Validation of a Newly Developed Sham Press Needle

Kyung Hee University

Status: Completed

Conditions: Healthy

Treatments: Device: Ring Sham (RS); Device: Kim Sham (KS); Device: Real Needle (RN)

Study type: Interventional

Funder types: Other

Identifiers

NCT03157024

KHSIRB-16-009

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 3 patient groups

Sham Press Needle - Ring Sham (RS)

Experimental group

Description:

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.

Treatment:

Device: Ring Sham (RS)

Real Needle (RN)

Active Comparator group

Description:

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.

Treatment:

Device: Real Needle (RN)

Kim Sham (KS)

Sham Comparator group

Description:

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.

Treatment:

Device: Kim Sham (KS)