Abstract
BackgroundFunctional 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.MethodsSix 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”.DiscussionIn 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.Trial registrationCurrent Controlled Trial ISRCTN76896018
Highlights
Functional neck/shoulder stiffness is one of the most well-known indications for acupuncture treatment in Japan
The acupuncture needles We use three types of needles sterilized with gaseous ethylene oxide for a double-blind study design: 1) penetrating needles that can pierce the skin; 2) skin-touch placebo needles, the tip of which can touch against the skin but cannot penetrate it; 3) no-touch placebo needles, the tip of which cannot reach the skin
Discussion acupuncture treatment has been administrated for thousands of years, the crucial components of acupuncture remain unclear [33]
Summary
Functional neck/shoulder stiffness is one of the most well-known indications for acupuncture treatment in Japan. There is little evidence for the efficacy of acupuncture treatment for functional neck/shoulder stiffness, and no randomised, placebo-controlled trials (RCTs) investigating acupuncture under double-blind (practitioner-patient) conditions has been reported. The gold standard was considered almost impossible to achieve because blinding an acupuncturist is very difficult due to the nature of the procedure [10,11,12,13,14,15] To solve this methodological difficulty, we designed two types of non-penetrating placebo needles: one where the tip touches the skin (skin-touch placebo needles), and another where the needle tip does not reach the skin (no-touch placebo needles). Our two placebos will allow disentanglement to what extent skin-touching plus ritual or ritual alone contributes to the non-specific effects of placebo acupuncture and allow for a precise estimate of the mechanism whereby acupuncture may work in clinical practice
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