Validation of a Newly Developed Sham Press Needle

NCT03157024 | Completed

• 1 other identifier: KHSIRB-16-009
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Blinding property

  Blinding property will be evaluated: the participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of real, sham, or don't know.

  After needling on the 1st day visit

Secondary Outcomes (4)

• Adhesive power

  On the next day visit (1 day after needling)

• Acupuncture sensation measured by De-qi questionnaire

  After needling on the 1st day visit

• Acupuncture sensation measured by De-qi questionnaire

  After needle removal on the next day visit (1 day after needling)

• Blinding property

  After needle removal on the next day visit (1 day after needling)

Other Outcomes (5)

• Acupuncture Belief Scale (ABS)

  After needling on the 1st day visit

• Tactile sensitivity

  On the 1st day visit

• Interoceptive sensitivity

  On the 1st day visit

Study Arms (3)

Sham Press Needle - Ring Sham (RS)

EXPERIMENTAL

A sterilised stainless steel press needle that only has the ring-shaped head of needle without needle body has three layers of adhesive tape. Between the first and second layer is the head of needle to support needle body while maintaining identical appearance and the third layer is attached to skin. RS will be placed on 1 cm medial to acupoint LI11 and ear wrist, a non-specific control auricular acupoint used in the previous literature of the non-dominant side. An acupoint detector (personal TENS electronic acupuncture, Hammtek Korea, Seoul, Korea) will be used to locate points with lower skin impedance than those nearby.

Device: Ring Sham (RS)

Real Needle (RN)

ACTIVE COMPARATOR

A sterilised stainless steel press needle (diameter 0.18 mm X length 1.5 mm, Dongbang Acupuncture Inc., Boryeong, Chungcheongnam-do, Korea) has three layers of adhesive tape. Between the first and second layer is the head of needle to support needle body and the third layer is attached to skin. RN will be placed on acupoint LI11 and ear shenmen of the non-dominant side. An acupoint detector (personal TENS electronic acupuncture, Hammtek Korea, Seoul, Korea) will be used to locate points with lower skin impedance than those nearby.

Device: Real Needle (RN)

Kim Sham (KS)

SHAM COMPARATOR

A sterilised stainless steel press needle (diameter 0.18 mm X length 1.5 mm, Dongbang Acupuncture Inc., Boryeong, Chungcheongnam-do, Korea) with a blunted tip has three layers of adhesive tape. Between the first and second layer is the head of needle to support needle body while maintaining identical appearance and the third layer is attached to skin. KS will be placed on 1 cm medial to acupoint LI11 and ear wrist, a non-specific control auricular acupoint used in the previous literature of the non-dominant side. An acupoint detector (personal TENS electronic acupuncture, Hammtek Korea, Seoul, Korea) will be used to locate points with lower skin impedance than those nearby.

Device: Kim Sham (KS)

Interventions

Ring Sham (RS) DEVICE

Sham Press Needle - Ring Sham (RS)

Real Needle (RN) DEVICE

Real Needle (RN)

Kim Sham (KS) DEVICE

Kim Sham (KS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Acupuncture & Meridian Science Research Centre, Kyung Hee University

Seoul, 02447, South Korea

Location

Related Publications (10)

• 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.

  PMID: 20633453 BACKGROUND

• 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.

  PMID: 21195294 BACKGROUND

• 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.

  PMID: 15020033 BACKGROUND

• 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.

  PMID: 23533515 BACKGROUND

• 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.

  PMID: 18925869 BACKGROUND

• 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.

  PMID: 26044714 BACKGROUND

• 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.

  PMID: 15166558 BACKGROUND

• 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.

  PMID: 19560110 BACKGROUND

• 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.

  PMID: 7267933 BACKGROUND

• Vincent C, Lewith G. Placebo controls for acupuncture studies. J R Soc Med. 1995 Apr;88(4):199-202.

  PMID: 7745565 BACKGROUND

Study Officials

• Hi-Joon Park, KMD, PhD

  Kyunghee University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: April 4, 2016
• Primary Completion: June 2, 2016
• Study Completion: June 2, 2016
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)