Design of a randomised acupuncture trial on functional neck/shoulder stiffness with two placebo controls

BMC Complementary and Alternative Medicine

Hiroyoshi Yajima¹  Jian Kong³  Ted J Kaptchuk²  Akiko Kawase¹  Miho Takayama¹  Nobuari Takakura¹ 

[1]Japan School of Acupuncture, Moxibustion, and Physiotherapy, 20-1 Sakuragaokacho, Shibuya-ku, Tokyo, Japan

[2]Program in Placebo Studies & Therapeutic Encounter, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA 02215, USA

[3]Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA

关键词: Randomised, placebo-controlled trial;    Double-blind;    Neck stiffness, Shoulder stiffness;    Placebo;    Acupuncture;   

Others  :  1087331
DOI  :  10.1186/1472-6882-14-246

 received in 2014-01-26, accepted in 2014-07-09,  发布年份 2014

【 摘 要 】

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”.

Discussion

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.

Trial registration

Current Controlled Trial ISRCTN76896018

【 授权许可】

   
2014 Takakura et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]Ministry of Health, Labour and Welfare: Comprehensive survey of living conditions: Rate of persons with subjective symptoms (per 1000 population) by type of symptoms, sex and age group (multiple answer). 2007. http://www.mhlw.go.jp/english/database/db-hss/cslc-tables.html webcite Accessed Dec 30, 2013)
• [2]Jimbo S, Stsuta Y, Lobayashi T, Matsuno T: Effects of dry needling at tender points for neck pain (Japanese: katakori): near-infrared spectroscopy for monitoring muscular oxygenation of the trapesius. J Orthop Sci 2008, 13:101-106.
• [3]Oda H: Acupuncture remedy on the trapezius stiffness (In Japanese). Pain Clinic 1990, 11:325-332.
• [4]Pomeranz B, Berman B: Scientific basis of acupuncture. In Basics of acupuncture. 5th edition. Edited by Stux G, Berman B, Pomeranz B. New York: Springer-Verlag; 2003:51-55. 146-148,242
• [5]Leknes S, Tracey I: A common neurobiology for pain and pleasure. Nat Rev Neurosci 2008, 9:314-320.
• [6]Kubo K, Yajima H, Takayama M, Ikebukuro T, Mizoguchi H, Takakura N: Effects of acupuncture and heating on blood volume and oxygen saturation of human Achilles tendon in vivo. Eur J Appl Physiol 2010, 109(3):545-550.
• [7]Kubo K, Yajima H, Takayama M, Ikebukuro T, Mizoguchi H, Takakura N: Changes in blood circulation of the contralateral Achilles tendon during and after acupuncture and heating. Int J Sports Med 2011, 32(10):807-813.
• [8]Yajima H, Takakura N, Takayama M, Kawase A, Homma I, Izumizaki M: Inhibitory effect of acupuncture on vibration-induced finger flexion reflex in human - Comparison between radial, median, ulnar nerve stimulation. Med Acupunct 2013, 25(4):269-274.
• [9]Singh S, Ernst E: Trick or treatment? Alternative medicine on trial. Great Britain: Transworld publishers; 2008:55-114.
• [10]Streitberger K, Kleinhenz J: Introducing a placebo needle into acupuncture research. Lancet 1998, 352:364-365.
• [11]Park J, White A, Lee H, Ernst E: Developing of a new sham needle. Acupunct Med 1999, 17:110-112.
• [12]Park J, White A, Stevinson C, Ernst E, James M: Validating a new non-penetrating sham acupuncture device: Two randomized controlled trials. Acupunct Med 2002, 20:168-174.
• [13]Fink M, Gutenbrunner C, Rollnik J, Karst M: Credibility of a newly designed placebo needle for clinical trials in acupuncture research. Forsch Komplementarmed Klass Naturheilkd 2001, 8:368-372.
• [14]Kaptchuk TJ: Placebo needle for acupuncture [Comment]. Lancet 1998, 352(9132):992.
• [15]Kaptchuk TJ: Methodological issues in trials of acupuncture [Comment]. JAMA 2001, 285:1015-1016. author reply 1016
• [16]Shapiro AK, Shapiro E: The powerful placebo: from ancient priest to modern physician. London, UK: The Johns Hopkins University Press; 1997:137-174. 190–216
• [17]Shapiro AK, Shapiro E: The placebo: is it much ado about nothing? In The placebo effect: an interdisciplinary exploration. Edited by Harrington A. Cambridge, Massachusetts, London, England: Harvard University Press; 1997:12-36.
• [18]Gracely RH, Dubener R, Deeter WR, Wolskee PJ: Clinicians’ expectations influence placebo analgesia. Lancet 1985, 15:43.
• [19]Turner JA, Deyo RA, Losser JD, Korff MV, Fordyce WE: The importance of placebo effects in pain treatment and research. JAMA 1994, 271:1609-1614.
• [20]Kenneth FS, Iain C, Richard JH, Douglas GA: Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995, 273:408-412.
• [21]Miller FG, Kaptchuk TJ: Sham procedures and the ethics of clinical trials. J Roy Soc Med 2004, 97:576-578.
• [22]Advances in double-blind research: A new needle may help investigators eliminate bias when evaluating the benefits of acupuncture treatment Acupuncture Today 2007, 8:12. www.acupuncturetoday.com/mpacms/at/article.php?id=31625 webcite Accessed on Dec 27, 2013
• [23]Takakura N, Yajima H: A double-blind placebo needle for acupuncture research. BMC Complement Altern Med 2007, 7:31. BioMed Central Full Text
• [24]Takakura N, Takayama M, Kawase A, Yajima H: Double-blind acupuncture needling: Does patient reaction reveal needle authenticity? Med Acupunct 2008, 20(3):169-174.
• [25]Takakura N, Yajima H: A placebo acupuncture needle with potential for double blinding - a validation study. Acupunct Med 2008, 26(4):224-230.
• [26]Takakura N, Yajima H: Analgesic effect of acupuncture needle penetration: a double-blind crossover study. Open Med 2009, 3(2):54-61.
• [27]Takakura N, Takayama M, Kawase A, Kaptchuk TJ, Yajima H: Double blinding with a new placebo needle: a further validation study. Acupunct Med 2010, 28(3):144-148.
• [28]Takakura N, Takayama M, Kawase A, Yajima H: Double blinding with a new placebo needle: a validation study on participant blinding. Acupunct Med 2011, 29(3):203-207.
• [29]Takakura N, Takayama M, Kawase A, Yajima H: Tapping-in method (skin penetration technique) with a placebo needle for double-blind acupuncture trials. J Altern Complement Med 2012, 19(4):308-312.
• [30]Takakura N: Effect of acupuncture treatment on stiff neck. Current Controlled Trial 2011. http://controlled-trials.com/ISRCTN76896018/ webcite
• [31]Zhu D, Gao Y, Chang J, Kong J: Placebo acupuncture devices: considerations for acupuncture research. Evid Based Complement Alternat Med 2013, 2013:628907.
• [32]WHO Regional Office for the Western Pacific: WHO standard acupuncture point locations in the Western Pacific Region. WHO Western Pacific Region, Geneva: Swiss Confederation; 2008:94,95,120,182.
• [33]Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA: A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med 2009, 169(9):858-866.