Validation of a Newly Developed Sham Press Needle

• ClinicalTrials.gov Identifier: NCT03157024
• Recruitment Status: Completed
• First Posted: May 17, 2017
• Last Update Posted: May 17, 2017
• Sponsor: Kyunghee University
• Collaborator: National Research Foundation of Korea
• Information provided by (Responsible Party): Hyangsook Lee, KMD, PhD, Kyunghee University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Device: Ring Sham (RS); Device: Real Needle (RN); Device: Kim Sham (KS)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Device Feasibility
• Official Title: Validation of a Newly Developed Sham Press Needle
• Actual Study Start Date: April 4, 2016
• Actual Primary Completion Date: June 2, 2016
• Actual Study Completion Date: June 2, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sham Press Needle - Ring Sham (RS); 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)
Active Comparator: Real Needle (RN); 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)
Sham Comparator: Kim Sham (KS); 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)

Outcome Measures

Primary Outcome Measures :

1. Blinding property [ Time Frame: After needling on the 1st day visit ]
   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.

Secondary Outcome Measures :

1. Adhesive power [ Time Frame: On the next day visit (1 day after needling) ]
   It will be assessed whether sham press needle remains in place for at least 2 days (yes/no).
2. Acupuncture sensation measured by De-qi questionnaire [ Time Frame: After needling on the 1st day visit ]
   De-qi questionnaire (Kim et al.) will be used to evaluate acupuncture sensation.
3. Acupuncture sensation measured by De-qi questionnaire [ Time Frame: After needle removal on the next day visit (1 day after needling) ]
   De-qi questionnaire (Kim et al.) will be used to evaluate acupuncture sensation.
4. Blinding property [ Time Frame: After needle removal on the next day visit (1 day after needling) ]
   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.

Other Outcome Measures:

1. Acupuncture Belief Scale (ABS) [ Time Frame: After needling on the 1st day visit ]
   A Korean version of Acupuncture Belief Scale (ABS), a 36-item self-report on a 5-point Likert scale will be used to evaluate acupuncture experiences and beliefs.
2. Tactile sensitivity [ Time Frame: On the 1st day visit ]
   Tactile sensitivity will be measured using von Frey filament.
3. Interoceptive sensitivity [ Time Frame: On the 1st day visit ]
   Using a modified method by Schandry, the participants will be asked to count their own heartbeats with eyes closed during the three counting phases that vary in length randomly, i.e. 25, 35, and 45 seconds. Beginning and end of a phase will be given verbally by the experimenter. Information on the length of the three counting phases will not be open to participants. Heart rate will also be recorded and analysed by a computer-based data acquisition system (MP150 data acquisition system, version 4.3.0, Biopac® Systems, Inc., Goleta, CA, USA).
4. Electrodermal activity (EDA) [ Time Frame: On the 1st day visit ]
   EDA data will be obtained to evaluate autonomic response following acupuncture needling (MP150 data acquisition system, version 4.3.0, Biopac® Systems, Inc., Goleta, CA, USA).
5. Acupuncture credibility [ Time Frame: After needle removal on the next day visit (1 day after needling) ]
   Credibility of the acupuncture treatment will be evaluated using a credibility test by Vincent et al.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Korea, Republic of

Acupuncture & Meridian Science Research Centre, Kyung Hee University

Seoul, Korea, Republic of, 02447

Sponsors and Collaborators

Kyunghee University

National Research Foundation of Korea

Investigators

• Study Director: Hi-Joon Park, KMD, PhD; Kyunghee University

More Information

Publications:

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.

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.

Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56.

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.

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.

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.

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.

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.

Schandry R. Heart beat perception and emotional experience. Psychophysiology. 1981 Jul;18(4):483-8.

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

• Responsible Party: Hyangsook Lee, KMD, PhD, Professor, Kyunghee University
• ClinicalTrials.gov Identifier: NCT03157024
• Other Study ID Numbers: KHSIRB-16-009
• First Posted: May 17, 2017
• Last Update Posted: May 17, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No