Clinical trial NCT03157024: Validation of a Newly Developed Sham Press Needle
Official title: Validation of a Newly Developed Sham Press Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Kyunghee University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2017-05-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a single blind randomised controlled trial involving healthy volunteers to determine feasibility and blinding property of two types of sham press needles.

Detailed description: A total of 84 healthy volunteers will be recruited and randomly allocated to receive real needles (RN), previously validated Kim Sham needles (KS), or newly developed Ring Sham needles (RS) at a 1:1:1 ratio. Acupuncture sensation, blinding, and feasibility in a future clinical trial will be measured along with other physiological measurements including tactile sensitivity, interoceptive sensitivity, and electrodermal activity.

Eligibility criteria: Inclusion Criteria:

* age over 18
* not participating in other clinical studies at the time of study participation
* voluntary participation

Exclusion Criteria:

* not satisfying the inclusion criteria
* pregnancy or breast-feeding at the time of study participation
* open sores or skin diseases on the non-dominant elbow or ear where needles would be placed
* having taken analgesics in 24 hours before participation
* any other diseases or conditions that might prevent the participant from receiving acupuncture

Primary outcomes:
measure: Blinding property
timeFrame: After needling on the 1st day visit
Secondary outcomes:
measure: Adhesive power
timeFrame: On the next day visit (1 day after needling)
measure: Acupuncture sensation measured by De-qi questionnaire
timeFrame: After needling on the 1st day visit
measure: Acupuncture sensation measured by De-qi questionnaire
timeFrame: After needle removal on the next day visit (1 day after needling)
measure: Blinding property
timeFrame: After needle removal on the next day visit (1 day after needling)
Other outcomes:
measure: Acupuncture Belief Scale (ABS)
timeFrame: After needling on the 1st day visit
measure: Tactile sensitivity
timeFrame: On the 1st day visit
measure: Interoceptive sensitivity
timeFrame: On the 1st day visit
measure: Electrodermal activity (EDA)
timeFrame: On the 1st day visit
measure: Acupuncture credibility
timeFrame: After needle removal on the next day visit (1 day after needling)
Locations:
city: Seoul
country: Korea, Republic of
facility: Acupuncture & Meridian Science Research Centre, Kyung Hee University
Study officials:
affiliation: Kyunghee University
name: Hi-Joon Park, KMD, PhD
role: STUDY_DIRECTOR
References:
citation: Kim S. Creating an instrument for a successful double-blind acupuncture placebo. J Acupunct Meridian Stud. 2008 Sep;1(1):36-41. doi: 10.1016/S2005-2901(09)60005-4. Epub 2009 Mar 24.
citation: Lee H, Bang H, Kim Y, Park J, Lee S, Lee H, Park HJ. Non-penetrating sham needle, is it an adequate sham control in acupuncture research? Complement Ther Med. 2011 Jan;19 Suppl 1:S41-8. doi: 10.1016/j.ctim.2010.12.002. Epub 2010 Dec 23.
citation: Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.
citation: Moroz A, Freed B, Tiedemann L, Bang H, Howell M, Park JJ. Blinding measured: a systematic review of randomized controlled trials of acupuncture. Evid Based Complement Alternat Med. 2013;2013:708251. doi: 10.1155/2013/708251. Epub 2013 Mar 3.
citation: Kim Y, Park J, Lee H, Bang H, Park HJ. Content validity of an acupuncture sensation questionnaire. J Altern Complement Med. 2008 Oct;14(8):957-63. doi: 10.1089/acm.2007.0565.
citation: Kim S, Lee S, Choi S, Park J, Kim S. Discrimination accuracy between real and sham press needles in the hands. Acupunct Med. 2015 Aug;33(4):293-8. doi: 10.1136/acupmed-2014-010678. Epub 2015 Jun 4.
citation: Wang SM, Maranets I, Weinberg ME, Caldwell-Andrews AA, Kain ZN. Parental auricular acupuncture as an adjunct for parental presence during induction of anesthesia. Anesthesiology. 2004 Jun;100(6):1399-404. doi: 10.1097/00000542-200406000-00011.
citation: Wang SM, Dezinno P, Lin EC, Lin H, Yue JJ, Berman MR, Braveman F, Kain ZN. Auricular acupuncture as a treatment for pregnant women who have low back and posterior pelvic pain: a pilot study. Am J Obstet Gynecol. 2009 Sep;201(3):271.e1-9. doi: 10.1016/j.ajog.2009.04.028. Epub 2009 Jun 26.
citation: Schandry R. Heart beat perception and emotional experience. Psychophysiology. 1981 Jul;18(4):483-8. doi: 10.1111/j.1469-8986.1981.tb02486.x. No abstract available.
citation: Vincent C, Lewith G. Placebo controls for acupuncture studies. J R Soc Med. 1995 Apr;88(4):199-202.