Validation of a Newly Developed Sham Press Needle

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation of a Newly Developed Sham Press Needle

Conditions
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Healthy

Intervention / Treatment
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* Device: Ring Sham (RS)
* Device: Real Needle (RN)
* Device: Kim Sham (KS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sham Press Needle - Ring Sham (RS)<br>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)<br> <br> |
| Active Comparator: Real Needle (RN)<br>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)<br> <br> |
| Sham Comparator: Kim Sham (KS)<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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