title: Evaluating validity of various acupuncture device types: a random sequence clinical trial.
abstract: BACKGROUND
  Although various placebo acupuncture devices have been developed and used in acupuncture research, there is controversy concerning whether these devices really serve as appropriate placebos for control groups.
  
  
  METHODS
  The proposed study is a single-center prospective random sequence participant- and assessor-blinded trial with two parallel arms. A total of 76 participants will be randomly assigned to Group 1 or Group 2 in a 1:1 ratio. Group 1 will consist of Sham Streitberger's needle, Real Streitberger's needle, and Phantom acupuncture session. Group 2 will consist of Park Sham device with real needle, Park Sham device with sham needle, and no treatment session. Participants will have a total of three acupuncture sessions in a day. The primary endpoint is blinding test questionnaire 1. Secondary endpoints are the Bang's blinding index, the Massachusetts General Hospital Acupuncture Sensation Scale index, and physiological data including heart rate, heart rate variability, and skin conductance response.
  
  
  CONCLUSIONS
  This trial will evaluate the relevance of using placebo acupuncture devices as controls using a validation test procedure.
  
  
  BACKGROUND
  Clinical Research Information Service: KCT0001347 .
authors.affiliation: Korean Medicine Clinical Trial Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.|Department of Clinical Research of Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
authors.forename: Jungtae
authors.initials: J
authors.lastname: Leem
authors.affiliation: Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea.
authors.forename: Jimin
authors.initials: J
authors.lastname: Park
authors.affiliation: Korean Medicine Clinical Trial Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.|Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
authors.forename: Gajin
authors.initials: G
authors.lastname: Han
authors.affiliation: Department of Biomedical Engineering, Kyung Hee University, Yongin, Gyeonggi, South Korea.
authors.forename: Seulgi
authors.initials: S
authors.lastname: Eun
authors.affiliation: Department of Biomedical Engineering, Kyung Hee University, Yongin, Gyeonggi, South Korea.|Systems and Biomedical Engineering Department, Faculty of Engineering, Cairo University, Giza, Egypt.
authors.forename: Meena M
authors.initials: MM
authors.lastname: Makary
authors.affiliation: Department of Biomedical Engineering, Kyung Hee University, Yongin, Gyeonggi, South Korea.
authors.forename: Kyungmo
authors.initials: K
authors.lastname: Park
authors.affiliation: Korean Medicine Clinical Trial Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea. ssljh@hanmail.net.|Department of Sasang Constitutional Medicine, College of Korean Medicine, Kyung Hee University, Seoul, South Korea. ssljh@hanmail.net.
authors.forename: Junhee
authors.initials: J
authors.lastname: Lee
authors.affiliation: Korean Medicine Clinical Trial Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea. shlee777@khu.ac.kr.|Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. shlee777@khu.ac.kr.
authors.forename: Sanghoon
authors.initials: S
authors.lastname: Lee
mesh_terms: D015670:Acupuncture Therapy / Q000295:instrumentation*; D000328:Adult; D002985:Clinical Protocols; D006801:Humans; D008875:Middle Aged; D009339:Needles; D011446:Prospective Studies; D055815:Young Adult
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