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Factors That Influence the Applicability of Sham Needle in Acupuncture Trials: Two Randomized, Single-Blind, Crossover Trials With Acupuncture-Experienced Subjects

Tsukayama, Hiroshi MPh*; Yamashita, Hitoshi PhD*; Kimura, Tomoaki PhD; Otsuki, Kuniharu BS*

The Clinical Journal of Pain: May 2006 - Volume 22 - Issue 4 - p 346-349
doi: 10.1097/01.ajp.0000176359.94644.mL
Original Articles
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Objectives In recent years the retractable type of sham needle has been anticipated to be a possible solution for masking patients in acupuncture research. However, this needle has been intended mainly for acupuncture-naïve subjects. The authors’ goal in this study was to assess the validity of the retractable type of sham needle.

Methods The authors conducted two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Different acupuncture points were used in each trial (a LI-4 trial and a BL-23 trial). The subjects received two sessions of different stimulations in each trial. A Park Sham Needle was used in one session, a genuine acupuncture needle in the other.

Results In the LI-4 trial, all of the 21 subjects (100%) felt penetration with the genuine needle, but only 7 of the 20 subjects (35%) felt a similar sensation with the sham needle (P=0.0002). Fifteen of the 21 subjects (71%) felt a dull sensation with the genuine needle, but only 4 of the 20 subjects (20%) felt a similar sensation with the sham needle (P=0.01). In the BL-23 trial, 14 of the 20 subjects (70%) felt penetration with the genuine needle and 10 of the 20 subjects (50%) felt “penetration” with the sham needle (P=0.39). Eight of the 20 subjects (40%) felt a dull sensation with the genuine needle and 2 of the 20 subjects (10%) did with the sham needle (P=0.109).

Conclusions Potential factors that influence the applicability of “placebo” needling include not only intertester variability but also the patient's knowledge and experience of acupuncture, acupuncture point selection, the visual impact of needling, and so on.

*Tsukuba College of Technology Clinic, Tsukuba City, Japan

Department of Acupuncture, Tsukuba College of Technology, Tsukuba City, Japan

Reprints: Hiroshi Tsukayama, Tsukuba College of Technology Clinic, 4-12-7 Kasuga, Tsukuba-City, 305-0821 Japan (e-mail: tsukayama@k.tsukuba-tech.ac.jp).

Received for publication August 18, 2004; revised May 1, 2005; accepted June 21, 2005

© 2006 Lippincott Williams & Wilkins, Inc.