| Project/Area Number |
16K09266
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
General internal medicine(including psychosomatic medicine)
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| Research Institution | Tokyo Ariake University of Medical and Health Sciences |
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Principal Investigator |
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| 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)
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| Project Period (FY) |
2016-04-01 – 2021-03-31
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| Project Status |
Completed (Fiscal Year 2020)
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| Budget Amount *help |
¥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)
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| 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 |
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| 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.
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| 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。
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