title: Design of a randomised acupuncture trial on functional neck/shoulder stiffness with two placebo controls.
abstract: BACKGROUND
  Functional neck/shoulder stiffness is one of the most well-known indications for acupuncture treatment in Japan. There is little evidence for the effectiveness of acupuncture treatment for functional neck/shoulder stiffness. Research using two different placebos may allow an efficient method to tease apart the components of real acupuncture from various kinds of 'non-specific' effects such as ritual with touch or ritual alone. Herein, we describe a protocol of an ongoing, single-centre, randomised, placebo-controlled trial which aims to assess whether, in functional neck/shoulder stiffness, acupuncture treatment with skin piercing has a specific effect over two types of placebo: skin-touching plus ritual or ritual alone.
  
  
  METHODS
  Six acupuncturists and 400 patients with functional neck/shoulder stiffness are randomly assigned to four treatment groups: genuine acupuncture penetrating the skin, skin-touch placebo or no-touch placebo needles in a double-blind manner (practitioner-patient blinding) or no-treatment control group. Each acupuncturist applies a needle to each of four acupoints (Bladder10, Small Intestine14, Gallbladder21 and Bladder42) in the neck/shoulder to 50 patients. Before, immediately after and 24 hours after the treatment, patients are asked about the intensity of their neck/shoulder stiffness. After the treatment, practitioners and patients are asked to guess whether the treatment is "penetrating", "skin-touch" or "no-touch" or to record "cannot identify the treatment".
  
  
  CONCLUSIONS
  In addition to intention-to-treat analysis, we will conduct subgroup analysis based on practitioners' or patients' guesses to discuss the efficacy and effectiveness of treatments with skin piercing and various placebo controls. The results of practitioner and patient blinding will be discussed. We believe this study will further distinguish the role of different components of acupuncture.
  
  
  BACKGROUND
  Current Controlled Trial ISRCTN76896018.
authors.affiliation: Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo 135-0063, Japan. takakura@tau.ac.jp.
authors.forename: Nobuari
authors.initials: N
authors.lastname: Takakura
authors.forename: Miho
authors.initials: M
authors.lastname: Takayama
authors.forename: Akiko
authors.initials: A
authors.lastname: Kawase
authors.forename: Ted J
authors.initials: TJ
authors.lastname: Kaptchuk
authors.forename: Jian
authors.initials: J
authors.lastname: Kong
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Yajima
mesh_terms: D015669:Acupuncture Points; D015670:Acupuncture Therapy / Q000379:methods*; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009334:Neck Muscles / Q000503:physiopathology*; D019547:Neck Pain / Q000628:therapy*; D012785:Shoulder Joint / Q000503:physiopathology*; D020069:Shoulder Pain / Q000628:therapy*; D055815:Young Adult