{"title":"Evaluation of Newly Developed Sham Acupuncture Needle with a Special Focus on Needling Sensation: a Randomized Controlled Trial.","authors":"Daiyu Shinohara, Namiki Shinozaki, Ryo Takahashi, Kenji Imai","doi":"10.51507/j.jams.2023.16.1.30","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Most non-penetrating sham and placebo acupuncture needles comprise a traditional pedestal for fixing the guide tube that makes these needles difficult to operate independently. We developed a simple sham acupuncture needle to overcome this problem and focused on managing the needling sensation.</p><p><strong>Objectives: </strong>To ascertain how differently participants feel sham and real needles and to evaluate whether sham needles are effective in clinical trials.</p><p><strong>Methods: </strong>After enrolling 64 healthy volunteers who had experienced and were knowledgeable about acupuncture, the practitioner randomly used real and sham needles at four sites (bilateral LI4 and LI10) on the participants' forearms. A custom-made sham blunt stainless acupuncture needle (40 mm, 0.80 mm) that was inserted into a guide tube was used. Immediately after needling, the participants were questioned in regard to their identification of the needle, skin penetration sensation, and <i>de qi</i>.</p><p><strong>Results: </strong>The sham needle resulted in 62.5% blinding. Inequivalent sensations were elicited by the sham needles compared to the real needles. Women reported similar needling sensations from the sham and real needles.</p><p><strong>Conclusion: </strong>This study achieved comparatively higher sham-needle blinding and is therefore worthy of use in clinical trials. The mutual independence of the sham needle from the real needle was mediated presumably by interindividual differences among the participants and the needling sites. Sex differences in sensation were likely related to the blinding capability of the sham needle.</p>","PeriodicalId":46854,"journal":{"name":"Journal of Acupuncture and Meridian Studies","volume":"16 1","pages":"30-39"},"PeriodicalIF":0.9000,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Acupuncture and Meridian Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.51507/j.jams.2023.16.1.30","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Most non-penetrating sham and placebo acupuncture needles comprise a traditional pedestal for fixing the guide tube that makes these needles difficult to operate independently. We developed a simple sham acupuncture needle to overcome this problem and focused on managing the needling sensation.
Objectives: To ascertain how differently participants feel sham and real needles and to evaluate whether sham needles are effective in clinical trials.
Methods: After enrolling 64 healthy volunteers who had experienced and were knowledgeable about acupuncture, the practitioner randomly used real and sham needles at four sites (bilateral LI4 and LI10) on the participants' forearms. A custom-made sham blunt stainless acupuncture needle (40 mm, 0.80 mm) that was inserted into a guide tube was used. Immediately after needling, the participants were questioned in regard to their identification of the needle, skin penetration sensation, and de qi.
Results: The sham needle resulted in 62.5% blinding. Inequivalent sensations were elicited by the sham needles compared to the real needles. Women reported similar needling sensations from the sham and real needles.
Conclusion: This study achieved comparatively higher sham-needle blinding and is therefore worthy of use in clinical trials. The mutual independence of the sham needle from the real needle was mediated presumably by interindividual differences among the participants and the needling sites. Sex differences in sensation were likely related to the blinding capability of the sham needle.
背景:大多数非穿透性假针和安慰剂针都有一个传统的底座来固定导管,这使得这些针难以独立操作。我们开发了一种简单的假针灸针来克服这个问题,并专注于控制针刺的感觉。目的:确定参与者对假针和真针的感觉有何不同,并评估假针在临床试验中是否有效。方法:招募64名有针灸经验和知识的健康志愿者,在参与者前臂的4个部位(双侧LI4和LI10)随机使用真针和假针。使用特制的假钝不锈钢针灸针(40 mm, 0.80 mm)插入导管。在针刺后,参与者立即被问及他们对针头的识别,皮肤穿透感和德气。结果:假针致盲率为62.5%。与真针相比,假针引起的感觉是不相等的。女性表示假针和真针的针刺感相似。结论:本研究取得了较高的假针盲性,值得在临床试验中应用。假针与真针的相互独立可能是由参与者和针刺部位之间的个体差异介导的。感觉上的性别差异可能与假针头的致盲能力有关。
期刊介绍:
The Journal of Acupuncture and Meridian Studies is a quarterly, peer-reviewed journal featuring high-quality studies related to basic and clinical acupuncture and meridian research. It also includes new paradigm of integrative research, covering East–West and traditional–modern medicine. Manuscripts should fall into one of the categories: topical review, original research paper, brief ... click here for full Aims & Scope The Journal of Acupuncture and Meridian Studies is a quarterly, peer-reviewed journal featuring high-quality studies related to basic and clinical acupuncture and meridian research. It also includes new paradigm of integrative research, covering East–West and traditional–modern medicine.