Validation of a Newly Developed Sham Press Needle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Blinding property
研究概览
简要总结
This is a single blind randomised controlled trial involving healthy volunteers to determine feasibility and blinding property of two types of sham press needles.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 18
- •not participating in other clinical studies at the time of study participation
- •voluntary participation
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: Kim Sham (KS) (Device)
结局指标
主要结局
Blinding property
时间窗: 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.
次要结局
- 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)
研究者
Hyangsook Lee, KMD, PhD
Professor
Kyunghee University