Is acupuncture really effective on neck/shoulder stiffness? Randomized double-blind placebo controlled clinical trials.

• Project/Area Number: 16K09266
• 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: Takakura Nobuari 東京有明医療大学, 保健医療学部, 教授 (60563400)
• 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) ; 高山 美歩 東京有明医療大学, 保健医療学部, 講師 (20563414)
• Project Period (FY): 2016-04-01 – 2021-03-31
• Project Status: Completed (Fiscal Year 2020)
• Budget Amount: ¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000); Fiscal Year 2019: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000); Fiscal Year 2018: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2017: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000); Fiscal Year 2016: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
• Keywords: 鍼 / プラセボ / ダブルブラインド / 肩こり / 補完代替医療 / ランダム化比較試験

Outline of Final Research Achievements

Participants with neck/shoulder stiffness were randomly assigned to four treatment groups: 1) 10 mm penetrating needles; 2) 2 mm skin-press placebo needles; 3) skin-touch placebo needles; or, 4) no-touch placebo needles. There was a clinically meaningful reduction in neck/shoulder stiffness in all four treatment groups. There were no significant differences in blood circulation and muscle activities in the associated stiff muscles between the four groups after treatment. The penetrating needle group showed a significantly greater improvement in neck/shoulder stiffness compared to the skin-touch and no-touch placebo, but not the 2 mm skin-press placebo groups. Findings may indicate that skin-touch and no-touch needles can be used as placebos. It is unclear if the 2 mm skin-press needles may be used as placebo. Studies on the effects of placebo needles are needed so they can be compared to effects of penetrating needles. This will enable determination of the true effect of acupuncture.

Academic Significance and Societal Importance of the Research Achievements

本研究は、これまで不可能とされていた二重盲検用の「刺さる鍼と、皮膚に刺さらないプラセボ鍼」を用いた、エビデンスレベルの高い厳格な臨床試験である。
本研究から、鍼治療はプラセボ効果を含む可能性があることが明らかになったが、皮膚に刺さらないプラセボ鍼治療でさえも、患者にとって意義のある程度の肩こり改善効果があることがわかった。この結果は、今後の鍼研究における「プラセボ鍼」の定義や効果の解釈、実際の「鍼治療」の効果の本質の検討に貢献し、患者にとって有益な治療方法の情報提供を行い、社会に正しいエビデンスを発信する指針作りに役立つと考えている。

Research Products

• [Int'l Joint Research] University of Illinois Chicago/Beth Israel Medical Center/Martinos Center for Biomedical Imaging(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/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)
• [Journal Article] Effects on Acupuncturist Blinding: Different Diameters of Double-blind Acupuncture Needles. (2020)
  • Author(s): Yajima H, Takayama M, Nasu M, Nishiwaki M, Kawase A, Hiramatsu Y, Nobe R, Schlaeger JM, Takakura N.
  • Journal Title: Alternative Therapies in Health and Medicine Volume: Online ahead of print.
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources. (2020)
  • Author(s): Alana D Steffen, Larisa A Burke, Heather A Pauls, Marie L Suarez, Yingwei Yao, William H Kobak, Miho Takayama, Hiroyoshi Yajima, Ted J Kaptchuk, Nobuari Takakura, Diana J Wilkie, Judith M Schlaeger
  • Journal Title: Clinical Trials Volume: 17(5) Issue: 5 Pages: 545-551
  • DOI: 10.1177/1740774520934910
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Changes in blood circulation of the tendon and heart rate variability during and after acupuncture (2020)
  • Author(s): Kubo K, Iizuka Y, Yajima H, Takayama M, Takakura N
  • Journal Title: Medical Acupuncture Volume: 32(2) Issue: 2 Pages: 99-107
  • DOI: 10.1089/acu.2019.1397
  • Peer Reviewed / Open Access
• [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 for post-stroke shoulder pain: a case report. (2020)
  • Author(s): Hiroyoshi Yajima, Miho Takayama, Ruka Nobe, Judith M Schlaeger, Nobuari Takakura
  • Journal Title: Acupuncture in Medicine Volume: 38(6) Issue: 6 Pages: 446-448
  • DOI: 10.1177/0964528420920292
  • Peer Reviewed / Int'l Joint Research
• [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: The Journal of Alternative and Complementary Medicine Volume: －
  • 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
• [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] 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
  • Int'l Joint Research / Invited
• [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例－ (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: 2019 第38回 （公社）全日本鍼灸学会 関東支部学術集会
• [Presentation] eスポーツ選手が抱える愁訴と鍼灸治療の有用性の検討-プロゲーマーに対するインタビュー調査- (2019)
  • Author(s): 平松 燿, 高梨知揚, 矢嶌裕義, 高山美歩, Crystal L. Patil, Judith M. Schlaeger, 高倉伸有
  • Organizer: 日本デジタルゲーム学会第9回年次大会
• [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] 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 (2018)
  • Author(s): 奈須守洋、高山美歩、矢嶌裕義、西脇政子、平川稚佳子、高倉伸有
  • Organizer: 第37回全日本鍼灸学会関東支部学術集会
• [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