Validation of a Newly Developed Sham Press Needle
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Blinding property
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Ring Sham (RS) (Device)
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.
Intervention: Real Needle (RN) (Device)
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.
Intervention: Kim Sham (KS) (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Adhesive power(On the next day visit (1 day after needling))
- 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))
- Acupuncture sensation measured by De-qi questionnaire(After needling on the 1st day visit)
Investigators
Hyangsook Lee, KMD, PhD
Professor
Kyunghee University