tape. The needle is held in place by the Park Tube. In a credibility test, 56 subjects received our new sham needle on the left LI-4 acupoint and were asked whether or not they felt the needle being inserted into the skin.
Results : Forty-six subjects (82%) were convinced that they received real needle insertion.
Conclusion : Park Sham Needle seems to be applicable to randomised, subject-blinded, and controlled trials on acupuncture.