title: Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects.
abstract: OBJECTIVE
  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 inter-tester variability but also the patient's knowledge and experience of acupuncture, acupuncture point selection, the visual impact of needling, and so on.
authors.affiliation: Tsukuba College of Technology Clinic, Tsukuba City, Japan. tsukayama@k.tsukuba-tech.ac.jp
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsukayama
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Yamashita
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Kimura
authors.forename: Kuniharu
authors.initials: K
authors.lastname: Otsuki
mesh_terms: D015670:Acupuncture Therapy / Q000295:instrumentation* / Q000379:methods / Q000523:psychology*; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009339:Needles; D017063:Outcome Assessment, Health Care; D059408:Pain Management; D010147:Pain Measurement; D010465:Perception; D010919:Placebos; D015203:Reproducibility of Results; D016037:Single-Blind Method
chemical_list: D010919:Placebos