Factors That Influence the Applicability of Sham Needle in... : The Clinical Journal of Pain (original) (raw)

Original Articles

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

*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: [email protected]).

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

Abstract

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