Validation of a Newly Developed Sham Press Needle

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Ring Sham (RS); Device: Kim Sham (KS); Device: Real Needle (RN)

• Registration Number: NCT03157024
• Lead Sponsor: Kyunghee University

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.

Study Timeline

• Study Start: 2016-04-04
• Primary Completion: 2016-06-02
• Study Completion: 2016-06-02
• Status Verified: 2017-05
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Press Needle - Ring Sham (RS)	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.
Kim Sham (KS)	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.
Real Needle (RN)	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.

Primary Outcome Measures

Name	Time	Method
Blinding property	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

Name	Time	Method
Adhesive power	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).
Acupuncture sensation measured by De-qi questionnaire	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.
Blinding property	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.

Trial Locations

Locations (1)

Acupuncture & Meridian Science Research Centre, Kyung Hee University; 🇰🇷 Seoul, Korea, Republic of