Design of a randomised acupuncture trial on functional neck/shoulder stiffness with two placebo controls
1 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
2 Department of Physiology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
3 Japan School of Acupuncture, Moxibustion, and Physiotherapy, 20-1 Sakuragaokacho, Shibuya-ku, Tokyo, Japan
4 Program in Placebo Studies & Therapeutic Encounter, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA 02215, USA
5 Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA
BMC Complementary and Alternative Medicine 2014, 14:246 doi:10.1186/1472-6882-14-246Published: 16 July 2014
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.
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”.
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.
Current Controlled Trial ISRCTN76896018