Healthy Participants Clinical Trial
Official title:
Study on Improving Acupuncture Needles and Physical Properties of Acupoints With Supercritical Fluid
Verified date | July 2018 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: To compare the differences in the needling sensation with acupuncture needles
surface treated with nitrogen applied supercritical fluid (SCF-N) and stainless steel
needles.
Materials and Methods: This was a double-blind prospective cohort study. The acupuncture
needles were randomly used in this experiment, including the SCF-N-treated needles and the
control stainless steel needles. LI 4 (Hegu) and LI 11 (Quchi) acupuncture points in the
Yangming Large Intestine Meridian of Hand were treated. Physical electrical resistance ,
scanning electron microscopy, energy dispersive spectrometry, and visual analog scale score
including the sensations of soreness, numbness, distention, and heaviness were assessed.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteer aged 20 to 40 years - Provided informed consent Exclusion Criteria: - Women with pregnancy or breast feeding - Bleeding tendencies (platelet counts less than 20000 and/or thrombocytopenic purpura) - Volunteers with chronic medical conditions and anti-coagulants use - Volunteers with pacemakers - Fasting - Unwilling to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resistance of the meridian | Electrical resistance was measured by applying a fixed electric current (110 µA) for 1 second and recording the I-V curve. A linear relationship of voltage=current x resistance was expected. The analyzer used in this experiment was Agilent B1500, a semi-conductor analyzer able to measure electrical resistance with high accuracy. | immediately after acupuncture needling | |
Secondary | Modified Visual Analog Scale (VAS) Score | The VAS score was used to assess the needling sensations of de-qi, i.e. distension, soreness, heaviness, or numbness. VAS score 0 indicated no sensation, while VAS 10 indicated the strongest sensation. | immediately after acupuncture needling |
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