Evaluation of Newly Developed Sham Acupuncture Needle with a Special Focus on Needling Sensation: a Randomized Controlled Trial.

Background: Most non-penetrating sham and placebo acupuncture needles comprise a traditional pedestal for fixing the guide tube that makes these needles difficult to operate independently. We developed a simple sham acupuncture needle to overcome this problem and focused on managing the needling sensation.

Objectives: To ascertain how differently participants feel sham and real needles and to evaluate whether sham needles are effective in clinical trials.

Methods: After enrolling 64 healthy volunteers who had experienced and were knowledgeable about acupuncture, the practitioner randomly used real and sham needles at four sites (bilateral LI4 and LI10) on the participants' forearms. A custom-made sham blunt stainless acupuncture needle (40 mm, 0.80 mm) that was inserted into a guide tube was used. Immediately after needling, the participants were questioned in regard to their identification of the needle, skin penetration sensation, and de qi.

Results: The sham needle resulted in 62.5% blinding. Inequivalent sensations were elicited by the sham needles compared to the real needles. Women reported similar needling sensations from the sham and real needles.

Conclusion: This study achieved comparatively higher sham-needle blinding and is therefore worthy of use in clinical trials. The mutual independence of the sham needle from the real needle was mediated presumably by interindividual differences among the participants and the needling sites. Sex differences in sensation were likely related to the blinding capability of the sham needle.