A randomized acupuncture trial on non-specific neck/shoulder stiffness to investigate placebo and nocebo effects lurking in blind study

• Project/Area Number: 15K08938
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: General internal medicine(including psychosomatic medicine)
• Research Institution: Tokyo Ariake University of Medical and Health Sciences
• Principal Investigator: Takayama Miho 東京有明医療大学, 保健医療学部, 講師 (20563414)
• Co-Investigator(Kenkyū-buntansha): 矢嶌 裕義 東京有明医療大学, 保健医療学部, 准教授 (00563412) ; 高倉 伸有 東京有明医療大学, 保健医療学部, 教授 (60563400)
• Project Period (FY): 2015-04-01 – 2020-03-31
• Project Status: Completed (Fiscal Year 2019)
• Budget Amount: ¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000); Fiscal Year 2018: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000); Fiscal Year 2017: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000); Fiscal Year 2016: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000); Fiscal Year 2015: ¥2,340,000 (Direct Cost: ¥1,800,000、Indirect Cost: ¥540,000)
• Keywords: 鍼 / プラセボ / ダブルブラインド / 肩こり / 補完代替医療 / ノセボ効果

Outline of Final Research Achievements

It is difficult to obtain a specific efficacy of acupuncture treatments with needle penetration in clinical trials since acupuncture has a large impact to patients to induce placebo effect that is the improvement induced by patients' positive perception of the treatment. In this study, we applied double-blind real or sham needles we developed to find a specific efficacy of acupuncture to neck/shoulder stiffness patients who were told "A treatment you will receive is effective" or "A treatment you will receive is ineffective." We found the neck/shoulder stiffness in real and sham groups were similarly improved and significant decrease of improvement in patients who were told the treatment they will receive is ineffective.
The results suggest the truth of the effectiveness of acupuncture and the significance of the patient's positive perception of the treatment in it. Further studies are necessary to evaluate usefulness of acupuncture for patients' benefit in daily life.

Academic Significance and Societal Importance of the Research Achievements

従来の鍼の臨床研究では、治療にあたるはり師が、その治療が本物か偽物かを知って治療していたため、患者様がその治療者の影響を受けて治療効果を判定する可能性があった。しかし本研究では、そのような治療者の影響がない特別な鍼を用いることにより、患者様に治療効果をより正しく評価してもらうことができた。その結果、患者様が鍼の刺激感や治療効果に関する事前情報を肯定的に受け止めることが、治療をより効果的なものにする可能性を示すことができた。

Research Products

• [Int'l Joint Research] University of Illinois at Chicago/Beth Israel Deaconess Medical Center/Harvard Medical School(米国)
• [Int'l Joint Research] University of Illinois at Chicago/Beth Israel Deaconess Medical Center/Harvard Medical School(米国)
• [Int'l Joint Research] University of Illinois at Chicago/Martinos center for Biomedical Imaging/Beth Israel Deaconess Medical Center(米国)
• [Int'l Joint Research] The University of Illinois at Chicago(米国)
• [Int'l Joint Research] Martinos Center for Biomedical Imaging(米国)
• [Int'l Joint Research] Beth Israel Deaconess Medical Center(米国)
• [Int'l Joint Research] University of Illinois at Chicago(米国)
• [Journal Article] Acupuncture- And Intermittent Compression-Induced Changes in Blood Circulation of Tendon (2020)
  • Author(s): Kubo K, Iizuka Y, Yajima H, Takayama M, Takakura N.
  • Journal Title: J Altern Complement Med. Volume: 26(3) Issue: 3 Pages: 231-238
  • DOI: 10.1089/acm.2019.0345
  • Peer Reviewed
• [Journal Article] Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial (2019)
  • Author(s): Schlaeger J, Cai HY, Steffen AD, Angulo V, Shroff AR, Briller JE, Hoppensteadt D, Uwizeye G, Pauls HA, Takayama M, Yajima H, Takakura N, DeVon HA.
  • Journal Title: JMIR Res Protoc Volume: 8(7) Issue: 7 Pages: e14705-e14705
  • DOI: 10.2196/14705
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] A double-blind study on acupuncture sensations with Japanese style of acupuncture: comparison between penetrating and placebo needles. (2018)
  • Author(s): Nishiwaki M, Takayama M, Yajima H, Nasu M, Park J, Kong J, Takakura N.
  • Journal Title: Evidence-Based Complementary and Alternative Medicine Volume: 8128147 Issue: 1 Pages: 11-11
  • DOI: 10.1155/2018/8128147
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Patient blinding with blunt tip of placebo acupuncture needles: comparison between 1 mm and 2 mm skin press. (2018)
  • Author(s): Takakura N, Takayama M, Nasu M, Nishiwaki M, Kawase A, Yajima H.
  • Journal Title: Journal of Integrative Medicine Volume: 16(3) Pages: 164-171
  • Peer Reviewed
• [Journal Article] Blinding indices and blinding scenarios of practitioners and patients with acupuncture needles for double blinding. (2018)
  • Author(s): Takakura N, Takayama M, Nishiwaki M, Yajima H.
  • Journal Title: Acupunct Med Volume: 36(2) Issue: 2 Pages: 123-124
  • DOI: 10.1136/acupmed-2017-011430
  • Peer Reviewed
• [Journal Article] Double-blind and single-blind retractable placebo needles. (2018)
  • Author(s): Takakura N, Takayama M, Yajima H.
  • Journal Title: Anaesthesia Volume: 73(2) Issue: 2 Pages: 258-260
  • DOI: 10.1111/anae.14208
  • Peer Reviewed / Open Access
• [Journal Article] The Japanese version of the Massachusetts General Hospital Acupuncture Sensation Scale: A validation study. (2017)
  • Author(s): Nishiwaki M, Takayama M, Yajima H, Nasu M, Kong J, Takakura N.
  • Journal Title: Evid Based Complement Alternat Med Volume: 2017 Issue: 1 Pages: 7093967-7093967
  • DOI: 10.1155/2017/7093967
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] The Japanese version of the Massachusetts General Hospital Acupuncture Sensation Scale: A validation study (2017)
  • Author(s): Masako Nishiwaki, Miho Takayama, Hiroyoshi Yajima, Morihiro Nasu, Jian Kong, Nobuari Takakura
  • Journal Title: Evidence-Based Complementary and Alternative Medicine Volume: In Press
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Acupuncture for Menopausal Hot Flashes (2016)
  • Author(s): Nobuari Takakura, Miho Takayama, Hiroyoshi Yajima
  • Journal Title: Annals of Internal Medicine Volume: 165(6) Issue: 6 Pages: 448-449
  • DOI: 10.7326/l16-0200
  • Peer Reviewed
• [Journal Article] Acupuncture and Acupressure in Labor (2016)
  • Author(s): Judith M. Schlaeger, Elizabeth M. Gabzdyl, Jeanie L. Bussell, Nobuari Takakura, Hiroyoshi Yajima, Miho Takayama, Diana J.Wilkie
  • Journal Title: Journal of Midwifery &Women’s Health Volume: 62(1) Issue: 1 Pages: 12-28
  • DOI: 10.1111/jmwh.12545
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Is skin-touch sham needle not placebo? A double-blind crossover study on pain alleviation. (2015)
  • Author(s): Takayama M, Yajima H, Kawase A, Homma I, Izumizaki M, Takakura N.
  • Journal Title: Evidence-Based Complementary and Alternative Medicine Volume: 2015 Pages: 152086-152086
  • DOI: 10.1155/2015/152086
  • Peer Reviewed / Open Access
• [Journal Article] The difference of Park and Streitberger single-blind needles from Takakura double-blind needle. (2015)
  • Author(s): Takakura N, Takayama M, Yajima H.
  • Journal Title: Journal of Integrative Medicine Volume: 13 Issue: 4 Pages: 212-214
  • DOI: 10.1016/s2095-4964(15)60189-3
  • Peer Reviewed / Open Access
• [Presentation] 東京有明医療大学附属鍼灸センターの受療患者像 （第2報） 受療の契機となった情報の分析 (2019)
  • Author(s): 水出 靖, 木村 友昭, Chuluunbat Oyunchimeg , 高梨 知揚, 藤本 英樹, 菅原 正秋, 高山 美歩, 谷口 博志, 矢嶌 裕義, 古賀 義久, 安野 富美子, 坂井 友実
  • Organizer: 第68回（公社）全日本鍼灸学会学術大会（名古屋）
• [Presentation] eスポーツアスリートが抱える愁訴に対する鍼治療の試み プロゲーミングチームにおける活動報告 (2019)
  • Author(s): 平松耀, 高梨知揚, 矢嶌裕義, 高山美歩, 納部瑠夏, 川瀬明子, Sclaeger Judith, 高倉伸有
  • Organizer: 第68回（公社）全日本鍼灸学会学術大会（名古屋）
• [Presentation] 安全鍼および今井式クリーンニードルの安全性の検証 第2報 細菌汚染押手によるリスクについて (2019)
  • Author(s): 菅原正秋, 高山美歩, 矢嶌裕義, 高倉伸有
  • Organizer: 第68回（公社）全日本鍼灸学会学術大会（名古屋）
• [Presentation] The usefulness of acupuncture to the eSport athletes (2019)
  • Author(s): You HIRAMATSU, Tomoaki TAKANASHI, Hiroyoshi YAJIMA, Miho TAKAYAMA, Crystal L. PATIL, Judith M. SCHLAEGER, Nobuari TAKAKURA
  • Organizer: 2019 DiGRA JAPAN Summer Conference Program
• [Presentation] 脳出血後に生じた肩関節痛と運動制限に対する鍼治療の効果-表面筋電図による肩周囲筋活動の評価の有用性を示す症状- (2019)
  • Author(s): 納部瑠夏, 奈須守洋, 平松燿, 内田裕, 田中智大, 喜多村崇, 荒木美紗江, 川上桃子, 高山美歩, 高倉伸有, 矢嶌裕義
  • Organizer: 日本鍼灸学会関東支部学術集会
• [Presentation] 鍼治療が膝蓋腱血液量に及ぼす影響ーダブルブラインド用鍼を用いて (2019)
  • Author(s): 飯塚洋二朗、矢嶌裕義、高山美歩、高倉伸有、久保啓太郎
  • Organizer: 第74回日本体力医学会（茨城）
• [Presentation] 鍼感覚質問紙(日本語版MASS)を用いた鍼感覚の検討(第2報) －圧迫深度による鍼感覚の違い－ (2018)
  • Author(s): 西脇政子、矢嶌裕義、高山美歩、奈須守洋、大渕修哉、川瀬明子、平川稚佳子、高倉伸有
  • Organizer: 第67回全日本鍼灸学会学術大会
• [Presentation] 下顎部の痛みに対する鍼の効果に関する基礎的研究 －ダブルブラインド用鍼を用いて－ (2018)
  • Author(s): 大渕修哉、高山美歩、西脇政子、奈須守洋、川瀬明子、平川稚佳子、矢嶌裕義、高倉伸有
  • Organizer: 第67回全日本鍼灸学会学術大会
• [Presentation] 安全鍼および今井式クリーンニードルの安全性の検証 (2018)
  • Author(s): 菅原正秋、高山美歩、矢嶌裕義、高倉伸有
  • Organizer: 第67回全日本鍼灸学会学術大会
• [Presentation] 鍼感覚質問紙(日本語版MASS)を用いた鍼感覚の検討(第1報)－刺入深度による鍼感覚の違い－ (2017)
  • Author(s): 西脇政子、矢嶌裕義、高山美歩、奈須守洋、大渕修哉、高倉伸有
  • Organizer: 第66回全日本鍼灸学会学術大会
• [Presentation] Double-blind acupuncture needles: A multi-needle, multi-session feasibility study. (2017)
  • Author(s): Schlaeger JM, Takakura N, Yajima H, Takayama M, Steffen AD, Gabzdyl EM, Nisi RA, McGowan Gruber KM, Bussell JM, Wilkie DJ.
  • Organizer: University of Illinois at Chicago Center for Research on Women and Gender, Women's Health Research Day.
  • Int'l Joint Research
• [Presentation] No Penetrating Sensations with Japanese Acupuncture? (2016)
  • Author(s): Hiroyoshi Yajima, Miho Takayama, Akiko Kawase, Chikako Hirakawa, Nobuari Takakura
  • Organizer: WFAS Tokyo/Tsukuba 2016 (世界鍼灸学会連合会学術大会)
  • Place of Presentation: つくば国際会議場
  • Year and Date: 2016-11-05
  • Int'l Joint Research
• [Presentation] The Japanese Version of the Massachusetts General Hospital Acupuncture Sensation Scale: Validation (2016)
  • Author(s): Masako Nishiwaki, Miho Takayama, Hiroyoshi Yajima, Morihiro Nasu, Syuya Ohbuchi, Junko Hirota, Nobuari Takakura
  • Organizer: WFAS Tokyo/Tsukuba 2016 (世界鍼灸学会連合会学術大会)
  • Place of Presentation: つくば国際会議場
  • Year and Date: 2016-11-05
  • Int'l Joint Research
• [Presentation] Double-blind Acupuncture Needles: A Multineedle, Multisession Feasibility Study (2016)
  • Author(s): Judith M. Schlaeger, Nobuari Takakura, Hiroyoshi Yajima, Miho Takayama, Alana D. Steffen, Elizabeth M. Gabzdyl, Diana J. Wilkie
  • Organizer: International Association for the Study of Pain (IASP)
  • Place of Presentation: パシフィコ横浜
  • Year and Date: 2016-09-26
  • Int'l Joint Research
• [Presentation] 皮膚に接触する鍼による鎮痛効果 －ダブルブラインド法を用いて－ (2016)
  • Author(s): 高山美歩, 矢嶌裕義, 川瀬明子, 高倉伸有
  • Organizer: 第65回全日本鍼灸学会学術大会
  • Place of Presentation: 北海道 札幌コンベンションセンター
  • Year and Date: 2016-06-10
• [Presentation] ダブルブラインド用非刺入鍼による皮膚感覚と患者ブラインド効果 (2016)
  • Author(s): 奈須守洋, 高山美歩, 矢嶌裕義, 広田順子, 西脇政子, 平川稚佳子, 高倉伸有
  • Organizer: 第65回全日本鍼灸学会学術大会
  • Place of Presentation: 北海道 札幌コンベンションセンター
  • Year and Date: 2016-06-10
• [Presentation] 鍼感覚質問紙「日本語版MASS(案)」の信頼性と妥当性の検討 －合谷穴への鍼刺激によるパイロット試験－ (2016)
  • Author(s): 西脇政子, 高山美歩, 矢嶌裕義, 奈須守洋, 広田順子, 高倉伸有
  • Organizer: 第65回全日本鍼灸学会学術大会
  • Place of Presentation: 北海道 札幌コンベンションセンター
  • Year and Date: 2016-06-10
• [Presentation] ダブルブラインド用の鍼のマスキング効果 －委中穴への鍼刺激－ (2015)
  • Author(s): 脇本美優、大渕修哉、平松燿、矢嶌裕義、高山美歩、高倉伸有
  • Organizer: 第63回全日本鍼灸学会学術大会
  • Place of Presentation: ビッグパレットふくしま（福島）
  • Year and Date: 2015-05-22
• [Presentation] Double-blind (practitioner-patient masking) placebo needle 7 －鍼体の太さが術者の鍼判別に及ぼす影響－ (2015)
  • Author(s): 矢嶌裕義、高山美歩、柳沢ゆかり、平川稚佳子、川瀬明子、高倉伸有
  • Organizer: 第63回全日本鍼灸学会学術大会
  • Place of Presentation: ビッグパレットふくしま（福島）
  • Year and Date: 2015-05-22