Healthy
Conditions
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.
Interventions
DEVICERing Sham (RS)
DEVICEReal Needle (RN)
DEVICEKim Sham (KS)
Sponsors
National Research Foundation of Korea
Kyunghee University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 needling on the 1st day visit | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acupuncture Belief Scale (ABS) | After needling on the 1st day visit | A Korean version of Acupuncture Belief Scale (ABS), a 36-item self-report on a 5-point Likert scale will be used to evaluate acupuncture experiences and beliefs. |
| Acupuncture credibility | After needle removal on the next day visit (1 day after needling) | Credibility of the acupuncture treatment will be evaluated using a credibility test by Vincent et al. |
| Tactile sensitivity | On the 1st day visit | Tactile sensitivity will be measured using von Frey filament. |
| Interoceptive sensitivity | On the 1st day visit | Using a modified method by Schandry, the participants will be asked to count their own heartbeats with eyes closed during the three counting phases that vary in length randomly, i.e. 25, 35, and 45 seconds. Beginning and end of a phase will be given verbally by the experimenter. Information on the length of the three counting phases will not be open to participants. Heart rate will also be recorded and analysed by a computer-based data acquisition system (MP150 data acquisition system, version 4.3.0, Biopac® Systems, Inc., Goleta, CA, USA). |
| Electrodermal activity (EDA) | On the 1st day visit | EDA data will be obtained to evaluate autonomic response following acupuncture needling (MP150 data acquisition system, version 4.3.0, Biopac® Systems, Inc., Goleta, CA, USA). |
Countries
South Korea
Outcome results
None listed