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Development and validity of new type sham acupuncture needle specialized for needling sensation

Development and validity of new type sham acupuncture needle specialized for needling sensation - Development and validity of new type sham acupuncture needle

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045923
Enrollment
64
Registered
2022-03-31
Start date
2021-10-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy condition

Interventions

Subjects put on an eye mask in sitting position, who place forearm on the table. Practitioner randomly perform Real and Sham acupuncture needle at four sites of bilateral LI4 and LI10 for a one subjec
length, 40 mm
SEIRIN Co., Shizuoka, Japan) were inserted perpendicularly to a depth of 15 mm under the skin surfaces with simple insertion technique (a certain depth and then withdrawn immediately). Subjects put on

Sponsors

Teikyo Heisei University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy person aged 16 and under 30 2) Those who can attend the study site within the study period 3) Persons who can get written consent for participation in this study

Exclusion criteria

Exclusion criteria: 1) Persons who go to the hospital or take medication for basic diseases (chronic respiratory diseases, heart diseases, kidney diseases, liver diseases, diabetes, blood diseases (hyponatremia, difficult-to-treat high blood pressure, etc.), immune function Decreasing illnesses (including malignant tumors), neurological disorders, neuromuscular disorders and severe mental illnesses) 2) Persons with extremely short sleep (less than 5 hours a day) and those with long sleep (10 hours or more a day) 3) Persons who complain of poor physical condition due to sleep disorders 4) Persons who have a habit of excessive smoking * 1 and excessive alcohol intake * 2, and those who have an extremely irregular diet * 3 5) Persons with significant abnormalities in blood pressure, blood test, urine test, etc. 6) Persons who have undergone major surgery on the digestive system such as gastrectomy, gastrointestinal suture, and intestinal resection 7) Those who donated 400 ml of blood within 12 weeks, 200 ml of blood within 4 weeks, and component blood within 2 weeks before the start of the experiment 8) Persons participating in other clinical trials <Notes> * 1 Excessive smoking generally means smoking 21 or more cigarettes a day. * 2 Excessive alcohol intake is roughly equivalent to 2 cups of sake per day (500 ml of beer bottle x 2 bottles, whiskey double 60 ml x 2 cups, 1 go of shochu 180 ml, 1 cup of red wine glass 60 ml x 7 cups) or more. Refers to drinking. * 3 Refers to a state in which one or more meals a day are one or more meals, and the meal time is constantly irregular.

Design outcomes

Primary

MeasureTime frame
In immediately after performed acupuncture, evaluation of the correctly or incorrectly of performed acupuncture needles are listen a 5-level scale of "Felt a real", "Maybe felt a real", "Didn't know", "Maybe felt a fake" and "Felt a fake".

Secondary

MeasureTime frame
Evaluation of skin penetration sensation: In immediately after performed acupuncture, evaluate the presence or absence of skin penetration sensation (the sensation of acupuncture penetrating the skin). Evaluation of de qi sensation: In immediately after performed acupuncture, evaluate the presence or absence of a de qi sensation in time of performing.

Countries

Japan

Contacts

Public ContactDaiyu Shinohara

Teikyo Heisei University Graduate School of Health Sciences

d.shinohara1@gmail.com080-5521-6516

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026